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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

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ClinicalTrials.gov Identifier: NCT04186871
Recruitment Status : Recruiting
First Posted : December 5, 2019
Last Update Posted : August 11, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
Study 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 Intervention/treatment Phase
Autoimmune Disorder Rheumatoid Arthritis Systemic Lupus Erythematosus Primary Sjögren's Syndrome Drug: branebrutinib Drug: abatacept Drug: branebrutinib placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 7, 2020
Estimated Primary Completion Date : June 23, 2022
Estimated Study Completion Date : June 23, 2022


Arm Intervention/treatment
Experimental: SLE: branebrutinib Drug: branebrutinib
specified dose on specified days

Placebo Comparator: SLE: placebo Drug: branebrutinib placebo
specified dose on specified days

Experimental: pSS: branebrutinib Drug: branebrutinib
specified dose on specified days

Placebo Comparator: pSS: placebo Drug: branebrutinib placebo
specified dose on specified days

Experimental: RA: branebrutinib followed by abatacept Drug: branebrutinib
specified dose on specified days

Drug: abatacept
open label 125 mg once weekly

Placebo Comparator: RA: placebo followed by abatacept Drug: abatacept
open label 125 mg once weekly

Drug: branebrutinib placebo
specified dose on specified days




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

  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.

  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)

  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

  3. RA: DAS28-CRP response [ Time Frame: at 12 weeks ]
    Change from baseline in DAS28-CRP (Disease Activity Score 28 - C reactive protein)

  4. RA: DAS28-ESR response [ Time Frame: at 12 weeks ]
    Change from baseline in DAS28-ESR (Disease Activity Score 28 - Erythrocyte Sedimentation Rate)

  5. RA: SDAI response [ Time Frame: at 12 weeks ]
    Change from baseline in SDAI (Simplified Disease Activity Index)

  6. RA: CDAI response [ Time Frame: at 12 weeks ]
    Change from baseline in CDAI (Clinical Disease Activity Index)

  7. RA: ACR20 response [ Time Frame: at 12 weeks ]
    Proportion of participants achieving ACR20 response (American College of Rheumatology 20 criteria)

  8. RA: ACR70 response [ Time Frame: at 12 weeks ]
    Proportion of participants achieving ACR70 response (American College of Rheumatology 70 criteria)

  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.

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 Systemic Lupus Erythematosus

  • Certain other autoimmune diseases and overlap syndromes

Sub-study for primary Sjögren's Syndrome

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

Sub-study for Rheumatoid Arthritis (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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04186871


Locations
Show Show 80 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04186871    
Other Study ID Numbers: IM014-029
2019-002205-22 ( EudraCT Number )
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Sjogren's Syndrome
Lupus Erythematosus, Systemic
Autoimmune Diseases
Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Immune System Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents