Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study. (NCT07396168) | Clinical Trial Compass
RecruitingPhase 4
Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.
United States10 participantsStarted 2026-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 inter…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI)
Timeframe: 24 weeks
2
Change from baseline at 24 weeks in Investigator Global Assessment (IGA) score (scarring alopecia version)