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BMS-986104

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986104 · 1 trial · 1 indication

Phase 1 1
NCT02211469A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male SubjectsRheumatoid Arthritis
COMPLETED41 Analytics
PHASE1COMPLETED
A Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986104 in Healthy Male Subjects
Rheumatoid Arthritis
NCT0221146941
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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 to 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 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
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Frequently asked questions about BMS-986104

What is BMS-986104 used for?

BMS-986104 is an investigational small molecule being developed for the treatment of rheumatoid arthritis. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and tolerability in clinical trials.

Who makes BMS-986104?

BMS-986104 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug.

What phase is BMS-986104 in?

BMS-986104 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial has been completed, but the drug remains in early-stage development.

What clinical trials is BMS-986104 in?

BMS-986104 has one completed clinical trial registered under NCT02211469. This was a randomized, placebo-controlled, double-blind, single ascending dose study that evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of BMS-986104 in healthy male subjects. The trial enrolled 41 participants in the United States.

Is BMS-986104 FDA approved?

BMS-986104 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for rheumatoid arthritis. The drug has completed a Phase 1 trial, but it has not yet received regulatory approval and is not available for commercial use.