Lichen Sclerosus of Vulva
Conditions
Keywords
lichen sclerosus, vulvar dermatoses, vulvar itch
Brief summary
Patients ≥ 18 years of age with Lichen sclerosis (LS)
Interventions
BIOLOGICALNemolizumab 30 mg
Participants will be treated with subcutaneous (SC) nemolizumab injections at doses determined by patient weight.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A ≥ 4-point improvement in Itch NRS score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to achieve a ≥4-point Itch NRS reduction | From Baseline to Week 24 | Study team will determine the average length of time it takes to achieve a ≥4-point Itch NRS reduction in study participants. |
| Change in Clinical Photographs based on internal physician-rated severity scale | Baseline to Week 24 | Photos will be taken at baseline, then each study visit to assess disease clinical signs and architecture change |
| Change in Vulvar Quality of Life Index (VQLI) Score | Baseline to Week 24 | 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. |
| Change in Pain NRS score | Baseline to Week 24 | 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). |
| Change in tissue stiffness and induration by measuring the exact force (in Newtons) through SkinFibrometer | Baseline to Week 24 | — |
| Change in the Clinical Lichen Sclerosus Score (CLISSCO) | Baseline to Week 24 | 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. |
| Change in Female Sexual Function Index (FSFI) score | Baseline to Week 24 | 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. |
| Change in Short Health Anxiety Inventory (SHAI) score | Baseline to Week 24 | 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. |
Countries
United States
Contacts
CONTACTStudy Coordinator
PRINCIPAL_INVESTIGATORMelissa Mauskar, MD
University of Texas Southwestern Medical Center
Outcome results
None listed