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

NCT ID: NCT07171983

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-22

Study Completion Date

2027-08-25

Brief Summary

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

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: Administration of BMS-986454

Group Type EXPERIMENTAL

BMS-986454

Intervention Type DRUG

Specified dose on specified days

Part A: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Specified dose on specified days

Part B: Administration of BMS-986454

Group Type EXPERIMENTAL

BMS-986454

Intervention Type DRUG

Specified dose on specified days

Part B: Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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BMS-986454

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0006

Hyderabad, Andhra Pradesh, India

Site Status

Local Institution - 0004

Ahmedabad, Gujarat, India

Site Status

Local Institution - 0003

Bangalore, Karnataka, India

Site Status

Local Institution - 0005

Pune, Maharashtra, India

Site Status

Local Institution - 0007

Bhubaneswar, Odisha, India

Site Status

Local Institution - 0002

Hyderabad, Telangana, India

Site Status

Local Institution - 0001

Secunderabad, Telangana, India

Site Status

Countries

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India

Central Contacts

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BMS Study Connect www.BMSStudyConnect.com

Role: CONTACT

8559073286

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

Role: CONTACT

Facility Contacts

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Site 0006

Role: primary

Site 0004

Role: primary

Site 0003

Role: primary

Site 0005

Role: primary

Site 0007

Role: primary

Site 0002

Role: primary

Site 0001

Role: primary

Related Links

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Other Identifiers

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IM055-1014

Identifier Type: -

Identifier Source: org_study_id

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