Study of Modzatinib (ATI-2138) in Adult Participants With Biopsy-proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies (ALPHA)

A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Efficacy and Safety of Modzatinib (ATI-2138) in Adult Participants With Biopsy-Proven Forms of Lichen Planus Not Adequately Controlled With Topical Therapies (ALPHA)

This study evaluates modzatinib versus placebo in participants with biopsy-proven forms of moderate-to-severe lichen planus (LP).

Study Overview

• Status: Not yet recruiting
• Conditions: Lichen Planus
• Intervention / Treatment: Drug: Placebo; Drug: Modzatinib

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Aclaris Clinical Operations; Phone Number: (484) 324-7933; Email: clintrials@aclaristx.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 the opinion of the Investigator.

Specific criteria for each subtype below:

• OLP: OLP IGA of ≥ 3 (moderate or severe) and either Baseline LP-related Pain or Burning Sensation NRS ≥ 3.
• CLP: CLP IGA ≥3 (moderate or severe) and Baseline LP-related Itch NRS ≥ 3.
• LPP: LPP IGA ≥ 3 (moderate or severe) and either Baseline LP-related Itch or Burning Sensation NRS ≥ 3.
• If using any of the permitted treatments (that is, topical treatments on the affected areas, oral pain medications, and systemic antihistamines), the dose and frequency should remain stable for at least 2 weeks prior to randomization (Day 1) and until Week 16 (OLP and CLP cohorts) or Week 24 (LPP cohort).
• Participant has a stable disease for at least 4 weeks prior to screening visit based on Investigator judgement.
• Participant must be willing and able to comply with all study procedures and must be available for the duration of the study.

Key Exclusion Criteria:

• Clinical history suspicious for and/or biopsy consistent with lichenoid drug eruption.
• History or diagnosed LP other than OLP, CLP, or LPP (for example, lichen planus pigmentosus, paraneoplastic mucosal lichen planus, hypertrophic lichen planus, as well as actinic, inverse, linear, or bullous variants).
• Participants with dysplastic changes in oral biopsy results.
• Participant has any clinically significant medical condition, other skin conditions (including skin, scalp or mucosa infections), or physical/laboratory/electrocardiogram (ECG)/vital signs abnormality that would, in the opinion of the investigator, put the participant at undue risk or interfere with the study assessments.
• Participant has any condition that could interfere with drug absorption including, but not limited to, short bowel syndrome, gastric bypass surgery (including sleeve gastrectomy). Participants with a history of gastric banding/segmentation are not to be excluded.
• Participant has a known or suspected allergy to modzatinib or any component of the investigational product.
• Participant is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study.

Note: Other protocol-defined inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Erosive Lichen Planus (OLP) Cohort; Participants will receive modzatinib or placebo administered orally twice daily (BID) for 16 weeks.	Drug: Placebo; Oral tablets; Drug: Modzatinib; Oral tablets; Other Names: ATI-2138
Experimental: Cutaneous Lichen Planus (CLP) Cohort; Participants will receive modzatinib or placebo administered orally BID for 16 weeks.	Drug: Placebo; Oral tablets; Drug: Modzatinib; Oral tablets; Other Names: ATI-2138
Experimental: Lichen Planopilaris (LPP) Cohort; Participants will receive modzatinib or placebo administered orally BID for 24 weeks.	Drug: Placebo; Oral tablets; Drug: Modzatinib; Oral tablets; Other Names: ATI-2138

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Participants With OLP: Change From Baseline in Total Reticulation Erythema and Ulceration (REU) Score Over Time		Baseline, up to Week 18
Participants With OLP: Change From Baseline in Weekly Average of Daily Worst Pain Numeric Rating Scale (NRS) Scores Over Time		Baseline, up to Week 18
Participants With OLP: Change From Baseline in Weekly Average of Daily Worst Burning Sensation NRS Scores Over Time		Baseline, up to Week 18
Participants With CLP: Change From Baseline in Modified LPASI Score Over Time		Baseline, up to Week 18
Participants With CLP: Change From Baseline in Weekly Average of Daily Worst Itch NRS Scores Over Time		Baseline, up to Week 18
Participants With LPP: Change From Baseline in LPPAI Score Over Time		Baseline, up to Week 26
Participants With LPP: Change From Baseline in Activity Score Over Time	Activity score represents the sum of the 3 severity signs from the LPPAI * body surface area (BSA).	Baseline, up to Week 26
Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Itch NRS Scores Over Time		Baseline, up to Week 26
Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Pain NRS Scores Over Time		Baseline, up to Week 26
Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Burning Sensation NRS Scores Over Time		Baseline, up to Week 26
Participants With LPP: Change From Baseline in Trichoscopy Parameters: Number of Hairs Over Time		Baseline, up to Week 26
Participants With LPP: Change From Baseline in Trichoscopy Parameters: Hair Diameter Over Time		Baseline, up to Week 26
Participants With LPP: Change From Baseline in Trichoscopy Parameters: Hair Density Over Time		Baseline, up to Week 26
Percentage of Participants in Each Category of Patient Global Impression of Change (PGIC) Over Time		Baseline up to Week 26
Participants With OLP: Change From Baseline in OLP Symptom Severity Measure (OLPSSM) Total Score Over Time		Baseline, up to Week 18
Participants With OLP: Change From Baseline in Oral Health Impact Profile (OHIP)-14 Total Score Over Time		Baseline, up to Week 18
Participants With CLP and LPP: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time		Baseline, up to Week 18 (for CLP) and Week 26 (for LPP)
Participants With CLP and LPP: Percentage of Participants With 4-point Improvement or Greater From Baseline in DLQI Total Score Over Time		Baseline up to Week 18 (for CLP) and Week 26 (for LPP)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Baseline up to Week 18 (for OLP and CLP) and Week 26 (for LPP)
Peak Concentration of Modzatinib		Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)
Trough Concentration of Modzatinib		Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)

Collaborators and Investigators

• Sponsor: Aclaris Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: November 9, 2026
• First Submitted That Met QC Criteria: November 9, 2026
• First Posted (Actual): November 13, 2026

Study Record Updates

• Last Update Posted (Actual): November 13, 2026
• Last Update Submitted That Met QC Criteria: November 9, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: LP; LPP; Oral Lichen Planus; CLP; OLP; Lichen Planus; Biopsy-Proven Forms of Lichen Planus; Cutaneous Lichen Planus; Lichen Planopilaris
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lichen Planus, Oral; Lichen Planus
• Other Study ID Numbers: ATI-2138-LP-201; 2026-528195-17-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No