Lichen Plano-Pilaris
Conditions
Brief 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.
Interventions
DRUGNemolizumab
subcutaneous injection
Sponsors
The Skin Center Dermatology Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline at 24 weeks in Investigator Global Assessment (IGA) score (scarring alopecia version) | 24 weeks |
| Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI) | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline at 24 weeks in Peak Pruritus NRS. | 24 weeks |
Countries
United States
Contacts
CONTACTPeter Friedman, MD PhD
Outcome results
None listed