drugset / Trial / NCT07396168
Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-02-01
- Primary completion
- 2027-06
- Completion
- 2027-06
Publications
- Background 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.
- Background 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.
- 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 Sep;86:106765. doi: 10.1016/j.intimp.2020.106765. Epub 2020 Jul 13.
- Background 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.
- Background 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.
- Background 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.
- 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. Epub 2023 Oct 18.
- Background 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.
- 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 Sep;22(5):681-692. doi: 10.1007/s40257-021-00630-7. Epub 2021 Aug 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nemolizumab | Monoclonal antibody | — | Subcutaneous |