← Back to Search

Bruton's Tyrosine Kinase (BTK) Inhibitor

branebrutinib for Rheumatoid Arthritis

Phase 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24

Summary

This trial is testing branebrutinib, a drug that reduces inflammation, in people with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS). For those with active Rheumatoid Arthritis (RA), the trial will also test if adding abatacept, which prevents immune attacks on the body, provides additional benefits. The goal is to find safer and more effective treatments for these autoimmune diseases.

Eligible Conditions
  • Sjögren's Syndrome
  • Autoimmune Disorders
  • Rheumatoid Arthritis
  • Lupus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of Participants With ACR50 Response at Week 12 Compared to Baseline - RA
The Percent of Participants With Composite Response at Week 24 - pSS
The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE
Secondary study objectives
Change From Baseline in CDAI at Week 12 - RA
Change From Baseline in DAS28-CRP at Week 12 - RA
Change From Baseline in DAS28-ESR at Week 12 - RA
+5 more

Side effects data

From 2022 Phase 2 trial • 119 Patients • NCT04186871
20%
Urinary tract infection
13%
Gastroenteritis
13%
Nasopharyngitis
7%
Rotator cuff syndrome
7%
Somnolence
7%
Drug eruption
7%
Atrioventricular block first degree
7%
Ventricular extrasystoles
7%
Pharyngotonsillitis
7%
Upper respiratory tract infection
7%
Scratch
7%
Headache
7%
Diarrhoea
7%
Myalgia
7%
Otitis media acute
7%
Sunburn
7%
Thrombocytopenia
7%
Dyslipidaemia
7%
Dry eye
7%
Pruritus
7%
Dyspnoea
7%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
RA- Placebo
SLE- Placebo
pSS- Placebo
SLE- Branebrutinib
RA Abatacept
RA- Branebrutinib
pSS- Branebrutinib

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Systemic Lupus Erythematosus (SLE): branebrutinibExperimental Treatment1 Intervention
Group II: Rheumatoid Arthritis (RA): branebrutinib followed by abataceptExperimental Treatment2 Interventions
Group III: Primary Sjögren's Syndrome (pSS): branebrutinibExperimental Treatment1 Intervention
Group IV: pSS: placeboPlacebo Group1 Intervention
Group V: SLE: placeboPlacebo Group1 Intervention
Group VI: RA: placebo followed by abataceptPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
branebrutinib
2020
Completed Phase 2
~120
abatacept
2006
Completed Phase 4
~1180

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,682 Previous Clinical Trials
4,129,450 Total Patients Enrolled
108 Trials studying Rheumatoid Arthritis
371,432 Patients Enrolled for Rheumatoid Arthritis
~20 spots leftby Nov 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top