Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Lichen Plano-Pilaris
• Intervention / Treatment: Drug: Nemolizumab

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Peter Friedman, MD PhD; Phone Number: 8453520500; Email: drfriedman@skincenterderm.com

Study Locations

• United States
  • New York
    • New City, New York, United States, 10956
      • Recruiting
      • The Skin Center Dermatology Group
      • Contact: Peter C Friedman, MD PhD; Phone Number: 8453520500; Email: drfriedman@skincenterderm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients receive nemolizumab injections every 4 weeks, weight based dosing	Drug: Nemolizumab; subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Change from baseline at 24 weeks in Peak Pruritus NRS.	24 weeks

Other Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: The Skin Center Dermatology Group

Publications and helpful links

General Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 1, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 7, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lichen Planus; nemolizumab
• Other Study ID Numbers: NemoLPP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No