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)

NCT06687980 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: EFC183662024-514762-39U1111-1310-5045
• Study Type: interventional
• Target: 138
• Locations: 17 countries
• Sites: 63

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.

Conditions

Lichen Simplex Chronicus

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24

  Worst-Itch numerical rating score (WI-NRS) is a patient report outcome (PRO) comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").

  Week 24

Secondary Outcomes (11)

• Absolute change in weekly average of daily WI-NRS from baseline to Week 24

  Baseline to Week 24

• Percentage change in weekly average of daily WI-NRS from baseline to Week 24

  Baseline to Week 24

• Absolute change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24

  Baseline to Week 24

• Percentage change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24

  Baseline to Week 24

• Absolute change in ItchyQoL score from baseline to Week 24

  Baseline to Week 24

Study Arms (2)

Dupilumab

EXPERIMENTAL

Dupilumab subcutaneous injection as per protocol

Drug: Dupilumab

Placebo

PLACEBO COMPARATOR

Placebo subcutaneous injection as per protocol

Drug: Placebo

Interventions

Dupilumab DRUG

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

Also known as: SAR231893, Dupixent

Dupilumab

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (63)

Cosmetic Dermatology of Orange County- Site Number : 8400232

Anaheim, California, 92807, United States

Location

Center for Dermatology Clinical Research- Site Number : 8400226

Fremont, California, 94538, United States

Location

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

Miami, Florida, 33136, United States

Location

TrueBlue Clinical Research- Site Number : 8400208

Tampa, Florida, 33609, United States

Location

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

Macon, Georgia, 31217, United States

Location

Southern Indiana Clinical Research Center- Site Number : 8400230

Columbus, Indiana, 47201, United States

Location

Equity Medical - Bowling Green- Site Number : 8400240

Bowling Green, Kentucky, 42104, United States

Location

Brigham & Women's Hospital- Site Number : 8400229

Boston, Massachusetts, 02115, United States

Location

Clinical Research of Philadelphia- Site Number : 8400215

Philadelphia, Pennsylvania, 19114, United States

Location

Bellaire Dermatology Associates,- Site Number : 8400202

Bellaire, Texas, 77401, United States

Location

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

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research - San Antonio- Site Number : 8400206

San Antonio, Texas, 78229, United States

Location

Investigational Site Number : 0320204

Berazategui, Buenos Aires, 1886, Argentina

Location

Investigational Site Number : 0320202

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Investigational Site Number : 0320201

Buenos Aires, 1427, Argentina

Location

Investigational Site Number : 0320203

Córdoba, 5000, Argentina

Location

Investigational Site Number : 0560202

Alken, 3570, Belgium

Location

Investigational Site Number : 0560203

Maldegem, 9990, Belgium

Location

Investigational Site Number : 1240210

Calgary, Alberta, T2W 4X9, Canada

Location

Investigational Site Number : 1240207

Edmonton, Alberta, T6W 0J5, Canada

Location

Investigational Site Number : 1240201

Surrey, British Columbia, V3R 6A7, Canada

Location

Investigational Site Number : 1240205

London, Ontario, L6A 2C2, Canada

Location

Investigational Site Number : 1240208

Markham, Ontario, L3P 1X3, Canada

Location

Investigational Site Number : 1240209

Toronto, Ontario, M2N 3A6, Canada

Location

Investigational Site Number : 1240203

Verdun, Quebec, H4G 2L8, Canada

Location

Investigational Site Number : 1520202

Santiago, Reg Metropolitana de Santiago, 7500505, Chile

Location

Investigational Site Number : 1520201

Santiago, Reg Metropolitana de Santiago, 8380465, Chile

Location

Investigational Site Number : 1560204

Chongqing, 400038, China

Location

Investigational Site Number : 1560206

Guangzhou, 510000, China

Location

Investigational Site Number : 1560201

Guangzhou, 510018, China

Location

Investigational Site Number : 1560202

Guangzhou, 510120, China

Location

Investigational Site Number : 1560203

Wuhan, 430022, China

Location

Investigational Site Number : 2030201

Prague, 110 01, Czechia

Location

Investigational Site Number : 2030202

Prague, 160 00, Czechia

Location

Investigational Site Number : 2030203

Prague, 180 81, Czechia

Location

Investigational Site Number : 2760201

Berlin, 12203, Germany

Location

Investigational Site Number : 2760205

Hamburg, 20095, Germany

Location

Investigational Site Number : 2760203

Kiel, 24105, Germany

Location

Investigational Site Number : 3000203

Athens, 142 33, Greece

Location

Investigational Site Number : 3000201

Athens, 161 21, Greece

Location

Investigational Site Number : 3000202

Ioannina, 455 00, Greece

Location

Investigational Site Number : 3480202

Orosháza, 5900, Hungary

Location

Investigational Site Number : 3480201

Pécs, 7632, Hungary

Location

Investigational Site Number : 3800201

Naples, Napoli, 80131, Italy

Location

Investigational Site Number : 3800202

Rome, Roma, 00168, Italy

Location

Investigational Site Number : 4840201

Guadalajara, Jalisco, 44657, Mexico

Location

Investigational Site Number : 4840202

Monterrey, Nuevo León, 64460, Mexico

Location

Investigational Site Number : 4840203

Mérida, Yucatán, 97070, Mexico

Location

Investigational Site Number : 4100202

Ansan-si, Gyeonggi-do, 15355, South Korea

Location

Investigational Site Number : 4100203

Bupyeong-gu, Incheon-gwangyeoksi, 21431, South Korea

Location

Investigational Site Number : 4100201

Seoul, Seoul-teukbyeolsi, 03080, South Korea

Location

Investigational Site Number : 4100204

Seoul, Seoul-teukbyeolsi, 03312, South Korea

Location

Investigational Site Number : 7240203

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Investigational Site Number : 7240204

Alicante, 03010, Spain

Location

Investigational Site Number : 7240202

Madrid, 28034, Spain

Location

Investigational Site Number : 7240201

Madrid, 28046, Spain

Location

Investigational Site Number : 1580203

Hsinchu, 300, Taiwan

Location

Investigational Site Number : 1580202

Taichung, 404, Taiwan

Location

Investigational Site Number : 1580201

Taoyuan, 333, Taiwan

Location

Investigational Site Number : 7920202

Gaziantep, 27310, Turkey (Türkiye)

Location

Investigational Site Number : 7920201

Istanbul, 34093, Turkey (Türkiye)

Location

Investigational Site Number : 7920203

Istanbul, 34722, Turkey (Türkiye)

Location

Investigational Site Number : 8260201

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Links

• EFC18366 Plain Language Results Summary

MeSH Terms

Conditions

Neurodermatitis

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): June 8, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

IT (2); HU (2); TU (3); CA (7); ME (3); ES (4); TW (3); CL (2); CZ (3); AR (4); BE (2); KR (4); GB (1); DE (3); US (12); GR (3); CN (5)