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

November 9, 2026 updated by: Aclaris Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Participants With OLP: Change From Baseline in Activity Score of the Oral Disease Severity Score (ODSS) at Week 16
Time Frame: Baseline, Week 16
Baseline, Week 16
Participants With CLP: Change From Baseline in Modified Lichen Planus Area and Severity Index (LPASI) Score at Week 16
Time Frame: Baseline, Week 16
Baseline, Week 16
Participants With LPP: Change From Baseline in Lichen Planopilaris Activity Index (LPPAI) Score at Week 24
Time Frame: Baseline, Week 24
Baseline, Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Baseline up to Week 26
Baseline up to Week 26
Participants With OLP: Change From Baseline in Activity Score of the ODSS Over Time
Time Frame: Baseline, up to Week 18
Baseline, up to Week 18
Participants With OLP: Change From Baseline in Total ODSS Over Time
Time Frame: Baseline, up to Week 18
Baseline, up to Week 18
Participants With OLP: Change From Baseline in Total Reticulation Erythema and Ulceration (REU) Score Over Time
Time Frame: Baseline, up to Week 18
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
Time Frame: Baseline, up to Week 18
Baseline, up to Week 18
Participants With OLP: Change From Baseline in Weekly Average of Daily Worst Burning Sensation NRS Scores Over Time
Time Frame: Baseline, up to Week 18
Baseline, up to Week 18
Participants With CLP: Change From Baseline in Modified LPASI Score Over Time
Time Frame: Baseline, up to Week 18
Baseline, up to Week 18
Participants With CLP: Change From Baseline in Weekly Average of Daily Worst Itch NRS Scores Over Time
Time Frame: Baseline, up to Week 18
Baseline, up to Week 18
Participants With LPP: Change From Baseline in LPPAI Score Over Time
Time Frame: Baseline, up to Week 26
Baseline, up to Week 26
Participants With LPP: Change From Baseline in Activity Score Over Time
Time Frame: Baseline, up to Week 26

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
Time Frame: Baseline, up to Week 26
Baseline, up to Week 26
Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Pain NRS Scores Over Time
Time Frame: Baseline, up to Week 26
Baseline, up to Week 26
Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Burning Sensation NRS Scores Over Time
Time Frame: Baseline, up to Week 26
Baseline, up to Week 26
Participants With LPP: Change From Baseline in Trichoscopy Parameters: Number of Hairs Over Time
Time Frame: Baseline, up to Week 26
Baseline, up to Week 26
Participants With LPP: Change From Baseline in Trichoscopy Parameters: Hair Diameter Over Time
Time Frame: Baseline, up to Week 26
Baseline, up to Week 26
Participants With LPP: Change From Baseline in Trichoscopy Parameters: Hair Density Over Time
Time Frame: Baseline, up to Week 26
Baseline, up to Week 26
Percentage of Participants in Each Category of Patient Global Impression of Change (PGIC) Over Time
Time Frame: Baseline up to Week 26
Baseline up to Week 26
Participants With OLP: Change From Baseline in OLP Symptom Severity Measure (OLPSSM) Total Score Over Time
Time Frame: Baseline, up to Week 18
Baseline, up to Week 18
Participants With OLP: Change From Baseline in Oral Health Impact Profile (OHIP)-14 Total Score Over Time
Time Frame: Baseline, up to Week 18
Baseline, up to Week 18
Participants With CLP and LPP: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score Over Time
Time Frame: Baseline, up to Week 18 (for CLP) and Week 26 (for LPP)
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
Time Frame: Baseline up to Week 18 (for CLP) and Week 26 (for LPP)
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)
Time Frame: Baseline up to Week 18 (for OLP and CLP) and Week 26 (for LPP)
Baseline up to Week 18 (for OLP and CLP) and Week 26 (for LPP)
Peak Concentration of Modzatinib
Time Frame: Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)
Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)
Trough Concentration of Modzatinib
Time Frame: Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)
Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aclaris Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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