BMS-986454 for adults with rheumatoid arthritis who had an incomplete response to methotrexate.
A 2-Part, Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986454 in Participants With Rheumatoid Arthritis
This trial will test whether BMS-986454 is safe and how the drug behaves in adults with rheumatoid arthritis who did not fully respond to methotrexate.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | methotrexate |
| Locations | 9 sites (Hyderabad, Andhra Pradesh and 8 other locations) |
| Trial ID | NCT07171983 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study gives adults with rheumatoid arthritis doses of BMS-986454 or placebo to measure safety, tolerability, and drug levels. Eligible participants must meet 2010 ACR/EULAR criteria, have disease onset after age 18, at least one swollen hand or wrist joint, and an incomplete response to methotrexate. Participants will be monitored for adverse events and pharmacokinetic measurements over the dosing and follow-up period. The study is sponsored by Bristol-Myers Squibb and conducted at multiple sites in India.
Who should consider this trial
Good fit: Adults with RA (onset after age 18) who meet 2010 ACR/EULAR criteria, have at least one swollen hand or wrist joint, and have an incomplete response to methotrexate are ideal candidates.
Not a fit: People with significant other medical conditions or other non-RA conditions that would increase risk or confound results are unlikely to benefit from participation.
Why it matters
Potential benefit: If shown to be safe and tolerable, BMS-986454 could become a treatment option for people with rheumatoid arthritis who do not respond adequately to methotrexate.
How similar studies have performed: Other biologic and targeted therapies have helped many methotrexate-inadequate responders, but the safety and effects of BMS-986454 itself have not yet been established in patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hyderabad, Andhra Pradesh and 8 other locations
- Local Institution - 0006 — Hyderabad, Andhra Pradesh, India (Not_yet_recruiting)
- Local Institution - 0004 — Ahmedabad, Gujarat, India (Not_yet_recruiting)
- Local Institution - 0003 — Bangalore, Karnataka, India (Not_yet_recruiting)
- Local Institution - 0009 — Mysuru, Karnataka, India (Not_yet_recruiting)
- All India Institute of Medical Sciences (AIIMS) - Nagpur — Nagpur, Maharashtra, India (Recruiting)
- Life Point Mutispecialty Hospital Pvt. Ltd. — Pune, Maharashtra, India (Recruiting)
- Kalinga Institute of Medical Sciences- Bhubaneswar — Bhubaneswar, Odisha, India (Recruiting)
- Local Institution - 0002 — Hyderabad, Telangana, India (Not_yet_recruiting)
- Krishna Institute of Medical Sciences Limited — Secunderabad, Telangana, India (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.