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)
EU CTIS ID: 2024-514762-39-00
What this study is testing
To demonstrate the efficacy of dupilumab on pruritus of LSC in adult participants with moderate-to-severe LSC inadequately controlled by topical therapies
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 likely can't join 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) (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 study team makes the final eligibility decision.
Where it's taking place
- China
- Argentina
- United Kingdom
- Korea, Republic of
- Mexico
- Canada
- Chile
- Turkey
- United States
- Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Argentina; United Kingdom; Korea, Republic of; Mexico; Canada and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.