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
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