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

Generalized Pustular Psoriasis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013969
• Other study ID #: 1368-0120
• Secondary ID: 2022-502128-38-0
• Status: Recruiting
• Phase: Phase 4
• Start date: October 11, 2023
• Est. completion date: April 8, 2027

Study information

• Verified date: June 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 8, 2027
• Est. primary completion date: December 24, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Generalized Pustular Psoriasis
• Psoriasis

Intervention

Drug:
• Spesolimab
Spesolimab intravenous (i.v.) infusion

Locations

Country	Name	City	State
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	Brussels - UNIV Saint-Luc	Bruxelles
Brazil	Hospital Universitario Evangelico Mackenzie	Curitiba
Brazil	Faculdade de Medicina do ABC	Santo André
China	Southern Medical University Dermatology Hospital	Guangzhou
China	Shandong Provincial Hospital of Dermatology	Jinan
China	Shanghai Skin Disease Hospital	Shanghai
China	Shanghai Tenth People's Hospital	Shanghai
China	Second Affiliated Hospital of Xi'an JiaoTong University	Xi'an
France	HOP Trousseau	Chambray-lès-Tours
France	HOP François Mitterrand	Dijon
France	HOP Saint-Louis	Paris
Germany	Universitätsklinikum Frankfurt	Frankfurt am Main
Germany	Klinikum der Universität München AÖR	München
India	SP medical college and associated group of hospitals	Bikaner
India	Kasturba Medical College and Hospital	Manipal
India	Nkp Salve Institute of Medical Sciences and Lata Mangeshkar Hospital	Nagpur
Italy	ASST degli Spedali Civili di Brescia	Brescia
Italy	Presidio Ospedaliero Palagi	Firenze
Italy	AOU Università degli Studi della Campania Luigi Vanvitelli	Napoli
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma
Korea, Republic of	Pusan National Univ. Hosp	Busan
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Malaysia	Hospital Selayang	Batu Caves
Malaysia	Hospital Pulau Pinang	Georgetown Pulau Pinang
Malaysia	Hospital Raja Permaisuri Bainun	Ipoh
Malaysia	Hospital Sultan Ismail	Johor Bahru
Malaysia	Hospital Sultanah Aminah	Johor Bahru
Malaysia	Hospital Raja Perempuan Zainab II, Kota Bharu	Kota Bharu
Malaysia	Queen Elizabeth Hospital	Kota Kinabalu
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur
Malaysia	Hospital Putrajaya	Putrajaya
Malaysia	Sunway Medical Centre	Selangor Darul Ehsan
Singapore	Changi General Hospital	Singapore
Singapore	National University Hospital	Singapore
South Africa	Nelson Mandela Academic Clinical Research Unit (NeMACRU)	Mthatha, Eastern Cape
Spain	Hospital Vall d'Hebron	Barcelona
Spain	Hospital Ramón y Cajal	Madrid
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital(Linkou)	Taoyuan
Thailand	Srinagarind Hospital	Khon Kaen
Thailand	Maharat Nakhonchiangmai Hospital	Muang Chiang Mai
Tunisia	Hedi Chaker Hospital, Department of Dermatology	Sfax
Tunisia	Farhat Hached Hospital	Sousse
Tunisia	La Rabta Hospital	Tunis
Turkey	Gazi University Medical Faculty	Ankara
United States	Oakland Hills Dermatology, PC	Auburn Hills	Michigan
United States	AXIS Clinicals	Fargo	North Dakota
United States	University of California Irvine	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  China,  France,  Germany,  India,  Italy,  Korea, Republic of,  Malaysia,  Singapore,  South Africa,  Spain,  Taiwan,  Thailand,  Tunisia,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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