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Afimetoran

Phase 2

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

Target and mechanism

Molecular targetTLR7, TLR8
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment248

FDA Designations

No designations recorded

Clinical trial landscape

Afimetoran · 3 trials · 3 indications

Phase 2 1Phase 1 2
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
Maximum observed plasma concentration (Cmax)
Up to 20 Days
Time to attain maximum observed plasma concentration (Tmax)
Up to 20 Days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
Up to 20 Days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 53 days

Parts 1 and 2

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 -
Afimetoran, followed by famotidine + afimetoranEXPERIMENTAL -
Famotidine + afimetoran, followed by afimetoranEXPERIMENTAL -
AfimetoranEXPERIMENTAL -
Famotidine, followed by afimetoranEXPERIMENTAL -
Part 1: Afimetoran followed by phenytoin + afimetoranEXPERIMENTAL -
Part 2: Midazolam followed by afimetoran + midazolamEXPERIMENTAL -

Interventions

NameTypeDescription
AfimetoranDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
FamotidineDRUGSpecified dose on specified days
PhenytoinDRUGSpecified dose on specified days
MidazolamDRUGSpecified 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
MEDIUMJun 13, 2026NCT05866627TRIAL_REMOVED: changed
MEDIUMJun 13, 2026NCT05866627TRIAL_REMOVED: changed
MEDIUMJun 13, 2026NCT05866627TRIAL_REMOVED: changed
MEDIUMJun 13, 2026NCT05866627TRIAL_REMOVED: changed

Frequently asked questions about Afimetoran

What is Afimetoran used for?

Afimetoran is an investigational small molecule being studied for the treatment of Systemic Lupus Erythematosus (SLE). It is also being evaluated in healthy volunteers and healthy participants in drug interaction studies. The drug is currently in clinical development and is not approved by the FDA.

Who is developing Afimetoran?

Afimetoran is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's efficacy, safety, and pharmacokinetics in patients with Systemic Lupus Erythematosus and in healthy participants.

What phase is Afimetoran in?

Afimetoran is in clinical development. A Phase 2 trial in Systemic Lupus Erythematosus is active but not recruiting participants, and two Phase 1 drug interaction studies in healthy participants have been completed. The drug remains investigational and has not received FDA approval.

What clinical trials is Afimetoran in?

Afimetoran is being studied in three clinical trials. NCT04895696 is a Phase 2 trial in Systemic Lupus Erythematosus with 248 participants, active but not recruiting. NCT05866627 is a completed Phase 1 study in healthy volunteers, and NCT05901714 is a completed Phase 1 study in healthy participants.

Is Afimetoran the same as BMS-986256?

Afimetoran is also known as BMS-986256. This alternative name is used in some research contexts. The drug is being developed by Bristol-Myers Squibb for Systemic Lupus Erythematosus and is currently in Phase 2 clinical trials.