Dupilumab for Eczema

Recruiting in Palo Alto (17 mi)

+76 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Regeneron Pharmaceuticals

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

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 dupilumab Optional Pre-filled Pen (PFP) Sub-Study in pediatric patients ≥2 to \<12 years of age with AD Co-Primary Objectives are: * To evaluate the pharmacokinetic (PK) of dupilumab PFPs * To evaluate the safety of dupilumab PFPs Secondary Objective is: - To evaluate the immunogenicity of dupilumab PFPs

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

You have already taken part in a study for dupilumab in kids with AD and finished all the required visits and tests for that study.

I've been on the same dupilumab dose for the last 12 weeks as in the PFP study.

My weight is between 5 kg and 60 kg.

+1 more

Exclusion Criteria

I haven't taken any experimental drugs recently, except for dupilumab.

I have or am at high risk for serious worm infections.

You have missed one or more of the last three planned injections in the main study before entering the sub-study.

+7 more

Participant Groups

The main goal is to check long-term safety of dupilumab in young patients with AD. It also looks at how well it works over time, its levels in blood after repeated use, and if bodies react against it. A sub-study tests a pre-filled pen version for safety, dosage levels in blood, and immune response.

4Treatment groups

Experimental Treatment

Group I: Body weight ≥60 kgExperimental Treatment1 Intervention

Administered every two weeks (Q2W)

Group II: Body weight 5 kg to <15 kgExperimental Treatment1 Intervention

Administered Q4W

Group III: Body weight 30 kg to <60 kgExperimental Treatment1 Intervention

Administered Q2W

Group IV: Body weight 15 kg to <30 kgExperimental Treatment1 Intervention

Administered every 4 weeks (Q4W)

Dupilumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Dupixent for: