Health TrialsbyHealthPanel

Nemolizumab for LS

ConditionLichen Sclerosus of Vulva
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Texas Southwestern Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Nemolizumab 30 mg

    Biological/Vaccine

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

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment ArmExperimental treatment 1 intervention

Trial outcomes

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).

Time frame
Baseline to Week 24

Secondary outcomes

1

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.

Time frame
From Baseline to Week 24
2

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

Time frame
Baseline to Week 24
3

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.

Time frame
Baseline to Week 24
4

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).

Time frame
Baseline to Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Southwestern Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: