CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 776 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/NCT01854047
NCT01854047Phase 2Completed

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

Sanofi·interventional·Posted May 15, 2013·Updated Jun 26, 2017

In Brief

A Phase 2 clinical trial evaluating Dupilumab, placebo, and 3 other interventions for Asthma. Completed, enrolled 776 participants across 201 sites in 16 countries.

Detailed Summary

Primary Objective: To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma. Secondary Objective: To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to: * Safety and tolerability * Dupilumab systemic exposure and anti-drug antibodies

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Australia, Chile, France, Italy, Japan, Mexico, New Zealand, Poland, Russia, South Africa, South Korea, Spain, Turkey (Türkiye), Ukraine, United States

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2013
Enrollment StartJun 1, 2013
Primary CompletionNov 1, 2014
Study CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 13.1 years ago

Interventions

Dupilumabdrug

Solution for injection, Subcutaneous injection

placebodrug

Solution for injection, Subcutaneous injection

ICS/LABA therapydrug

Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose

Salbutamol/albuteroldrug

Oral inhalation as needed

Levosalbutamol/levalbuteroldrug

Oral inhalation as needed