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

The Skin Center Dermatology Group

Status and phase

Enrolling

Phase 4

Conditions

Lichen Plano-Pilaris

Treatments

Drug: Nemolizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT07396168

NemoLPP

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.