Last updated 33 days ago
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)
136 patients around the world
Available in Chile
Sanofi
136Patients around the world
This study is for people with
Lichen
Lichen Simplex Chronicus (LSC)
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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), 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.
SponsorSanofi
Study typeInterventional
Conditions
Lichen Simplex Chronicus (LSC)
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06687967
