Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis

Completed · Phase 2 · Has a placebo group

Conditions studied: Generalized Pustular Psoriasis

In brief

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 intensity.

Key facts

Study ID

NCT03782792

Run by

Boehringer Ingelheim

People needed

53

Starts

2019-01-31

Expected to finish

2021-01-05

Last updated by the study team

2025-10-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Miami — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• The First Hospital of Dalian Medical University — Dalian, China
• 2nd Affiliated Hosp Zhejiang University College of Medical — Hangzhou, China
• Shanghai Skin Disease Hospital — Shanghai, China
• Huashan Hospital, Fudan University — Shanghai, China
• Tianjin Medical University General Hospital — Tianjin, China
• HOP Saint-André — Bordeaux, France
• HOP Saint-Louis — Paris, France
• HOP Robert Debré — Reims, France
• Charité - Universitätsmedizin Berlin — Berlin, Germany
• Universitätsklinikum Bonn AöR — Bonn, Germany
• Universitätsklinikum Essen AöR — Essen, Germany
• Klinikum der Universität München - Campus Innenstadt — München, Germany
• Nagoya City University Hospital — Aichi, Nagoya, Japan
• Fukuoka University Hospital — Fukuoka, Fukuoka, Japan
• Asahikawa Medical University Hospital — Hokkaido, Asahikawa, Japan
• Tohoku University Hospital — Miyagi, Sendai, Japan
• Tokyo Medical University Hachioji Medical Center — Tokyo, Hachioji, Japan
• Tokyo Medical University Hospital — Tokyo, Shinjuku-ku, Japan
• Hospital Sultanah Aminah — Johor Bahru, Malaysia
• Hospital Sultan Ismail — Johor Bahru, Malaysia
• Hospital Kuala Lumpur — Kuala Lumpur, Malaysia

Full record on ClinicalTrials.gov

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