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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lichen Simplex Chronicus
• Intervention / Treatment: Drug: Dupilumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1427
    • Investigational Site Number : 0320201
  • Córdoba, Argentina, 5000
    • Investigational Site Number : 0320203
  • Buenos Aires
    • Berazategui, Buenos Aires, Argentina, 1886
      • Investigational Site Number : 0320204
  • Tucumán Province
    • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
      • Investigational Site Number : 0320202
• Belgium
  • Alken, Belgium, 3570
    • Investigational Site Number : 0560202
  • Maldegem, Belgium, 9990
    • Investigational Site Number : 0560203
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2W 4X9
      • Investigational Site Number : 1240210
    • Edmonton, Alberta, Canada, T6W 0J5
      • Investigational Site Number : 1240207
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Investigational Site Number : 1240201
  • Ontario
    • London, Ontario, Canada, L6A 2C2
      • Investigational Site Number : 1240205
    • Markham, Ontario, Canada, L3P 1X3
      • Investigational Site Number : 1240208
    • Toronto, Ontario, Canada, M2N 3A6
      • Investigational Site Number : 1240209
  • Quebec
    • Verdun, Quebec, Canada, H4G 2L8
      • Investigational Site Number : 1240203
• Chile
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 7500505
      • Investigational Site Number : 1520202
    • Santiago, Reg Metropolitana de Santiago, Chile, 8380465
      • Investigational Site Number : 1520201
• China
  • Chongqing, China, 400038
    • Investigational Site Number : 1560204
  • Guangzhou, China, 510000
    • Investigational Site Number : 1560206
  • Guangzhou, China, 510018
    • Investigational Site Number : 1560201
  • Guangzhou, China, 510120
    • Investigational Site Number : 1560202
  • Wuhan, China, 430022
    • Investigational Site Number : 1560203
• Czechia
  • Prague, Czechia, 110 01
    • Investigational Site Number : 2030201
  • Prague, Czechia, 160 00
    • Investigational Site Number : 2030202
  • Prague, Czechia, 180 81
    • Investigational Site Number : 2030203
• Germany
  • Berlin, Germany, 12203
    • Investigational Site Number : 2760201
  • Hamburg, Germany, 20095
    • Investigational Site Number : 2760205
  • Kiel, Germany, 24105
    • Investigational Site Number : 2760203
• Greece
  • Athens, Greece, 142 33
    • Investigational Site Number : 3000203
  • Athens, Greece, 161 21
    • Investigational Site Number : 3000201
  • Ioannina, Greece, 455 00
    • Investigational Site Number : 3000202
• Hungary
  • Orosháza, Hungary, 5900
    • Investigational Site Number : 3480202
  • Pécs, Hungary, 7632
    • Investigational Site Number : 3480201
• Italy
  • Napoli
    • Naples, Napoli, Italy, 80131
      • Investigational Site Number : 3800201
  • Roma
    • Rome, Roma, Italy, 00168
      • Investigational Site Number : 3800202
• Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44657
      • Investigational Site Number : 4840201
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Investigational Site Number : 4840202
  • Yucatán
    • Mérida, Yucatán, Mexico, 97070
      • Investigational Site Number : 4840203
• South Korea
  • Gyeonggi-do
    • Ansan-si, Gyeonggi-do, South Korea, 15355
      • Investigational Site Number : 4100202
  • Incheon-gwangyeoksi
    • Bupyeong-gu, Incheon-gwangyeoksi, South Korea, 21431
      • Investigational Site Number : 4100203
  • Seoul-teukbyeolsi
    • Seoul, Seoul-teukbyeolsi, South Korea, 03080
      • Investigational Site Number : 4100201
    • Seoul, Seoul-teukbyeolsi, South Korea, 03312
      • Investigational Site Number : 4100204
• Spain
  • Alicante, Spain, 03010
    • Investigational Site Number : 7240204
  • Madrid, Spain, 28034
    • Investigational Site Number : 7240202
  • Madrid, Spain, 28046
    • Investigational Site Number : 7240201
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Investigational Site Number : 7240203
• Taiwan
  • Hsinchu, Taiwan, 300
    • Investigational Site Number : 1580203
  • Taichung, Taiwan, 404
    • Investigational Site Number : 1580202
  • Taoyuan, Taiwan, 333
    • Investigational Site Number : 1580201
• Turkey (Türkiye)
  • Gaziantep, Turkey (Türkiye), 27310
    • Investigational Site Number : 7920202
  • Istanbul, Turkey (Türkiye), 34093
    • Investigational Site Number : 7920201
  • Istanbul, Turkey (Türkiye), 34722
    • Investigational Site Number : 7920203
• United Kingdom
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • Investigational Site Number : 8260201
• United States
  • California
    • Anaheim, California, United States, 92807
      • Cosmetic Dermatology of Orange County- Site Number : 8400232
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research- Site Number : 8400226
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine- Site Number : 8400218
    • Tampa, Florida, United States, 33609
      • TrueBlue Clinical Research- Site Number : 8400208
  • Georgia
    • Macon, Georgia, United States, 31217
      • Skin Care Physicians of Georgia - Macon- Site Number : 8400236
  • Indiana
    • Columbus, Indiana, United States, 47201
      • Southern Indiana Clinical Research Center- Site Number : 8400230
  • Kentucky
    • Bowling Green, Kentucky, United States, 42104
      • Equity Medical - Bowling Green- Site Number : 8400240
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital- Site Number : 8400229
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19114
      • Clinical Research of Philadelphia- Site Number : 8400215
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates,- Site Number : 8400202
    • Pflugerville, Texas, United States, 78660
      • Austin Institute for Clinical Research - Pflugerville- Site Number : 8400203
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research - San Antonio- Site Number : 8400206

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dupilumab; Dupilumab subcutaneous injection as per protocol	Drug: Dupilumab; Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection; Other Names: Dupixent; SAR231893
Placebo Comparator: Placebo; Placebo subcutaneous injection as per protocol	Drug: Placebo; Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 12	WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").	Week 12
Incidence of treatment-emergent anti-drug antibody (ADA) against dupilumab		Baseline through Week 36
Percentage of participants experiencing treatment-emergent adverse events (TEAEs) or serious adverse events (SAEs)		Baseline through Week 36
Absolute change in weekly average of daily WI-NRS from baseline to Week 24	WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").	Baseline to Week 24
Percentage change in weekly average of daily WI-NRS from baseline to Week 24	WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch").	Baseline to Week 24
Absolute change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24	The Itch-related Sleep Disturbance NRS is a single-item PRO to report the degree of sleep loss related to itch over the past 24 hours, from 0 ("no sleep loss related to itch") to 10 ("I cannot sleep at all due to itch").	Baseline to Week 24
Percentage change in weekly average of daily Itch-related Sleep Disturbance NRS from baseline to Week 24	The Itch-related Sleep Disturbance NRS is a single-item PRO to report the degree of sleep loss related to itch over the past 24 hours, from 0 ("no sleep loss related to itch") to 10 ("I cannot sleep at all due to itch").	Baseline to Week 24
Absolute change in ItchyQoL score from baseline to Week 24	Itchy quality of life survey (ItchyQoL) is a pruritus-specific QoL instrument to measure dermatology-specific QoL in patients aged 16 years and older. The overall score ranging from 1 to 5. A higher score corresponds to a more adverse impact on health-related QoL	Baseline to Week 24
Absolute change in DLQI total score from baseline to Week 24	Dermatology life quality index (DLQI) is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer health-related QoL.	Baseline to Week 24
Proportion of participants with IGA 0 or 1 score for LSC at Week 12 and Week 24	Investigator's Global Assessment (IGA) for LSC is a clinician-reported outcome using a 5-point scale from 0 (clear) to 4 (severe).	Week 12 and 24
Proportion of participants with both an improvement (reduction) in weekly average of daily WI-NRS by ≥4 from baseline to Week 24 and an IGA 0 or 1 score for LSC at Week 24	WI-NRS is a PRO comprised of a single item rated on a scale from 0 ("No itch") to 10 ("Worst imaginable itch"). IGA for LSC is a clinician-reported outcome using a 5-point scale from 0 (clear) to 4 (severe).	Baseline through Week 24

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

Helpful Links

• EFC18366 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Estimated): June 8, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Dermatitis; Skin and Connective Tissue Diseases; Neurodermatitis; dupilumab
• Other Study ID Numbers: EFC18366; 2024-514762-39 (Registry Identifier: CTIS); U1111-1310-5045 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No