Generalized Pustular Psoriasis (GPP)
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1a) 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 1b) 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). OR 1c) Patients with first episode of an acute GPP flare of moderate to severe intensity with evidence of fever, and/or asthenia, and/or myalgia, and/or elevated C-reactive protein, and/or leucocytosis with peripheral blood neutrophilia (above ULN). For these patients the diagnosis will be confirmed retrospectively by a central external expert/committee. 2. Patients may or may not be receiving background treatment with retinoids and/or methotrexate and/or cyclosporine. Patients must discontinue retinoids/methotrexate/cyclosporine prior to receiving the first dose of BI 655130/ placebo
Exclusion criteria
Exclusion criteria: 1. Patients with SAPHO (Synovitis-acne-puatulosis-hyperostosis-osteitis) syndrome. 2. Patients with primary erythrodermic paoriasis vulgaris. 3. Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques. 4. Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP). 5. 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. 6. Severe, progressive, or uncontrolled hepatic disease, difined as >3-fold Upper Limit of Normal (ULN) elevation in AST or ALT or alkaline phosphatase, or 2-fold ULN elevation in total bilirubin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy - A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation subscore of 0 indicating no visible pustules at Week 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy - A Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) score of 0 or 1 at Week 1. - A Psoriasis Area and Severity Index for Generalized Pustular Psoriasis (GPPASI) 75 at Week 4. - Change from baseline in Pain Visual Analog Scale (VAS) score at Week 4. - Change from baseline in Psoriasis Symptom Scale (PSS) score at Week 4. - Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score at Week 4. | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America
Outcome results
None listed