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

At a glance

Phase

Phase 1

Study type

Interventional

Sponsor

Bristol-Myers Squibb

Enrolment target

46

Started

27 February 2026

Main results due (estimated)

28 June 2027

Study ends (estimated)

25 August 2027

Allocation

Randomized

Design

Parallel

Purpose

Treatment

Masking

Double (participant, investigator)

Sites

9 · 9 in India

First posted

15 September 2025

Registry updated

1 October 2026

Can you take part?

• Ages 18 years to 65 years.
• Open to any sex.
• You need the condition being studied. Healthy volunteers are not accepted.

Age groups: adult, older adult.

These are the headline rules. Every study has a longer list, and whether you are eligible is decided by the research team at the site, never by this page.

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.

What this study is about

In the sponsor’s own words, from the registry.

Keywords: Rheumatoid Arthritis (RA) · Autoimmune Disease · Chronic Inflammatory Disease · Methotrexate-Inadequate Responders (MTX-IR)

What participants receive

• Experimental

  Part A: Administration of BMS-986454

  Drug: BMS-986454

• Placebo comparator

  Part A: Placebo

  Other: Placebo

• Experimental

  Part B: Administration of BMS-986454

  Drug: BMS-986454

• Placebo comparator

  Part B: Placebo

  Other: Placebo

What the study measures

Who is running it

Lead sponsor

Bristol-Myers Squibb

Sponsor type

Industry

Responsible party

The sponsor

Organisation

Bristol-Myers Squibb

Data monitoring committee

No

US FDA-regulated drug

Yes

US FDA-regulated device

No

Sponsor's study ID

IM055-1014

• Bristol-Myers Squibb

  Study director

  Bristol-Myers Squibb

Study sites(9)

References and data sharing

• BMS Clinical Trial Information

Participant data shared

Yes

What is shared

Study protocol, Sap, Csr

When

See Plan Description

Access

See Plan Description

Where

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html