drugset / Trial / NCT04186871

Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

Phase 2 Completed 119 enrolled Bristol-Myers Squibb

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).

Timeline

Start: 2020-01-07
Primary completion: 2022-12-05
Completion: 2022-12-05

Outcome

Missed primary endpoint

registry analysis (superiority test); SLE- Placebo vs SLE- Branebrutinib; p = 0.3117; Odds Ratio (OR) 0.32 (95% CI 0.04 to 2.73); Cochran-Mantel-Haenszel NCT04186871 ↗

registry analysis (superiority test); pSS- Placebo vs pSS- Branebrutinib; Response Difference -11.9 (95% CI -57.1 to 33.3) NCT04186871 ↗

registry analysis (superiority test); pSS- Placebo vs pSS- Branebrutinib; p = 0.5930; Odds Ratio (OR) 0.40 (95% CI 0.02 to 10.02); Cochran-Mantel-Haenszel NCT04186871 ↗

registry analysis (superiority test); RA- Placebo vs RA- Branebrutinib; p = 0.1639; Odds Ratio (OR) 0.46 (95% CI 0.15 to 1.39); Chi-squared NCT04186871 ↗

paper The primary endpoint of ACR50 response at week 12 was not met PMID 42081904 ↗

Publications

Ostergaard M, Haavardsholm EA, Nowak M, Luo Y, Landis J, Fura A, Pachai C, Rotich D, Wang-Fischer Y, Carayannopoulos LN, Zammit D, Karabeber H, Wang A, Grasela DM. Efficacy and safety of branebrutinib (BMS-986195), an irreversible Bruton's tyrosine kinase inhibitor, for the treatment of rheumatoid arthritis: a phase 2a, randomised, double-blind, placebo-controlled study. Lancet Rheumatol. 2026 Jul;8(7):e539-e549. doi: 10.1016/S2665-9913(25)00374-1. Epub 2026 May 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Abatacept	Other / unclassified	—	—
Subject	Branebrutinib	Small molecule	9 mg	Oral