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

RecruitingPhase 4Ages 18 Years - anyAllThe Skin Center Dermatology Group
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years. * Clinical and/or histopathologic diagnosis of LPP. * Presence of scalp pruritus. * Average Peak Pruritus Numerical Rating Scale (PP-NRS) score โ‰ฅ4 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.
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What it tests

  • Nemolizumab
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Where

1 site
The Skin Center Dermatology Group
New City, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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