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

NCT07171983 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IM055-1014
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis (RA); Autoimmune Disease; Chronic Inflammatory Disease; Methotrexate-Inadequate Responders (MTX-IR)

Outcome Measures

Primary Outcomes (6)

• 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

• Number of participants with vital sign measurement findings

  Up to 6 months

• Number of participants with 12-lead electrocardiogram (ECG) findings

  Up to 6 months

• Number of participants with clinical laboratory test findings

  Up to 6 months

Secondary Outcomes (13)

• Maximum observed concentration (Cmax)

  Up to 6 months

• Concentration at the end of a dosing interval (Ctau)

  Up to 6 months

• Trough observed plasma concentration (Ctrough)

  Up to 6 months

• Time of maximum observed concentration (Tmax)

  Up to 6 months

• Area under the curve over the dosing interval (AUC(TAU))

  Up to 6 months

Study Arms (4)

Part A: Administration of BMS-986454

EXPERIMENTAL

Drug: BMS-986454

Part A: Placebo

PLACEBO COMPARATOR

Other: Placebo

Part B: Administration of BMS-986454

EXPERIMENTAL

Drug: BMS-986454

Part B: Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

BMS-986454 DRUG

Specified dose on specified days

Part A: Administration of BMS-986454; Part B: Administration of BMS-986454

Placebo OTHER

Specified dose on specified days

Part A: Placebo; Part B: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (9)

Local Institution - 0006

Hyderabad, Andhra Pradesh, 500 082, India

NOT YET RECRUITING

Local Institution - 0004

Ahmedabad, Gujarat, 382428, India

NOT YET RECRUITING

Local Institution - 0003

Bangalore, Karnataka, 560 034, India

NOT YET RECRUITING

Local Institution - 0009

Mysuru, Karnataka, 5700004, India

NOT YET RECRUITING

Local Institution - 0008

Nagpur, Maharashtra, 441108, India

NOT YET RECRUITING

Life Point Mutispecialty Hospital Pvt. Ltd.

Pune, Maharashtra, 411057, India

RECRUITING

Local Institution - 0007

Bhubaneswar, Odisha, 751024, India

NOT YET RECRUITING

Local Institution - 0002

Hyderabad, Telangana, 500004, India

NOT YET RECRUITING

Local Institution - 0001

Secunderabad, Telangana, 500003, India

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Arthritis, Rheumatoid; Autoimmune Diseases

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

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

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 15, 2025
• Study Start: February 27, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): August 25, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

IN (9)