CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,282 enrolled
Drug / intervention
Dupilumabdrug
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/NCT02134028
NCT02134028Phase 3Completed
CompareCT.gov

Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study

Sanofi·interventional·Posted May 8, 2014·Updated Mar 28, 2022

In Brief

A Phase 3 clinical trial evaluating Dupilumab for Asthma. Completed, enrolled 2,282 participants across 365 sites in 27 countries.

Detailed Summary

Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in participants with asthma who participated in a previous dupilumab asthma study (DRI12544, PDY14192, EFC13579, EFC13691). Secondary Objectives: To evaluate the long-term efficacy of dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study. To evaluate dupilumab in participants with asthma who participated in a previous dupilumab asthma clinical study, with regards to: * Systemic exposure * Anti-drug antibodies * Biomarkers

Study Details

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

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 8, 2014
Enrollment StartAug 5, 2014
Primary CompletionOct 11, 2019
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 12.2 years ago

Interventions

Dupilumabdrug

Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous