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Clinical Trials in India / NCT06013969
Active, not recruiting Phase 4

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

NCT06013969 · tracked via the Priya Life Science India tracker
Sponsor
LEO Pharma
Phase
Phase 4
Started
2023-10-22
Last updated
2026-09-02

Condition(s) studied

Generalized Pustular Psoriasis

Investigational drug(s) / intervention(s)

Spesolimab

Spesolimab: Spesolimab intravenous (i.v.) infusion

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Patients with a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 or 1 and a known and documented history of Generalized Pustular Psoriasis (GPP) (per European Rare And Severe Psoriasis Expert Network - ERASPEN - criteria), regardless of Interleukin 36 Receptor Antagonist (IL-36RN) gene mutation status or Patients with a GPP flare and a known and documented history of GPP (per ERASPEN criteria) regardless of IL-36RN gene mutation status. * Patients must have a history of frequent GPP flares in the past * Male or female patients, aged ≥18 years (if local legislation for age of consent differs, then local legislation will be followed) at screening * Signed and dated written informed consent prior to admission to the trial in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to start of any screening procedures * Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly Exclusion Criteria: * Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP) * Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques * Patients with primary erythrodermic psoriasis vulgaris * Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome * Immediate life-threatening flare of GPP or requiring intensive care treatment, according to the investigator's judgement. Life-threatening complications mainly include, but are not limited to, cardiovascular/cytokine driven shock, pulmonary distress syndrome, or acute renal failure * Severe, progressive, or uncontrolled hepatic disease, defined as \>3-fold upper limit normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or \>2-fold ULN elevation in total bilirubin * Presence of acute demyelinating neuropathy * Treatment with any drug considered likely to interfere with the safe conduct of the trial, as assessed by the investigator * Further exclusion criteria apply.

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
University of California Irvine Irvine California
Red River Research Partners, LLC Fargo North Dakota
Liverpool Hospital Liverpool New South Wales
Westmead Hospital Westmead New South Wales
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 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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06013969 on ClinicalTrials.gov ↗ ← All trials in India