Print

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

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

ArmDescriptionAssigned Intervention
Experimental
Patients receive nemolizumab injections every 4 weeks, weight based dosing
  • Drug: Nemolizumab
    subcutaneous injection

Recruiting Locations

The Skin Center Dermatology Group
New City 5128481, New York 5128638 10956
Contact:
Peter C Friedman, MD PhD
8453520500
drfriedman@skincenterderm.com

More Details

Status
Recruiting
Sponsor
The Skin Center Dermatology Group

Study Contact

Peter Friedman, MD PhD
8453520500
drfriedman@skincenterderm.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.