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Bruton's Tyrosine Kinase (BTK) Inhibitor
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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
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 moreSide effects data
From 2022 Phase 2 trial • 119 Patients • NCT0418687120%
Urinary tract infection
13%
Gastroenteritis
13%
Nasopharyngitis
7%
Somnolence
7%
Ventricular extrasystoles
7%
Pharyngotonsillitis
7%
Upper respiratory tract infection
7%
Scratch
7%
Diarrhoea
7%
Myalgia
7%
Atrioventricular block first degree
7%
Sunburn
7%
Dyslipidaemia
7%
Thrombocytopenia
7%
Headache
7%
Urticaria
7%
Rotator cuff syndrome
7%
Pruritus
7%
Dry eye
7%
Dyspnoea
7%
Drug eruption
7%
Otitis media acute
100%
80%
60%
40%
20%
0%
Study treatment Arm
SLE- Placebo
RA- 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
2,691 Previous Clinical Trials
4,097,469 Total Patients Enrolled
108 Trials studying Rheumatoid Arthritis
371,432 Patients Enrolled for Rheumatoid Arthritis