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branebrutinib

Phase 2

Autoimmune Disorder | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Jan 16, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment119
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04186871Study 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 ArthritisPHASE2 COMPLETED 119Jan 7, 2020Dec 5, 2022Jan 16, 202481 United States, Argentina +8
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Study Endpoints
Primary Endpoints
The Percent of Participants With mCLASI Response at Week 24 and Corticosteroid (CS) < 10 mg/Day at Week 20 and Week 24 - SLE
Week 24

mCLASI response is defined as a decrease of ≥ 50% from baseline mCLASI activity score, in participants with a baseline mCLASI activity score ≥ 10, at Week 24. Baseline values are defined as the last nonmissing value prior to the first dose of study treatment. To be considered as meeting the second criterion, the CS (prednisone or equivalent) dose had to remain stable and ≤ 10 mg from Week 16 until Week 24. The modified CLASI (mCLASI) is defined as the activity portions of CLASI that describe skin erythema and scale/hypertrophy and inflammation of the scalp. The percentage of patients who entered the study with a positive mCLASI activity score (≥ 10) and who achieved a ≥ 50% decrease from baseline at Week 24 is considered to likely represent a clinically meaningful improvement. The scores are calculated by simple addition based on the extent of the symptoms. mCLASI: Modified Cutaneous Lupus Erythematosus Disease Area and Severity Index

The Percent of Participants With Composite Response at Week 24 - pSS
Week 24

Composite response is defined as the percent of participants with at least 3 of the following at Week 24: * Decrease of ≥ 1 point or 15% from baseline in the ESSPRI Total Score * Decrease of ≥ 3 points from baseline in ESSDAI score * Decrease of ≥ 25% from baseline in ocular staining score, or if normal score at baseline no change to abnormal * Increase of ≥ 25% from baseline in stimulated salivary flow * Improvement in one or more serological markers (rheumatoid factor (RF), immunoglobulin G protein (IgG), complement C3 or C4, cryoglobulin).

Percent of Participants With ACR50 Response at Week 12 Compared to Baseline - RA
Week 12

ACR50 response is defined as both improvement of 50% in the number of tender and swollen joints and a 50% improvement in 3 of the following 5 criteria: * Subject global assessment (SGA) * Physician global assessment (PGA) * Functional ability measure * Pain visual analog scale (VAS) * Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP). Baseline values are defined as the last nonmissing value prior to the first dose of study treatment.

Secondary Endpoints
Change From Baseline in SLEDAI-2K Score at Week 24 - SLE
Week 24
Percent of Participants With BICLA Response at Week 24 - SLE
Week 24
Change From Baseline in DAS28-CRP at Week 12 - RA
Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Systemic Lupus Erythematosus (SLE): branebrutinibEXPERIMENTAL -
SLE: placeboPLACEBO_COMPARATOR -
Primary Sjögren's Syndrome (pSS): branebrutinibEXPERIMENTAL -
pSS: placeboPLACEBO_COMPARATOR -
Rheumatoid Arthritis (RA): branebrutinib followed by abataceptEXPERIMENTAL -
RA: placebo followed by abataceptPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
branebrutinibDRUGSpecified dose on specified days
abataceptDRUGSpecified dose on specified days
branebrutinib placeboDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites81

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)...

Countries:United StatesArgentinaBelgiumFranceGermanyMexicoNetherlandsPolandSpainUnited Kingdom
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