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Trial number: 2022-502361-15-00 Overall trial status: Ongoing, recruitment ended Trial title: An Open-Label, Multi-Center Extension Study to Characterize the Long-Term Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Plaque Psoriasis Medical conditions: Moderate-to-Severe Plaque Psoriasis Status in each country: Hungary:Ongoing, recruitment ended, Germany:Ongoing, recruitment ended, Sweden:Ongoing, recruitment ended, France:Ongoing, recruitment ended, Poland:Ongoing, recruitment ended, Finland:Ongoing, recruitment ended, Spain:Ongoing, recruitment ended, Czechia:Ongoing, recruitment ended Trial phase: Therapeutic confirmatory (Phase III) Therapeutic Areas: Diseases [C] - Skin and Connective Tissue Diseases [C17] Primary end point: Adverse events and serious adverse events Secondary end point: sPGA 0/1 response, PASI 75 response Age of participants: 65+ years, 18-64 years Gender of participants: Female, Male Trial region: In both EEA and non-EEA Planned number of participants: 664 Sponsor: Bristol Myers Squibb International Corporation Sponsor type: Pharmaceutical company Trial product: Placebo to match BMS 986165 tablet, deucravacitinib Results posted: No Overall decision date: 05/04/2024 Countries decision date: FR: 21/05/2024, HU: 05/04/2024, PL: 12/04/2024, CZ: 09/04/2024, ES: 09/04/2024, FI: 09/04/2024, SE: 05/04/2024, DE: 10/04/2024 Last updated date: 27/05/2025Den kompletten Artikel zeigen

Trial number: 2022-501362-22-00 Overall trial status: Ended Trial title: 22104: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2b/3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Active Psoriatic Arthritis Medical conditions: Psoriatic Arthritis Status in each country: Hungary:Ended, Czechia:Ended, Poland:Ended, Spain:Ended, Germany:Ended, Bulgaria:Ended Trial phase: Phase II and Phase III (Integrated) Therapeutic Areas: Diseases [C] - Musculoskeletal Diseases [C05] Primary end point: ACR50 at Week 16 Secondary end point: • Resolution of enthesitis (LEI = 0) at Week 16 • PsAID response at Week 16 • PASI90 at Week 16 • HAQ-DI change from baseline to Week 16 • ACR20 at Week 16 • TEAEs, events of interest, and SAEs • Laboratory values and vital signs at collected timepoints • Treatment-emergent ADAs Age of participants: 18-64 years, 65+ years Gender of participants: Female, Male Trial region: In both EEA and non-EEA Planned number of participants: 78 Sponsor: Acelyrin Inc., Acelyrin Inc. Sponsor type: Pharmaceutical company, Pharmaceutical company Trial product: Izokibep, Placebo Results posted: Yes Overall decision date: 29/03/2023 Countries decision date: PL: 03/04/2023, DE: 29/03/2023, HU: 30/03/2023, ES: 03/04/2023, CZ: 30/03/2023, BG: 03/04/2023 Last updated date: 16/10/2024Den kompletten Artikel zeigen