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 (56) 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
Dermatology Research Associates - Los Angeles- Site Number : 8400004
RECRUITING
Los Angeles
Michigan
Michigan Center for Research Company- Site Number : 8400013
RECRUITING
Clarkston
North Dakota
Red River Research Partners - Fargo- Site Number : 8400007
RECRUITING
Fargo
New York
Equity Medical- Site Number : 8400017
RECRUITING
New York
Texas
MedCare Pharma - Houston - Cypress Creek Parkway- Site Number : 8400014
RECRUITING
Houston
Virginia
Care Access - Arlington- Site Number : 8400022
RECRUITING
Arlington
Other Locations
Argentina
Investigational Site Number : 0320001
RECRUITING
Buenos Aires
Investigational Site Number : 0320004
RECRUITING
Buenos Aires
Investigational Site Number : 0320002
RECRUITING
Mendoza
Investigational Site Number : 0320003
RECRUITING
Rosario
Canada
Investigational Site Number : 1240005
RECRUITING
Edmonton
Investigational Site Number : 1240001
RECRUITING
London
Investigational Site Number : 1240007
RECRUITING
Mississauga
Investigational Site Number : 1240009
RECRUITING
Montreal
Investigational Site Number : 1240008
RECRUITING
Québec
Investigational Site Number : 1240010
RECRUITING
Regina
Investigational Site Number : 1240002
RECRUITING
Saskatoon
Chile
Investigational Site Number : 1520001
RECRUITING
Santiago
Investigational Site Number : 1520002
RECRUITING
Santiago
Investigational Site Number : 1520003
RECRUITING
Santiago
China
Investigational Site Number : 1560002
RECRUITING
Beijing
Investigational Site Number : 1560004
RECRUITING
Hangzhou
Investigational Site Number : 1560001
RECRUITING
Shanghai
Investigational Site Number : 1560003
RECRUITING
Shijiazhuang
Investigational Site Number : 1560005
RECRUITING
Suzhou
Germany
Investigational Site Number : 2760003
RECRUITING
Bad Bentheim
Investigational Site Number : 2760002
RECRUITING
Lübeck
Investigational Site Number : 2760001
RECRUITING
Magdeburg
Greece
Investigational Site Number : 3000001
RECRUITING
Athens
Investigational Site Number : 3000002
RECRUITING
Thessaloniki
Investigational Site Number : 3000003
RECRUITING
Thessaloniki
Hungary
Investigational Site Number : 3480001
RECRUITING
Debrecen
Investigational Site Number : 3480002
RECRUITING
Kaposvár
Italy
Investigational Site Number : 3800002
RECRUITING
Bologna
Investigational Site Number : 3800001
RECRUITING
Rome
Japan
Investigational Site Number : 3920002
RECRUITING
Ebina-shi
Investigational Site Number : 3920009
RECRUITING
Fukuoka
Investigational Site Number : 3920005
RECRUITING
Kagoshima
Investigational Site Number : 3920001
RECRUITING
Kamiamakusa
Investigational Site Number : 3920007
RECRUITING
Sakai
Investigational Site Number : 3920003
RECRUITING
Tachikawa
Mexico
Investigational Site Number : 4840001
RECRUITING
Chihuahua City
Portugal
Investigational Site Number : 6200002
RECRUITING
Coimbra
Investigational Site Number : 6200003
RECRUITING
Lisbon
Investigational Site Number : 6200001
RECRUITING
Porto
Spain
Investigational Site Number : 7240002
RECRUITING
Barcelona
Investigational Site Number : 7240003
RECRUITING
Barcelona
Investigational Site Number : 7240005
RECRUITING
Barcelona
Investigational Site Number : 7240004
RECRUITING
Valencia
Taiwan
Investigational Site Number : 1580002
RECRUITING
Kaohsiung City
Investigational Site Number : 1580001
RECRUITING
Taipei
Turkey
Investigational Site Number : 7920003
RECRUITING
Adapazarı
Investigational Site Number : 7920002
RECRUITING
Istanbul
Investigational Site Number : 7920001
RECRUITING
Samsun
United Kingdom
Investigational Site Number : 8260001
RECRUITING
London
Investigational Site Number : 8260002
RECRUITING
Milton Keynes
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2024-11-28
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