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ACTIVE NOT RECRUITING

NCT06687980

PHASE3

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)

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2024-11-25

Completion Date

2026-08-31

Last Updated

2026-01-21

Healthy Volunteers

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

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply (at screening and baseline unless otherwise specified): * Participant must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the informed consent. * Participants with moderate-to-severe LSC, as defined by Investigator's Global Assessment (IGA) score ≥3 and one or more of the following: * at least 1 single anogenital lesion; * at least 2 lesions including 1 lesion of ≥3 cm in diameter; * at least 1 severe lesion (IGA score = 4). * History of LSC for at least 6 months prior to the screening visit. * On the Worst-Itch Numerical Rating Scale (WI-NRS) ranging from 0 to 10, participants must have an average worst-itch of LSC score of ≥7 in the 7 days prior to Day 1. A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score. For participants who do not have at least 4 daily scores reported during the 7 days immediately preceding the planned randomization date, randomization can be postponed until this requirement is met, but without exceeding the 28-day maximum duration of the screening period. * History of failing a 2-week course of medium-to-superpotent topical corticosteroid (TCS) +/- topical calcineurin inhibitor (TCI) for the treatment of LSC within the last 6 months, unless TCS/TCI are medically not advisable. Patients with documented systemic treatment for LSC (other than antihistamines) in the past 6 months are also considered as inadequate responders to topical treatments and are potentially eligible for treatment with dupilumab after appropriate washout. * Appropriate contraceptive measures Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply (at screening and baseline unless otherwise specified): * Participants diagnosed with active lesions of prurigo nodularis (broadly distributed nodules) or active lesions of atopic dermatitis (AD) within 6 months, contact dermatitis, psoriasis, cutaneous T-cell lymphoma (CTCL) XE "CTCL" \\f Abbreviation \\t "cutaneous T-cell lymphoma" (or suspected of CTCL), vulvar lichen planus, or vulvar lichen sclerosus. * Presence of skin morbidities other than LSC that, in the opinion of the Investigator, may interfere with the assessment of the study outcomes. For example: scabies, insect bite, folliculitis, lymphomatoid papulosis, chronic actinic dermatitis, dermatitis herpetiformis, sporotrichosis, bullous disease, lichen planus hypertrophicus. * Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study. * Severe psychiatric disease that, in the Investigator's judgement, would affect the study intervention evaluation. * Having received or planning to use any of the treatments within the timeframe as specified in the protocol. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (63)

Cosmetic Dermatology of Orange County- Site Number : 8400232

Anaheim, California, United States

Center for Dermatology Clinical Research- Site Number : 8400226

Fremont, California, United States

University of Miami Miller School of Medicine- Site Number : 8400218

Miami, Florida, United States

TrueBlue Clinical Research- Site Number : 8400208

Tampa, Florida, United States

Skin Care Physicians of Georgia - Macon- Site Number : 8400236

Macon, Georgia, United States

Southern Indiana Clinical Research Center- Site Number : 8400230

Columbus, Indiana, United States

Equity Medical - Bowling Green- Site Number : 8400240

Bowling Green, Kentucky, United States

Brigham & Women's Hospital- Site Number : 8400229

Boston, Massachusetts, United States

Clinical Research of Philadelphia- Site Number : 8400215

Philadelphia, Pennsylvania, United States

Bellaire Dermatology Associates,- Site Number : 8400202

Bellaire, Texas, United States

Austin Institute for Clinical Research - Pflugerville- Site Number : 8400203

Pflugerville, Texas, United States

Progressive Clinical Research - San Antonio- Site Number : 8400206

San Antonio, Texas, United States

Investigational Site Number : 0320204

Berazategui, Buenos Aires, Argentina

Investigational Site Number : 0320202

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320201

Buenos Aires, Argentina

Investigational Site Number : 0320203

Córdoba, Argentina

Investigational Site Number : 0560202

Alken, Belgium

Investigational Site Number : 0560203

Maldegem, Belgium

Investigational Site Number : 1240210

Calgary, Alberta, Canada

Investigational Site Number : 1240207

Edmonton, Alberta, Canada

Investigational Site Number : 1240201

Surrey, British Columbia, Canada

Investigational Site Number : 1240205

London, Ontario, Canada

Investigational Site Number : 1240208

Markham, Ontario, Canada

Investigational Site Number : 1240209

Toronto, Ontario, Canada

Investigational Site Number : 1240203

Verdun, Quebec, Canada

Investigational Site Number : 1520202

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520201

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1560204

Chongqing, China

Investigational Site Number : 1560206

Guangzhou, China

Investigational Site Number : 1560201

Guangzhou, China

Investigational Site Number : 1560202

Guangzhou, China

Investigational Site Number : 1560203

Wuhan, China

Investigational Site Number : 2030201

Prague, Czechia

Investigational Site Number : 2030202

Prague, Czechia

Investigational Site Number : 2030203

Prague, Czechia

Investigational Site Number : 2760201

Berlin, Germany

Investigational Site Number : 2760205

Hamburg, Germany

Investigational Site Number : 2760203

Kiel, Germany

Investigational Site Number : 3000203

Athens, Greece

Investigational Site Number : 3000201

Athens, Greece

Investigational Site Number : 3000202

Ioannina, Greece

Investigational Site Number : 3480202

Orosháza, Hungary

Investigational Site Number : 3480201

Pécs, Hungary

Investigational Site Number : 3800201

Naples, Napoli, Italy

Investigational Site Number : 3800202

Rome, Roma, Italy

Investigational Site Number : 4840201

Guadalajara, Jalisco, Mexico

Investigational Site Number : 4840202

Monterrey, Nuevo León, Mexico

Investigational Site Number : 4840203

Mérida, Yucatán, Mexico

Investigational Site Number : 4100202

Ansan-si, Gyeonggi-do, South Korea

Investigational Site Number : 4100203

Bupyeong-gu, Incheon-gwangyeoksi, South Korea

Investigational Site Number : 4100201

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 4100204

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 7240203

Pozuelo de Alarcón, Madrid, Spain

Investigational Site Number : 7240204

Alicante, Spain

Investigational Site Number : 7240202

Madrid, Spain

Investigational Site Number : 7240201

Madrid, Spain

Investigational Site Number : 1580203

Hsinchu, Taiwan

Investigational Site Number : 1580202

Taichung, Taiwan

Investigational Site Number : 1580201

Taoyuan, Taiwan

Investigational Site Number : 7920202

Gaziantep, Turkey (Türkiye)

Investigational Site Number : 7920201

Istanbul, Turkey (Türkiye)

Investigational Site Number : 7920203

Istanbul, Turkey (Türkiye)

Investigational Site Number : 8260201

Southampton, Hampshire, United Kingdom

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (63)