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

Обзор

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.

Вмешательства

• Препарат Nemolizumab
  subcutaneous injection

Первичные конечные точки

• Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI) [Срок оценки: 24 weeks]
• Change from baseline at 24 weeks in Investigator Global Assessment (IGA) score (scarring alopecia version) [Срок оценки: 24 weeks]

Вторичные конечные точки (1)

• Change from baseline at 24 weeks in Peak Pruritus NRS. [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Skin Center Dermatology Group — New City

Публикации

• 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 Aug;35(8):e15639. doi: 10.1111/dth.15639. Epub 2022 Jun 24. PMID 35703373
• Cho BK, Sah D, Chwalek J, Roseborough I, Ochoa B, Chiang C, Price VH. Efficacy and safety of mycophenolate mofetil for lichen planopilaris. J Am Acad Dermatol. 2010 Mar;62(3):393-7. doi: 10.1016/j.jaad.2009.05.018. Epub 2010 Jan 12. PMID 20061053
• 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 Sep;86:106765. doi: 10.1016/j.intimp.2020.106765. Epub 2020 Jul 13. PMID 32674048
• Lajevardi V, Ghiasi M, Balighi K, Daneshpazhooh M, Azar PM, Kianfar N, Dasdar S, Peymanfar AA. Efficacy and safety of oral pioglitazone in the management of lichen planopilaris in comparison with clobetasol: A randomized clinical trial. Dermatol Ther. 2022 Nov;35(11):e15868. doi: 10.1111/dth.15868. Epub 2022 Oct 9. PMID 36169160
• Mahmoudi H, Daneshpajooh M, Dadkhahfar S, Robati RM, Tehranchinia Z, Farokh P, Shariatnia M, Shahidi-Dadras M, Moravvej H. Efficacy and safety of tofacitinib in the treatment of adults with lichen planopilaris: A randomized placebo-controlled trial. Int Immunopharmacol. 2025 Sep 23;162:115129. doi: 10.1016/j.intimp.2025.115129. Epub 2025 Jun 28. PMID 40582144
• Racz E, Gho C, Moorman PW, Noordhoek Hegt V, Neumann HA. Treatment of frontal fibrosing alopecia and lichen planopilaris: a systematic review. J Eur Acad Dermatol Venereol. 2013 Dec;27(12):1461-70. doi: 10.1111/jdv.12139. Epub 2013 Mar 26. PMID 23531029
• 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. Epub 2023 Oct 18. PMID 37852211
• Valdez-Zertuche JA, Ramirez-Marin HA, Tosti A. Efficacy, safety and tolerability of drugs for alopecia: a comprehensive review. Expert Opin Drug Metab Toxicol. 2025 Apr;21(4):347-371. doi: 10.1080/17425255.2025.2461483. Epub 2025 Feb 5. PMID 39893632

Идентификаторы

NCT: NCT07396168 · NemoLPP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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