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Modzatinib

Phase 2

Lichen Planus | Small Molecules | Other |Aclaris Therapeutics, Inc.|Trials Updated: Nov 13, 2026

Modzatinib development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Sep 2024

Modzatinib target and mechanism

Target class-Tinib (Kinase)
ModalitySmall Molecules

Also known as ATI-2138

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment116

FDA Designations

FAST_TRACK

Modzatinib clinical trials

Modzatinib · 2 trials · 2 indications

Phase 2 2
NCT07935590Study of Modzatinib (ATI-2138) in Adult Participants With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical TherapiesLichen Planus
NOT YET_RECRUITING102 Analytics
NCT06585202Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic DermatitisAtopic Dermatitis
COMPLETED14 Analytics
PHASE2NOT YET_RECRUITING
Study of Modzatinib (ATI-2138) in Adult Participants With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies
Lichen Planus
NCT07935590102
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PHASE2COMPLETED
Study of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis
Atopic Dermatitis
NCT0658520214
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Study Endpoints

Primary Endpoints

Participants With OLP: Change From Baseline in Activity Score of the Oral Disease Severity Score (ODSS) at Week 16
Baseline, Week 16
Participants With CLP: Change From Baseline in Modified Lichen Planus Area and Severity Index (LPASI) Score at Week 16
Baseline, Week 16
Participants With LPP: Change From Baseline in Lichen Planopilaris Activity Index (LPPAI) Score at Week 24
Baseline, Week 24
Incidence and severity of treatment emergent adverse events (TEAEs)
From baseline up to two weeks after treatment (Day 98)

Secondary Endpoints

Percentage of Participants With Investigator Global Assessment (IGA) Score of 0 or 1 and at Least a 2-point Improvement Over Time
Baseline up to Week 26
Participants With OLP: Change From Baseline in Activity Score of the ODSS Over Time
Baseline, up to Week 18
Participants With OLP: Change From Baseline in Total ODSS Over Time
Baseline, up to Week 18
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Oral Erosive Lichen Planus (OLP) CohortEXPERIMENTALParticipants will receive modzatinib or placebo administered orally twice daily (BID) for 16 weeks.
Cutaneous Lichen Planus (CLP) CohortEXPERIMENTALParticipants will receive modzatinib or placebo administered orally BID for 16 weeks.
Lichen Planopilaris (LPP) CohortEXPERIMENTALParticipants will receive modzatinib or placebo administered orally BID for 24 weeks.
ATI-2138EXPERIMENTALATI-2138 oral tablets BID

Interventions

NameTypeDescription
ModzatinibDRUGOral tablets
PlaceboDRUGOral tablets
ATI-2138DRUGATI-2138 Oral Tablets BID
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo

Key Inclusion Criteria: * Participants must have biopsy-confirmed OLP, CLP, or LPP eligible for systemic therapy and a history of inadequate response to topical corticosteroids (TCS) of high or ultra-high potency (based on the World Health Organization \[WHO\] definition) for at least 4 weeks in th...

Countries:United States
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Recent Changes (Last 90 Days)

LOWNov 13, 2026NCT07935590NEW_TRIAL: changed
LOWNov 13, 2026NCT07935590NEW_TRIAL: changed

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