Tulisokibart
Sponsors
Prometheus Biosciences Inc., Merck Sharp & Dohme LLC, Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions
Arthritis, RheumatoidColitis, UlcerativeCrohn DiseaseCrohn's diseaseCrohn’s Disease or Ulcerative ColitisDiffuse Cutaneous Systemic SclerosisHealthyHidradenitis Suppurativa
Phase 1
Pharmacokinetic (PK) Characterization of Subcutaneous Tulisokibart (MK-7240-010)
CompletedNCT06575595
Start: 2024-09-24End: 2025-01-31Updated: 2025-02-18
Single Dose Study of Tulisokibart (MK-7240) in Healthy Chinese Participants (MK-7240-002)
CompletedNCT06829225
Start: 2024-06-13End: 2024-11-11Updated: 2025-02-17
Phase 2
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
CompletedNCT04996797
Start: 2021-07-14End: 2025-07-14Updated: 2026-09-01
A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006)
CompletedNCT05013905
Start: 2021-07-28End: 2025-05-27Updated: 2026-07-22
Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) (MK-7240-007)
Active, not recruitingNCT05270668
Start: 2022-03-29End: 2029-07-31Updated: 2026-05-18
A Phase 2a, Multi-Center, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of PRA023 in Subjects with Moderately to Severely Active Crohn’s Disease
CompletedCTIS2023-509742-35-00
Start: 2021-11-17End: 2025-06-24Target: 6Updated: 2025-01-27
A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis
CompletedCTIS2023-509741-12-00
Start: 2021-09-23End: 2025-07-15Target: 52Updated: 2025-02-17
Study to Evaluate Tulisokibart for Hidradenitis Suppurativa (MK-7240-012)
Active, not recruitingNCT06956235
Start: 2025-06-09End: 2028-06-06Updated: 2026-09-15
A Clinical Study of Tulisokibart (MK-7240) to Treat Radiographic Axial Spondyloarthritis (MK-7240-013)
RecruitingNCT07133633
Start: 2025-09-26End: 2030-02-05Target: 315Updated: 2026-09-14
A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)
Active, not recruitingNCT07176390
Start: 2025-10-08End: 2029-03-03Target: 182Updated: 2026-06-12
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis
RecruitingCTIS2025-521745-25-00
Start: 2025-11-06Target: 58Updated: 2025-10-31
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)
RecruitingCTIS2025-521059-21-00
Start: 2025-11-25Target: 62Updated: 2025-10-31
Study to Evaluate Tulisokibart in Adults With Psoriatic Arthritis (MK-7240-015)
RecruitingNCT07486960
Start: 2026-04-20End: 2030-01-11Target: 140Updated: 2026-09-14
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Psoriatic Arthritis.
Not yet recruitingCTIS2025-520997-21-00
Target: 37Updated: 2026-04-30
Phase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
RecruitingNCT06651281
Start: 2024-11-25End: 2037-12-17Target: 1380Updated: 2026-09-09
A Phase 3 Extension Study to Evaluate the Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn’s Disease or Ulcerative Colitis
RecruitingCTIS2024-513533-20-00
Start: 2025-02-25Target: 137Updated: 2025-10-09