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)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Lichen Simplex Chronicus

In brief

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.

Key facts

Study ID: NCT06687980
Run by: Sanofi
People needed: 138
Starts: 2024-11-25
Expected to finish: 2026-08-31
Last updated by the study team: 2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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
Cosmetic Dermatology of Orange County- Site Number : 8400232 — Anaheim, California, United States

Full record on ClinicalTrials.gov

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