Study Description

Brief 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).

• Condition or Disease:Primary Sjögren's Syndrome
  Systemic Lupus Erythematosus
  Rheumatoid Arthritis
  Autoimmune Disorder
• Intervention/Treatment: Drug: branebrutinib
  Drug: abatacept
  Drug: branebrutinib placebo
• Phase: Phase 2

Detailed Description

N/A

Study Design

Arms and interventions

Outcome Measures

• Primary Outcome Measures: 1. SLE: mCLASI activity score response [ Time Frame: at 24 weeks ]
  Proportion of participants with a ≥ 50% reduction of mCLASI from baseline
• Primary Outcome Measures: 2. pSS: Proportion of subjects with changes in a composite score that includes ESSPRI (EULAR Sjögren's Syndrome Patient Reported Index), ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index), ocular staining, salivary flow and serological marker [ Time Frame: at 24 weeks ]
  Clinically significant improvements from baseline in ESSPRI, ESSDAI, ocular staining, salivary flow, and serological marker (rheumatoid factor [RF], IgG, complement C3 or C4, cryoglobulin) used in the composite measure.
• Primary Outcome Measures: 3. RA: ACR50 response [ Time Frame: at 12 weeks ]
  Proportion of participants achieving ACR50 response (American College of Rheumatology 50 criteria)
• Secondary Outcome Measures: 1. SLE: SLEDAI-2K score response [ Time Frame: at 24 weeks ]
  Change from baseline in SLEDAI-2K score (Systemic Lupus Erythematosus Disease Activity Index 2000)
• Secondary Outcome Measures: 2. SLE: BILAG-based Composite Lupus Assessment response [ Time Frame: at 24 weeks ]
  Change from baseline in BILAG-based (British Isles Lupus Assessment Group) Composite Lupus Assessment response
• Secondary Outcome Measures: 3. RA: DAS28-CRP response [ Time Frame: at 12 weeks ]
  Change from baseline in DAS28-CRP (Disease Activity Score 28 - C reactive protein)
• Secondary Outcome Measures: 4. RA: DAS28-ESR response [ Time Frame: at 12 weeks ]
  Change from baseline in DAS28-ESR (Disease Activity Score 28 - Erythrocyte Sedimentation Rate)
• Secondary Outcome Measures: 5. RA: SDAI response [ Time Frame: at 12 weeks ]
  Change from baseline in SDAI (Simplified Disease Activity Index)
• Secondary Outcome Measures: 6. RA: CDAI response [ Time Frame: at 12 weeks ]
  Change from baseline in CDAI (Clinical Disease Activity Index)
• Secondary Outcome Measures: 7. RA: ACR20 response [ Time Frame: at 12 weeks ]
  Proportion of participants achieving ACR20 response (American College of Rheumatology 20 criteria)
• Secondary Outcome Measures: 8. RA: ACR70 response [ Time Frame: at 12 weeks ]
  Proportion of participants achieving ACR70 response (American College of Rheumatology 70 criteria)
• Secondary Outcome Measures: 9. SLE, pSS, RA: Safety [ Time Frame: up to 28 weeks ]
  Incidence of Serious Adverse Events, Adverse Events; number of clinically significant changes in lab assessment of blood, number of clinically significant changes in vital sign of body temperature, blood pressure, and respiratory rate; number of clinically significant changes in electrocardiogram.

Eligibility Criteria

Information from the National Library of Medicine

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• Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

More Information

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT04186871 History of Changes
• Other Study ID Numbers: IM014-029, 2019-002205-22
• First Posted: December 5, 2019 Key Record Dates
• Last Update Posted: September 16, 2021
• Last Verified: September 2021
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Syndrome
  Autoimmune Diseases
  Lupus Erythematosus, Systemic Sjogren's Syndrome
  Arthritis, Rheumatoid
  Arthritis