CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 24 enrolled
Drug / intervention
Dupilumab/Dupixent +1 morebiological
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/NCT03884842
NCT03884842Phase 3Completed
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A Two-arm, Placebo-controlled Randomized Clinical Trial to Evaluate the Effect of Dupilumab on Airway Hyper-responsiveness and Ventilation Heterogeneity in Patients With Asthma With a "T2 Immune Signature"

McMaster University·interventional·Posted Mar 21, 2019·Updated Jan 20, 2023

In Brief

A Phase 3 clinical trial evaluating Dupilumab/Dupixent and Placebo for Asthma. Completed, enrolled 24 participants across 1 site.

Detailed Summary

In asthmatics with airway hyperresponsiveness and a "T2 immune signature" (type 2), Dupilumab will suppress airway hyperresponsiveness (assessed by methacholine PC20 ≤ 4 mg/mL (PC20: provocative concentration causing a 20% fall in FEV1) OR ≥15% decreased in forced expired volume in 1 second (FEV1) during saline inhalation for sputum induction OR ≥25% improvement in FEV1 after bronchodilator) and airway eosinophilia (assessed by sputum eosinophils) and this will be associated with greater asthma control and improved ventilation heterogeneity.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesCanada
CollaboratorsSanofi

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMar 21, 2019
Enrollment StartJul 1, 2019
Primary CompletionOct 12, 2022
Study CompletionJan 17, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 7.3 years ago

Interventions

Dupilumab/Dupixentbiological

a monoclonal antibody designed for the treatment asthma and atopic dermatitis.

Placebobiological

Matched placebo