Overall trial status: Ongoing, recruitment ended
Trial title: EffisayilTM ON: An open-label, long term extension study to assess the safety and efficacy of spesolimab treatment in patients with Generalized Pustular Psoriasis (GPP)
Medical conditions: Generalized Pustular Psoriasis
Status in each country: France:Ongoing, recruitment ended, Italy:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, Belgium:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended
Trial phase: Therapeutic exploratory (Phase II)
Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Primary end point: Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment
Secondary end point: The reoccurrence of a GPP flare defined by GPPGA, Time to first achievement of a GPPGA score of 0 or 1 in patients who received flare rescue treatment, A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit in patients who received flare rescue treatment, Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit in patients who received flare rescue treatment
Age of participants: 65+ years, 0-17 years, 18-64 years
Gender of participants: Female, Male
Trial region: In both EEA and non-EEA
Planned number of participants: 25
Sponsor: Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Sponsor type: Pharmaceutical company, Pharmaceutical company
Trial product: Spesolimab
Results posted: No
Overall decision date: 12/02/2024
Countries decision date: FR: 13/02/2024, DE: 13/02/2024, BE: 19/02/2024, ES: 12/02/2024, IT: 18/03/2024
Last updated date: 20/07/2026
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