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ACTIVE NOT RECRUITING
NCT06013969
PHASE4

A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

This study is open to adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares. During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.

Official title: Effisayil® REP:An Open-label, Multicenter, Single-arm, Post-marketing Trial (in Select Countries) to Evaluate Efficacy and Safety and the Impact of Immunogenicity on Efficacy, Safety, and Pharmacokinetics of Spesolimab i.v. in Treatment of Patients With Generalized Pustular Psoriasis (GPP) Presenting With a Recurrent Flare Following Their Initial GPP Flare Treatment With Spesolimab i.v.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2023-10-22

Completion Date

2026-08-14

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

DRUG

Spesolimab

Spesolimab intravenous (i.v.) infusion

Locations (35)

University of California Irvine

Irvine, California, United States

Red River Research Partners, LLC

Fargo, North Dakota, United States

Liverpool Hospital

Liverpool, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Hospital Universitario Evangelico Mackenzie

Curitiba, Brazil

Faculdade de Medicina do ABC

Santo André, Brazil

Southern Medical University Dermatology Hospital

Guangzhou, China

Shanghai Skin Disease Hospital

Shanghai, China

Shanghai Tenth People's Hospital

Shanghai, China

HOP Trousseau

Chambray-lès-Tours, France

HOP Saint-Louis

Paris, France

Universitätsklinikum Frankfurt

Frankfurt am Main, Germany

Klinikum der Universität München AÖR

München, Germany

SP medical college and associated group of hospitals

Bikaner, India

Nkp Salve Institute of Medical Sciences and Lata Mangeshkar Hospital

Nagpur, India

ASST degli Spedali Civili di Brescia

Brescia, Italy

Hospital Selayang

Batu Caves, Malaysia

Hospital Pulau Pinang-Pulau Pinang-21953

Georgetown Pulau Pinang, Malaysia

Hospital Sultanah Aminah

Johor Bahru, Malaysia

Hospital Sultan Ismail

Johor Bahru, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

Hospital Putrajaya

Putrajaya, Malaysia

Sunway Medical Centre

Selangor Darul Ehsan, Malaysia

National University Hospital-Singapore-42005

Singapore, Singapore

Nelson Mandela Academic Clinical Research Unit (NeMACRU)

Mthatha, Eastern Cape, South Africa

Seoul National University Hospital

Seoul, South Korea

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Ramon Y Cajal

Madrid, Spain

National Taiwan University Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Srinagarind Hospital

Khon Kaen, Thailand

Maharat Nakhonchiangmai Hospital

Muang Chiang Mai, Thailand

Hedi Chaker Hospital, Department of Dermatology

Sfax, Tunisia

Farhat Hached Hospital

Sousse, Tunisia