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ATI-450

Phase 2

Hidradenitis Suppurativa | Small molecule | Dermatology |Aclaris Therapeutics, Inc.|Last Updated: Jan 7, 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
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment95
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05216224ATI-450 vs Placebo in Participants With Moderate to Severe Hidradenitis Suppurativa (HS)PHASE2 COMPLETED 95Dec 29, 2021Jan 24, 2023Jan 7, 202620 United States
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Study Endpoints
Primary Endpoints
Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 12
Baseline, Week 12

AN count was the sum of number of abscess and inflammatory nodules across anatomical regions. The least square (LS) mean change from baseline in the count at Week 12 was estimated from the Mixed Model Repeated Measures (MMRM) model.

Secondary Endpoints
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR50) at Week 12
Week 12
Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS-4) at Week 12
Baseline, Week 12
Percentage of Participants Achieving NRS30
Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ATI-450EXPERIMENTALATI-450 50 milligrams (mg) oral tablet twice daily (BID)
PlaceboEXPERIMENTALPlacebo oral tablet BID
Interventions
NameTypeDescription
ATI-450DRUGOral, small molecule MK2 inhibitor
Placebo oral tabletDRUGPlacebo tablet manufactured to match ATI-450 in appearance
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Able to comprehend and be willing to sign the Institutional Review Board (IRB)-approved participant informed consent form prior to administration of any study-related procedures. * Participant must have stable HS. * Total abscesses and/or nodule (AN) count of ≥5 at Baseline vi...

Countries:United States
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