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

Last updated: April 15, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Not Recruiting

Phase

4

Condition

Warts

Skin Wounds

Psoriasis And Psoriatic Disorders

Treatment

Spesolimab

Clinical Study ID

NCT06013969
1368-0120
2022-502128-38-00
U1111-1291-3088
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 GeneralizedPustular Psoriasis (GPP) (per European Rare And Severe Psoriasis Expert Network -ERASPEN - criteria), regardless of Interleukin 36 Receptor Antagonist (IL-36RN) genemutation status or Patients with a GPP flare and a known and documented history ofGPP (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 consentdiffers, then local legislation will be followed) at screening

  • Signed and dated written informed consent prior to admission to the trial inaccordance 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 highlyeffective methods of birth control per ICH M3 (R2) that result in a low failure rateof less than 1% per year when used consistently and correctly

Exclusion

Exclusion Criteria:

  • Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP)

  • Patients with primary plaque psoriasis vulgaris without presence of pustules or withpustules 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 mainlyinclude, but are not limited to, cardiovascular/cytokine driven shock, pulmonarydistress syndrome, or acute renal failure

  • Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold upper limitnormal (ULN) elevation in Aspartate Aminotransferase (AST) or AlanineAminotransferase (ALT) or alkaline phosphatase, or >2-fold ULN elevation in totalbilirubin

  • Presence of acute demyelinating neuropathy

  • Treatment with any drug considered likely to interfere with the safe conduct of thetrial, as assessed by the investigator

  • Further exclusion criteria apply.

Study Design

Total Participants: 42
Treatment Group(s): 1
Primary Treatment: Spesolimab
Phase: 4
Study Start date:
October 22, 2023
Estimated Completion Date:
November 05, 2026

Connect with a study center

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Site Not Available

  • Brussels - UNIV Saint-Luc

    Bruxelles, 1200
    Belgium

    Site Not Available

  • Hospital Universitario Evangelico Mackenzie

    Curitiba, 80440-220
    Brazil

    Site Not Available

  • Faculdade de Medicina do ABC

    Santo André, 09060-870
    Brazil

    Site Not Available

  • Southern Medical University Dermatology Hospital

    Guangzhou, 510091
    China

    Site Not Available

  • Shandong Provincial Hospital of Dermatology

    Jinan, 250063
    China

    Site Not Available

  • Shanghai Skin Disease Hospital

    Shanghai, 200000
    China

    Site Not Available

  • Shanghai Tenth People's Hospital

    Shanghai, 200072
    China

    Site Not Available

  • Second Affiliated Hospital of Xi'an JiaoTong University

    Xi'an, 710004
    China

    Site Not Available

  • HOP Trousseau

    Chambray-lès-Tours, 37170
    France

    Site Not Available

  • HOP François Mitterrand

    Dijon, 21079
    France

    Site Not Available

  • HOP Saint-Louis

    Paris, 75010
    France

    Site Not Available

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60596
    Germany

    Site Not Available

  • Klinikum der Universität München AÖR

    München, 80337
    Germany

    Site Not Available

  • SP medical college and associated group of hospitals

    Bikaner, 334003
    India

    Site Not Available

  • Kasturba Medical College and Hospital

    Manipal, 576104
    India

    Site Not Available

  • Nkp Salve Institute of Medical Sciences and Lata Mangeshkar Hospital

    Nagpur, 440019
    India

    Site Not Available

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Site Not Available

  • Presidio Ospedaliero Palagi

    Firenze, 50125
    Italy

    Site Not Available

  • AOU Università degli Studi della Campania Luigi Vanvitelli

    Napoli, 80131
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Pusan National Univ. Hosp

    Busan, 602-739
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Hospital Selayang

    Batu Caves, 68100
    Malaysia

    Site Not Available

  • Hospital Pulau Pinang

    Georgetown Pulau Pinang, 10990
    Malaysia

    Site Not Available

  • Hospital Pulau Pinang-Pulau Pinang-21953

    Georgetown Pulau Pinang, 10990
    Malaysia

    Site Not Available

  • Hospital Raja Permaisuri Bainun

    Ipoh, 30450
    Malaysia

    Site Not Available

  • Hospital Sultan Ismail

    Johor Bahru, 81100
    Malaysia

    Site Not Available

  • Hospital Sultanah Aminah

    Johor Bahru, 80100
    Malaysia

    Site Not Available

  • Hospital Raja Perempuan Zainab II, Kota Bharu

    Kota Bharu, 15200
    Malaysia

    Site Not Available

  • Queen Elizabeth Hospital

    Kota Kinabalu, 88586
    Malaysia

    Site Not Available

  • Hospital Kuala Lumpur

    Kuala Lumpur, 50586
    Malaysia

    Site Not Available

  • Hospital Putrajaya

    Putrajaya, 62250
    Malaysia

    Site Not Available

  • Sunway Medical Centre

    Selangor Darul Ehsan, 47500
    Malaysia

    Site Not Available

  • Changi General Hospital

    Singapore, 529889
    Singapore

    Active - Recruiting

  • National University Hospital

    Singapore, 119228
    Singapore

    Site Not Available

  • Nelson Mandela Academic Clinical Research Unit (NeMACRU)

    Mthatha, Eastern Cape, 5099
    South Africa

    Site Not Available

  • Hospital Vall d'Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Vall d'Hebron-Barcelona-47683

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Ramón y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital(Linkou)

    Taoyuan, 330
    Taiwan

    Site Not Available

  • Srinagarind Hospital

    Khon Kaen, 40000
    Thailand

    Site Not Available

  • Maharat Nakhonchiangmai Hospital

    Muang Chiang Mai, 50200
    Thailand

    Site Not Available

  • Hedi Chaker Hospital, Department of Dermatology

    Sfax, 1053
    Tunisia

    Site Not Available

  • Farhat Hached Hospital

    Sousse, 4000
    Tunisia

    Site Not Available

  • La Rabta Hospital

    Tunis, 1007
    Tunisia

    Site Not Available

  • Gazi University Medical Faculty

    Ankara, 06500
    Turkey

    Site Not Available

  • University of California Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • Oakland Hills Dermatology, PC

    Auburn Hills, Michigan 48326
    United States

    Site Not Available

  • AXIS Clinicals

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • Red River Research Partners, LLC

    Fargo, North Dakota 58103
    United States

    Site Not Available

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