Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.
Purpose
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.
Condition
- Lichen Plano-Pilaris
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 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.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Patients receive nemolizumab injections every 4 weeks, weight based dosing |
|
Recruiting Locations
The Skin Center Dermatology Group
New City 5128481, New York 5128638 10956
New City 5128481, New York 5128638 10956
More Details
- Status
- Recruiting
- Sponsor
- The Skin Center Dermatology Group