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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

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: 27/05/2025

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