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A Study to Investigate Improvement in Pruritus of Lichen Simplex Chronicus With Dupilumab Injections Compared With Placebo in Male and Female Participants Aged at Least 18 Years (STYLE 1)

NCT06687967 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-01-21

No results posted yet for this study

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.

Conditions

  • Lichen Simplex Chronicus

Interventions

DRUG

Dupilumab

Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection

DRUG

Placebo

Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-28
Primary Completion
2026-06-08
Completion
2026-08-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Canada
  • Chile
  • China
  • Czechia
  • Germany
  • Greece
  • Hungary
  • Italy
  • Japan
  • Mexico
  • Portugal
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06687967 on ClinicalTrials.gov