Status:
ACTIVE_NOT_RECRUITING
A Study to Test Whether Spesolimab Helps People With Generalized Pustular Psoriasis (GPP) Who Need Treatment for Repeated Flares
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Generalized Pustular Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06013969
Start Date
October 22 2023
End Date
August 14 2026
Last Update
December 19 2025
Active Locations (35)
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1
University of California Irvine
Irvine, California, United States, 92697
2
Red River Research Partners, LLC
Fargo, North Dakota, United States, 58103
3
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
4
Westmead Hospital
Westmead, New South Wales, Australia, 2145