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)

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): 142
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1012
    • Investigational Site Number : 0320001
  • Buenos Aires, Argentina, 1061
    • Investigational Site Number : 0320004
  • Mendoza, Argentina, 5500
    • Investigational Site Number : 0320002
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Investigational Site Number : 0320003
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5K 2V4
      • Investigational Site Number : 1240005
  • Ontario
    • London, Ontario, Canada, N6H 5L5
      • Investigational Site Number : 1240001
    • Mississauga, Ontario, Canada, L5H 1G9
      • Investigational Site Number : 1240007
  • Quebec
    • Montreal, Quebec, Canada, H1Y 3L1
      • Investigational Site Number : 1240009
    • Québec, Quebec, Canada, G1W 4R4
      • Investigational Site Number : 1240008
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4V 1R9
      • Investigational Site Number : 1240010
    • Saskatoon, Saskatchewan, Canada, S7K 0H6
      • Investigational Site Number : 1240002
• Chile
  • Reg Metropolitana de Santiago
    • Santiago, Reg Metropolitana de Santiago, Chile, 7640881
      • Investigational Site Number : 1520001
    • Santiago, Reg Metropolitana de Santiago, Chile, 7580206
      • Investigational Site Number : 1520002
    • Santiago, Reg Metropolitana de Santiago, Chile, 8420383
      • Investigational Site Number : 1520003
• China
  • Beijing, China, 100191
    • Investigational Site Number : 1560002
  • Hangzhou, China, 310014
    • Investigational Site Number : 1560004
  • Shanghai, China, 200443
    • Investigational Site Number : 1560001
  • Shijiazhuang, China, 050031
    • Investigational Site Number : 1560003
  • Suzhou, China, 215006
    • Investigational Site Number : 1560005
• Czechia
  • Ostrava, Czechia, 702 00
    • Investigational Site Number : 2030001
• Germany
  • Bad Bentheim, Germany, 48455
    • Investigational Site Number : 2760003
  • Magdeburg, Germany, 39104
    • Investigational Site Number : 2760001
• Greece
  • Athens, Greece, 124 62
    • Investigational Site Number : 3000001
  • Thessaloniki, Greece, 546 42
    • Investigational Site Number : 3000002
  • Thessaloniki, Greece, 564 29
    • Investigational Site Number : 3000003
• Hungary
  • Debrecen, Hungary, 4032
    • Investigational Site Number : 3480001
  • Kaposvár, Hungary, 7400
    • Investigational Site Number : 3480002
• Italy
  • Bologna, Italy, 40138
    • Investigational Site Number : 3800002
  • Roma
    • Rome, Roma, Italy, 00133
      • Investigational Site Number : 3800001
• Japan
  • Fukuoka, Japan, 819-0167
    • Investigational Site Number : 3920009
  • Kagoshima, Japan, 890-0063
    • Investigational Site Number : 3920005
  • Kanagawa
    • Ebina-shi, Kanagawa, Japan, 243-0432
      • Investigational Site Number : 3920002
  • Kumamoto
    • Kamiamakusa, Kumamoto, Japan, 861-3106
      • Investigational Site Number : 3920001
  • Osaka
    • Sakai, Osaka, Japan, 593-8324
      • Investigational Site Number : 3920007
  • Tokyo
    • Tachikawa, Tokyo, Japan, 190-0023
      • Investigational Site Number : 3920003
• Mexico
  • Aguascalientes, Mexico, 20127
    • Investigational Site Number : 4840003
  • Chihuahua City, Mexico, 31000
    • Investigational Site Number : 4840001
• Portugal
  • Coimbra, Portugal, 3000-075
    • Investigational Site Number : 6200002
  • Lisbon, Portugal, 1998-018
    • Investigational Site Number : 6200003
  • Porto, Portugal, 4099-001
    • Investigational Site Number : 6200001
• Spain
  • Valencia, Spain, 46015
    • Investigational Site Number : 7240004
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 08035
      • Investigational Site Number : 7240003
  • Catalunya [Cataluña]
    • Barcelona, Catalunya [Cataluña], Spain, 08036
      • Investigational Site Number : 7240005
    • Barcelona, Catalunya [Cataluña], Spain, 08041
      • Investigational Site Number : 7240002
• Taiwan
  • Kaohsiung City, Taiwan, 833
    • Investigational Site Number : 1580002
  • New Taipei City, Taiwan, 235
    • Investigational Site Number : 1580003
  • Taipei, Taiwan, 100
    • Investigational Site Number : 1580001
• Turkey (Türkiye)
  • Adapazarı, Turkey (Türkiye), 54100
    • Investigational Site Number : 7920003
  • Istanbul, Turkey (Türkiye), 34662
    • Investigational Site Number : 7920002
  • Samsun, Turkey (Türkiye), 55139
    • Investigational Site Number : 7920001
• United Kingdom
  • Buckinghamshire
    • Milton Keynes, Buckinghamshire, United Kingdom, MK19 6FG
      • Investigational Site Number : 8260002
  • England
    • London, England, United Kingdom, E1 1BB
      • Investigational Site Number : 8260001
• United States
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates - Los Angeles- Site Number : 8400004
  • Florida
    • Miami, Florida, United States, 33142
      • Quality Care Clinical Research- Site Number : 8400034
  • Michigan
    • Clarkston, Michigan, United States, 48346
      • Michigan Center for Research Company- Site Number : 8400013
  • Nevada
    • Las Vegas, Nevada, United States, 89145
      • JDR Dermatology Research- Site Number : 8400023
  • New York
    • New York, New York, United States, 10023
      • Equity Medical- Site Number : 8400017
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Onsite Clinical Solutions - Huntersville- Site Number : 8400033
    • Winston-Salem, North Carolina, United States, 27104
      • Wake Forest University Health Sciences- Site Number : 8400028
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Red River Research Partners - Fargo- Site Number : 8400007
  • Texas
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies - Houston - Binz Street- Site Number : 8400011
    • Houston, Texas, United States, 77090
      • MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400014
  • Virginia
    • Arlington, Virginia, United States, 22206
      • Care Access - Arlington- Site Number : 8400022

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 event (TEAEs) or serious adverse event (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 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
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

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

Helpful Links

• EFC18365 Plain Language Results Summary

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 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: EFC18365; 2024-514737-37-00 (Registry Identifier: CTIS); U1111-1307-7329 (Registry Identifier: WHO 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