Dupilumab for Itching
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication that reduces skin inflammation and itching in adults with severe, unexplained itching. It works by blocking proteins that cause these symptoms. The medication has shown promise in treating conditions like atopic dermatitis and asthma.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop your current medications. However, you will be required to take a non-sedative antihistamine and a moisturizer during the trial.
What safety data exists for Dupilumab (Dupixent) in humans?
Dupilumab, used for conditions like atopic dermatitis, has been associated with some side effects, including injection site reactions, conjunctivitis (eye inflammation), headaches, and nasopharyngitis (cold-like symptoms). Some patients have experienced facial redness and neck dermatitis, and there is a risk of ocular (eye-related) adverse reactions, which need prompt management.12345
What makes the drug Dupilumab unique for treating itching?
What data supports the effectiveness of the drug Dupilumab for itching?
Are You a Good Fit for This Trial?
Adults aged 18-90 with severe, chronic itching of unknown origin that affects at least two body areas (legs, arms, or trunk) and have not found relief from previous treatments. Participants must score 'severe' on itch severity scales and be in good health otherwise. Those with certain infections, immune deficiencies, severe kidney failure, hypersensitivity to antihistamines or a history of cancer within the last five years are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in
Participants with severe pruritus enter a 4-week run-in period with a non-sedative antihistamine and an emollient
Treatment
Participants are randomized to receive either dupilumab or placebo for 24 weeks (Study A) or 12 weeks (Study B) in addition to their antihistamine and emollient regimen
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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