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BMS-986256

Phase 2

Lupus Erythematosus, Cutaneous | Small molecule | Immunology |Bristol-Myers Squibb Company|Trials Updated: Jul 30, 2026

BMS-986256 development status

Highest phase Phase 2 (NCT04895696)
Phase scored for BMYPhase 1
Registered trials 11 across 1 sponsor since Aug 2018

BMS-986256 target and mechanism

ModalitySmall molecule

Also known as Afimetoran

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment261

FDA Designations

No designations recorded

BMS-986256 clinical trials

BMS-986256 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT04895696A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus
ACTIVE NOT_RECRUITING248 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Study Evaluating the Efficacy and Safety of Afimetoran Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Systemic Lupus ErythematosusUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of participants that achieve an SLE (Systemic Lupus Erythematosus) Responder Index (4) (SRI(4)) response at Week 48
Up to 48 Weeks
Incidence of Serious Adverse Events (SAEs)
Up to 24 weeks
Incidence of Adverse Events (AEs)
Up to 20 weeks
Number of laboratory test abnormalities: Hematology
Up to 20 weeks
Number of laboratory test abnormalities: Urinalysis
Up to 20 weeks
Number of laboratory test abnormalities: Clinical Chemistry
Up to 20 weeks
Incidence of clinically significant changes in physical examination findings
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Body temperature
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Respiratory rate
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Blood pressure
Up to 20 weeks
Incidence of clinically significant changes in vital signs: Heart rate
Up to 20 weeks
Incidence of clinically significant changes in Electrocardiogram (ECG) parameters
Up to 20 weeks

Secondary Endpoints

Proportion of participants that achieve a British Isles Lupus Assessment Group (BILAG)-based Combine Lupus Assessment (BICLA) response at Week 24 and Week 48
Up to 48 Weeks
Proportion of participants who achieve an SRI(4) response at Week 24
Up to 24 Weeks
Proportion of participants who achieve a Lupus Low Disease Activity State (LLDAS) response at Week 24 and Week 48
Up to 48 Weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Afimetoran: Dose 1EXPERIMENTAL -
Afimetoran: Dose 2EXPERIMENTAL -
Afimetoran: Dose 3EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
BMS-986256EXPERIMENTAL -

Interventions

NameTypeDescription
AfimetoranDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
BMS-986256DRUGSpecified Dose on Specified Days
BMS-986256 PlaceboOTHERSpecified Dose on Specified Days
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites147

Inclusion Criteria: * Diagnosed ≥ 12 weeks before the screening visit and qualify as having SLE according to the SLE International Collaborating Clinics (SLICC) Classification Criteria at the screening visit * Test positive, as determined by the central laboratory, for at least one of the following...

Countries:United StatesArgentinaAustraliaBrazilChileChinaColombiaFranceGermanyIndiaIrelandJapanMexicoPolandPuerto RicoRomaniaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJul 30, 2026NCT04895696Enrollment: 268 → 248
LOWJul 30, 2026NCT04895696Enrollment: 268 → 248

Frequently asked questions about BMS-986256

What is BMS-986256?

BMS-986256 is an investigational small molecule being developed by Bristol-Myers Squibb for cutaneous lupus erythematosus, a form of lupus that affects the skin. It has been studied in a Phase 1 clinical trial and is not approved for any use.

What is BMS-986256 used for?

BMS-986256 is being studied for the treatment of active cutaneous lupus erythematosus, a skin manifestation of lupus. Its only clinical trial enrolled participants with this condition. It is investigational and has not been approved for treating cutaneous lupus or any other indication.

Who makes BMS-986256?

BMS-986256 is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company sponsored the Phase 1 study of the compound in participants with active cutaneous lupus erythematosus.

What phase is BMS-986256 in?

BMS-986256 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The drug remains investigational and has not been approved by the FDA or any other regulatory agency for cutaneous lupus erythematosus.

What clinical trials is BMS-986256 in?

BMS-986256 has been evaluated in one clinical trial, NCT04493541, titled A Study to Assess the Safety and Drug Levels of BMS-986256 in Participants With Active Cutaneous Lupus Erythematosus. The Phase 1 trial was completed, enrolled 13 participants in Germany, and was randomized, double-blind, and placebo-controlled.

How was the BMS-986256 Phase 1 trial designed?

The Phase 1 trial NCT04493541 assessed the safety and drug levels of BMS-986256 in adults with active cutaneous lupus erythematosus. It was a randomized, double-blind, placebo-controlled study that enrolled 13 participants aged 18 years and older in Germany. The trial has been completed.