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BMS-986553

Phase 1

Systemic Lupus Erythematosus | Small molecule | Other |Bristol-Myers Squibb Company|Trials Updated: Oct 14, 2026

BMS-986553 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

BMS-986553 clinical trials

BMS-986553 · 1 trial · 6 indications

Phase 1 1
NCT07873931A Study of BMS-986553 in Participants With Refractory Autoimmune DiseasesSystemic Lupus Erythematosus
NOT YET_RECRUITING60 Analytics
PHASE1NOT YET_RECRUITING
A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases
Systemic Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with treatment emergent adverse events (TEAEs)
Up to approximately 90 days post BMS-986553 infusion
Number of participants with serious adverse events (SAEs)
Up to approximately 90 days post BMS-986553 infusion
Number of participants with adverse events of special interest (AESIs)
Up to approximately 90 days post BMS-986553 infusion
Number of participants with clinically significant laboratory abnormalities
Up to approximately 90 days post BMS-986553 infusion
Number of participants with dose limiting toxicities (DLTs) that occur in DLT evaluation period
28 days after first infusion of BMS-986553

Secondary Endpoints

Maximum observed blood concentration (Cmax) of BMS-986553
Up to approximately week 96
Time of maximum observed blood concentration (Tmax) of BMS-986553
Up to approximately week 96
Area under the curve (AUC) of BMS-986553
Up to approximately week 96
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BMS-986553EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986553DRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

Inclusion Criteria: * SLE participants: Must have diagnosis of SLE defined as fulfilling the 2019 ACR/EULAR classification criteria of SLE. * IIM participants: Must have diagnosis of IIM defined as fulfilling the 2017 ACR/EULAR classification criteria for probable or definite IIM. * SSc participant...

Countries:United StatesBelgiumFranceGermanyNetherlandsPoland
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Recent Changes (Last 90 Days)

LOWOct 14, 2026NCT07873931NEW_TRIAL: changed
LOWOct 14, 2026NCT07873931NEW_TRIAL: changed

Frequently asked questions about BMS-986553

What is BMS-986553?

BMS-986553 is an investigational small molecule drug being developed by Bristol-Myers Squibb Company for systemic lupus erythematosus and other autoimmune conditions. It is in Phase 1 clinical development and has not been approved by the FDA. It is being studied in a single early-stage trial that has not yet begun recruiting participants.

What is BMS-986553 used for?

BMS-986553 is being studied for systemic lupus erythematosus, along with Sjogren's disease, rheumatoid arthritis, idiopathic inflammatory myopathies, systemic sclerosis, and lupus nephritis. These are the conditions listed in its ongoing clinical program. It is investigational, so it is not currently approved for any use, and its use is limited to research settings.

Who makes BMS-986553?

Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, is developing BMS-986553. The company is the sponsor of the drug's clinical program in autoimmune diseases. The compound is a small molecule in Phase 1 development.

What phase is BMS-986553 in?

BMS-986553 is in Phase 1 clinical development. It is an investigational drug and is not FDA approved. The program consists of one Phase 1 trial that is not yet recruiting, with a planned enrollment of 60 participants. No trials of BMS-986553 have been completed.

What clinical trials is BMS-986553 in?

BMS-986553 is being evaluated in one Phase 1 trial, NCT07873931, titled A Study of BMS-986553 in Participants With Refractory Autoimmune Diseases. The trial is not yet recruiting and plans to enroll 60 participants across the United States, Belgium, France, Germany, the Netherlands, and Poland. It is an uncontrolled study open to adults 18 years and older.