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Not yet recruitingNCT07935590ALPHAUpdated Nov 13, 2026

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

A Phase 2 interventional study of Modzatinib and Placebo in Lichen Planus, sponsored by Aclaris Therapeutics, Inc.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-13.

Sponsored by Aclaris Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Updated Nov 13, 2026Newly registeredGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Lichen Planus

Keywords

  • Biopsy-Proven Forms of Lichen Planus
  • Lichen Planus
  • OLP
  • CLP
  • LPP
  • LP
  • Oral Lichen Planus
  • Cutaneous Lichen Planus
  • Lichen Planopilaris
03

In context

Lichen Planus

75 studies on the registry are indexed under Lichen Planus; 16 are open to participants now.

This study's planned enrollment of 102 is above the median of 30 across 56 interventional studies indexed under Lichen Planus.

Browse Lichen Planus studies →

Lead sponsor

Aclaris Therapeutics, Inc. is the lead sponsor of 34 studies on the registry; 1 is open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 22 (88%) have results posted.

Browse Aclaris Therapeutics, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Participants must have -confirmed OLP, CLP, or LPP eligible for systemic therapy and a history of inadequate response to topical (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 medical condition, other skin conditions (including skin, scalp or mucosa infections), or physical/laboratory/ (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 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.

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
102 participants (estimated)

Study arms

  • Experimental
    Oral Erosive Lichen Planus (OLP) Cohort

    Participants will receive modzatinib or placebo administered orally twice daily (BID) for 16 weeks.

    Drug: Modzatinib · Drug: Placebo

  • Experimental
    Cutaneous Lichen Planus (CLP) Cohort

    Participants will receive modzatinib or placebo administered orally BID for 16 weeks.

    Drug: Modzatinib · Drug: Placebo

  • Experimental
    Lichen Planopilaris (LPP) Cohort

    Participants will receive modzatinib or placebo administered orally BID for 24 weeks.

    Drug: Modzatinib · Drug: Placebo

Interventions

  • DrugModzatinib

    Oral tablets

    Also known as: ATI-2138

  • DrugPlacebo

    Oral tablets

06

What researchers measure

Primary outcomes

  1. Participants With OLP: Change From Baseline in Activity Score of the Oral Disease Severity Score (ODSS) at Week 16

    Time frame: Baseline, Week 16

  2. Participants With CLP: Change From Baseline in Modified Lichen Planus Area and Severity Index (LPASI) Score at Week 16

    Time frame: Baseline, Week 16

  3. Participants With LPP: Change From Baseline in Lichen Planopilaris Activity Index (LPPAI) Score at Week 24

    Time frame: Baseline, Week 24

Secondary outcomes

  1. 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

  2. Participants With OLP: Change From Baseline in Activity Score of the ODSS Over Time

    Time frame: Baseline, up to Week 18

  3. Participants With OLP: Change From Baseline in Total ODSS Over Time

    Time frame: Baseline, up to Week 18

  4. Participants With OLP: Change From Baseline in Total Reticulation Erythema and Ulceration (REU) Score Over Time

    Time frame: Baseline, up to Week 18

  5. 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

  6. 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

  7. Participants With CLP: Change From Baseline in Modified LPASI Score Over Time

    Time frame: Baseline, up to Week 18

  8. Participants With CLP: Change From Baseline in Weekly Average of Daily Worst Itch NRS Scores Over Time

    Time frame: Baseline, up to Week 18

  9. Participants With LPP: Change From Baseline in LPPAI Score Over Time

    Time frame: Baseline, up to Week 26

  10. 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).

    Time frame: Baseline, up to Week 26

  11. Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Itch NRS Scores Over Time

    Time frame: Baseline, up to Week 26

  12. Participants With LPP: Change From Baseline in Weekly Average of Daily Worst Pain NRS Scores Over Time

    Time frame: Baseline, up to Week 26

  13. 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

  14. Participants With LPP: Change From Baseline in Trichoscopy Parameters: Number of Hairs Over Time

    Time frame: Baseline, up to Week 26

  15. Participants With LPP: Change From Baseline in Trichoscopy Parameters: Hair Diameter Over Time

    Time frame: Baseline, up to Week 26

  16. Participants With LPP: Change From Baseline in Trichoscopy Parameters: Hair Density Over Time

    Time frame: Baseline, up to Week 26

  17. Percentage of Participants in Each Category of Patient Global Impression of Change (PGIC) Over Time

    Time frame: Baseline up to Week 26

  18. Participants With OLP: Change From Baseline in OLP Symptom Severity Measure (OLPSSM) Total Score Over Time

    Time frame: Baseline, up to Week 18

  19. Participants With OLP: Change From Baseline in Oral Health Impact Profile (OHIP)-14 Total Score Over Time

    Time frame: Baseline, up to Week 18

  20. 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)

  21. 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)

  22. 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)

  23. Peak Concentration of Modzatinib

    Time frame: Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)

  24. Trough Concentration of Modzatinib

    Time frame: Baseline up to Week 16 (for OLP and CLP) and Week 24 (for LPP)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Mar 2029, 28 months later.

Of 16 phase 2 interventional studies under Lichen Planus, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 28. This study's planned 28 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 9, 2026
First posted
Nov 13, 2026
StartEst.
Nov 2026
Primary completionEst.
Mar 2029
CompletionEst.
Apr 2029
Last update
Nov 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 13, 2026
Show all 1 update
  1. Nov 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07935590
Lead sponsor
Aclaris Therapeutics, Inc.
Responsible party
Sponsor
First posted
Nov 13, 2026
Start date
Nov 2026 (estimated)
Primary completion
Mar 2029 (estimated)
Completion
Apr 2029 (estimated)
Last update
Nov 13, 2026

Study contacts

Aclaris Clinical Operations
Contact
clintrials@aclaristx.com
(484) 324-7933

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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