Generalized Pustular Psoriasis (GPP)
Conditions
Sponsors
Boehringer Ingelheim
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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. 2) Patients with a GPPGA score of 0 or 1 at screening and randomization. 3) Male or female patients, aged 12 to 75 years at screening. For all patients, a minimum weight of 40 kg is required. 4) Signed and dated written informed consent and assent in accordance with ICH-GCP and local legislation prior to admission in the trial. 5) 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 criteria
Exclusion criteria: 1) Patients with SAPHO (Synovitis-acne-pustulosis-hyperostosis-osteitis) syndrome. 2) Patients with primary erythrodermic psoriasis vulgaris. 3) 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. 4) Relevant chronic or acute infections including active tuberculosis, human immunodeficiency virus (HIV) infection or viral hepatitis at the time of randomization. 5) Adolescent patients (12-17 years) with hereditary fructose intolerance (HFI).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Time to first Generalized Pustular Psoriasis (GPP) flare [ Time Frame: up to 48 weeks ] | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy 1) Occurrence of at least one GPP flare [ Time Frame: up to 48 weeks ] 2) Time to first worsening of Psoriasis Symptom Scale (PSS) [ Time Frame: up to 48 weeks ] 3) Time to first worsening of Dermatology Quality of Life Index (DLQI) [ Time Frame: up to 48 weeks ] 4) Sustained remission [ Time Frame: up to 48 weeks ] Defined as a patient with a GPPGA score of 0 or 1 (clear or almost clear) at all visits up to week 48, without intake of rescue medication, or investigator-prescribed Standard of Care (SoC). 5) Occurrence of treatment emergent adverse events (TEAEs) [ Time Frame: up to 64 weeks ] | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed