Nemolizumab for LS

NCT07704775 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: STU20261109
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Patients ≥ 18 years of age with Lichen sclerosis (LS)

Conditions

Lichen Sclerosus of Vulva

Keywords

lichen sclerosus; vulvar dermatoses; vulvar itch

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline to Week 24

Secondary Outcomes (8)

• Time to achieve a ≥4-point Itch NRS reduction

  From Baseline to Week 24

• Change in Clinical Photographs based on internal physician-rated severity scale

  Baseline to Week 24

• Change in Vulvar Quality of Life Index (VQLI) Score

  Baseline to Week 24

• Change in Pain NRS score

  Baseline to Week 24

• Change in tissue stiffness and induration by measuring the exact force (in Newtons) through SkinFibrometer

  Baseline to Week 24

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Participants will be treated with subcutaneous (SC) nemolizumab injections

Biological: Nemolizumab 30 mg

Interventions

Nemolizumab 30 mg BIOLOGICAL

Participants will be treated with subcutaneous (SC) nemolizumab injections at doses determined by patient weight.

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus

Interventions

nemolizumab

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Melissa Mauskar, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

2146458968; aleuna.lee@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Locations

US (1)