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A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis
NCT07171983 · Bristol-Myers Squibb
In plain English
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Official title
A 2-Part, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986454 in Participants With Rheumatoid Arthritis
About this study
The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986454 in participants with Rheumatoid Arthritis
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 design
Enrollment target: 46 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2026-02-27
Estimated completion: 2027-08-25
Last updated: 2026-07-20
Interventions
Drug: BMS-986454Other: Placebo
Primary outcomes
- • Number of participants with adverse events (AEs) (Up to 6 months)
- • Number of participants with serious adverse events (SAEs) (Up to 6 months)
- • Number of participants with physical examination findings (Up to 6 months)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (9)
Nizams Institute Of Medical SciencesRecruiting
Hyderabad, Andhra Pradesh, India
Apollo Hospitals AhmedabadRecruiting
Ahmedabad, Gujarat, India
Local Institution - 0003Not Yet Recruiting
Bangalore, Karnataka, India
Local Institution - 0009Not Yet Recruiting
Mysuru, Karnataka, India
All India Institute of Medical Sciences (AIIMS) - NagpurRecruiting
Nagpur, Maharashtra, India
Life Point Mutispecialty Hospital Pvt. Ltd.Recruiting
Pune, Maharashtra, India
Kalinga Institute of Medical Sciences- BhubaneswarRecruiting
Bhubaneswar, Odisha, India
Local Institution - 0002Not Yet Recruiting
Hyderabad, Telangana, India
Krishna Institute of Medical Sciences LimitedRecruiting
Secunderabad, Telangana, India