EFC18365 Enrolling

Research Trial for Lichen Simplex Chronicus (40 Weeks) (STYLE 1)


Treatment: Injection Age: 18 Years


Who Can Participate?

Adults at least 18 years of age with lichen simplex chronicus (LSC), may be eligible to participate.

 

Inclusion Criteria:

      • History of LSC for at least 6 months
      • Moderate-to-severe LSC
      • History of failing a 2-week course of medium-to-superpotent topical corticosteroids (TCS) +/- topical calcineurin inhibitors (TCI) for the treatment of LSC within the last 6 months, unless TCS/TCI are medically not advisable

 

Participant Info:

      • No cost to participate or receive study treatment
      • Regular visits with study doctors who are familiar with lichen simplex chronicus
      • Will receive investigational injected medication (active study drug) or placebo
      • Reimbursement for study-related expenses may be provided

 

How Long Will The Study Last?

      • About 40 weeks and involve about 6 visits to the study research site

Participating Locations

COUNTRY
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Canada

Participating Experts

No Doctors Found

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The following information is from ClinicalTrials.gov

Last Update Posted: January 24, 2025

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Dupilumab for the Treatment of Pruritus of Lichen Simplex Chronicus (LSC) in Adults

ClinicalTrials.gov ID

NCT06687967

Sponsor

Sanofi

Study Description

  • Brief Summary:

    This is a parallel, Phase 3, 2-arm study for treatment. The purpose of this study is to measure improvement in pruritus with dupilumab subcutaneous injections compared with placebo injections in male and female participants aged at least 18 years with LSC. Study details include: The study duration will be up to 40 weeks. The treatment duration will be up to 24 weeks. The follow-up duration after treatment will be 12 weeks. The number of visits will be 6.

  • Condition or Disease:

    Lichen Simplex Chronicus

  • Intervention/Treatment:

    Drug: Dupilumab Drug: Placebo
  • Phase:

    PHASE 3

  • Ages Eligible for Study:

    18 Years and older (ADULT,OLDER_ADULT)

  • Sexes Eligible for Study:

    ALL


Terms and Conditions – ClinicalTrials.gov
Purpose of ClinicalTrials.gov Database. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has developed ClinicalTrials.gov to provide patients, family members, and members of the public current information about clinical research studies.



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Lichen Simplex Chronicus

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