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)
NCT ID: NCT06687967
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
2024-11-28
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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Dermatology Research Associates - Los Angeles- Site Number : 8400004
Los Angeles, California, United States
Quality Care Clinical Research- Site Number : 8400034
Miami, Florida, United States
Michigan Center for Research Company- Site Number : 8400013
Clarkston, Michigan, United States
JDR Dermatology Research- Site Number : 8400023
Las Vegas, Nevada, United States
Equity Medical- Site Number : 8400017
New York, New York, United States
Onsite Clinical Solutions - Huntersville- Site Number : 8400033
Huntersville, North Carolina, United States
Wake Forest University Health Sciences- Site Number : 8400028
Winston-Salem, North Carolina, United States
Red River Research Partners - Fargo- Site Number : 8400007
Fargo, North Dakota, United States
Center for Clinical Studies - Houston - Binz Street- Site Number : 8400011
Houston, Texas, United States
MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400014
Houston, Texas, United States
Care Access - Arlington- Site Number : 8400022
Arlington, Virginia, United States
Investigational Site Number : 0320003
Rosario, Santa Fe Province, Argentina
Investigational Site Number : 0320001
Buenos Aires, , Argentina
Investigational Site Number : 0320004
Buenos Aires, , Argentina
Investigational Site Number : 0320002
Mendoza, , Argentina
Investigational Site Number : 1240005
Edmonton, Alberta, Canada
Investigational Site Number : 1240001
London, Ontario, Canada
Investigational Site Number : 1240007
Mississauga, Ontario, Canada
Investigational Site Number : 1240009
Montreal, Quebec, Canada
Investigational Site Number : 1240008
Québec, Quebec, Canada
Investigational Site Number : 1240010
Regina, Saskatchewan, Canada
Investigational Site Number : 1240002
Saskatoon, Saskatchewan, Canada
Investigational Site Number : 1520002
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile
Investigational Site Number : 1560002
Beijing, , China
Investigational Site Number : 1560004
Hangzhou, , China
Investigational Site Number : 1560001
Shanghai, , China
Investigational Site Number : 1560003
Shijiazhuang, , China
Investigational Site Number : 1560005
Suzhou, , China
Investigational Site Number : 2030001
Ostrava, , Czechia
Investigational Site Number : 2760003
Bad Bentheim, , Germany
Investigational Site Number : 2760002
Lübeck, , Germany
Investigational Site Number : 2760001
Magdeburg, , Germany
Investigational Site Number : 3000001
Athens, , Greece
Investigational Site Number : 3000002
Thessaloniki, , Greece
Investigational Site Number : 3000003
Thessaloniki, , Greece
Investigational Site Number : 3480001
Debrecen, , Hungary
Investigational Site Number : 3480002
Kaposvár, , Hungary
Investigational Site Number : 3800001
Rome, Roma, Italy
Investigational Site Number : 3800002
Bologna, , Italy
Investigational Site Number : 3920002
Ebina-shi, Kanagawa, Japan
Investigational Site Number : 3920001
Kamiamakusa, Kumamoto, Japan
Investigational Site Number : 3920007
Sakai, Osaka, Japan
Investigational Site Number : 3920003
Tachikawa, Tokyo, Japan
Investigational Site Number : 3920009
Fukuoka, , Japan
Investigational Site Number : 3920005
Kagoshima, , Japan
Investigational Site Number : 4840003
Aguascalientes, , Mexico
Investigational Site Number : 4840001
Chihuahua City, , Mexico
Investigational Site Number : 6200002
Coimbra, , Portugal
Investigational Site Number : 6200003
Lisbon, , Portugal
Investigational Site Number : 6200001
Porto, , Portugal
Investigational Site Number : 7240003
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240005
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240002
Barcelona, Catalunya [Cataluña], Spain
Investigational Site Number : 7240004
Valencia, , Spain
Investigational Site Number : 1580002
Kaohsiung City, , Taiwan
Investigational Site Number : 1580003
New Taipei City, , Taiwan
Investigational Site Number : 1580001
Taipei, , Taiwan
Investigational Site Number : 7920003
Adapazarı, , Turkey (Türkiye)
Investigational Site Number : 7920002
Istanbul, , Turkey (Türkiye)
Investigational Site Number : 7920001
Samsun, , Turkey (Türkiye)
Investigational Site Number : 8260002
Milton Keynes, Buckinghamshire, United Kingdom
Investigational Site Number : 8260001
London, England, 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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EFC18365 Plain Language Results Summary
Other Identifiers
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EFC18365
Identifier Type: -
Identifier Source: org_study_id
2024-514737-37-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1307-7329
Identifier Type: REGISTRY
Identifier Source: secondary_id