New RA drug BMS-986454 enters early human testing
NCT ID NCT07171983
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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All India Institute of Medical Sciences (AIIMS) - Nagpur
RECRUITINGNagpur, Maharashtra, 441108, India
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Apollo Hospitals Ahmedabad
RECRUITINGAhmedabad, Gujarat, 382428, India
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Kalinga Institute of Medical Sciences- Bhubaneswar
RECRUITINGBhubaneswar, Odisha, 751024, India
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Krishna Institute of Medical Sciences Limited
RECRUITINGSecunderabad, Telangana, 500003, India
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Life Point Mutispecialty Hospital Pvt. Ltd.
RECRUITINGPune, Maharashtra, 411057, India
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Local Institution - 0002
NOT_YET_RECRUITINGHyderabad, Telangana, 500004, India
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Local Institution - 0003
NOT_YET_RECRUITINGBangalore, Karnataka, 560 034, India
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Local Institution - 0009
NOT_YET_RECRUITINGMysuru, Karnataka, 5700004, India
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Nizams Institute Of Medical Sciences
RECRUITINGHyderabad, Andhra Pradesh, 500 082, India
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