NCT01639040

Study to Assess the Safety of Dupilumab (REGN668/SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)

A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Safety of REGN668 Administered Concomitantly With Topical Corticosteroids to Patients With Moderate-to-Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to assess the safety of Dupilumab administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Dupilumab	Dupilumab 300 mg once weekly (QW) for 4 weeks
DRUG	Placebo (for Dupilumab)	Placebo (for Dupilumab) once weekly (QW) for 4 weeks
OTHER	Topical Corticosteroid (TCS)	TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%

Timeline

• Start date: 2012-07-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-07-12
• Last updated: 2017-10-13
• Results posted: 2017-10-13

Locations

13 sites across 3 countries: Germany, Hungary, Poland