Recruiting

Nemolizumab

Sponsor:

The Skin Center Dermatology Group

Code:

NCT07396168

Conditions

Lichen Plano-Pilaris

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nemolizumab

Study Details

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.

Conditions

Lichen Plano-Pilaris

Study ID

NCT07396168

Start date

Feb 1, 2026

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Patients receive nemolizumab injections every 4 weeks, weight based dosing

Interventions

Nemolizumab

subcutaneous injection

Primary outcome measure

  • Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI) [ Time Frame: 24 weeks ]
  • Change from baseline at 24 weeks in Investigator Global Assessment (IGA) score (scarring alopecia version) [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Peter Friedman, MD PhD

8453520500drfriedman@skincenterderm.com

Locations

The Skin Center Dermatology Group

Recruiting

New City, New York, United States, 10956

Contacts

Peter C Friedman, MD PhD

8453520500drfriedman@skincenterderm.com

More Information

Sponsor

The Skin Center Dermatology Group

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Skin Center Dermatology Group on 2026-02-10.