About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Nemolizumab
Drugsubcutaneous injection
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI)
Change from baseline at 24 weeks in Investigator Global Assessment (IGA) score (scarring alopecia version)
Secondary outcomes
Change from baseline at 24 weeks in Peak Pruritus NRS.
Other outcomes
Change from baseline at 24 weeks in hair count and average hair shaft thickness (digital trichoscopy).
Incidence and severity of treatment-emergent adverse events.
Sponsors and contacts
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