New biologic aims to quiet the itch of a chronic skin condition
NCT ID NCT07704775
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether nemolizumab, an injectable biologic, can reduce severe itching in women with vulvar lichen sclerosus, a chronic inflammatory skin condition. Participants receive weight-based doses of the drug and track their itch scores daily. The study focuses on symptom relief rather than curing the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nemolizumab, an injectable biologic drug
- What this could lead to
- If successful, this could offer a new treatment option for severe itching in lichen sclerosus, especially for those who don't respond well to steroid creams.
- What could go wrong
- This is a small, early-phase trial with only 25 participants, so results may not apply to everyone. The drug may not prove effective or could have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
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