Nemolizumab for Lichen Sclerosus

SC
Overseen ByStudy Coordinator
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: University of Texas Southwestern Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

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Melissa Mauskar, MD

Principal Investigator

University of Texas Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18 or older who have been diagnosed with lichen sclerosus, a chronic skin condition affecting the vulva. People with other major health issues or certain infections may not be able to join.

Inclusion Criteria

I am a woman who is 18 years old or older.
Participants who agree to discontinue all agents used to treat LS from screening through final safety follow-up visit, aside from specified rescue therapy
I have a biopsy confirming anogenital lichen sclerosus.
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Exclusion Criteria

I have not had a skin infection or needed antibiotics in the past 2 weeks.
I have used systemic medications for skin conditions or itch in the last 4 months.
Body weight <30 kg
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What Are the Treatments Tested in This Trial?

Interventions

  • Nemolizumab

Trial Overview

The study is testing Nemolizumab, given as a 30 mg dose, to see if it helps treat symptoms of lichen sclerosus and related vulvar conditions in adult patients.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+