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)

NCT06687967 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: EFC183652024-514737-37-00U1111-1307-7329
• Study Type: interventional
• Target: 142
• 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)

Dermatology Research Associates - Los Angeles- Site Number : 8400004

Los Angeles, California, 90045, United States

Location

Quality Care Clinical Research- Site Number : 8400034

Miami, Florida, 33142, United States

Location

Michigan Center for Research Company- Site Number : 8400013

Clarkston, Michigan, 48346, United States

Location

JDR Dermatology Research- Site Number : 8400023

Las Vegas, Nevada, 89145, United States

Location

Equity Medical- Site Number : 8400017

New York, New York, 10023, United States

Location

Onsite Clinical Solutions - Huntersville- Site Number : 8400033

Huntersville, North Carolina, 28078, United States

Location

Wake Forest University Health Sciences- Site Number : 8400028

Winston-Salem, North Carolina, 27104, United States

Location

Red River Research Partners - Fargo- Site Number : 8400007

Fargo, North Dakota, 58103, United States

Location

Center for Clinical Studies - Houston - Binz Street- Site Number : 8400011

Houston, Texas, 77004, United States

Location

MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400014

Houston, Texas, 77090, United States

Location

Care Access - Arlington- Site Number : 8400022

Arlington, Virginia, 22206, United States

Location

Investigational Site Number : 0320003

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320001

Buenos Aires, 1012, Argentina

Location

Investigational Site Number : 0320004

Buenos Aires, 1061, Argentina

Location

Investigational Site Number : 0320002

Mendoza, 5500, Argentina

Location

Investigational Site Number : 1240005

Edmonton, Alberta, T5K 2V4, Canada

Location

Investigational Site Number : 1240001

London, Ontario, N6H 5L5, Canada

Location

Investigational Site Number : 1240007

Mississauga, Ontario, L5H 1G9, Canada

Location

Investigational Site Number : 1240009

Montreal, Quebec, H1Y 3L1, Canada

Location

Investigational Site Number : 1240008

Québec, Quebec, G1W 4R4, Canada

Location

Investigational Site Number : 1240010

Regina, Saskatchewan, S4V 1R9, Canada

Location

Investigational Site Number : 1240002

Saskatoon, Saskatchewan, S7K 0H6, Canada

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 7580206, Chile

Location

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

Location

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 8420383, Chile

Location

Investigational Site Number : 1560002

Beijing, 100191, China

Location

Investigational Site Number : 1560004

Hangzhou, 310014, China

Location

Investigational Site Number : 1560001

Shanghai, 200443, China

Location

Investigational Site Number : 1560003

Shijiazhuang, 050031, China

Location

Investigational Site Number : 1560005

Suzhou, 215006, China

Location

Investigational Site Number : 2030001

Ostrava, 702 00, Czechia

Location

Investigational Site Number : 2760003

Bad Bentheim, 48455, Germany

Location

Investigational Site Number : 2760001

Magdeburg, 39104, Germany

Location

Investigational Site Number : 3000001

Athens, 124 62, Greece

Location

Investigational Site Number : 3000002

Thessaloniki, 546 42, Greece

Location

Investigational Site Number : 3000003

Thessaloniki, 564 29, Greece

Location

Investigational Site Number : 3480001

Debrecen, 4032, Hungary

Location

Investigational Site Number : 3480002

Kaposvár, 7400, Hungary

Location

Investigational Site Number : 3800001

Rome, Roma, 00133, Italy

Location

Investigational Site Number : 3800002

Bologna, 40138, Italy

Location

Investigational Site Number : 3920002

Ebina-shi, Kanagawa, 243-0432, Japan

Location

Investigational Site Number : 3920001

Kamiamakusa, Kumamoto, 861-3106, Japan

Location

Investigational Site Number : 3920007

Sakai, Osaka, 593-8324, Japan

Location

Investigational Site Number : 3920003

Tachikawa, Tokyo, 190-0023, Japan

Location

Investigational Site Number : 3920009

Fukuoka, 819-0167, Japan

Location

Investigational Site Number : 3920005

Kagoshima, 890-0063, Japan

Location

Investigational Site Number : 4840003

Aguascalientes, 20127, Mexico

Location

Investigational Site Number : 4840001

Chihuahua City, 31000, Mexico

Location

Investigational Site Number : 6200002

Coimbra, 3000-075, Portugal

Location

Investigational Site Number : 6200003

Lisbon, 1998-018, Portugal

Location

Investigational Site Number : 6200001

Porto, 4099-001, Portugal

Location

Investigational Site Number : 7240003

Barcelona, Barcelona [Barcelona], 08035, Spain

Location

Investigational Site Number : 7240005

Barcelona, Catalunya [Cataluña], 08036, Spain

Location

Investigational Site Number : 7240002

Barcelona, Catalunya [Cataluña], 08041, Spain

Location

Investigational Site Number : 7240004

Valencia, 46015, Spain

Location

Investigational Site Number : 1580002

Kaohsiung City, 833, Taiwan

Location

Investigational Site Number : 1580003

New Taipei City, 235, Taiwan

Location

Investigational Site Number : 1580001

Taipei, 100, Taiwan

Location

Investigational Site Number : 7920003

Adapazarı, 54100, Turkey (Türkiye)

Location

Investigational Site Number : 7920002

Istanbul, 34662, Turkey (Türkiye)

Location

Investigational Site Number : 7920001

Samsun, 55139, Turkey (Türkiye)

Location

Investigational Site Number : 8260002

Milton Keynes, Buckinghamshire, MK19 6FG, United Kingdom

Location

Investigational Site Number : 8260001

London, England, E1 1BB, United Kingdom

Location

Related Links

• EFC18365 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 28, 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

ES (4); CZ (1); TW (3); HU (2); IT (2); US (11); JP (6); GR (3); PT (3); AR (4); CA (7); ME (2); TU (3); CL (3); DE (2); GB (2); CN (5)