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

NCT06013969 | Active Not Recruiting Phase 4 FDA Drug

• 3 other identifiers: 1368-01202022-502128-38-00U1111-1291-3088
• Study Type: interventional
• Target: 42
• Locations: 17 countries
• Sites: 35

Brief 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.

Conditions

Generalized Pustular Psoriasis

Outcome Measures

Primary Outcomes (1)

• Achievement of a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1

  Up to week 1

Secondary Outcomes (1)

• Achievement of a GPPGA pustulation sub-score of 0 or 1, with a ≥2-point reduction from baseline at Week 1

  Up to week 1

Study Arms (1)

GPP Patients

EXPERIMENTAL

Generalized Pustular Psoriasis (GPP) patients with a recurrent flare following initial GPP flare treatment with intravenous (i.v.) spesolimab.

Drug: Spesolimab

Interventions

Spesolimab DRUG

Spesolimab intravenous (i.v.) infusion

Also known as: Spevigo®

GPP Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (35)

University of California Irvine

Irvine, California, 92697, United States

Location

Red River Research Partners, LLC

Fargo, North Dakota, 58103, United States

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Hospital Universitario Evangelico Mackenzie

Curitiba, 80440-220, Brazil

Location

Faculdade de Medicina do ABC

Santo André, 09060-870, Brazil

Location

Southern Medical University Dermatology Hospital

Guangzhou, 510091, China

Location

Shanghai Skin Disease Hospital

Shanghai, 200000, China

Location

Shanghai Tenth People's Hospital

Shanghai, 200072, China

Location

HOP Trousseau

Chambray-lès-Tours, 37170, France

Location

HOP Saint-Louis

Paris, 75010, France

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, 60596, Germany

Location

Klinikum der Universität München AÖR

München, 80337, Germany

Location

SP medical college and associated group of hospitals

Bikaner, 334003, India

Location

Nkp Salve Institute of Medical Sciences and Lata Mangeshkar Hospital

Nagpur, 440019, India

Location

ASST degli Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Hospital Selayang

Batu Caves, 68100, Malaysia

Location

Hospital Pulau Pinang-Pulau Pinang-21953

Georgetown Pulau Pinang, 10990, Malaysia

Location

Hospital Sultanah Aminah

Johor Bahru, 80100, Malaysia

Location

Hospital Sultan Ismail

Johor Bahru, 81100, Malaysia

Location

Hospital Kuala Lumpur

Kuala Lumpur, 50586, Malaysia

Location

Hospital Putrajaya

Putrajaya, 62250, Malaysia

Location

Sunway Medical Centre

Selangor Darul Ehsan, 47500, Malaysia

Location

National University Hospital-Singapore-42005

Singapore, 119228, Singapore

Location

Nelson Mandela Academic Clinical Research Unit (NeMACRU)

Mthatha, Eastern Cape, 5099, South Africa

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Ramon Y Cajal

Madrid, 28034, Spain

Location

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Chang Gung Memorial Hospital, Linkou

Taoyuan District, 330, Taiwan

Location

Srinagarind Hospital

Khon Kaen, 40000, Thailand

Location

Maharat Nakhonchiangmai Hospital

Muang Chiang Mai, 50200, Thailand

Location

Hedi Chaker Hospital, Department of Dermatology

Sfax, 1053, Tunisia

Location

Farhat Hached Hospital

Sousse, 4000, Tunisia

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

spesolimab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 28, 2023
• Study Start: October 22, 2023
• Primary Completion (Estimated): July 23, 2026
• Study Completion (Estimated): August 14, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); US (2); ES (2); CN (3); IN (2); ZA (1); BR (2); SG (1); DE (2); AU (2); MY (7); IT (1); BE (1); TH (2); KR (1); TW (2); TU (2)