CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 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/NCT04203797
NCT04203797Phase 4Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Patients With Moderate-to-Severe Asthma

Regeneron Pharmaceuticals·interventional·Posted Dec 18, 2019·Updated Apr 18, 2024

In Brief

A Phase 4 clinical trial evaluating dupilumab and Matching placebo for Asthma. Completed, enrolled 40 participants across 30 sites in 5 countries.

Detailed Summary

The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma. The secondary objectives of the study are: * To demonstrate that dupilumab treatment increases physical activity of daily living in patients with moderate-to-severe asthma * To demonstrate that dupilumab treatment improves pre- and post-exercise lung function in patients with moderate-to-severe asthma

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesFrance, Germany, Poland, Spain, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedDec 18, 2019
Enrollment StartJul 16, 2020
Primary CompletionJul 15, 2023
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 6.5 years ago

Interventions

dupilumabdrug

Pre-filled syringe administered by subcutaneous (SC) injections

Matching placebodrug

Pre-filled syringe administered by subcutaneous (SC)