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BMS-986104

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Sep 18, 2015

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02211469A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male SubjectsPHASE1 COMPLETED 41 — — Aug 1, 2014Jul 1, 2015Sep 18, 20151 United States
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Study Endpoints
Primary Endpoints
Incidence of all adverse events (AEs) / serious adverse events (SAEs)
Up to 1 month post discharge
Mean difference in ECG heart rate (HR) nadir values
Up to 4 days postdose
Nadir absolute lymphocyte count (ALC) defined as the lowest ALC measured at any time after the dose
Up to 4 days postdose
Secondary Endpoints
Safety and tolerability based on severity, investigator causality assessment and outcomes of all AEs (regardless of seriousness criteria), association between AEs and study drug exposure parameters, and physical examination
Up to 1 month post discharge
Mean difference in ECG HR values in BMS-986104-treated versus placebo-treated healthy male subjects, identifying nadir ECG HR
Day -1 up to 24h and Days 1-5
Percent reduction in ECG HR
Day -1 up to 24h and Days 1-5
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Panel 1: BMS-986104 or PlaceboEXPERIMENTALBMS-986104 or Placebo single dose by mouth as specified
Panel 2: BMS-986104 or PlaceboEXPERIMENTALBMS-986104 or Placebo single dose by mouth as specified
Panel 3: BMS-986104 or PlaceboEXPERIMENTALBMS-986104 or Placebo single dose by mouth as specified
Panel 4: BMS-986104 or PlaceboEXPERIMENTALBMS-986104 or Placebo single dose by mouth as specified
Interventions
NameTypeDescription
BMS-986104DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 49 Years
SexMALE
Healthy VolunteersYes
Study Sites1

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Healthy male subjects as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligi...

Countries:United States
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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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