Lichen Plano-PilarisPhase 4NCT07396168
Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.
A Phase 4 study testing Nemolizumab in people with Lichen Plano-Pilaris, run by The Skin Center Dermatology Group at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lichen Plano-Pilaris
- What is being tested?
- Nemolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2026to Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Skin Center Dermatology Group
New City, New York, 10956
Peter C Friedman, MD PhD, 8453520500, drfriedman@skincenterderm.com
About this 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.
- Conditions
- Lichen Plano-Pilaris
- Being tested
- Nemolizumab
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NemolizumabDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Patients receive nemolizumab injections every 4 weeks, weight based dosing | Experimental | Not described Receives: Drug: Nemolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI)
Measured: 24 weeks
Change from baseline at 24 weeks in Investigator Global Assessment (IGA) score (scarring alopecia version)
Measured: 24 weeks
Secondary outcomes (1)
Change from baseline at 24 weeks in Peak Pruritus NRS.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Feb 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Lichen Plano-PilarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Skin Center Dermatology Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396168
- Sponsor's protocol ID
- NemoLPP
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 35703373Cho 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 20061053Fatemi 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 32674048Lajevardi 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 36169160Mahmoudi 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 40582144Racz 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 23531029Husein-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 37852211Valdez-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 39893632Svigos 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nemolizumab to Treat Lichen Planopilaris, a Noncontrolled, Prospective, Pilot Study.
- ClinicalTrials.gov ID
- NCT07396168
- Acronym / sponsor ID
- NemoLPP
- Conditions
- Lichen Plano-Pilaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Skin Center Dermatology GroupIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receive nemolizumab injections every 4 weeks, weight based dosing | Experimental | Drug: Nemolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nemolizumabsubcutaneous injection | Drug | Patients receive nemolizumab injections every 4 weeks, weight based dosing |
Primary outcome
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
1 secondary outcome
Change from baseline at 24 weeks in Peak Pruritus NRS.
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 35703373Ahmadi 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.
- Background: PubMed 20061053Cho 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.
- Background: PubMed 32674048Fatemi 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.
- Background: PubMed 36169160Lajevardi 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.
- Background: PubMed 40582144Mahmoudi 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.
- Background: PubMed 23531029Racz 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.
- Background: PubMed 37852211Husein-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.
- Background: PubMed 39893632Valdez-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.
- Background: PubMed 34347282Svigos 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nemolizumab in people with Lichen Plano-Pilaris, run by The Skin Center Dermatology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Friedman, MD PhD (8453520500, drfriedman@skincenterderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline at 24 weeks in Lichen Planopilaris Activity Index (LPPAI) (time frame: 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07396168, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.