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BMS-986195

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Bristol-Myers Squibb Company|Trials Updated: Jan 16, 2024

BMS-986195 development status

Highest phase Phase 2 (NCT04186871)
Phase scored for BMYPhase 1
Registered trials 8 across 1 sponsor since Mar 2016

BMS-986195 target and mechanism

ModalitySmall molecule

Also known as Branebrutinib

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials5
Total Enrollment666

FDA Designations

No designations recorded

BMS-986195 clinical trials

BMS-986195 · 5 trials · 4 indications

Phase 2 1Phase 1 4
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 ArthritisAutoimmune Disorder
COMPLETED119 Analytics
PHASE2COMPLETED
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
Autoimmune DisorderUnlock trial analytics

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.

Maximum concentration (Cmax) derived from plasma concentration versus time
Approximately 1 day
Area under the plasma concentration-time curve to the end of the dosing period [AUC(tau)] derived from plasma concentration versus time
Approximately 1 day
Maximum observed plasma concentration (Cmax)
Up to 16 days
Time to attain maximum observed plasma concentration (tmax)
Up to 16 days
Area under the plasma concentration-time curve up to time t, where t is the last point with concentrations above the lower limit of quantitation [AUC(t-0)]
Up to 16 days
Area under the plasma concentration-time curve from time 0 to infinity calculated as: AUC0-inf = AUC0-t + Ĉlast/kel [AUC(0-inf)]
Up to 16 days
Percentage of estimated part for the calculation of AUC0-inf (%AUCextra)
Up to 16 days
Terminal elimination rate constant (kel)
Up to 16 days
Terminal elimination half life, calculated as 0.693/kel (t1/2)
Up to 16 days
Apparent oral clearance, calculated as dose/AUC0-inf (CL/F)
Up to 16 days
Apparent volume of distribution at terminal phase (Vz/F)
Up to 16 days
Ratio of AUC0-inf of BMS-986195 relative to total radioactivity (TRA) (%)
Up to 16 days
Ratio of AUC0-inf of plasma TRA relative to blood TRA (%)
Up to 16 days
Cumulative amount of TRA excreted in urine (Aeurine)
Up to 16 days
Cumulative amount of TRA excreted in feces (Aefeces)
Up to 16 days
Cumulative amount of TRA excreted in bile (Aebile)
Up to 16 days
Total amount of TRA excreted, calculated as Aetotal = Aeurine + Aefeces
Up to 16 days
Fraction of the dose administered excreted in urine (feurine)
Up to 16 days
Fraction of the dose administered excreted in feces (fefeces)
Up to 16 days
Fraction of the dose administered excreted in bile (febile)
Up to 16 days
Fraction of the dose administered excreted in urine and feces (fetotal)
Up to 16 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Up to 26 days

Measured by plasma concentrations

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to 26 days

Measured by plasma concentrations

Safety and tolerability of single oral dose of BMS-986195 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
Up to 8 days during and after last dose
Safety and tolerability of multiple oral doses of BMS-986195 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
Up to 21 days during and after last dose

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 -
BMS-986195 and Oral ContraceptiveEXPERIMENTALOral administration of contraceptive, then progress to combination
BMS-986195EXPERIMENTALA single oral solution dose of BMS-986195
MethotrexateEXPERIMENTALMethotrexate single oral dose followed by leucovorin single oral dose on specified days followed by BMS-986195 coadministered with methotrexate single oral dose followed by leucovorin single oral dose on specified days
Cytochrome P450 and Transporter SubstratesEXPERIMENTALCaffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days, BMS-986195 multiple oral dose administration on specified days, and BMS-986195 coadministered with caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin single oral dose on specified days.
Single Ascending Dose (SAD)PLACEBO_COMPARATORSingle ascending dose of BMS-986195 or Placebo matching BMS-986195
Multiple Ascending Dose(MAD)PLACEBO_COMPARATORMultiple ascending dose of BMS-986195 or Placebo matching BMS-986195
Japanese-Multiple Ascending Dose(MAD)PLACEBO_COMPARATORMultiple ascending dose of BMS-986195 or Placebo matching BMS-986195 in subjects with Japanese heritage
Relative Bioavailability with Food Effects (Open Label)EXPERIMENTAL -

Interventions

NameTypeDescription
branebrutinibDRUGSpecified dose on specified days
abataceptDRUGSpecified dose on specified days
branebrutinib placeboDRUGSpecified dose on specified days
BMS-986195DRUGOral administration of specified dose on specified days
Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)DRUGOral Contraceptive
MethotrexateDRUGSpecified dose on specified days
LeucovorinDRUGSpecified dose on specified days
CaffeineDRUGSpecified dose on specified days
MontelukastDRUGSpecified dose on specified days
FlurbiprofenDRUGSpecified dose on specified days
OmeprazoleDRUGSpecified dose on specified days
MidazolamDRUGSpecified dose on specified days
DigoxinDRUGSpecified dose on specified days
PravastatinDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified day
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Eligibility Criteria

Age Range18 Years to 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 KingdomAustralia
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Frequently asked questions about BMS-986195

What is BMS-986195 used for?

BMS-986195 is an investigational small molecule being developed for rheumatoid arthritis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being studied in healthy volunteers to evaluate its safety, tolerability, and interactions with other medications.

Who makes BMS-986195?

BMS-986195 is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in healthy subjects.

What phase is BMS-986195 in?

BMS-986195 is in Phase 1 clinical development. All four clinical trials for this drug have been completed, with no active trials currently ongoing. The drug remains investigational and has not received FDA approval for any indication.

What clinical trials is BMS-986195 in?

BMS-986195 has completed four Phase 1 clinical trials: NCT02705989, a safety and bioavailability study in healthy subjects; NCT03131973, a drug interaction study with methotrexate and other medications; NCT03245515, a study in healthy male subjects; and NCT03262740, a study with an oral contraceptive in healthy female subjects.

Is BMS-986195 the same as any other drug?

No alternative names for BMS-986195 have been identified. The drug is referred to solely by its development code BMS-986195 in clinical trial registries and available information.