Dupilumab for Chronic Itch
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it mentions a 'washout period' for those who have had systemic treatment for LSC in the past 6 months. It's best to discuss your specific medications with the trial team.
What data supports the effectiveness of the drug Dupilumab for chronic itch?
Dupilumab has shown significant effectiveness in reducing chronic itch, particularly in conditions like atopic dermatitis, where it greatly reduces itch severity. In a study, 89% of patients experienced a significant reduction in itch severity, and 83% noticed improvement within four weeks of starting treatment.12345
Is dupilumab generally safe for humans?
How is the drug Dupilumab unique for treating chronic itch?
What is the purpose of this trial?
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 Criteria
This trial is for adults with Lichen Simplex Chronicus (LSC) who've had it for at least 6 months, have severe skin lesions, and experience chronic itching. Participants must have tried and failed a course of topical treatments or be unable to use them. They should also practice appropriate contraception.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dupilumab or placebo subcutaneous injections for the treatment of pruritus in Lichen Simplex Chronicus
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dupilumab
Dupilumab is already approved in United States, European Union for the following indications:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
Paul Hudson
Sanofi
Chief Executive Officer since 2019
Degree in Economics from Manchester Metropolitan University
Christopher Corsico
Sanofi
Chief Medical Officer
MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University
Regeneron Pharmaceuticals
Industry Sponsor
Leonard Schleifer
Regeneron Pharmaceuticals
Chief Executive Officer since 1988
MD and PhD in Medicine
George Yancopoulos
Regeneron Pharmaceuticals
Chief Medical Officer since 1997
MD from Harvard Medical School