BIIB091
Sponsors
Biogen Idec Research Limited, Biogen
Conditions
Healthy VolunteerHealthy VolunteersRelapsing Forms of Multiple Sclerosis
Phase 1
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
CompletedNCT03943056
Start: 2019-05-13End: 2020-01-10Updated: 2021-03-22
Study of BIIB091 Formulations in Healthy Participants
CompletedNCT04564612
Start: 2020-09-28End: 2022-09-07Updated: 2023-04-18
A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants
CompletedNCT06574828
Start: 2024-08-29End: 2025-03-22Updated: 2025-03-28
A Study to Find Out How Different Forms of BIIB091 is Processed in The Body With and Without Food in Healthy Participants
CompletedNCT06640933
Start: 2024-10-16End: 2025-02-07Updated: 2025-02-18
Phase 2
A Study to Learn About the Safety of BIIB091 and Its Effect on Brain Inflammation When Taken Alone or With Diroximel Fumarate (DRF) in Adults With Relapsing Forms of Multiple Sclerosis (MS)
CompletedNCT05798520
Start: 2023-07-25End: 2026-02-10Updated: 2026-02-20
A 2-Part, Multicenter, Randomized, Blinded, Active-Controlled Phase 2 Study to Sequentially Evaluate the Safety and Efficacy of BIIB091 Monotherapy and BIIB091 Combination Therapy With Diroximel Fumarate in Participants With Relapsing Forms of Multiple Sclerosis
Active, not recruitingCTIS2022-502552-31-00
Start: 2023-10-03Target: 225Updated: 2025-07-21