Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.
The Skin Center Dermatology Group
10 participants
Feb 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria14
- 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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Interventions
subcutaneous injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07396168