Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:06 AM
Study NCT ID:
NCT07396168
Status:
RECRUITING
Last Update Posted:
2026-02-10
First Post:
2026-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008010', 'term': 'Lichen Planus'}], 'ancestors': [{'id': 'D017512', 'term': 'Lichenoid Eruptions'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000612881', 'term': 'nemolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-07', 'studyFirstSubmitDate': '2026-02-01', 'studyFirstSubmitQcDate': '2026-02-01', 'lastUpdatePostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline at 24 weeks in hair count and average hair shaft thickness (digital trichoscopy).', 'timeFrame': '24 weeks'}, {'measure': 'Incidence and severity of treatment-emergent adverse events.', 'timeFrame': '28 weeks'}], 'primaryOutcomes': [{'measure': 'Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI)', 'timeFrame': '24 weeks'}, {'measure': 'Change from baseline at 24 weeks in Investigator Global Assessment (IGA) score (scarring alopecia version)', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline at 24 weeks in Peak Pruritus NRS.', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lichen Plano-Pilaris']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}, {'type': 'BACKGROUND', 'citation': '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'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years.\n* Clinical and/or histopathologic diagnosis of LPP.\n* Presence of scalp pruritus.\n* Average Peak Pruritus Numerical Rating Scale (PP-NRS) score ≥4 in the 7 days prior to Day 1.\n* Ability and willingness to provide written informed consent and comply with study procedures.\n* Willingness to undergo optional scalp biopsy for research purposes.\n\nExclusion Criteria:\n\n* Other forms of alopecia that may interfere with study assessments.\n* Any systemic disease associated with hair loss.\n* Inflammatory or infectious scalp disease that may interfere with the study.\n* Any other conditions associated with pruritus.\n* Prior use of nemolizumab.\n* Current treatment with systemic or topical JAK inhibitors or biologics (unless appropriate washout period completed; minimum 12 weeks).\n* Current treatment with DMARDs (unless appropriate washout period completed; minimum 12 weeks).\n* Prior treatment failure of scarring alopecia with systemic or topical JAK inhibitors or\n* biologics.\n* Current treatment with topical or intralesional corticosteroids (unless appropriate washout period completed; minimum 4 weeks).\n* 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.\n* Allergy or hypersensitivity to nemolizumab or any excipients.\n* Pregnancy or unwillingness to use highly effective contraception.\n* Any medical condition that, in the opinion of the investigator, may interfere with study participation or interpretation of results.'}, 'identificationModule': {'nctId': 'NCT07396168', 'briefTitle': 'Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.', 'organization': {'class': 'INDUSTRY', 'fullName': 'The Skin Center Dermatology Group'}, 'officialTitle': 'Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.', 'orgStudyIdInfo': {'id': 'NemoLPP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients receive nemolizumab injections every 4 weeks, weight based dosing', 'interventionNames': ['Drug: Nemolizumab']}], 'interventions': [{'name': 'Nemolizumab', 'type': 'DRUG', 'description': 'subcutaneous injection', 'armGroupLabels': ['Patients receive nemolizumab injections every 4 weeks, weight based dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10956', 'city': 'New City', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Peter C Friedman, MD PhD', 'role': 'CONTACT', 'email': 'drfriedman@skincenterderm.com', 'phone': '8453520500'}], 'facility': 'The Skin Center Dermatology Group', 'geoPoint': {'lat': 41.1476, 'lon': -73.98931}}], 'centralContacts': [{'name': 'Peter Friedman, MD PhD', 'role': 'CONTACT', 'email': 'drfriedman@skincenterderm.com', 'phone': '8453520500'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Skin Center Dermatology Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}