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

Recruiting now · Phase 4

Conditions studied: Lichen Plano-Pilaris

In brief

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.

Key facts

Study ID

NCT07396168

Run by

The Skin Center Dermatology Group

People needed

10

Starts

2026-02-01

Expected to finish

2027-06-01

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Skin Center Dermatology Group — New City, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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