Phase 2 N=119 Randomized Quadruple-blind Treatment

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

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

Bottom Line

View on ClinicalTrials.gov: NCT04186871 ↗

Enrolled (actual)

119

Serious AEs

0.0%

Results posted

Jan 2024

Primary outcome: Primary: The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE — 60.0; 33.3 Percentage of participants — p=0.3117

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: branebrutinib (Drug); abatacept (Drug); branebrutinib placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE	60.0; 33.3	0.3117
PRIMARY The Percent of Participants With Composite Response at Week 24 - pSS	25; 10	0.5930
PRIMARY Percent of Participants With ACR50 Response at Week 12 Compared to Baseline - RA	33.3; 18.8	0.1639
SECONDARY Change From Baseline in SLEDAI-2K Score at Week 24 - SLE	-7.0; -7.0	—
SECONDARY Percent of Participants With BICLA Response at Week 24 - SLE	20.0; 33.3	—
SECONDARY Change From Baseline in DAS28-CRP at Week 12 - RA	-1.615; -1.542	—
SECONDARY Change From Baseline in DAS28-ESR at Week 12 - RA	-1.758; -1.670	—
SECONDARY Change From Baseline in SDAI at Week 12- RA	-19.430; -18.303	—
SECONDARY Change From Baseline in CDAI at Week 12 - RA	-19.4; -18.0	—
SECONDARY Percent of Participants With ACR20 Response Compared to Baseline at Week 12 - RA	61.9; 57.8	—
SECONDARY Percent of Participants With ACR70 Response Compared to Baseline at Week 12 - RA	14.3; 7.8	—

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).

Eligibility Criteria

Inclusion Criteria

Sub-study for Systemic Lupus Erythematosus (SLE)

Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) classification
Diagnosed with SLE more than 24 weeks before screening visit

Sub-study for primary Sjögren's Syndrome (pSS)

Moderate to severe pSS, meeting ACR-EULAR classification criteria

Sub-study for active Rheumatoid Arthritis (RA)

Moderate to severe adult-onset RA
ACR global functional status class I to III

Women and men must agree to follow instructions for methods of contraception.

Exclusion Criteria

Sub-study for SLE

Certain other autoimmune diseases and overlap syndromes

Sub-study for pSS

Certain other immune-mediated diseases, active fibromyalgia, or other medical conditions

Sub-study for RA

Diagnosis with juvenile arthritis or idiopathic arthritis before age 16

For all sub-studies:

History of any significant drug allergy
Active infection, significant concurrent medical condition, or clinically significant abnormalities

Other protocol defined inclusion/exclusion criteria could apply

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04186871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.