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

NCT ID
NCT07171983
Registry status
Recruiting
Study type
Interventional
Phase
Phase 1
Sponsor
Bristol-Myers Squibb
Conditions
Rheumatoid Arthritis

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 46 participants (Estimated).

What is being studied

  • Drug: BMS-986454
  • Other: Placebo

Who may be eligible

Ages
18 Years to 65 Years
Sex
All
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

9 study locations are listed.

Recruiting site status is explicitly provided for 9 locations; 5 are listed as Recruiting.

Countries: India

  • Andhra Pradesh, India: 1
  • Gujarat, India: 1
  • Karnataka, India: 2
  • Maharashtra, India: 2
  • Odisha, India: 1
  • Telangana, India: 2

Sample of listed locations

  • Nizams Institute Of Medical Sciences — Hyderabad, Andhra Pradesh, 500 082, India — Recruiting
  • Apollo Hospitals Ahmedabad — Ahmedabad, Gujarat, 382428, India — Recruiting
  • All India Institute of Medical Sciences (AIIMS) - Nagpur — Nagpur, Maharashtra, 441108, India — Recruiting
  • Life Point Mutispecialty Hospital Pvt. Ltd. — Pune, Maharashtra, 411057, India — Recruiting
  • Krishna Institute of Medical Sciences Limited — Secunderabad, Telangana, 500003, India — Recruiting
  • Local Institution - 0003 — Bangalore, Karnataka, 560 034, India — Not yet recruiting
  • Local Institution - 0009 — Mysuru, Karnataka, 5700004, India — Not yet recruiting
  • Local Institution - 0007 — Bhubaneswar, Odisha, 751024, India — Active, not recruiting
  • Local Institution - 0002 — Hyderabad, Telangana, 500004, India — Not yet recruiting

Study details

Start date
February 27, 2026
Primary completion date
June 28, 2027
Completion date
August 25, 2027
First posted
September 15, 2025

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07171983
Registry last updated
October 1, 2026
QualifiedStudies registry data refreshed
October 5, 2026
QualifiedStudies record fetched
October 5, 2026

View NCT07171983 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

About joining clinical research

Find clinical trials you may match with

QualifiedStudies can help you search for research opportunities related to your health. Availability of this specific study through QualifiedStudies has not been established.

Find clinical trials you may match with | Clinical trial FAQ