NCT06687980

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 2)

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Dupilumab	Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection
DRUG	Placebo	Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection

Timeline

• Start date: 2024-11-25
• Primary completion: 2026-06-08
• Completion: 2026-08-31
• First posted: 2024-11-14
• Last updated: 2026-01-21

Locations

63 sites across 17 countries: United States, Argentina, Belgium, Canada, Chile, China, Czechia, Germany, Greece, Hungary, Italy, Mexico, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study