NCT07396168

Brief Summary

Lichen planopilaris (LPP) is a primary lymphocytic cicatricial alopecia characterized by progressive, permanent hair loss and scalp symptoms such as pruritus and burning. Current treatments-including topical and intralesional corticosteroids, hydroxychloroquine, and immunosuppressants-are often inadequate, with limited evidence for efficacy and frequent treatment switching or discontinuation due to side effects or lack of response.1,2 Recent systematic reviews and meta-analyses highlight the need for new, targeted therapies. 3,4 Nemolizumab, an IL-31 receptor antagonist, FDA-approved for prurigo nodularis and atopic dermatitis, has demonstrated efficacy in pruritic and fibrosing dermatoses, making it a rational candidate for LPP.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
12mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Feb 2026Jun 2027

First Submitted

Initial submission to the registry

February 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

February 1, 2026

Last Update Submit

February 7, 2026

Conditions

Lichen Plano-Pilaris

Outcome Measures

Primary Outcomes (2)

  • Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI)

    24 weeks

  • Change from baseline at 24 weeks in Investigator Global Assessment (IGA) score (scarring alopecia version)

    24 weeks

Secondary Outcomes (1)

  • Change from baseline at 24 weeks in Peak Pruritus NRS.

    24 weeks

Other Outcomes (2)

  • Change from baseline at 24 weeks in hair count and average hair shaft thickness (digital trichoscopy).

    24 weeks

  • Incidence and severity of treatment-emergent adverse events.

    28 weeks

Study Arms (1)

Patients receive nemolizumab injections every 4 weeks, weight based dosing

EXPERIMENTAL
Drug: Nemolizumab

Interventions

NemolizumabDRUG

subcutaneous injection

Patients receive nemolizumab injections every 4 weeks, weight based dosing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years.
  • Clinical and/or histopathologic diagnosis of LPP.
  • Presence of scalp pruritus.
  • Average Peak Pruritus Numerical Rating Scale (PP-NRS) score ≥4 in the 7 days prior to Day 1.
  • Ability and willingness to provide written informed consent and comply with study procedures.
  • Willingness to undergo optional scalp biopsy for research purposes.

You may not qualify if:

  • Other forms of alopecia that may interfere with study assessments.
  • Any systemic disease associated with hair loss.
  • Inflammatory or infectious scalp disease that may interfere with the study.
  • Any other conditions associated with pruritus.
  • Prior use of nemolizumab.
  • Current treatment with systemic or topical JAK inhibitors or biologics (unless appropriate washout period completed; minimum 12 weeks).
  • Current treatment with DMARDs (unless appropriate washout period completed; minimum 12 weeks).
  • Prior treatment failure of scarring alopecia with systemic or topical JAK inhibitors or
  • biologics.
  • Current treatment with topical or intralesional corticosteroids (unless appropriate washout period completed; minimum 4 weeks).
  • Any other current treatments for hair loss (e.g., oral/topical minoxidil, PRP) unless stable for at least 6 months or 3 months washout completed.
  • Allergy or hypersensitivity to nemolizumab or any excipients.
  • Pregnancy or unwillingness to use highly effective contraception.
  • Any medical condition that, in the opinion of the investigator, may interfere with study participation or interpretation of results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Skin Center Dermatology Group

New City, New York, 10956, United States

RECRUITING

Related Publications (9)

  • Ahmadi Kahjoogh H, Yazdanian N, Behrangi E, Roohaninasab M, Hejazi P, Goodarzi A. Efficacy, safety, tolerability, and satisfaction of N-acetylcysteine and pentoxifylline in lichen planopilaris patients under treatment with topical clobetasol: A triple arm blinded randomized controlled trial. Dermatol Ther. 2022;35(8). doi:10.1111/dth.15639

    BACKGROUND

  • Cho BK, Sah D, Chwalek J, et al. Efficacy and safety of mycophenolate mofetil for lichen planopilaris. J Am Acad Dermatol. 2010;62(3):393-397. doi:10.1016/j.jaad.2009.05.018

    BACKGROUND

  • Fatemi Naeini F, Mohaghegh F, Jelvan M, Asilian A, Saber M. Cyclosporine or methotrexate, which one is more promising in the treatment of lichen planopilaris?; A comparative clinical trial. Int Immunopharmacol. 2020;86:106765. doi:10.1016/j.intimp.2020.106765

    BACKGROUND

  • Lajevardi V, Ghiasi M, Balighi K, et al. Efficacy and safety of oral pioglitazone in the management of lichen planopilaris in comparison with clobetasol: A randomized clinical trial. Dermatol Ther. 2022;35(11). doi:10.1111/dth.15868

    BACKGROUND

  • Mahmoudi H, Daneshpajooh M, Dadkhahfar S, et al. Efficacy and safety of tofacitinib in the treatment of adults with lichen planopilaris: A randomized placebo-controlled trial. Int Immunopharmacol. 2025;162:115129. doi:10.1016/j.intimp.2025.115129

    BACKGROUND

  • Rácz E, Gho C, Moorman PW, Noordhoek Hegt V, Neumann HAM. Treatment of frontal fibrosing alopecia and lichen planopilaris: a systematic review. J Eur Acad Dermatology Venereol. 2013;27(12):1461-1470. doi:10.1111/jdv.12139

    BACKGROUND

  • Husein-ElAhmed H, Husein-ElAhmed S. A Systematic Review and Bayesian Network Meta-Analysis of Medical Therapies for Lichen Planopilaris. Dermatology. 2024;240(1):103-110. doi:10.1159/000534364

    BACKGROUND

  • Valdez-Zertuche JA, Ramírez-Marín HA, Tosti A. Efficacy, safety and tolerability of drugs for alopecia: a comprehensive review. Expert Opin Drug Metab Toxicol. 2025;21(4):347-371. doi:10.1080/17425255.2025.2461483

    BACKGROUND

  • Svigos K, Yin L, Fried L, Lo Sicco K, Shapiro J. A Practical Approach to the Diagnosis and Management of Classic Lichen Planopilaris. Am J Clin Dermatol. 2021;22(5):681-692. doi:10.1007/s40257-021-00630-7

    BACKGROUND

MeSH Terms

Conditions

Lichen Planus

Interventions

nemolizumab

Condition Hierarchy (Ancestors)

Lichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Peter Friedman, MD PhD

CONTACT

8453520500drfriedman@skincenterderm.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2026

First Posted

February 9, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations

US(1)