Studienzentrum
Willkommen auf den Seiten des klinischen Studienzentrums der Essener Universitäts-Hautklinik.
Das klinische Studienzentrum der Essener Universitäts-Hautklinik ermöglicht qualitativ hochwertige klinische Forschung, die zur Einführung neuer Medikamente, Geräte, Diagnostika, Therapieverfahren oder zu epidemiologischen und sozioökonomischen Fragestellungen beitragen. Durch unsere Arbeit wollen wir die Qualität von klinischen Studien fördern und verbessern. Dies erreichen wir durch qualifiziert ausgebildetes Personal, das sich um die Belange der Studienpatienten kümmert. Unser Ziel ist, den Patienten einen Zugang zu neuartigen Therapien und innovativen Forschungsmöglichkeiten zu bieten.Wir sind erfahren in Planung, Organisation und Management pharmazeutischer Phase I, II, III und IV-Studien in den unterschiedlichsten therapeutischen Bereichen der Dermatologie. Ergänzend können wir diagnostische Untersuchungen zur Therapie- und Sicherheitskontrolle während des Studienverlaufs anbieten. Alle Studien werden gemäß der aktuell gültigen GCP (Good Clinical Practice)-Guidelines durchgeführt.
Unser klinisches Studienzentrum besteht aus 3 Bereichen. Der Studienambulanz für Studien aus dem Bereich der allgemeinen Dermatologie, der Dermatoonkologie und dem Spektrum der Dermatologie sowie aus einer Studienambulanz, die Studien zum Thema HIV/AIDS/Geschlechtserkrankungen durchführt.
Einrichtung
Die Studienambulanz steht allen Bereichen der Hautklinik der Universitätsklinik Essen zur Verfügung. Die Einrichtung ist…
Erfahrung in klinischen Studien
Unsere Klinik blickt auf eine jahrelange Erfahrung in der Durchführung von klinischen Studien und Anwendungsbeobachtungen…
Allgemeine Dermatologie-Studien
Studienzentrum allgemeine Dermatologie Wir freuen uns, Patienten im Studienzentrum „allgemeine Dermatologie“ einen möglichst frühzeitig einen…
Dermatoonkologische Studien
Dermatoonkologische Studienambulanz In unserer onkologischen Studienambulanz werden zahlreiche multizentrische klinische Studien zur adjuvanten und palliativen…
HIV/HPSTD Studien
HIV/HPSTD-Studienambulanz Sehr geehrter Websitebesucher,in der HIV Ambulanz der Universitätshautklinik Essen bieten wir viele klinische Studien…
Klinische Studien des Wundzentrums -Bereich Dermatologie
Neben der bestmöglichen Diagnostik und Therapie wie diese von Fachgesellschaften und aktuellen Leitlinien empfohlen wird,…
Prof. Dr. med.
Lisa Zimmer
Leitende Oberärztin,
Fachärztin für Haut- und Geschlechtskrankheiten,
Zusatzbezeichnung: Medikamentöse Tumortherapie
PD Dr. med.
Wiebke Sondermann
Leitende Oberärztin,
Fachärztin für Haut- und Geschlechtskrankheiten
Prof. Dr. med.
Elisabeth Livingstone
Oberärztin,
Fachärztin für Haut- und Geschlechtskrankheiten,
Zusatzbezeichnung: Medikamentöse Tumortherapie
Prof. Dr. med.
Stefan Esser
Leitender Oberarzt,
Facharzt für Haut- und Geschlechtskrankheiten, Infektiologe
Zusatzbezeichnung: Allergologie
Prof. Dr. med.
Joachim Dissemond
Oberarzt,
Facharzt für Haut- und Geschlechtskrankheiten,
Zusatzbezeichnung: Allergologie, Sportmedizin
NeuroID
Psychoonkologische Wirksamkeit einer EEG Neurofeedback-Intervention bei Menschen mit malignem Melanom
Berufsordnung (BO) / Interventionell
Im Rahmen dieser Studie wurden psychoonkologische Patient*innen nach einer fünfwöchigen Warteliste randomisiert einer von zwei Interventionsbedingungen (Neurofeedback vs. Achtsamkeit) zugeteilt. Fragebogenerhebungen sowie EEG-Untersuchungen wurden vor der Warteliste, vor und nach der fünfwöchigen Intervention, sowie bei einem Follow-Up nach weiteren fünf Wochen durchgeführt.
Zurück
NeuroID
Studieninformationen
Studien-Code
UME-ID-8079
UME-ID-8079
Studien-Akronym
NeuroID
NeuroID
Studientitel
Psychoonkologische Wirksamkeit einer EEG Neurofeedback-Intervention bei Menschen mit malignem Melanom
Psychoonkologische Wirksamkeit einer EEG Neurofeedback-Intervention bei Menschen mit malignem Melanom
Kurzbeschreibung
Im Rahmen dieser Studie wurden psychoonkologische Patient*innen nach einer fünfwöchigen Warteliste randomisiert einer von zwei Interventionsbedingungen (Neurofeedback vs. Achtsamkeit) zugeteilt. Fragebogenerhebungen sowie EEG-Untersuchungen wurden vor der Warteliste, vor und nach der fünfwöchigen Intervention, sowie bei einem Follow-Up nach weiteren fünf Wochen durchgeführt.
Im Rahmen dieser Studie wurden psychoonkologische Patient*innen nach einer fünfwöchigen Warteliste randomisiert einer von zwei Interventionsbedingungen (Neurofeedback vs. Achtsamkeit) zugeteilt. Fragebogenerhebungen sowie EEG-Untersuchungen wurden vor der Warteliste, vor und nach der fünfwöchigen Intervention, sowie bei einem Follow-Up nach weiteren fünf Wochen durchgeführt.
Aktueller Studienstatus
Geschlossen
Geschlossen
Studie aktiv in den Jahren
2021,2023
2021,2023
Beteiligte
Institute
Klinik für Dermatologie, LVR Kliniken-Essen - Klinik für Psychosomatische Medizin und Psychotherapie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, LVR Kliniken-Essen - Klinik für Psychosomatische Medizin und Psychotherapie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Frau Madeleine Fink
+49 (0)201 7227-208
Madeleine.fink@uni-due.de
Virchowstr 174
45147 Essen
Studiendesign
Indikation
Melanom
Melanom
Medizinischer Befund
malignes Melanom
malignes Melanom
ENCORAFENIB t BINIMETINIB
Encorafenib plus binimetinib in patients with locally advanced, unresectable or metastatic BRAFV600-mutated melanoma: a multi-centric, multi-national, prospective, longitudinal, non-interventional study in Germany and Austria
Berufsordnung (BO) / Nicht-interventionell
Zurück
ENCORAFENIB t BINIMETINIB
Studieninformationen
Studien-Code
UME-ID-8771
UME-ID-8771
Studien-Akronym
ENCORAFENIB t BINIMETINIB
ENCORAFENIB t BINIMETINIB
Studientitel
Encorafenib plus binimetinib in patients with locally advanced, unresectable or metastatic BRAFV600-mutated melanoma: a multi-centric, multi-national, prospective, longitudinal, non-interventional study in Germany and Austria
Encorafenib plus binimetinib in patients with locally advanced, unresectable or metastatic BRAFV600-mutated melanoma: a multi-centric, multi-national, prospective, longitudinal, non-interventional study in Germany and Austria
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2020,2021,2022
2020,2021,2022
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
Alcedis GmbH, Giessen
Studiendesign
Indikation
Melanom
Melanom
Medizinischer Befund
melanoma
melanoma
IRINA
Influence of timing of Radiotherapy on Immune respoNse to checkpoint blocker treatment in patients with metastasized melanomA
Berufsordnung (BO) / Nicht-interventionell
Zurück
IRINA
Studieninformationen
Studien-Code
UME-ID-10396
UME-ID-10396
Studien-Akronym
IRINA
IRINA
Studientitel
Influence of timing of Radiotherapy on Immune respoNse to checkpoint blocker treatment in patients with metastasized melanomA
Influence of timing of Radiotherapy on Immune respoNse to checkpoint blocker treatment in patients with metastasized melanomA
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2021,2023
2021,2023
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
Universitätsklinik Essen (AöR)
+49 (0)201 723-0
info@uk-essen.de
Hufelandstraße 55
45147 Essen
Studiendesign
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Melanoma
Melanoma
R3767-ONC-2055
A Phase 3 Trial of Fianlimab (Anti-Lag-3) and Cemiplimab versus Pembrolizumab in the adjuvant setting in patients with completely resected High-Risk-Melanoma
Clinical Trial Regulation (CTR) / Interventionell
Zurück
R3767-ONC-2055
Studieninformationen
Studien-Code
UME-ID-11266
UME-ID-11266
Studien-Akronym
R3767-ONC-2055
R3767-ONC-2055
Studientitel
A Phase 3 Trial of Fianlimab (Anti-Lag-3) and Cemiplimab versus Pembrolizumab in the adjuvant setting in patients with completely resected High-Risk-Melanoma
A Phase 3 Trial of Fianlimab (Anti-Lag-3) and Cemiplimab versus Pembrolizumab in the adjuvant setting in patients with completely resected High-Risk-Melanoma
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2023,2024
2023,2024
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
Regeneron Pharmaceuticals, Inc, USA
Studiendesign
randomisiert, doppelt verblindet
randomisiert, doppelt verblindet
Einschlusskriterien
- All patients must be either stage IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
- Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
- All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol
Note: Other Protocol Defined Inclusion Criteria Apply
- All patients must be either stage IIC, III, or stage IV per American Joint Committee on Cancer (AJCC) 8th edition and have histologically confirmed melanoma that is completely surgically resected in order to be eligible as defined by the protocol
- Complete surgical resection must be performed within 12 weeks prior to randomization, and enrollment may occur only after satisfactory wound healing from the surgery
- All patients must have disease-free status documented by a complete physical examination and imaging studies within 4 weeks prior to randomization, as described in the protocol
Note: Other Protocol Defined Inclusion Criteria Apply
Ausschlusskriterien
- Uveal melanoma
- Any evidence of residual disease after surgery by imaging, pathology, or cytology.
- Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required systemic treatment with immunosuppressive agents
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
- Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
- Adolescent patients (=12 to <18 years old) with body weight <40 kg
Note: Other Protocol Defined Exclusion Criteria Apply
- Uveal melanoma
- Any evidence of residual disease after surgery by imaging, pathology, or cytology.
- Ongoing or recent (within 2 years) evidence of clinically significant autoimmune disease that required systemic treatment with immunosuppressive agents
- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol
- Another malignancy that is currently progressing or that required active treatment in the past 5 years, as described in the protocol
- Adolescent patients (=12 to <18 years old) with body weight <40 kg
Note: Other Protocol Defined Exclusion Criteria Apply
Studienteilnehmende Mindestalter
12 Jahr(e)
12 Jahr(e)
Geschlecht
Männlich, Weiblich
Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Melanoma
Melanoma
IMCgp100-203
EudraCT-Nummer: 2022-502732-39-00
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
Zurück
IMCgp100-203
Studieninformationen
Studien-Code
UME-ID-11435
UME-ID-11435
Studien-Akronym
IMCgp100-203
IMCgp100-203
Studientitel
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)
Phase 2/3 Randomized Study of Tebentafusp as Monotherapy and in Combination With Pembrolizumab Versus Investigator's Choice in HLA-A*02:01-positive Participants With Previously Treated Advanced Melanoma (TEBE-AM)
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024
EudraCT-Nummer: 2022-502732-39-00 2024
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
Immunocore Limited, UK
Studiendesign
randomisiert, offen, Multizentrisch, International
randomisiert, offen, Multizentrisch, International
Einschlusskriterien
- HLA-A*02:01-positive.
- unresectable Stage III or Stage IV non-ocular melanoma
- archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
- measurable or non-measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- If applicable, must agree to use highly effective contraception
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
- HLA-A*02:01-positive.
- unresectable Stage III or Stage IV non-ocular melanoma
- archival tumor tissue sample or a newly obtained biopsy of a tumor lesion not previously irradiated has been provided.
- measurable or non-measurable disease per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- If applicable, must agree to use highly effective contraception
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent (ICF) and protocol
Ausschlusskriterien
- Pregnant or lactating women
- diagnosis of ocular or metastatic uveal melanoma
- history of a malignant disease other than those being treated in this study
- ineligible to be retreated with pembrolizumab due to a treatment-related AE
- known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
- previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
-active autoimmune disease requiring immunosuppressive treatment
- clinically significant medical condition
- known psychiatric or substance abuse disorders
- received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication
- received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
- received cellular therapies within 90 days of first dose
- received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose
- have not progressed on treatment with an anti-PD(L)1 mAb
- have not received prior ipilimumab
- a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
- currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose
- known history of chronic viral infections
- Out of range Laboratory values
- history of allogenic tissue/solid organ transplant
- Pregnant or lactating women
- diagnosis of ocular or metastatic uveal melanoma
- history of a malignant disease other than those being treated in this study
- ineligible to be retreated with pembrolizumab due to a treatment-related AE
- known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
- previous severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb)
-active autoimmune disease requiring immunosuppressive treatment
- clinically significant medical condition
- known psychiatric or substance abuse disorders
- received prior treatment with a licensed or investigative Immune-mobilizing monoclonal T-cell receptor Against Cancer (ImmTAC) medication
- received chemotherapy or biological cancer therapy (excluding anti-PD(L)1 mAb, ipilimumab, and BRAF TKI regimen) within 14 days of first dose
- received cellular therapies within 90 days of first dose
- received systemic treatment with steroids or any other immunosuppressive drug within 2 weeks of first dose
- have not progressed on treatment with an anti-PD(L)1 mAb
- have not received prior ipilimumab
- a BRAF V600 mutation, who have not received a prior BRAF/MEK TKI regimen
- currently participating or have participated in a study of an investigational agent or using an investigational device within 30 days of the first dose
- known history of chronic viral infections
- Out of range Laboratory values
- history of allogenic tissue/solid organ transplant
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Advanced Melanoma
Advanced Melanoma
IMA402-101
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-tumor Activity of IMA402, a Bispecific T Cell Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
Zurück
IMA402-101
Studieninformationen
Studien-Code
UME-ID-11436
UME-ID-11436
Studien-Akronym
IMA402-101
IMA402-101
Studientitel
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-tumor Activity of IMA402, a Bispecific T Cell Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Initial Anti-tumor Activity of IMA402, a Bispecific T Cell Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients With Recurrent and/or Refractory Solid Tumors
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2023,2024
2023,2024
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
immatics biotechnologies GmbH, Tübingen
Studiendesign
Multizentrisch, National
Multizentrisch, National
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Refractory Cancer\nRecurrent Cancer\nSolid Tumor, Adult\nCancer
Refractory Cancer\nRecurrent Cancer\nSolid Tumor, Adult\nCancer
PH-L19IL2TNFNMSC-04/19
A phase II study of intratumoral administration of L19IL2/L19TNF in non-melanoma skin cancer patients with presence of injectable lesions.
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
Intratumoral administration of L19IL2/L19TNF in non-melanoma skin cancer patients
EudraCT-Nummer: 2020-003299-42
Zurück
PH-L19IL2TNFNMSC-04/19
Studieninformationen
Studien-Code
UME-ID-11434
UME-ID-11434
Studien-Akronym
PH-L19IL2TNFNMSC-04/19
PH-L19IL2TNFNMSC-04/19
Studientitel
A phase II study of intratumoral administration of L19IL2/L19TNF in non-melanoma skin cancer patients with presence of injectable lesions.
A phase II study of intratumoral administration of L19IL2/L19TNF in non-melanoma skin cancer patients with presence of injectable lesions.
Kurzbeschreibung
Intratumoral administration of L19IL2/L19TNF in non-melanoma skin cancer patients
Intratumoral administration of L19IL2/L19TNF in non-melanoma skin cancer patients
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2023
EudraCT-Nummer: 2020-003299-42 2023
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
Philogen S.p.A, Italien
Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
Einschlusskriterien
- Patients with high-risk, locally advanced (non-metastatic, node negative, single or multifocal), BCC or cSCC amenable to intratumoral injection, not eligible to surgery according to the evaluation of a local interdisciplinary tumor board or who refuse surgery and for whom an histological evaluation is available according to international guidelines.
- Patients with injectable and measurable regional cutaneous or subcutaneous in-transit or satellite metastasis but without regional nodal involvement are also eligible.
- Male or female patients, age 18 - 100 years.
- ECOG Performance Status/WHO Performance Status ≤ 1.
- Hemoglobin > 10.0 g/dL.
- Platelets > 100 x 109/L.
- ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).
- Serum creatinine 60 mL/min.
- All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.
- Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomised partner.
- Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
- Patients with high-risk, locally advanced (non-metastatic, node negative, single or multifocal), BCC or cSCC amenable to intratumoral injection, not eligible to surgery according to the evaluation of a local interdisciplinary tumor board or who refuse surgery and for whom an histological evaluation is available according to international guidelines.
- Patients with injectable and measurable regional cutaneous or subcutaneous in-transit or satellite metastasis but without regional nodal involvement are also eligible.
- Male or female patients, age 18 - 100 years.
- ECOG Performance Status/WHO Performance Status ≤ 1.
- Hemoglobin > 10.0 g/dL.
- Platelets > 100 x 109/L.
- ALT and AST, GGT and Lipase ≤ 1.5 x the upper limit of normal (ULN).
- Serum creatinine 60 mL/min.
- All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v. 5.0) Grade ≤ 1 unless otherwise specified.
- Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening. WOCBP must be using, from screening to three months following the last study drug administration, highly effective contraception methods, as defined by the "Recommendations for contraception and pregnancy testing in clinical trials" issued by the Head of Medicine Agencies' Clinical Trial Facilitation Group and which include, for instance, progesterone-only or combined (estrogen- and progesterone-containing) hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone-releasing systems, bilateral tubal occlusion, vasectomised partner.
- Male patients with WOCBP partners must agree to use simultaneously two acceptable methods of contraception (i.e. spermicidal gel plus condom) from the screening to three months following the last study drug administration.
- Willingness and ability to comply with the scheduled visits, treatment plan, laboratory tests and other study procedures.
Ausschlusskriterien
- Previous or concurrent cancer type that is distinct from the cancers being evaluated in this study, except any cancer curatively treated more than 2 years prior to study entry.
- Patients may have previously received topical or systemic chemotherapy, immunotherapy or radiation therapy on the tumor sites. Such therapies must be completed at least 4 weeks prior to study drug administration.
- Patients with node positive BCC/cSCC who are candidate to SHH inhibitor or checkpoint inhibitor therapy.
- Presence of active severe bacterial or viral infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. In particular a documented test for HIV, HBV and HCV excluding active infection is needed.
- History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).
- Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
- Known arterial aneurysms.
- INR > 3.
- Uncontrolled hypertension.
- Known uncontrolled coagulopathy or bleeding disorder.
- Known hepatic cirrhosis or severe pre-existing hepatic impairment.
- Moderate to severe respiratory failure.
- Active autoimmune disease.
- Patient requires or is taking systemic corticosteroids (>5 mg/day) or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma/COPD is not considered an exclusion criterion.
- Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies.
- Pregnancy or breast-feeding.
- Ischemic peripheral vascular disease (Grade IIb-IV).
- Severe diabetic retinopathy.
- Recovery from major trauma including surgery within 4 weeks prior to enrollment.
- Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.
- Any conditions that in the opinion of the investigator could hamper compliance with the study protocol
- Previous or concurrent cancer type that is distinct from the cancers being evaluated in this study, except any cancer curatively treated more than 2 years prior to study entry.
- Patients may have previously received topical or systemic chemotherapy, immunotherapy or radiation therapy on the tumor sites. Such therapies must be completed at least 4 weeks prior to study drug administration.
- Patients with node positive BCC/cSCC who are candidate to SHH inhibitor or checkpoint inhibitor therapy.
- Presence of active severe bacterial or viral infections or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study. In particular a documented test for HIV, HBV and HCV excluding active infection is needed.
- History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris, inadequately treated cardiac arrhythmias and heart insufficiency (any grade, New York Heart Association (NYHA) criteria).
- Any abnormalities observed during baseline ECG investigations that are considered clinically significant by the investigator.
- Known arterial aneurysms.
- INR > 3.
- Uncontrolled hypertension.
- Known uncontrolled coagulopathy or bleeding disorder.
- Known hepatic cirrhosis or severe pre-existing hepatic impairment.
- Moderate to severe respiratory failure.
- Active autoimmune disease.
- Patient requires or is taking systemic corticosteroids (>5 mg/day) or other immunosuppressant drugs on a long-term basis. Limited use of corticosteroids to treat or prevent acute hypersensitivity reactions and asthma/COPD is not considered an exclusion criterion.
- Known history of allergy to IL2, TNF, or other human proteins/peptides/antibodies.
- Pregnancy or breast-feeding.
- Ischemic peripheral vascular disease (Grade IIb-IV).
- Severe diabetic retinopathy.
- Recovery from major trauma including surgery within 4 weeks prior to enrollment.
- Solid organ transplant recipient or patient with iatrogenic or pathologic severe immune suppression.
- Any conditions that in the opinion of the investigator could hamper compliance with the study protocol
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Männlich, Weiblich
Indikation
BCC - Basalzellkarzinom
BCC - Basalzellkarzinom
Medizinischer Befund
Patients with high-risk, locally advanced (non-metastatic, node negative, single or multifocal), basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC) amenable to intratumoral injection, not eligible to surgery according to the evaluation of a local interdisciplinary tumor board or who refuse surgery and for whom an histological evaluation is available according to international guidelines
Patients with high-risk, locally advanced (non-metastatic, node negative, single or multifocal), basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC) amenable to intratumoral injection, not eligible to surgery according to the evaluation of a local interdisciplinary tumor board or who refuse surgery and for whom an histological evaluation is available according to international guidelines
MedDRA Term
Basal cell carcinoma
Basal cell carcinoma
ARCHITECT
Non-Interventionelle ADOREG Registerstudie zur Charakterisierung einer Kombination aus Immuntherapie und Elektrochemotherapie beim malignen Melanom
Berufsordnung (BO) / Nicht-interventionell
Zurück
ARCHITECT
Studieninformationen
Studien-Code
UME-ID-11475
UME-ID-11475
Studien-Akronym
ARCHITECT
ARCHITECT
Studientitel
Non-Interventionelle ADOREG Registerstudie zur Charakterisierung einer Kombination aus Immuntherapie und Elektrochemotherapie beim malignen Melanom
Non-Interventionelle ADOREG Registerstudie zur Charakterisierung einer Kombination aus Immuntherapie und Elektrochemotherapie beim malignen Melanom
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2015,2016,2017,2018,2019,2021,2022,2023
2015,2016,2017,2018,2019,2021,2022,2023
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Selma Ugurel
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Studiendesign
Registerstudie
Registerstudie
Indikation
Melanom
Melanom
Medizinischer Befund
maligne Melanome
maligne Melanome
IOB-032/PN-E40
Phase II, multi-cohort trial of neoadjuvant and post-surgery IO102-IO103 and pembrolizumab in patients with selected resectable tumors
Arzneimittelgesetz (AMG) / Phase 2, Interventionell, Multizentrisch
This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment. This proof-of-concept trial will include patients with resectable tumors in at least 2 indications.
Zurück
IOB-032/PN-E40
Studieninformationen
Studien-Code
UME-ID-11493
UME-ID-11493
Studien-Akronym
IOB-032/PN-E40
IOB-032/PN-E40
Studientitel
Phase II, multi-cohort trial of neoadjuvant and post-surgery IO102-IO103 and pembrolizumab in patients with selected resectable tumors
Phase II, multi-cohort trial of neoadjuvant and post-surgery IO102-IO103 and pembrolizumab in patients with selected resectable tumors
Kurzbeschreibung
This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment. This proof-of-concept trial will include patients with resectable tumors in at least 2 indications.
This is a multicenter, multi-arm trial evaluating anti-tumor activity, safety, and immune infiltration of IO102-IO103 in combination with pembrolizumab as neoadjuvant and adjuvant treatment. This proof-of-concept trial will include patients with resectable tumors in at least 2 indications.
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2023,2024
2023,2024
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Dirk Schadendorf
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstraße 55
45147 Essen
Sponsor
IO Biotech ApS, Dänemark
Studiendesign
nicht-randomisiert, offen, Multizentrisch
nicht-randomisiert, offen, Multizentrisch
Einschlusskriterien
- Measurable disease based on RECIST 1.1
- Candidate for surgical resection with curative intent
- Willing and able to provide written informed consent for the trial
- Age ≥18 years on the day of signing the informed consent form
- Willing for archival tissue to be submitted for analysis
- Willing to undergo tumor biopsies (core, punch, incisional or excisional) before and during trial treatment
- Willing to undergo dwMRI (if available)
- Willing to undergo PD-L1 status evaluation
- ECOG performance score status of 0 or 1
- Adequate organ function performed on screening labs obtained within 4 weeks before first dose.
- Women of childbearing potential: Negative urine or serum pregnancy within 72 hours prior to receiving the first dose of trial medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Women of childbearing potential: Willing to use highly effective contraception or abstain from heterosexual activity for the duration of the trial and for at least 120 days after the last dose of trial medication.
- Patients who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to start of trial intervention.
- Patients with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
- Measurable disease based on RECIST 1.1
- Candidate for surgical resection with curative intent
- Willing and able to provide written informed consent for the trial
- Age ≥18 years on the day of signing the informed consent form
- Willing for archival tissue to be submitted for analysis
- Willing to undergo tumor biopsies (core, punch, incisional or excisional) before and during trial treatment
- Willing to undergo dwMRI (if available)
- Willing to undergo PD-L1 status evaluation
- ECOG performance score status of 0 or 1
- Adequate organ function performed on screening labs obtained within 4 weeks before first dose.
- Women of childbearing potential: Negative urine or serum pregnancy within 72 hours prior to receiving the first dose of trial medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Women of childbearing potential: Willing to use highly effective contraception or abstain from heterosexual activity for the duration of the trial and for at least 120 days after the last dose of trial medication.
- Patients who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to start of trial intervention.
- Patients with a history of HCV infection are eligible if HCV viral load is undetectable at screening.
Ausschlusskriterien
- Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks of the first dose of trial treatment. Note: Patients who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Any prior treatment for the tumor under study
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137), and discontinued from that treatment due to a grade 3 or higher irAE
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial treatment. Note: Patients must have recovered from all AEs due to previous therapies (i.e., grade =1 at baseline). Patients with grade =2 neuropathy are eligible for the trial. Patients with endocrine-related AEs grade =2 requiring treatment or hormone replacement are also eligible. Note: If the patient has had major surgery, the patient must have recovered adequately from the procedure and/or complications from the surgery prior to starting trial treatment.
- Live or live-attenuated vaccine within 30 days prior to first dose of trial treatment. Note: Administration of inactivated vaccines, mRNA-based vaccines [e.g.,COVID-19] and vector-based vaccines are allowed.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of trial treatment. Patients who are currently receiving steroids at a dose equivalent to >10mg/day of hydrocortisone or >5mg/day of prednisone equivalent do not need to discontinue steroids prior to enrollment. Patients who require topical, ophthalmologic and inhalational steroids will not be excluded from the trial. Patients with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the trial.
- Active (i.e., symptomatic or growing) CNS metastases
- Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- History of an allogeneic tissue/solid organ transplant
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Patients with type I diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- History or current evidence of non-infectious pneumonitis/ interstitial lung disease that required steroids.
- Active infection requiring systemic therapy.
- History of HIV infection.
- Has known active HBV(defined as HBsAg reactive and/or detectable HBV DNA) or known active HCV(defined as anti HCV Ab positive and detectable HCV RNA [qualitative]) infection.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Psychiatric or substance abuse disorders that would interfere with the patient's ability to cooperate with the trial requirements.
- Severe hypersensitivity (grade =3) to pembrolizumab and/or any of its excipients.
- Women of childbearing potential:Pregnant or breastfeeding, or expecting to conceive a child within the projected duration of the trial, from time of informed consent until at least 120 days after the last dose of trial treatment.
- Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks of the first dose of trial treatment. Note: Patients who have entered the follow-up phase of an investigational trial may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Any prior treatment for the tumor under study
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX40, CD137), and discontinued from that treatment due to a grade 3 or higher irAE
- Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to first dose of trial treatment. Note: Patients must have recovered from all AEs due to previous therapies (i.e., grade =1 at baseline). Patients with grade =2 neuropathy are eligible for the trial. Patients with endocrine-related AEs grade =2 requiring treatment or hormone replacement are also eligible. Note: If the patient has had major surgery, the patient must have recovered adequately from the procedure and/or complications from the surgery prior to starting trial treatment.
- Live or live-attenuated vaccine within 30 days prior to first dose of trial treatment. Note: Administration of inactivated vaccines, mRNA-based vaccines [e.g.,COVID-19] and vector-based vaccines are allowed.
- Diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to first dose of trial treatment. Patients who are currently receiving steroids at a dose equivalent to >10mg/day of hydrocortisone or >5mg/day of prednisone equivalent do not need to discontinue steroids prior to enrollment. Patients who require topical, ophthalmologic and inhalational steroids will not be excluded from the trial. Patients with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the trial.
- Active (i.e., symptomatic or growing) CNS metastases
- Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- History of an allogeneic tissue/solid organ transplant
- Active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Patients with type I diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment; or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- History or current evidence of non-infectious pneumonitis/ interstitial lung disease that required steroids.
- Active infection requiring systemic therapy.
- History of HIV infection.
- Has known active HBV(defined as HBsAg reactive and/or detectable HBV DNA) or known active HCV(defined as anti HCV Ab positive and detectable HCV RNA [qualitative]) infection.
- History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- Psychiatric or substance abuse disorders that would interfere with the patient's ability to cooperate with the trial requirements.
- Severe hypersensitivity (grade =3) to pembrolizumab and/or any of its excipients.
- Women of childbearing potential:Pregnant or breastfeeding, or expecting to conceive a child within the projected duration of the trial, from time of informed consent until at least 120 days after the last dose of trial treatment.
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Männlich, Weiblich
Männlich, Weiblich
Indikation
Melanom
Melanom
Medizinischer Befund
Melanoma\nSquamous Cell Carcinoma of Head and Neck
Melanoma\nSquamous Cell Carcinoma of Head and Neck
GSK 219538
A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled Dose Finding study to evaluate the Efficacy, Safety, Pharmacokinetics, and Target Engement of GSK1070806 SC injection in participants with Moderate to Severe Atopic Dermatitis
Arzneimittelgesetz (AMG) / Phase 2, Interventionell
Zurück
GSK 219538
Studieninformationen
Studien-Code
UME-ID-11708
UME-ID-11708
Studien-Akronym
GSK 219538
GSK 219538
Studientitel
A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled Dose Finding study to evaluate the Efficacy, Safety, Pharmacokinetics, and Target Engement of GSK1070806 SC injection in participants with Moderate to Severe Atopic Dermatitis
A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled Dose Finding study to evaluate the Efficacy, Safety, Pharmacokinetics, and Target Engement of GSK1070806 SC injection in participants with Moderate to Severe Atopic Dermatitis
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024
2024
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
PD Dr. med. Wiebke Sondermann
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Studiendesign
randomisiert, doppelt verblindet, kontrolliert
randomisiert, doppelt verblindet, kontrolliert
Indikation
AD - Atopische Dermatitis
AD - Atopische Dermatitis
Medizinischer Befund
Atopic Dermatitis
Atopic Dermatitis
IFX-1-P3.4
A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate the efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum.
Arzneimittelgesetz (AMG) / Phase 3, Interventionell, Multizentrisch
Zurück
IFX-1-P3.4
Studieninformationen
Studien-Code
UME-ID-11709
UME-ID-11709
Studien-Akronym
IFX-1-P3.4
IFX-1-P3.4
Studientitel
A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate the efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum.
A randomized, double-blind, placebo-controlled, multicenter, adaptive phase III trial to investigate the efficacy and safety of vilobelimab in the treatment of ulcerative pyoderma gangrenosum.
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024
2024
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Joachim Dissemond
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Sponsor
InflaRx GmbH, Jena
Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch
Einschlusskriterien
* clinical diagnosis of ulcerative PG
* clinical diagnosis of ulcerative PG
Ausschlusskriterien
* Women of childbearing potential (WOCBP) who have a positive serum pregnancy test result within 7 days before treatment or are breast feeding.
* Women of childbearing potential (WOCBP) who have a positive serum pregnancy test result within 7 days before treatment or are breast feeding.
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Indikation
Diverse
Diverse
Medizinischer Befund
Pyoderma Gangrenosum
Pyoderma Gangrenosum
DICIT
Efficacy of diclofenac added to ongoing PD-1 inhibitor therapy in metastatic melanoma patients
Arzneimittelgesetz (AMG) / Phase 2, Interventionell
Efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved stable disease as best response in metastatic melanoma patients. A single arm phase II trial
Zurück
DICIT
Studieninformationen
Studien-Code
UME-ID-11602
UME-ID-11602
Studien-Akronym
DICIT
DICIT
Studientitel
Efficacy of diclofenac added to ongoing PD-1 inhibitor therapy in metastatic melanoma patients
Efficacy of diclofenac added to ongoing PD-1 inhibitor therapy in metastatic melanoma patients
Kurzbeschreibung
Efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved stable disease as best response in metastatic melanoma patients. A single arm phase II trial
Efficacy of diclofenac added to an approved, ongoing PD-1 inhibitor therapy that achieved stable disease as best response in metastatic melanoma patients. A single arm phase II trial
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024
2024
Beteiligte
Institute
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Klinik für Dermatologie, Westdeutsches Tumorzentrum
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Lisa Zimmer
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Studiendesign
Indikation
Melanom
Melanom
D346BC00001 LAVENDER
EudraCT-Nummer: 2021-003698-70
Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Animalarial Therapy
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
D346BC00001 LAVENDER
Studieninformationen
Studien-Code
UME-ID-12163
UME-ID-12163
Studien-Akronym
D346BC00001 LAVENDER
D346BC00001 LAVENDER
Studientitel
Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Animalarial Therapy
Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults with Chronic and/or Subacute Cutaneous Lupus Erythematosus who are Refractory and/or Intolerant to Animalarial Therapy
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024
EudraCT-Nummer: 2021-003698-70 2024
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
PD Dr. med. Wiebke Sondermann
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Sponsor
AstraZeneca GmbH
+49 (0)4103 708-0
service.center@astrazeneca.com
Tinsdaler Weg 183 183
22880 Wedel
Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
Einschlusskriterien
* Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:
- CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.
- CLA-IGA-R erythema score of ≥ 3 and CLA-IGA-R-OMC score of ≥ 1 at Screening and confirmed at randomization.
- Inadequate response or intolerant to antimalarial therapy.
* Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.
* Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.
* Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:
- CLASI-A total score ≥ 10 points at Screening and confirmed at randomization.
- CLA-IGA-R erythema score of ≥ 3 and CLA-IGA-R-OMC score of ≥ 1 at Screening and confirmed at randomization.
- Inadequate response or intolerant to antimalarial therapy.
* Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.
* Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.
Ausschlusskriterien
* History or evidence of suicidal ideation.
* Severe or life-threatening Systemic lupus erythematosus (SLE).
* Active SLE or Sjögren's Syndrome.
* Any active skin conditions other than CLE that may interfere with the study.
* History of recurrent infection requiring hospitalization and IV antibiotics.
* COVID-19 infection
* Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
* At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.
* History or evidence of suicidal ideation.
* Severe or life-threatening Systemic lupus erythematosus (SLE).
* Active SLE or Sjögren's Syndrome.
* Any active skin conditions other than CLE that may interfere with the study.
* History of recurrent infection requiring hospitalization and IV antibiotics.
* COVID-19 infection
* Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
* At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Studienteilnehmende Höchstalter
70 Jahr(e)
70 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Lupus Erythematodes
Lupus Erythematodes
Medizinischer Befund
Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus
M1095-HS-301 MoonLake
A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa
Clinical Trial Regulation (CTR) / Interventionell
Zurück
M1095-HS-301 MoonLake
Studieninformationen
Studien-Code
UME-ID-12164
UME-ID-12164
Studien-Akronym
M1095-HS-301 MoonLake
M1095-HS-301 MoonLake
Studientitel
A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa
A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of subcutaneous sonelokimab in adult participants with moderate to severe hidradenitis suppurativa
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024
2024
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
PD Dr. med. Wiebke Sondermann
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Studiendesign
randomisiert, doppelt verblindet, kontrolliert
randomisiert, doppelt verblindet, kontrolliert
Indikation
Hidradenitis suppurativa (HS)
Hidradenitis suppurativa (HS)
Medizinischer Befund
moderate to severe hidradenitis suppurativa
moderate to severe hidradenitis suppurativa
M1095-PPP-201
A Phase 2, multicentre open-label study to explore the effects of sonelokimab in patients with moderate-to-severe pustulosis palmoplantaris
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
M1095-PPP-201
Studieninformationen
Studien-Code
UME-ID-12167
UME-ID-12167
Studien-Akronym
M1095-PPP-201
M1095-PPP-201
Studientitel
A Phase 2, multicentre open-label study to explore the effects of sonelokimab in patients with moderate-to-severe pustulosis palmoplantaris
A Phase 2, multicentre open-label study to explore the effects of sonelokimab in patients with moderate-to-severe pustulosis palmoplantaris
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024
2024
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
PD Dr. med. Wiebke Sondermann
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Studiendesign
offen, Multizentrisch
offen, Multizentrisch
Indikation
Palmoplantare Pustulose (PPP)
Palmoplantare Pustulose (PPP)
Medizinischer Befund
moderate-to-severe pustulosis palmoplantaris
moderate-to-severe pustulosis palmoplantaris
allo-APZ2-CVU-III
A PIVOTAL, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, INTERNATIONAL PHASE III CLINICAL TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF ALLO-APZ2-CVU ON CHRONIC VENOUS ULCERS (CVU)
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
allo-APZ2-CVU-III
Studieninformationen
Studien-Code
UME-ID-12251
UME-ID-12251
Studien-Akronym
allo-APZ2-CVU-III
allo-APZ2-CVU-III
Studientitel
A PIVOTAL, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, INTERNATIONAL PHASE III CLINICAL TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF ALLO-APZ2-CVU ON CHRONIC VENOUS ULCERS (CVU)
A PIVOTAL, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTER, INTERNATIONAL PHASE III CLINICAL TRIAL TO INVESTIGATE THE EFFICACY AND SAFETY OF ALLO-APZ2-CVU ON CHRONIC VENOUS ULCERS (CVU)
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024
2024
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
Prof. Dr. med. Joachim Dissemond
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
Indikation
Diverse
Diverse
Medizinischer Befund
CHRONIC VENOUS ULCERS
CHRONIC VENOUS ULCERS
SKABUP
Multizentrische, prospektive, randomisierte, doppelblinde Phase III-Studie zum Vergleich der Wirksamkeit und Sicherheit der Therapie der Skabies mit zwei unterschiedlich konzentrierten Permethrin-Cremes
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
SKABUP
Studieninformationen
Studien-Code
UME-ID-12252
UME-ID-12252
Studien-Akronym
SKABUP
SKABUP
Studientitel
Multizentrische, prospektive, randomisierte, doppelblinde Phase III-Studie zum Vergleich der Wirksamkeit und Sicherheit der Therapie der Skabies mit zwei unterschiedlich konzentrierten Permethrin-Cremes
Multizentrische, prospektive, randomisierte, doppelblinde Phase III-Studie zum Vergleich der Wirksamkeit und Sicherheit der Therapie der Skabies mit zwei unterschiedlich konzentrierten Permethrin-Cremes
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024
2024
Beteiligte
Institut
Klinik für Dermatologie
Klinik für Dermatologie
Prüfarzt (AMG) / Studienleitung (BO)
PD Dr. med. Wiebke Sondermann
+49 (0)201 723-2225
Hautklinik.Studienzentrum@uk-essen.de
Hufelandstr 55
45147 Essen
Studiendesign
randomisiert, doppelt verblindet, Multizentrisch
randomisiert, doppelt verblindet, Multizentrisch
Indikation
Skabies
Skabies