ClinicalTrials.gg
RecruitingNCT07396168Updated Feb 10, 2026

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

A Phase 4 interventional study of Nemolizumab in Lichen Plano-Pilaris, sponsored by The Skin Center Dermatology Group. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.

Sponsored by The Skin Center Dermatology Group · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Lichen Plano-Pilaris

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03

In context

Lichen Planus

74 studies on the registry are indexed under Lichen Planus; 15 are open to participants now.

This study's planned enrollment of 10 is below the median of 30 across 55 interventional studies indexed under Lichen Planus.

Browse Lichen Planus studies →

Lead sponsor

The Skin Center Dermatology Group is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 and comply with study procedures.
  • Willingness to undergo optional scalp for research purposes.

Exclusion criteria

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 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 (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 to nemolizumab or any .
  • Pregnancy or unwillingness to use highly effective .
  • Any medical condition that, in the opinion of the investigator, may interfere with study participation or interpretation of results.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Patients receive nemolizumab injections every 4 weeks, weight based dosing

    Drug: Nemolizumab

Interventions

06

What researchers measure

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

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Ahmadi Kahjoogh H, Yazdanian N, Behrangi E, Roohaninasab M, Hejazi P, Goodarzi A. Efficacy, safety, tolerability, and satisfaction of N-acetylcysteine and pentoxifylline in lichen planopilaris patients under treatment with topical clobetasol: A triple arm blinded randomized controlled trial. Dermatol Ther. 2022 Aug;35(8):e15639. doi: 10.1111/dth.15639. Epub 2022 Jun 24. PubMed 35703373 ↗
  • Cho BK, Sah D, Chwalek J, Roseborough I, Ochoa B, Chiang C, Price VH. Efficacy and safety of mycophenolate mofetil for lichen planopilaris. J Am Acad Dermatol. 2010 Mar;62(3):393-7. doi: 10.1016/j.jaad.2009.05.018. Epub 2010 Jan 12. PubMed 20061053 ↗
  • Fatemi Naeini F, Mohaghegh F, Jelvan M, Asilian A, Saber M. Cyclosporine or methotrexate, which one is more promising in the treatment of lichen planopilaris?; A comparative clinical trial. Int Immunopharmacol. 2020 Sep;86:106765. doi: 10.1016/j.intimp.2020.106765. Epub 2020 Jul 13. PubMed 32674048 ↗
  • Lajevardi V, Ghiasi M, Balighi K, Daneshpazhooh M, Azar PM, Kianfar N, Dasdar S, Peymanfar AA. Efficacy and safety of oral pioglitazone in the management of lichen planopilaris in comparison with clobetasol: A randomized clinical trial. Dermatol Ther. 2022 Nov;35(11):e15868. doi: 10.1111/dth.15868. Epub 2022 Oct 9. PubMed 36169160 ↗
  • Mahmoudi H, Daneshpajooh M, Dadkhahfar S, Robati RM, Tehranchinia Z, Farokh P, Shariatnia M, Shahidi-Dadras M, Moravvej H. Efficacy and safety of tofacitinib in the treatment of adults with lichen planopilaris: A randomized placebo-controlled trial. Int Immunopharmacol. 2025 Sep 23;162:115129. doi: 10.1016/j.intimp.2025.115129. Epub 2025 Jun 28. PubMed 40582144 ↗
  • Racz E, Gho C, Moorman PW, Noordhoek Hegt V, Neumann HA. Treatment of frontal fibrosing alopecia and lichen planopilaris: a systematic review. J Eur Acad Dermatol Venereol. 2013 Dec;27(12):1461-70. doi: 10.1111/jdv.12139. Epub 2013 Mar 26. PubMed 23531029 ↗
  • Husein-ElAhmed H, Husein-ElAhmed S. A Systematic Review and Bayesian Network Meta-Analysis of Medical Therapies for Lichen Planopilaris. Dermatology. 2024;240(1):103-110. doi: 10.1159/000534364. Epub 2023 Oct 18. PubMed 37852211 ↗
  • Valdez-Zertuche JA, Ramirez-Marin HA, Tosti A. Efficacy, safety and tolerability of drugs for alopecia: a comprehensive review. Expert Opin Drug Metab Toxicol. 2025 Apr;21(4):347-371. doi: 10.1080/17425255.2025.2461483. Epub 2025 Feb 5. PubMed 39893632 ↗
  • Svigos K, Yin L, Fried L, Lo Sicco K, Shapiro J. A Practical Approach to the Diagnosis and Management of Classic Lichen Planopilaris. Am J Clin Dermatol. 2021 Sep;22(5):681-692. doi: 10.1007/s40257-021-00630-7. Epub 2021 Aug 4. PubMed 34347282 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2026 (actual). Primary completion is estimated for Jun 2027, 16 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 1, 2026
First posted
Feb 9, 2026
StartActual
Feb 1, 2026
Primary completionEst.
Jun 2027
CompletionEst.
Jun 2027
Last update
Feb 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07396168
Lead sponsor
The Skin Center Dermatology Group
Responsible party
Sponsor
First posted
Feb 9, 2026
Start date
Feb 1, 2026
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Feb 10, 2026

Study contacts

Peter Friedman, MD PhD
Contact
drfriedman@skincenterderm.com
8453520500

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Nemolizumab

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