Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Dupilumab Exercise Capacity Study in Asthma
NCT04203797Phase 4
Key facts
- Status
- Completed
- Start
- Jul 2020
- Primary completion
- Jul 2023
- Countries
- 5
- Sponsor
- Regeneron Pharmaceuticals
- Modality
- Monoclonal Antibodies
- Drugs
- dupilumab
- Conditions
- asthma
01
Overview
Phase 4, randomised, double-blind trial in asthma comparing Dupilumab with Placebo (2 arms). Primary endpoint: Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time. Started Jul 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Dupilumab
Dupilumab SC Q2W
Placebo
Matching Placebo SC Q2W
03
Who it enrols
Adult patients (18-55 years) with moderate-to-severe asthma, on stable medium-to-high dose ICS and a second controller, with elevated eosinophils (>=300 cells/uL) and ACQ-5 >= 1.5.
04
Endpoints
Primary
Change From Baseline to Week 12 in Constant Work Rate Exercise Endurance Time
Secondary
Change From Baseline to Week 12 in Average Number of Steps Walked Per Day
Change From Baseline to Week 12 in Total Energy Expenditure
Change From Baseline to Week 12 in the Mean Duration of Moderate-to-vigorous Physical Activity
Change From Baseline to Week 12 in Pre- and Post-exercise Forced Expiratory Volume in One Second
Beyond the preview
Go deeper on NCT04203797.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT04203797.