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NCT Number: NCT07171983

A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nizams Institute Of Medical Sciences, Hyderabad, Andhra Pradesh, India

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with Rheumatoid Arthritis must have onset after age 18.
  • Participants who meet 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA.
  • Participants must have evidence of swelling in at least 1 joint of the hand or wrist by clinical examination at screening and Day -1.
  • Participants must have been an incomplete responder to prior methotrexate (MTX) treatment.

Exclusion criteria

  • Participants must not have any significant medical condition, with the exception of Rheumatoid Arthritis (including but not limited to, neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders) that, in the Investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.
  • Participants must not have any condition aside from RA that confounds the ability to interpret data from the study.
  • Participants must not have severe Rheumatoid Arthritis as assessed by Disease Activity Score 28 c-reactive protein (DAS28-CRP) at screening or Day -1.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BMS-986454

Drug

Specified dose on specified days

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 6 months

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 6 months

  3. Number of participants with physical examination findings

    Time frame: Up to 6 months

  4. Number of participants with vital sign measurement findings

    Time frame: Up to 6 months

  5. Number of participants with 12-lead electrocardiogram (ECG) findings

    Time frame: Up to 6 months

  6. Number of participants with clinical laboratory test findings

    Time frame: Up to 6 months

Secondary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to 6 months

  2. Concentration at the end of a dosing interval (Ctau)

    Time frame: Up to 6 months

  3. Trough observed plasma concentration (Ctrough)

    Time frame: Up to 6 months

  4. Time of maximum observed concentration (Tmax)

    Time frame: Up to 6 months

  5. Area under the curve over the dosing interval (AUC(TAU))

    Time frame: Up to 6 months

  6. Area under the serum concentration time curve extrapolated to infinite time (AUC(INF))

    Time frame: Up to 6 months

  7. Area under the serum concentration time curve from time zero to the last quantifiable concentration (AUC(0-T))

    Time frame: Up to 6 months

  8. Terminal-phase half-life (T-HALF)

    Time frame: Up to 6 months

  9. Accumulation index of the area under the curve over the dosing interval (AI_AUC(TAU))

    Time frame: Up to 6 months

  10. Accumulation index of the maximum observed concentration (AI_Cmax)

    Time frame: Up to 6 months

  11. Apparent total body clearance (CLT/F)

    Time frame: Up to 6 months

  12. Apparent volume of distribution of terminal phase (Vz/F)

    Time frame: Up to 6 months

  13. Number of participants with anti-drug antibody (ADA) formation

    Time frame: Up to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A 2-Part, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986454 in Participants With Rheumatoid Arthritis

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2025
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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