Nemolizumab for lichen planopilaris

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

This will test whether nemolizumab reduces scalp itching and hair loss in adults with lichen planopilaris.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Skin Center Dermatology Group (Industry-sponsored)
• Drugs / interventions: nemolizumab
• Locations: 1 site (New City, New York)
• Trial ID: NCT07396168 on ClinicalTrials.gov

What this trial studies

This is an open-label, noncontrolled, prospective Phase 4 pilot testing nemolizumab in adults with LPP who report scalp pruritus (PP-NRS ≥4). Enrolled participants receive nemolizumab with symptom and safety assessments over the treatment period and may opt into an optional research scalp biopsy. Current biologics, JAK inhibitors, and DMARDs require an appropriate washout before enrollment to limit confounding effects. The single-center study at The Skin Center Dermatology Group emphasizes pruritus reduction and tolerability rather than randomized comparison.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with a clinical or histopathologic diagnosis of LPP who have bothersome scalp pruritus (PP-NRS ≥4) and can comply with visits, washout requirements, and optional biopsy.

Not a fit: Patients without significant scalp itch, those with other types of alopecia or active scalp infections, prior nemolizumab exposure, or who cannot discontinue conflicting immunomodulatory therapies are unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, nemolizumab could reduce severe scalp itch and potentially slow scarring hair loss in people with LPP while offering a targeted treatment option.

How similar studies have performed: Nemolizumab is FDA-approved for prurigo nodularis and atopic dermatitis and has shown efficacy in other pruritic or fibrosing skin conditions, but its application to LPP is novel with limited prior LPP-specific data.

Eligibility criteria

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.

Where this trial is running

New City, New York

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

Study contacts

• Study coordinator: Peter Friedman, MD PhD

Conditions Lichen Plano-Pilaris