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BMS-986195

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Mar 20, 2020

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_CONTROLLEDBiomarker
Total Trials4
Total Enrollment547
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03262740The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female PatientsPHASE1 COMPLETED 58 — — Sep 11, 2017Jan 30, 2018Mar 20, 20202 United States
NCT03245515A Study of BMS-986195 in Healthy Male SubjectsPHASE1 COMPLETED 24 — — Aug 15, 2017Oct 5, 2017Jan 5, 20181 Netherlands
NCT03131973Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and PravastatinPHASE1 COMPLETED 26 — — May 13, 2017Nov 10, 2017Dec 15, 20171 United States
NCT02705989Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy SubjectsPHASE1 COMPLETED 439 — — Aug 18, 2016Aug 16, 2017Jan 30, 20191 Australia
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Study Endpoints
Primary Endpoints
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
Adverse events measured by incidence
Approximately 86 days
Serious adverse events measured by incidence
Approximately 86 days
Number of adverse events (AE)
Up to 16 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
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
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 — 40 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive, * Weight ≥ 50 kg * Negative result for tuberculosis (TB) as evidenced by a QuantiFERON-TB Gold Plus test at screening, or documentation of a negative result within 4 weeks before Cycle 1, Day 1 * Women of childbearin...

Countries:United StatesNetherlandsAustralia
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Competitive Landscape -Rheumatoid Arthritis 97 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV6PHASE3Upadacitinib, Adalimumab, Tocilizumab, Lutikizumab, Ravagalimab
Eli Lilly and CompanyLLY5PHASE3Baricitinib, Tocilizumab, LY3541860, LY4213663, LY4298445
Bristol-Myers Squibb CompanyBMY6PHASE3Abatacept, Adalimumab, Methotrexate, BMS-986528, CC-97540
Johnson & JohnsonJNJ2PHASE3Ustekinumab, Guselkumab
AstraZeneca PLCAZN4PHASE2AZD1163, AZD0120, AZD5492, Surovatamig
Novartis AG Sponsored ADRNVS4PHASE2VAY736 PFS, VAY736 AI, PIT565, Secukinumab
Merck & Co., Inc.MRK2PHASE2Tulisokibart, Methotrexate, MK-1045
Sanofi SA Sponsored ADRSNY3PHASE2Sarilumab SAR153191, SAR448501, Leflunomide
AnaptysBio, Inc.ANAB1PHASE2Rosnilimab
Spyre Therapeutics, IncSYRE1PHASE2SPY002-072
Immunovant IncIMVT1PHASE2IMVT-1402
XBiotech, Inc.XBIT1PHASE2Natrunix, Methotrexate
Amgen Inc.AMGN1PHASE2Inebilizumab, Blinatumomab
Artiva Biotherapeutics, Inc.ARTV2PHASE2Allogeneic NK Cells, AB-101, Rituximab, Cyclophosphamide, Fludarabine
Gilead Sciences, Inc.GILD1PHASE1GS-0151
Zenas BioPharma, Inc.ZBIO1PHASE1ZB002
Stryker CorporationSYK5NAUndisclosed
Sonoma Pharmaceuticals, Inc.SNOA2PHASE1SBT777101
Zimmer Biomet Holdings, Inc.ZBH29NAUndisclosed
Adicet Bio IncACET1PHASE1ADI-001, Fludarabine, Cyclophosphamide
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