Lichen Sclerosus of VulvaPhase 2NCT07704775
Nemolizumab for LS
A Phase 2 study testing Nemolizumab 30 mg in people with Lichen Sclerosus of Vulva, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Patients ≥ 18 years of age with Lichen sclerosis (LS) Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lichen Sclerosus of Vulva
- What is being tested?
- Nemolizumab 30 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Dec 2027
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
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
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Nemolizumab for the Treatment of Lichen Sclerosus
Patients ≥ 18 years of age with Lichen sclerosis (LS)
- Conditions
- Lichen Sclerosus of Vulva
- Being tested
- Nemolizumab 30 mg
- Keywords
- lichen sclerosus, vulvar dermatoses, vulvar itch
- Medical subject headings
- Vulvar Lichen Sclerosus, Lichen Sclerosus et Atrophicus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nemolizumab 30 mgBiological
Participants will be treated with subcutaneous (SC) nemolizumab injections at doses determined by patient weight.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Participants will be treated with subcutaneous (SC) nemolizumab injections Receives: Biological: Nemolizumab 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
A ≥ 4-point improvement in Itch NRS score
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).
Measured: Baseline to Week 24
Secondary outcomes (8)
Time to achieve a ≥4-point Itch NRS reduction
Study team will determine the average length of time it takes to achieve a ≥4-point Itch NRS reduction in study participants.
Measured: From Baseline to Week 24
Change in Clinical Photographs based on internal physician-rated severity scale
Photos will be taken at baseline, then each study visit to assess disease clinical signs and architecture change
Measured: Baseline to Week 24
Change in Vulvar Quality of Life Index (VQLI) Score
The VQLI is a 15-question survey used to measure the impact of vulvar conditions on a patient's quality of life. The higher the score, the more significant an impact is present.
Measured: Baseline to Week 24
Change in Pain NRS score
Participants are instructed to complete and record the Skin Pain 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 pain) to 10 (worst pain imaginable).
Measured: Baseline to Week 24
Change in tissue stiffness and induration by measuring the exact force (in Newtons) through SkinFibrometer
Measured: Baseline to Week 24
Change in the Clinical Lichen Sclerosus Score (CLISSCO)
This score consists of 12 items in three categories: Symptoms (itch, pain, dysuria); Signs (whitening, petechiae/ecchymosis, fissures); and Architectural changes (clitoral hood fusion, labial fusion or resorption, narrowing of the introitus, anterior changes, perianal involvement, formation of posterior commissure band). Severe disease has a higher score.
Measured: Baseline to Week 24
Change in Female Sexual Function Index (FSFI) score
The FSFI is a 19-item questionnaire that measures six domains of sexual function: desire, arousal, lubrication, orgasm, satisfaction, and pain. The higher the score, the more significant impact is present.
Measured: Baseline to Week 24
Change in Short Health Anxiety Inventory (SHAI) score
The SHAI is an 18-item questionnaire used to measure the severity of health anxiety and illness-related fears. Higher scores indicate greater levels of health anxiety.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Sclerosus of VulvaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Mauskar, University of Texas Southwestern Medical Center
- Investigators
- Melissa Mauskar, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704775
- Sponsor's protocol ID
- STU20261109
- Status last verified
- Jul 2026
- First submitted
- 9 Jun 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nemolizumab for the Treatment of Lichen Sclerosus
- ClinicalTrials.gov ID
- NCT07704775
- Acronym / sponsor ID
- STU20261109
- Conditions
- Lichen Sclerosus of Vulva
- Keywords
- lichen sclerosus, vulvar dermatoses, vulvar itch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Jul 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.
Patients ≥ 18 years of age with Lichen sclerosis (LS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: Nemolizumab 30 mgParticipants will be treated with subcutaneous (SC) nemolizumab injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
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 |
|---|---|---|
| Nemolizumab 30 mgParticipants will be treated with subcutaneous (SC) nemolizumab injections at doses determined by patient weight. | Biological | Treatment Arm |
Primary outcome
A ≥ 4-point improvement in Itch NRS score
Time frame: Baseline 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).
8 secondary outcomes
Time to achieve a ≥4-point Itch NRS reduction
Time frame: From Baseline to Week 24
Change in Clinical Photographs based on internal physician-rated severity scale
Time frame: Baseline to Week 24
Change in Vulvar Quality of Life Index (VQLI) Score
Time frame: Baseline to Week 24
Change in Pain NRS score
Time frame: Baseline to Week 24
Change in tissue stiffness and induration by measuring the exact force (in Newtons) through SkinFibrometer
Time frame: Baseline to Week 24
Change in the Clinical Lichen Sclerosus Score (CLISSCO)
Time frame: Baseline to Week 24
Change in Female Sexual Function Index (FSFI) score
Time frame: Baseline to Week 24
Change in Short Health Anxiety Inventory (SHAI) score
Time frame: Baseline to Week 24
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 15 Jul 2026.
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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.
Melissa Mauskar, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nemolizumab 30 mg in people with Lichen Sclerosus of Vulva, run by University of Texas Southwestern Medical Center 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 24 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: opening soon, as of the sponsor's last update on 15 Jul 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Study Coordinator (2146458968, aleuna.lee@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A ≥ 4-point improvement in Itch NRS score (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2026.