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)
NCT ID: NCT06687980
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
136 participants
INTERVENTIONAL
2024-11-25
2027-07-05
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dupilumab
Dupilumab subcutaneous injection as per protocol
Dupilumab
Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection
Placebo
Placebo subcutaneous injection as per protocol
Placebo
Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection
Interventions
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Dupilumab
Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection
Placebo
Pharmaceutical form: Solution for injection Route of administration: subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Sanofi
INDUSTRY
Responsible Party
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Locations
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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 : 2760202
Frankfurt, , 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
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Related Links
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EFC18366 Plain Language Results Summary
Other Identifiers
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EFC18366
Identifier Type: -
Identifier Source: org_study_id
2024-514762-39
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1310-5045
Identifier Type: REGISTRY
Identifier Source: secondary_id