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BMS-986326

Phase 1

Dermatitis, Atopic | Small molecule | Dermatology |Bristol-Myers Squibb Company|Trials Updated: May 26, 2026

BMS-986326 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Feb 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment109

FDA Designations

No designations recorded

BMS-986326 clinical trials

BMS-986326 · 2 trials · 2 indications

Phase 1 2
NCT06248814A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic DermatitisDermatitis, Atopic
COMPLETED64 Analytics
NCT06013995A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of LupusLupus
COMPLETED45 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986326 in Participants With Atopic Dermatitis
Dermatitis, AtopicUnlock trial analytics
PHASE1COMPLETED
A Study to Investigate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986326 in Adult Participants With Different Forms of Lupus
LupusUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of participants with adverse events (AEs)
Up to approximately 224 days
Number of participants with serious adverse events (SAEs)
Up to approximately 224 days
Number of participants with clinical laboratory abnormalities
Up to approximately 224 days
Number of participants with vital sign abnormalities
Up to approximately 224 days
Number of participants with electrocardiogram (ECG) abnormalities
Up to approximately 224 days
Number of participants with physical examination abnormalities
Up to approximately 224 days

Secondary Endpoints

Maximum observed concentration (Cmax)
Up to approximately 224 days
Time of maximum observed concentration (Tmax)
Up to approximately 224 days
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Up to approximately 224 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Placebo, followed by BMS-986326 Dose A or Dose BEXPERIMENTAL -
BMS-986326 Dose A, followed by PlaceboEXPERIMENTAL -
BMS-986326 Dose B, followed by PlaceboEXPERIMENTAL -
Cohort A: BMS-986326 Dose 1 IVEXPERIMENTAL -
Cohort B: BMS-986326 Dose 2 IVEXPERIMENTAL -
Cohort C1: BMS-986326 Dose 3 IVEXPERIMENTAL -
Cohort C2: BMS-986326 Dose 3 SCEXPERIMENTAL -
Cohort D2: BMS-986326 Dose 4 SCEXPERIMENTAL -
Cohort E2: BMS-986326 Dose 3 SCEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986326DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
Placebo for BMS-986326OTHERSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Must have diagnosis of atopic dermatitis (AD) at least 12 months prior to screening * Documented history of inadequate response to treatment with topical medication for at least 4 weeks, unless topical treatments are otherwise medically inadvisable, or has required systemic th...

Countries:CzechiaFranceGermanyPolandSpainUnited StatesArgentinaBulgariaNetherlandsRomania
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Frequently asked questions about BMS-986326

What is BMS-986326?

BMS-986326 is an investigational small molecule being developed by Bristol-Myers Squibb for inflammatory skin and autoimmune conditions. It has been studied in Phase 1 clinical trials in adults with atopic dermatitis and in adults with different forms of lupus. It is not an approved therapy and remains in clinical development.

What is BMS-986326 used for?

BMS-986326 has been evaluated in clinical studies for atopic dermatitis and for different forms of lupus. Both are inflammatory conditions, and the trials were designed to assess safety, tolerability, drug levels, and drug effects in adults. No approved use has been established for BMS-986326.

Who makes BMS-986326?

Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, is the developer of BMS-986326. The company sponsored the Phase 1 studies of the compound in atopic dermatitis and lupus.

What phase is BMS-986326 in?

BMS-986326 is in Phase 1 development. Two Phase 1 trials have been completed, one in atopic dermatitis and one in different forms of lupus. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is BMS-986326 in?

BMS-986326 has been studied in two completed Phase 1 trials. NCT06248814 evaluated safety, tolerability, drug levels, and drug effects in participants with atopic dermatitis across Czechia, France, Germany, Poland, and Spain. NCT06013995 studied the same endpoints in adults with different forms of lupus across the United States, Argentina, Bulgaria, Germany, Netherlands, Poland, Romania, and Spain.

How many participants were enrolled in BMS-986326 trials?

The atopic dermatitis trial NCT06248814 enrolled 64 participants, and the lupus trial NCT06013995 enrolled 45 participants. Both were Phase 1, randomized, double-blind, controlled studies in adults aged 18 years and older, and both have been completed.