Recent Updates
Recently added Catalysts

BMS-986195

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials4
Total Enrollment547

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986195 · 4 trials · 1 indication

Phase 1 4
NCT03262740The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female PatientsRheumatoid Arthritis
COMPLETED58 Analytics
NCT03245515A Study of BMS-986195 in Healthy Male SubjectsRheumatoid Arthritis
COMPLETED24 Analytics
NCT03131973Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and PravastatinRheumatoid Arthritis
COMPLETED26 Analytics
NCT02705989Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy SubjectsRheumatoid Arthritis
COMPLETED439 Analytics
PHASE1COMPLETED
The Effect of BMS-986195 Combined With an Oral Contraceptive (Ethinyl Estradiol/Norethindrone) in Healthy Female Patients
Rheumatoid Arthritis
NCT0326274058
Unlock trial analytics
PHASE1COMPLETED
A Study of BMS-986195 in Healthy Male Subjects
Rheumatoid Arthritis
NCT0324551524
Unlock trial analytics
PHASE1COMPLETED
Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin
Rheumatoid Arthritis
NCT0313197326
Unlock trial analytics
PHASE1COMPLETED
Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
Rheumatoid Arthritis
NCT02705989439
Unlock trial analytics

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
Unlock Study Endpoints

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
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 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
Unlock Eligibility Criteria

Competitive Landscape -Rheumatoid Arthritis 92 trials

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV5PHASE3Adalimumab, Upadacitinib
Bristol-Myers Squibb CompanyBMY6PHASE3Abatacept, Adalimumab, Methotrexate
Eli Lilly and CompanyLLY4PHASE3Baricitinib, Tocilizumab
Johnson & JohnsonJNJ1PHASE3Guselkumab
AstraZeneca PLCAZN4PHASE2AZD1163
Novartis AG Sponsored ADRNVS3PHASE2VAY736 PFS, VAY736 AI
Merck & Co., Inc.MRK2PHASE2Tulisokibart, Methotrexate
AnaptysBio, Inc.ANAB1PHASE2Rosnilimab
Spyre Therapeutics, IncSYRE1PHASE2SPY002-072
Sanofi SA Sponsored ADRSNY2PHASE2Sarilumab SAR153191
Immunovant IncIMVT1PHASE2IMVT-1402
XBiotech, Inc.XBIT1PHASE2Natrunix, Methotrexate
Amgen Inc.AMGN1PHASE2Inebilizumab, Blinatumomab
Artiva Biotherapeutics, Inc.ARTV2PHASE2Allogeneic NK Cells
Gilead Sciences, Inc.GILD1PHASE1GS-0151
Zenas BioPharma, Inc.ZBIO1PHASE1ZB002
Stryker CorporationSYK5N/AUndisclosed
Zimmer Biomet Holdings, Inc.ZBH29N/AUndisclosed
Cullinan Therapeutics, Inc.CGEM1PHASE1CLN-978
Sonoma Pharmaceuticals, Inc.SNOA2PHASE1SBT777101
Unlock Competitive Intelligence

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.