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

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 119 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Autoimmune Disorder
• Rheumatoid Arthritis
• Systemic Lupus Erythematosus
• Primary Sjögren's Syndrome

Interventions

Type	Name	Description
DRUG	branebrutinib	Specified dose on specified days
DRUG	abatacept	Specified dose on specified days
DRUG	branebrutinib placebo	Specified dose on specified days

Timeline

• Start date: 2020-01-07
• Primary completion: 2022-12-05
• Completion: 2022-12-05
• First posted: 2019-12-05
• Last updated: 2024-01-16
• Results posted: 2024-01-16

Locations

81 sites across 10 countries: United States, Argentina, Belgium, France, Germany, Mexico, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study