Dupilumab for Eczema
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you have not used immunosuppressive or immunomodulating drugs within 4 weeks before starting. If you're on such medications, you may need to stop them before joining the trial.
What data supports the effectiveness of the drug Dupilumab for eczema?
Dupilumab has been shown to improve symptoms of moderate-to-severe eczema, such as skin inflammation, itching, and sleep disturbances, in adults who did not respond well to other treatments. It is also generally well tolerated, with most side effects being mild, like injection site reactions and conjunctivitis.12345
What is the safety profile of Dupilumab for eczema?
Dupilumab is generally considered safe for treating eczema, with common side effects including injection site reactions, conjunctivitis (eye inflammation), headache, and nasopharyngitis (cold-like symptoms). Some rare side effects have been reported, such as increased sweating and certain eye conditions, but overall, its safety profile is similar to a placebo.26789
What makes the drug Dupilumab unique for treating eczema?
Dupilumab is unique because it is the first FDA-approved biological therapy for moderate-to-severe eczema that works by blocking the IL-4 receptor, which helps reduce inflammation caused by the immune system. Unlike traditional topical treatments, it is administered as an injection and is specifically designed for patients whose eczema is not well-controlled with topical therapies.1291011
What is the purpose of this trial?
The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD.The secondary objectives of the study are:* To assess the long-term efficacy of dupilumab in pediatric participants with AD* To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with AD after re-treatment with dupilumabOptional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to \<12 years of age with ADCo-Primary Objectives are:* To evaluate the pharmacokinetic (PK) of dupilumab PFPs* To evaluate the safety of dupilumab PFPsSecondary Objective is:- To evaluate the immunogenicity of dupilumab PFPs
Research Team
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Eligibility Criteria
This trial is for children aged ≥6 months to <18 years with Atopic Dermatitis (AD) who have participated in a prior dupilumab study. For the sub-study, only kids ≥2 to <12 years old and weighing between 5kg and 60kg can join. Participants must not have severe illnesses or recent treatments that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dupilumab with dosing frequency based on body weight, assessing long-term safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants continue to receive dupilumab to assess long-term safety and efficacy
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?
Regeneron Pharmaceuticals
Lead 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
Sanofi
Industry 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