A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Efficacy and Safety of Dupilumab for the Treatment of Pruritus of Lichen Simplex Chronicus (LSC) in Adults

Status: Recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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

Locations
United States
California
Center for Dermatology Clinical Research- Site Number : 8400226
RECRUITING
Fremont
Florida
Moore Clinical Research - Brandon- Site Number : 8400208
RECRUITING
Brandon
Indiana
Southern Indiana Clinical Research Center- Site Number : 8400230
RECRUITING
Columbus
Pennsylvania
Clinical Research of Philadelphia- Site Number : 8400215
RECRUITING
Philadelphia
Texas
Austin Institute for Clinical Research - Pflugerville- Site Number : 8400203
RECRUITING
Pflugerville
Progressive Clinical Research - San Antonio- Site Number : 8400206
RECRUITING
San Antonio
Other Locations
Argentina
Investigational Site Number : 0320204
RECRUITING
Berazategui
Investigational Site Number : 0320201
RECRUITING
Buenos Aires
Investigational Site Number : 0320203
RECRUITING
Córdoba
Investigational Site Number : 0320202
RECRUITING
San Miguel De Tucumán
Belgium
Investigational Site Number : 0560202
RECRUITING
Alken
Canada
Investigational Site Number : 1240210
RECRUITING
Calgary
Investigational Site Number : 1240207
RECRUITING
Edmonton
Investigational Site Number : 1240205
RECRUITING
London
Investigational Site Number : 1240208
RECRUITING
Markham
Investigational Site Number : 1240201
RECRUITING
Surrey
Investigational Site Number : 1240209
RECRUITING
Toronto
Investigational Site Number : 1240203
RECRUITING
Verdun
Chile
Investigational Site Number : 1520201
RECRUITING
Santiago
Investigational Site Number : 1520202
RECRUITING
Santiago
China
Investigational Site Number : 1560204
RECRUITING
Chongqing
Investigational Site Number : 1560201
RECRUITING
Guangzhou
Investigational Site Number : 1560202
RECRUITING
Guangzhou
Investigational Site Number : 1560206
RECRUITING
Guangzhou
Investigational Site Number : 1560203
RECRUITING
Wuhan
Germany
Investigational Site Number : 2760201
RECRUITING
Berlin
Investigational Site Number : 2760202
RECRUITING
Frankfurt
Investigational Site Number : 2760205
RECRUITING
Hamburg
Investigational Site Number : 2760203
RECRUITING
Kiel
Greece
Investigational Site Number : 3000201
RECRUITING
Athens
Investigational Site Number : 3000203
RECRUITING
Athens
Investigational Site Number : 3000202
RECRUITING
Ioannina
Hungary
Investigational Site Number : 3480202
RECRUITING
Orosháza
Investigational Site Number : 3480201
RECRUITING
Pécs
Italy
Investigational Site Number : 3800201
RECRUITING
Naples
Investigational Site Number : 3800202
RECRUITING
Rome
Mexico
Investigational Site Number : 4840201
RECRUITING
Guadalajara
Investigational Site Number : 4840203
RECRUITING
Mérida
Investigational Site Number : 4840202
RECRUITING
Monterrey
Republic of Korea
Investigational Site Number : 4100202
RECRUITING
Ansan-si
Investigational Site Number : 4100203
RECRUITING
Bupyeong-gu
Investigational Site Number : 4100201
RECRUITING
Seoul
Investigational Site Number : 4100204
RECRUITING
Seoul
Spain
Investigational Site Number : 7240204
RECRUITING
Alicante
Investigational Site Number : 7240201
RECRUITING
Madrid
Investigational Site Number : 7240202
RECRUITING
Madrid
Investigational Site Number : 7240203
RECRUITING
Pozuelo De Alarcón
Taiwan
Investigational Site Number : 1580203
RECRUITING
Hsinchu
Investigational Site Number : 1580202
RECRUITING
Taichung
Investigational Site Number : 1580201
RECRUITING
Taoyuan
Turkey
Investigational Site Number : 7920202
RECRUITING
Gaziantep
Investigational Site Number : 7920201
RECRUITING
Istanbul
Investigational Site Number : 7920203
RECRUITING
Istanbul
United Kingdom
Investigational Site Number : 8260201
RECRUITING
Southampton
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-11-25
Estimated Completion Date: 2027-07-05
Participants
Target number of participants: 136
Treatments
Experimental: Dupilumab
Dupilumab subcutaneous injection as per protocol
Placebo_comparator: Placebo
Placebo subcutaneous injection as per protocol
Related Therapeutic Areas
Sponsors
Collaborators: Regeneron Pharmaceuticals
Leads: Sanofi

This content was sourced from clinicaltrials.gov