NCT02755649

A Study to Assess the Efficacy and Safety of Dupilumab in Participants With Severe Atopic Dermatitis (AD) That Are Not Controlled With Oral Cyclosporine A (CSA) or for Those Who Cannot Take Oral CSA Because it is Not Medically Advisable

A Phase 3 Study Investigating the Efficacy, Safety, and Tolerability of Dupilumab Administered to Adult Patients With Severe Atopic Dermatitis Who Are Not Adequately Controlled With or Are Intolerant to Oral Cyclosporine A, or When This Treatment is Not Medically Advisable

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 325 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial is to evaluate the efficacy of 2 dose regimens of dupilumab compared to placebo, administered with concomitant topical corticosteroids (TCS), in adult patients with severe AD who are not adequately controlled with, or are intolerant to, oral Cyclosporine A (CSA), or when this treatment is currently not medically advisable. The secondary objective is to assess the safety and tolerability of 2 dose regimens of dupilumab compared to placebo, administered with concomitant TCS, in adult patients with severe AD who are not adequately controlled with, or are intolerant to, oral CSA, or when this treatment is currently not medically advisable.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Dupilumab
DRUG	Matching Placebo

Timeline

• Start date: 2016-01-31
• Primary completion: 2017-01-04
• Completion: 2017-03-31
• First posted: 2016-04-29
• Last updated: 2020-08-20
• Results posted: 2020-08-20

Locations

73 sites across 10 countries: Austria, Belgium, Germany, Ireland, Netherlands, Poland, Russia, Slovakia, Spain, United Kingdom