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 Studien zum Thema HIV/AIDS/Geschlechtserkrankungen.
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 neoadjuvanten, adjuvanten und…
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
Prof. 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
Zusatzbezeichnung: Allergologie
Infektiologisch tätiger Venerologe
Prof. Dr. med.
Joachim Dissemond
Oberarzt,
Facharzt für Haut- und Geschlechtskrankheiten,
Zusatzbezeichnung: Allergologie, Sportmedizin
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 Wound Healing of Therapy-Resistant Non-Healing 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 Wound Healing of Therapy-Resistant Non-Healing 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 Wound Healing of Therapy-Resistant Non-Healing 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
Sponsor
RHEACELL GmbH & Co. KG, Heidelberg
Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
Einschlusskriterien
1 Patients at least 18 years old
2 Chronic venous leg ulcer at lower leg and/or ankle region that has not been present longer than 15 years, diagnosed by Doppler or Duplex sonography, ankle brachial index (ABI, 0.9-1.3; optionally, in case ABI > 1.3 or not measurable: toe brachial index (TBI) =0.7)), physical examination and dermatological review
3 Wound size at V1 and V2 between 1 and 25 cm2 as measured by standardized photograph
4 If patients have 2 or more ulcers at the same extremity, the target ulcer (defined at V2) has to be separated from the other ulcers with a bridge of epithelialized skin at least 1 cm wide
5 Body mass index between 15 and 50 kg/m²
6 Patients able to understand the nature of the study and able to provide written informed consent prior to any clinical trial procedures
7 Women of childbearing potential must have a negative urine pregnancy test at Visit 1
8 During the course of the clinical trial women of childbearing potential and their male partners must be willing to use highly effective contraceptive methods as defined in the EMA CTCG “Recommendations related to contraception and pregnancy testing in clinical trials", Version 1.2.
1 Patients at least 18 years old
2 Chronic venous leg ulcer at lower leg and/or ankle region that has not been present longer than 15 years, diagnosed by Doppler or Duplex sonography, ankle brachial index (ABI, 0.9-1.3; optionally, in case ABI > 1.3 or not measurable: toe brachial index (TBI) =0.7)), physical examination and dermatological review
3 Wound size at V1 and V2 between 1 and 25 cm2 as measured by standardized photograph
4 If patients have 2 or more ulcers at the same extremity, the target ulcer (defined at V2) has to be separated from the other ulcers with a bridge of epithelialized skin at least 1 cm wide
5 Body mass index between 15 and 50 kg/m²
6 Patients able to understand the nature of the study and able to provide written informed consent prior to any clinical trial procedures
7 Women of childbearing potential must have a negative urine pregnancy test at Visit 1
8 During the course of the clinical trial women of childbearing potential and their male partners must be willing to use highly effective contraceptive methods as defined in the EMA CTCG “Recommendations related to contraception and pregnancy testing in clinical trials", Version 1.2.
Ausschlusskriterien
1 Evidence of the ulcer extending to the underlying muscle, tendon, or bone
2 Uncontrolled Diabetes mellitus i.e. Hemoglobin A1c (HbA1c) >9.0% (75 mmol/mol) (measured by blood test)
3 Peripheral Artery Disease including claudication with need of treatment or intervention
4 Acute deep vein thrombosis diagnosed within 30 days before V1, or untreated deep vein thrombosis
5 Wounds showing size reduction of more than 40% at Visit 2 compared to Visit 1
6 Patients with known hypersensitivity and/or clinical contraindications to the compression systems used in the clinical trial, or inability/unwillingness to tolerate leg ulcer compression systems
7 Acute wound infection of ulcer requiring treatment as judged clinically
8 Current use of medications that are known to influence wound healing i.e. systemic immunosuppressives, cytotoxic medicinal products, systemic steroids (above Cushing-threshold level) at investigator´s discretion
9 Patients who, in the opinion of the investigator, for any reason are unable or unwilling to complete the trial per protocol (e.g. alcohol or substance abuse, not mobile, short life expectancy) or there is an evidence of any other medical condition (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the patient’s compliance, or place the patient at high risk of complications related to the treatment
10 Any malignancy within the past 5 years, excluding successfully treated carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin without evidence of metastases
11 Pregnant or lactating women
12 Known hypersensitivities to the active substance or to any of the excipients in the IP or the placebo
13 Surgical procedure affecting the CVU, such as bypass or mesh graft performed within two months prior to Visit 1
14 Current or previous (within 30 days of enrollment) treatment with another IP, or participation in another clinical trial, including follow-up phase
15 Previous participation in this clinical trial (except for screening failures due to an inclusion or exclusion criterion)
16 Employees of the sponsor, or employees or relatives of the investigator(s)
1 Evidence of the ulcer extending to the underlying muscle, tendon, or bone
2 Uncontrolled Diabetes mellitus i.e. Hemoglobin A1c (HbA1c) >9.0% (75 mmol/mol) (measured by blood test)
3 Peripheral Artery Disease including claudication with need of treatment or intervention
4 Acute deep vein thrombosis diagnosed within 30 days before V1, or untreated deep vein thrombosis
5 Wounds showing size reduction of more than 40% at Visit 2 compared to Visit 1
6 Patients with known hypersensitivity and/or clinical contraindications to the compression systems used in the clinical trial, or inability/unwillingness to tolerate leg ulcer compression systems
7 Acute wound infection of ulcer requiring treatment as judged clinically
8 Current use of medications that are known to influence wound healing i.e. systemic immunosuppressives, cytotoxic medicinal products, systemic steroids (above Cushing-threshold level) at investigator´s discretion
9 Patients who, in the opinion of the investigator, for any reason are unable or unwilling to complete the trial per protocol (e.g. alcohol or substance abuse, not mobile, short life expectancy) or there is an evidence of any other medical condition (such as psychiatric illness, physical examination, or laboratory findings) that may interfere with the planned treatment, affect the patient’s compliance, or place the patient at high risk of complications related to the treatment
10 Any malignancy within the past 5 years, excluding successfully treated carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin without evidence of metastases
11 Pregnant or lactating women
12 Known hypersensitivities to the active substance or to any of the excipients in the IP or the placebo
13 Surgical procedure affecting the CVU, such as bypass or mesh graft performed within two months prior to Visit 1
14 Current or previous (within 30 days of enrollment) treatment with another IP, or participation in another clinical trial, including follow-up phase
15 Previous participation in this clinical trial (except for screening failures due to an inclusion or exclusion criterion)
16 Employees of the sponsor, or employees or relatives of the investigator(s)
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Diverse
Diverse
Medizinischer Befund
chronic venous ulcers (CVU)
chronic venous ulcers (CVU)
MedDRA Term
Chronic leg ulcer
Chronic leg ulcer
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
2015,2016,2017,2018,2019,2021,2022,2023,2025
2015,2016,2017,2018,2019,2021,2022,2023,2025
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
CFT1946-1101
A Phase 1/2 Open-Label Multicenter Trial to Characterize the Safety, Tolerability, and Preliminary Efficacy of Cft1946 as Monotherapy and in Combination with Trametinib in Subjects with Braf-V600 Mutant Solid Tumors
Arzneimittelgesetz (AMG) / Phase 1, Interventionell, Multizentrisch
Zurück
CFT1946-1101
Studieninformationen
Studien-Code
UME-ID-11713
UME-ID-11713
Studien-Akronym
CFT1946-1101
CFT1946-1101
Studientitel
A Phase 1/2 Open-Label Multicenter Trial to Characterize the Safety, Tolerability, and Preliminary Efficacy of Cft1946 as Monotherapy and in Combination with Trametinib in Subjects with Braf-V600 Mutant Solid Tumors
A Phase 1/2 Open-Label Multicenter Trial to Characterize the Safety, Tolerability, and Preliminary Efficacy of Cft1946 as Monotherapy and in Combination with Trametinib in Subjects with Braf-V600 Mutant Solid Tumors
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2025
2025
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
C4 Therapeutics, Inc.
(617)231-0770
clinicaltrials@c4therapeutics.com
490 Arsenal Way Suite 120
MA 02472 Watertown
Studiendesign
offen, Multizentrisch, International
offen, Multizentrisch, International
Einschlusskriterien
* Subject (or legal guardian, where applicable) is willing and able to provide signed informed consent and can follow protocol requirements
* Subject is ≥18 years of age at time of informed consent
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Subject has documented evidence of a BRAF V600 mutation obtained from tumor tissue or liquid biopsy: (other protocol conditions may apply)
* Subject must have received ≥1 prior line of SoC therapy for their locally advanced or metastatic disease, NSCLC, CRC, ATC or other BRAF-V600 mutation positive tumors:
- Melanoma or NSCLC (Phase 1 and Phase 2 Arms A1 and B1): Prior receipt of a BRAF inhibitor and an immune checkpoint inhibitor (any sequence or combination). Prior (neo)adjuvant immunotherapy may be acceptable.
- NSCLC (Phase 2 Arm B2): Prior receipt of a regimen including an immune checkpoint inhibitor (any sequence or combination). BRAF inhibitor naïve. Prior (neo)adjuvant immunotherapy may be acceptable.
- CRC: Receipt of a SoC chemotherapy regimen and a prior BRAF inhibitor in combination with an EGFR monoclonal antibody. Subjects with documented MSI-H or dMMR CRC must have received prior immunotherapy. Subjects with MSS disease must have received at least 2 prior treatments. Subjects who received neo(adjuvant) chemotherapy regimens may be eligible.
- ATC: Subjects must have received SoC therapy options including BRAF inhibitor if available and of benefit to the subject
- Other BRAF V600 mutant solid tumors (non-CNS): Subjects must have received SoC therapy options per their Investigator's best judgment and be BRAF inhibitor naïve
* Subject has measurable disease per RECIST v1.1
* Adequate bone marrow, liver, renal, and cardiac organ function
* A female subject may be eligible if not pregnant, planning a pregnancy, not breast feeding, a women of non-child bearing potential or a WOCBP willing to comply with protocol conditions relating to the use contraception, ova or blood donation and pregnancy testing prior to the first dose
* A male subject must agree to comply with protocol conditions relating to the use of contraception, sperm and blood donation
* Subject can safely swallow a tablet or pill
* Subject (or legal guardian, where applicable) is willing and able to provide signed informed consent and can follow protocol requirements
* Subject is ≥18 years of age at time of informed consent
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Subject has documented evidence of a BRAF V600 mutation obtained from tumor tissue or liquid biopsy: (other protocol conditions may apply)
* Subject must have received ≥1 prior line of SoC therapy for their locally advanced or metastatic disease, NSCLC, CRC, ATC or other BRAF-V600 mutation positive tumors:
- Melanoma or NSCLC (Phase 1 and Phase 2 Arms A1 and B1): Prior receipt of a BRAF inhibitor and an immune checkpoint inhibitor (any sequence or combination). Prior (neo)adjuvant immunotherapy may be acceptable.
- NSCLC (Phase 2 Arm B2): Prior receipt of a regimen including an immune checkpoint inhibitor (any sequence or combination). BRAF inhibitor naïve. Prior (neo)adjuvant immunotherapy may be acceptable.
- CRC: Receipt of a SoC chemotherapy regimen and a prior BRAF inhibitor in combination with an EGFR monoclonal antibody. Subjects with documented MSI-H or dMMR CRC must have received prior immunotherapy. Subjects with MSS disease must have received at least 2 prior treatments. Subjects who received neo(adjuvant) chemotherapy regimens may be eligible.
- ATC: Subjects must have received SoC therapy options including BRAF inhibitor if available and of benefit to the subject
- Other BRAF V600 mutant solid tumors (non-CNS): Subjects must have received SoC therapy options per their Investigator's best judgment and be BRAF inhibitor naïve
* Subject has measurable disease per RECIST v1.1
* Adequate bone marrow, liver, renal, and cardiac organ function
* A female subject may be eligible if not pregnant, planning a pregnancy, not breast feeding, a women of non-child bearing potential or a WOCBP willing to comply with protocol conditions relating to the use contraception, ova or blood donation and pregnancy testing prior to the first dose
* A male subject must agree to comply with protocol conditions relating to the use of contraception, sperm and blood donation
* Subject can safely swallow a tablet or pill
Ausschlusskriterien
Subject has had major surgery within 21 days prior to the planned first dose. Minor surgery is permitted within 21 days prior to enrollment
* Subject with CNS involvement (primary tumor or metastatic disease), except if clinically stable, have no evidence of new or enlarging brain metastases and are on stable or tapering doses of steroids for at least 7 days prior to first dose. Subjects with untreated brain metastases may be eligible to enter without prior radiation therapy.
* Subject with known malignancy other than trial indication that is progressing or has required treatment within the past 3 years, except for conditions that have undergone potentially curative therapy
* Subject with history of thromboembolic or cerebrovascular events =6 months as defined in the protocol
* Subject with impaired cardiac function or clinically significant cardiac disease, as defined in the protocol
* Subject with history of uncontrolled diabetes mellitus (only for subjects who will receive CFT1946 + trametinib)
* Subject with history or current evidence of retinal vein occlusion (RVO), chorioretinopathy, or current risk factors for RVO (only for subjects who will receive CFT1946 + trametinib)
* Subject has received live, attenuated vaccine within 28 days prior to first dose administration
* Subject has history of pneumonitis or interstitial lung disease
* Subject has history of uveitis
* Subject has known human immunodeficiency virus (HIV) infection (with exceptions)
* Subject has history of or known HBV or active HCV infection
* Subject has concurrent administration of strong CYP3A4/5 inhibitors and inducers, including any herbal medications/supplements
* Subject has presence of Grade =2 toxicity due to prior cancer therapy, excepting alopecia and hypothyroidism requiring thyroid replacement therapy
* Subject has initiation or receipt of the following =7 days prior to first dose administration: Hematopoietic colony-stimulating growth factors, transfusion of packed red blood cells (pRBC), and transfusion of platelets
* Subject is pregnant, breastfeeding, or expecting to conceive or father children any time during the study
Subject has had major surgery within 21 days prior to the planned first dose. Minor surgery is permitted within 21 days prior to enrollment
* Subject with CNS involvement (primary tumor or metastatic disease), except if clinically stable, have no evidence of new or enlarging brain metastases and are on stable or tapering doses of steroids for at least 7 days prior to first dose. Subjects with untreated brain metastases may be eligible to enter without prior radiation therapy.
* Subject with known malignancy other than trial indication that is progressing or has required treatment within the past 3 years, except for conditions that have undergone potentially curative therapy
* Subject with history of thromboembolic or cerebrovascular events =6 months as defined in the protocol
* Subject with impaired cardiac function or clinically significant cardiac disease, as defined in the protocol
* Subject with history of uncontrolled diabetes mellitus (only for subjects who will receive CFT1946 + trametinib)
* Subject with history or current evidence of retinal vein occlusion (RVO), chorioretinopathy, or current risk factors for RVO (only for subjects who will receive CFT1946 + trametinib)
* Subject has received live, attenuated vaccine within 28 days prior to first dose administration
* Subject has history of pneumonitis or interstitial lung disease
* Subject has history of uveitis
* Subject has known human immunodeficiency virus (HIV) infection (with exceptions)
* Subject has history of or known HBV or active HCV infection
* Subject has concurrent administration of strong CYP3A4/5 inhibitors and inducers, including any herbal medications/supplements
* Subject has presence of Grade =2 toxicity due to prior cancer therapy, excepting alopecia and hypothyroidism requiring thyroid replacement therapy
* Subject has initiation or receipt of the following =7 days prior to first dose administration: Hematopoietic colony-stimulating growth factors, transfusion of packed red blood cells (pRBC), and transfusion of platelets
* Subject is pregnant, breastfeeding, or expecting to conceive or father children any time during the study
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Geschlecht
Divers, Männlich, Weiblich
Divers, Männlich, Weiblich
Indikation
Solide Tumoren
Solide Tumoren
Medizinischer Befund
Solid Tumors\nMelanoma\nNSCLC\nCRC\nATC
Solid Tumors\nMelanoma\nNSCLC\nCRC\nATC
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
MedDRA Term
Cutaneous lupus erythematosus
Cutaneous lupus erythematosus
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
2024,2025
2024,2025
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
GSK 219538
A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Dose Finding study to evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GSK1070806 SC injection in adult participants with Moderate to Severe Atopic Dermatitis
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Dose Finding study to evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GSK1070806 SC injection in Adult Participants with Moderate to Severe Atopic Dermatitis
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 Pharmacodynamics of GSK1070806 SC injection in adult 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 Pharmacodynamics of GSK1070806 SC injection in adult participants with Moderate to Severe Atopic Dermatitis
Kurzbeschreibung
A Phase 2b, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Dose Finding study to evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GSK1070806 SC injection in Adult 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 Pharmacodynamics of GSK1070806 SC injection in Adult 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
Sponsor
GlaxoSmithKline Research & Development Limited, USA
Studiendesign
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
randomisiert, doppelt verblindet, kontrolliert, Multizentrisch, International
Einschlusskriterien
• Adult participants 18 years to 75 years of age
• Participants with:
o AtD defined by the AAD Consensus Criteria.
o Diagnosis of AtD =1 year.
o An IGA score =3.
o AtD involvement of =10% body surface area (BSA).
o EASI score =16
o Baseline pruritus numerical rating scale average score for maximum intensity of at least 3.
• Participants may have had exposure to 1 biologic therapy meeting at least 1 of the following conditions:
o Participants who stopped treatment due to non-response, partial response, loss of efficacy.
o Participants who stopped treatment due to intolerance or AEs.
• Participant with a recent history less than or equal to (=6) months prior to the Screening visit) of inadequate response to a stable regimen of prescription topical medication.
• Participants for whom prescription topical medications are not tolerated.
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical study
• Adult participants 18 years to 75 years of age
• Participants with:
o AtD defined by the AAD Consensus Criteria.
o Diagnosis of AtD =1 year.
o An IGA score =3.
o AtD involvement of =10% body surface area (BSA).
o EASI score =16
o Baseline pruritus numerical rating scale average score for maximum intensity of at least 3.
• Participants may have had exposure to 1 biologic therapy meeting at least 1 of the following conditions:
o Participants who stopped treatment due to non-response, partial response, loss of efficacy.
o Participants who stopped treatment due to intolerance or AEs.
• Participant with a recent history less than or equal to (=6) months prior to the Screening visit) of inadequate response to a stable regimen of prescription topical medication.
• Participants for whom prescription topical medications are not tolerated.
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical study
Ausschlusskriterien
• Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, anti-protozoal, or antifungals within 4 weeks before the Screening visit or anytime between the Screening and Baseline visits.
• Superficial skin infections within 1 week before the Screening visit or active infections (including localized infections), or history of recurrent infections (excluding recurrent fungal infections of the nail bed)
• Known, pre-existing or suspected parasitic infection within 6 months before the Screening visit.
• Symptomatic herpes zoster within 3 months prior to screening
• Uncontrolled hypertension.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities.
• Known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgment.
• Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
• Breast cancer within the past 10 years.
• History or presence of significant medical illness including but not limited to cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurological, or psychiatric disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
• Previously treated with any oral Janus Kinase inhibitor (JAKi) or other kinase inhibitors, experimental or approved.
• Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma.
• Presence of Hepatitis B surface antibody (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.
• Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
• Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
• Positive HIV antibody test.
• Evidence of active or latent TB as documented by medical history, examination, and TB testing with a positive QuantiFERON test at initial Screening visit.
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
• Chronic or acute infection requiring treatment with oral or IV antibiotics, antivirals, anti-protozoal, or antifungals within 4 weeks before the Screening visit or anytime between the Screening and Baseline visits.
• Superficial skin infections within 1 week before the Screening visit or active infections (including localized infections), or history of recurrent infections (excluding recurrent fungal infections of the nail bed)
• Known, pre-existing or suspected parasitic infection within 6 months before the Screening visit.
• Symptomatic herpes zoster within 3 months prior to screening
• Uncontrolled hypertension.
• Current or chronic history of liver disease or known hepatic or biliary abnormalities.
• Known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution or unusually frequent, recurrent, or prolonged infections, per the Investigator's judgment.
• Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
• Breast cancer within the past 10 years.
• History or presence of significant medical illness including but not limited to cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurological, or psychiatric disorders which in the opinion of the investigator would interfere with the study procedures and/or assessments.
• Previously treated with any oral Janus Kinase inhibitor (JAKi) or other kinase inhibitors, experimental or approved.
• Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma.
• Presence of Hepatitis B surface antibody (HBsAg) or Hepatitis B core antibody (HBcAb) at screening or within 3 months prior to first dose of study intervention.
• Positive hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
• Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
• Positive HIV antibody test.
• Evidence of active or latent TB as documented by medical history, examination, and TB testing with a positive QuantiFERON test at initial Screening visit.
• Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Studienteilnehmende Höchstalter
75 Jahr(e)
75 Jahr(e)
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
2024,2025
2024,2025
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
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
2023,2024,2025
2023,2024,2025
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
IMC-F106C-301
A Phase 3 Randomized, Controlled Study of IMC-F 106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
IMC-F106C-301
Studieninformationen
Studien-Code
UME-ID-11454
UME-ID-11454
Studien-Akronym
IMC-F106C-301
IMC-F106C-301
Studientitel
A Phase 3 Randomized, Controlled Study of IMC-F 106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)
A Phase 3 Randomized, Controlled Study of IMC-F 106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2024,2025
2024,2025
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, kontrolliert, Multizentrisch, International
randomisiert, offen, kontrolliert, Multizentrisch, International
Einschlusskriterien
- Participants must be HLA-A*02:01-positive
- Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
- Archived or fresh tumor tissue sample that must be confirmed as adequate
- Participants must have measurable disease per RECIST 1.1
- Participant must have BRAF V600 mutation status determined
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention
- Participants must be HLA-A*02:01-positive
- Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
- Archived or fresh tumor tissue sample that must be confirmed as adequate
- Participants must have measurable disease per RECIST 1.1
- Participant must have BRAF V600 mutation status determined
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the study screening date until 5 months after the final dose of study intervention
Ausschlusskriterien
- Participants with a history of a malignant disease other than those being treated in this study
- Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
- Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
- Participants with clinically significant pulmonary disease or impaired lung function
- Participants with clinically significant cardiac disease or impaired cardiac function
- Participants with active autoimmune disease requiring immunosuppressive treatment
- Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
- Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
- Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3
- Participants with a history of a malignant disease other than those being treated in this study
- Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
- Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
- Participants with clinically significant pulmonary disease or impaired lung function
- Participants with clinically significant cardiac disease or impaired cardiac function
- Participants with active autoimmune disease requiring immunosuppressive treatment
- Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
- Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
- Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3
Studienteilnehmende Mindestalter
18 Jahr(e)
18 Jahr(e)
Indikation
Melanom
Melanom
Medizinischer Befund
Advanced melanoma
Advanced 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
2024,2025
EudraCT-Nummer: 2022-502732-39-00 2024,2025
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
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
2024,2025
2024,2025
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
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
2024,2025
2024,2025
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
23-BI-1607-02
AN OPEN-LABEL, MULTICENTRE PHASE 1B/2A CLINICAL TRIAL OF BI-1607, AN FC-ENGINEERED MONOCLONAL ANTIBODY TO FCyRIIB (CD32B), IN COMBINATION WITH IPILIMUMAB AND PEMBROLIZUMAB IN PARTICIPANTS WITH UNRESECTABLE OR METASTATIC MELANOMA
Clinical Trial Regulation (CTR) / Interventionell, Multizentrisch
Zurück
23-BI-1607-02
Studieninformationen
Studien-Code
UME-ID-12270
UME-ID-12270
Studien-Akronym
23-BI-1607-02
23-BI-1607-02
Studientitel
AN OPEN-LABEL, MULTICENTRE PHASE 1B/2A CLINICAL TRIAL OF BI-1607, AN FC-ENGINEERED MONOCLONAL ANTIBODY TO FCyRIIB (CD32B), IN COMBINATION WITH IPILIMUMAB AND PEMBROLIZUMAB IN PARTICIPANTS WITH UNRESECTABLE OR METASTATIC MELANOMA
AN OPEN-LABEL, MULTICENTRE PHASE 1B/2A CLINICAL TRIAL OF BI-1607, AN FC-ENGINEERED MONOCLONAL ANTIBODY TO FCyRIIB (CD32B), IN COMBINATION WITH IPILIMUMAB AND PEMBROLIZUMAB IN PARTICIPANTS WITH UNRESECTABLE OR METASTATIC MELANOMA
Aktueller Studienstatus
Aktiv, rekrutierend
Aktiv, rekrutierend
Studie aktiv in den Jahren
2025
2025
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
Studiendesign
offen, Multizentrisch
offen, Multizentrisch
Indikation
Melanom
Melanom
Medizinischer Befund
UNRESECTABLE OR METASTATIC MELANOMA
UNRESECTABLE OR METASTATIC MELANOMA