CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 325 enrolled
Drug / intervention
Dupilumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02755649
NCT02755649Phase 3Completed

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

Regeneron Pharmaceuticals·interventional·Posted Apr 29, 2016·Updated Aug 20, 2020

In Brief

A Phase 3 clinical trial evaluating Dupilumab and Matching Placebo for Atopic Dermatitis. Completed, enrolled 325 participants across 73 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Germany, Ireland, Netherlands, Poland, Russia, Slovakia, Spain, United Kingdom
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 29, 2016
Enrollment StartJan 31, 2016
Primary CompletionJan 4, 2017
Study CompletionMar 31, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.2 years ago

Interventions

Dupilumabdrug

Matching Placebodrug