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NCT Number: NCT07396168

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Skin Center Dermatology Group

New City, New York, 10956, United States

Location status: Recruiting

Location contact

Peter C Friedman, MD PhD

CONTACT

[email protected]

8453520500

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nemolizumab

Drug

subcutaneous injection

Primary outcomes

  1. Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI)

    Time frame: 24 weeks

  2. Change from baseline at 24 weeks in Investigator Global Assessment (IGA) score (scarring alopecia version)

    Time frame: 24 weeks

Secondary outcomes

  1. Change from baseline at 24 weeks in Peak Pruritus NRS.

    Time frame: 24 weeks

Other outcomes

  1. Change from baseline at 24 weeks in hair count and average hair shaft thickness (digital trichoscopy).

    Time frame: 24 weeks

  2. Incidence and severity of treatment-emergent adverse events.

    Time frame: 28 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Peter Friedman, MD PhD

CONTACT

[email protected]

8453520500

Sponsors and collaborators

Lead sponsor

The Skin Center Dermatology Group

Industry

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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