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)

Sanofi

Status and phase: Enrolling; Phase 3

Conditions: Lichen Simplex Chronicus

Treatments: Drug: Placebo; Drug: Dupilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06687980

EFC18366

2024-514762-39 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups, including a placebo group

Dupilumab

Experimental group

Description:

Dupilumab subcutaneous injection as per protocol

Treatment:

Drug: Dupilumab

Placebo

Placebo Comparator group

Description:

Placebo subcutaneous injection as per protocol

Treatment:

Drug: Placebo