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ATI-2138

Phase 2

Atopic Dermatitis | Small molecule | Immunology |Aclaris Therapeutics, Inc.|Last Updated: Mar 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06585202Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic DermatitisPHASE2 COMPLETED 14 — — Aug 19, 2024Mar 31, 2025Mar 12, 20266 United States
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Study Endpoints
Primary Endpoints
Incidence and severity of treatment emergent adverse events (TEAEs)
From baseline up to two weeks after treatment (Day 98)
Secondary Endpoints
Change from baseline Eczema Area and Severity Index (EASI) Over Time
Up to Week 12
Proportions of participants who achieve at least 50%, 75%, and 90% improvement in EASI Over Time
Up to Week 12
Proportion of participants achieving Investigator's Global Assessment-Treatment Success Over Time
Up to Week 12
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ATI-2138EXPERIMENTALATI-2138 oral tablets BID
Interventions
NameTypeDescription
ATI-2138DRUGATI-2138 Oral Tablets BID
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Able to comprehend and willing to sign the IRB approved ICF/assent prior to administration of study-related procedures. * Male patients or non-pregnant, non-nursing female patients 18 to 60 years old, inclusive, at the time of informed consent/assent. * Have at least a 1-year ...

Countries:United States
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Competitive Landscape -Atopic Dermatitis 82 trials
CompanyTickerTrialsLead PhaseDrugs
Eli Lilly and CompanyLLY6PHASE3Baricitinib, corticosteroid, Lebrikizumab, Corticosteroid
AbbVie, Inc.ABBV10PHASE3Upadacitinib, corticosteroids, Dupilumab, Upadacitinib Dose, Dupilumab Dose
Pfizer Inc.PFE12PHASE3Abrocitinib, PF-08049820, PF-07275315, PF-07264660, Midazolam
Sanofi SA Sponsored ADRSNY13PHASE3Amlitelimab, corticosteroids, tacrolimus or pimecrolimus, calcineurin inhibitors, Dupilumab SAR231893
Regeneron Pharmaceuticals, Inc.REGN4PHASE3Dupilumab, REGN20423, dupilumab
Incyte CorporationINCY3PHASE3Ruxolitinib, Vehicle, TCS
Amgen Inc.AMGN1PHASE3Rocatinlimab
Organon & Co.OGN1PHASE3Tapinarof , 1%, Vehicle
Novartis AG Sponsored ADRNVS2PHASE2GIA632, GHZ339
Apogee Therapeutics, Inc.APGE3PHASE2APG777, APG990, Dupilumab
Johnson & JohnsonJNJ1PHASE2JNJ-95597528
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Nektar TherapeuticsNKTR1PHASE2Rezpegaldesleukin
Corvus Pharmaceuticals, Inc.CRVS1PHASE2Soquelitinib
Celldex Therapeutics, Inc.CLDX1PHASE2Barzolvolimab
Evommune, Inc.EVMN1PHASE2EVO756
Aclaris Therapeutics, Inc.ACRS1PHASE2ATI-045
Q32 Bio IncQTTB1PHASE2ADX-914
Turn Therapeutics Inc.TTRX1PHASE2GX-03
Arcutis Biotherapeutics IncARQT1PHASE1ARQ-234
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Recent Changes (Last 90 Days)
MEDIUMMay 21, 2026NCT06585202TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT06585202TRIAL_REMOVED: changed