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)

Launched by SANOFI · Nov 12, 2024

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ClinConnect Summary

This clinical trial, called STYLE 2, is looking at whether dupilumab injections can help reduce itching in people with a condition called Lichen Simplex Chronicus (LSC). LSC is characterized by intense itching and thickened skin in certain areas. The study involves both men and women who are at least 18 years old and have had moderate to severe LSC for at least six months. To be eligible, participants must have experienced significant itching, as measured on a scale from 0 to 10, and have not found relief from previous treatments using strong topical creams.

Participants in the trial will receive either dupilumab or a placebo (a harmless injection with no active medication) over a period of up to 24 weeks, followed by 12 weeks of follow-up. During the study, participants will have six visits to the clinic. This trial is currently recruiting and aims to determine if dupilumab can provide better relief from itching compared to the placebo. If you or someone you know is struggling with LSC and meets the eligibility criteria, this study could be an opportunity to explore a new treatment option.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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
• Exclusion Criteria:
• 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.