A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Boehringer Ingelheim
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Updated on 19 February 2024
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Summary

The present trial will be performed to characterize the dose-response curve for BI 655130 in patients with a history of Generalized Pustular Psoriasis (GPP, per European Rare and Severe Psoriasis Expert Network (ERASPEN) criteria) who are now (at screening and at randomization) presenting with a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of 0 or 1 (clear, or almost clear).

Details
Condition Generalized Pustular Psoriasis
Age 12years - 75years
Treatment Placebo, Spesolimab
Clinical Study IdentifierNCT04399837
SponsorBoehringer Ingelheim
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients with a known and documented history of GPP per ERASPEN criteria regardless of IL36RN mutation status, with at least 2 presentations of moderate to severe GPP flares with fresh pustulation (new appearance or worsening) in the past
Patients with a GPPGA score of 0 or 1 at screening and randomization
Male or female patients, aged 12 to 75 years at screening. For all patients, a minimum weight of 40 kg is required
Signed and dated written informed consent and assent in accordance with ICH-GCP and local legislation prior to admission in the trial
Women of childbearing potential (WOCBP)1 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. A list of contraception methods meeting these criteria is provided in the Clinical Trial Protocol (CTP) as well as in the patient, parent(s) (or patient's legal guardian) information
Further inclusion criteria apply

Exclusion Criteria

Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome
Patients with primary erythrodermic psoriasis vulgaris
Severe, progressive, or uncontrolled hepatic disease, defined as >3-fold Upper Limit of Normal (ULN) elevation in Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) or alkaline phosphatase, or >2-fold ULN elevation in total bilirubin
Treatment with
Any restricted medication as specified in the CTP, or any drug considered likely to interfere with the safe conduct of the study, as assessed by the investigator
Any prior exposure to BI 655130 or another IL36R inhibitor biologic
Increased risk of infectious complications (e.g. recent pyogenic infection, any congenital or acquired immunodeficiency (e.g. HIV), past organ or stem cell transplantation), as assessed by the investigator
Relevant chronic or acute infections including active tuberculosis, human immunodeficiency virus (HIV) infection or viral hepatitis at the time of randomization. A patient can be re-screened if the patient was treated and is cured from the acute infection
Active or Latent Tuberculosis (TB)
Patients with active tuberculosis should be excluded
Patients with a positive QuantiFERON (or if applicable, T-Spot) TB test during screening are excluded, unless the patient had previous diagnosis of active or latent TB and has completed appropriate treatment per the discretion of the local investigator within the last 3 years and at the latest at the time of screening (i.e. 2 to 4 weeks before study drug administration); patients may be re-screened once to meet this criterion)
Patients with suspected false positive or indeterminate QuantiFERON (or if applicable, T-Spot) TB result may be re-tested once
If QuantiFERON (or if applicable, T-Spot) TB testing is not available or provides indeterminate results after repeat testing, a tuberculin skin test (TST) can be performed: A TST reaction of 10mm (5mm if receiving 15mg/d prednisone or its equivalent) is considered positive
History of allergy/hypersensitivity to the systemically administered trial medication agent or its excipients
Further exclusion criteria apply
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