CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,902 enrolled
Drug / intervention
Dupilumab +4 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/NCT02414854
NCT02414854Phase 3Completed
CompareCT.gov

A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Persistent Asthma

Sanofi·interventional·Posted Apr 13, 2015·Updated Oct 23, 2018

In Brief

A Phase 3 clinical trial evaluating Dupilumab, Placebo, and 3 other interventions for Asthma. Completed, enrolled 1,902 participants across 389 sites in 22 countries.

Detailed Summary

Primary Objective: To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma. Secondary Objectives: * To evaluate the safety and tolerability of dupilumab. * To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life. * To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Hungary, Italy, Japan, Mexico, Poland, Russia, South Africa, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsRegeneron Pharmaceuticals

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedApr 13, 2015
Enrollment StartApr 27, 2015
Primary CompletionJul 29, 2017
Study CompletionNov 23, 2017
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 11.2 years ago

Interventions

Dupilumabdrug

Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

Placebodrug

Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.

Inhaled corticosteroid (ICS) therapydrug

Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)

Albuterol/Salbutamoldrug

Oral inhalation as needed

Levalbuterol/Levosalbutamoldrug

Oral inhalation as needed