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)

Conditions

• Lichen Simplex Chronicus

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dupilumab — DRUG
  Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection
• Placebo — DRUG
  Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection

Study Details

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.

Key Dates

Start date

Nov 28, 2024

Status verified

Jan 2026

Primary completion

Jun 8, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

142 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dupilumab
  Dupilumab subcutaneous injection as per protocol
• Placebo Comparator: Placebo
  Placebo subcutaneous injection as per protocol

Primary Outcome Measure

Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24 [ Time Frame: Week 24 ]

Locations (11)

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