NCT03050151

Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis

An Open-label, Randomized, Actual Use Study of Dupilumab Auto-injector Device in Patients With Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To collect data on actual-use to assess technical performance and user injections of dupilumab auto-injection device by patients with atopic dermatitis (AD).

Detailed description

Study is conducted in 2 parts: part A and part B. Part A - Patients with moderate-to-severe AD will be randomized to receive dupilumab (dose 1) by auto-injector (AI) device or prefilled syringe. Once part A is completely enrolled, part B will randomize patients with moderate-to-severe AD to receive dupilumab (dose 2) by auto-injector (AI) device or prefilled syringe.

Conditions

• Atopic Disorders
• Eczema, Atopic

Interventions

Type	Name	Description
DRUG	Dupilumab	Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe
DEVICE	Auto-injector Device	Delivery of Dupilumab by auto-injector device
DEVICE	Prefilled syringe	Delivery of Dupilumab by prefilled syringe

Timeline

• Start date: 2017-02-28
• Primary completion: 2017-11-14
• Completion: 2018-02-12
• First posted: 2017-02-10
• Last updated: 2018-08-01

Locations

37 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study