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New RA drug BMS-986454 enters early human testing

NCT ID NCT07171983

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times

Summary

This early-phase trial is testing a new drug called BMS-986454 in 46 adults with rheumatoid arthritis who did not fully respond to methotrexate. The main goal is to check the drug's safety, tolerability, and how it moves through the body. Participants will receive either the drug or a placebo, and researchers will monitor for side effects and measure drug levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BMS-986454
What this could lead to
If this early trial shows the drug is safe and well-tolerated, it could pave the way for larger studies to see if BMS-986454 helps control rheumatoid arthritis symptoms.
What could go wrong
This is a very early Phase 1b study with only 46 participants, focused on safety and drug levels—not yet on effectiveness. The drug may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 46 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • All India Institute of Medical Sciences (AIIMS) - Nagpur

    RECRUITING

    Nagpur, Maharashtra, 441108, India

  • Apollo Hospitals Ahmedabad

    RECRUITING

    Ahmedabad, Gujarat, 382428, India

  • Kalinga Institute of Medical Sciences- Bhubaneswar

    RECRUITING

    Bhubaneswar, Odisha, 751024, India

  • Krishna Institute of Medical Sciences Limited

    RECRUITING

    Secunderabad, Telangana, 500003, India

  • Life Point Mutispecialty Hospital Pvt. Ltd.

    RECRUITING

    Pune, Maharashtra, 411057, India

  • Local Institution - 0002

    NOT_YET_RECRUITING

    Hyderabad, Telangana, 500004, India

  • Local Institution - 0003

    NOT_YET_RECRUITING

    Bangalore, Karnataka, 560 034, India

  • Local Institution - 0009

    NOT_YET_RECRUITING

    Mysuru, Karnataka, 5700004, India

  • Nizams Institute Of Medical Sciences

    RECRUITING

    Hyderabad, Andhra Pradesh, 500 082, India

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