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Nemolizumab for Lichen Sclerosus of the Vulva

This study is testing a drug called nemolizumab for women with Lichen Sclerosus (LS) of the vulva. Nemolizumab is a monoclonal antibody, a type of medicine that targets specific cells in the body. You may be able to join if you are a woman aged 18 or older with LS that has been confirmed by a biopsy, and you have an itch score of 6 or higher. You must also have used topical corticosteroids before. The study is looking to see if nemolizumab can reduce your itch by at least 4 points on a scale, measured from the beginning of the study to 24 weeks later. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 25 participants. The phase of the study is not specified.
What's involved
You will receive nemolizumab injections under the skin. You will need to stop using other treatments for LS from your screening visit until the end of the study.
Compensation
Not stated in the trial record.
Follow-up
Your itch score will be measured from the start of the study to Week 24.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07704775

Nemolizumab for LS

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~25 participants
Updated 2026-07-15 on ClinicalTrials.gov
What's tested:Nemolizumab 30 mg

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
A ≥ 4-point improvement in Itch NRS score
Measured over Baseline to Week 24

Conditions

Lichen Sclerosus of Vulva

Explore related trials

Lichen Sclerosus et Atrophicus

NCT07704775

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Texas Southwestern Medical Center

    Dallas, Texasno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Melissa Mauskar, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Study Coordinator
[email protected]
2146458968
Email the study team

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Eligibility criteria

Inclusion

Ability to comprehend and willingness to sign a written
Females only ≥18 years of age at time of screening
Documentation of biopsy-proven anogenital LS.
Baseline itch NRS score ≥ 6 in anogenital area.
Prior use of topical corticosteroid.
Participants who agree to discontinue all agents used by the participant to treat LS from the screening visit through the final safety follow-up visit, aside from rescue therapy as specified in "Concomitant therapy" in the protocol

Exclusion

Participants who do not have LS involving anogenital area.
Need for receiving a live vaccine right before or during treatment with the study drug.
Planned or expected major surgical procedure during the clinical study.
Pregnant or lactating participants or those considering pregnancy during the period of their study participation.
Participants unwilling to refrain from using prohibited medications during the clinical study.
Patients who have been treated with systemic medications for other dermatologic conditions or itch within the past 4 months.
Patients that undergone had physical treatment modalities, such as CO2 laser or radiofrequency microneedling to the anogenital region.
Body weight \<30 kg.
Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.
Previous treatment with nemolizumab.
History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, e.g., monoclonal antibody) or to any of the study drug excipients.
Employees of the funder or investigator or otherwise dependents of them.
In the opinion of the investigator, are unable or unlikely to comply with the administration schedule and study evaluations.
Concurrent conditions and history of other diseases:
Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including: candidiasis, chlamydia trachomatis, trichomonas vaginalis, neisseria gonorrhoeae, bacterial vaginosis, or herpes simplex. If treatment is needed for vaginal infections (eg, for bacterial vaginosis), the screening window can be extended to 6 weeks to accommodate the treatment and washout requirements.
Have active genital/vulvar lesions at screening and Day 1, not related to LS, including active herpes simplex lesions, hyperkeratotic lesions concerning for cutaneous malignancy, or other vaginal or vulvar conditions, which could confound the interpretation of the clinical response, as determined by the investigator.
Cutaneous infection within 1 week before the baseline visit, any infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics, or antifungals within 2 weeks before the baseline visit.
Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Any of the following clinical laboratory test results at screening:
Liver function tests: serum AST or ALT (\>3x upper limit of normal) in conjunction with serum bilirubin (\>2x upper limit of normal)
Positive serology test results at screening for HIV antibody.
Positive serolgy test results at screening for tuberculosis (QuantiFERON®-TB Gold).
History of acute or chronic active hepatitis B or C virus infection.
Any other clinically significant laboratory result that, in the opinion of the investigator, poses a significant risk to the participant receiving nemolizumab.

What this trial measures

  • A ≥ 4-point improvement in Itch NRS scoreBaseline to Week 24

    Participants are instructed to complete and record the Skin Itch NRS in a diary each night for the first 6 weeks, then at study visits for the duration of treatment. Participants will select a number from 0 (no itch) to 10 (worst itch imaginable).