Status:
COMPLETED
Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Generalized Pustular Psoriasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate efficacy, safety, and tolerability of spesolimab (BI 655130) compared to placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe ...
Eligibility Criteria
Inclusion
- Patients with GPPGA of 0 or 1 and a known and documented history of GPP per European Rare And Severe Psoriasis Expert Network (ERASPEN) criteria regardless of IL36RN mutation status, with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above ULN) OR
- \-- Patients with an acute flare of moderate to severe intensity meeting the (ERASPEN) criteria of GPP with a known and documented history of GPP (per ERASPEN criteria) regardless of IL36RN mutation status, with previous evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above ULN)
- Male or female patients, aged 18 to 75 years at screening.
- Signed and dated written informed consent prior to admission to the study in accordance with ICH GCP and local legislation prior to start of any screening procedures.
- Women of childbearing potential 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. Note: A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is not a method of permanent sterilization. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause
- Further inclusion criteria apply
Exclusion
- Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome.
- Patients with primary erythrodermic psoriasis vulgaris.
- Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques.
- Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP).
- 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 renal failure.
- Severe, progressive, or uncontrolled hepatic disease, defined as \>3- fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or \>2-fold ULN elevation in total bilirubin.
- Further exclusion criteria apply
Key Trial Info
Start Date :
January 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2021
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03782792
Start Date
January 31 2019
End Date
January 5 2021
Last Update
October 16 2025
Active Locations (37)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Miami
Miami, Florida, United States, 33125
3
University of South Florida
Tampa, Florida, United States, 33612
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029