Trials / Active Not Recruiting
Active Not RecruitingNCT05097287
Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma
A Randomized, Double-Blind, Placebo Controlled Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Patients With Uncontrolled Moderate to Severe Asthma
- Status
- Active Not Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 1,339 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma. The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dupilumab | solution for injection subcutaneous |
| DRUG | Placebo | solution for injection subcutaneous |
Timeline
- Start date
- 2021-12-16
- Primary completion
- 2027-03-16
- Completion
- 2029-06-08
- First posted
- 2021-10-28
- Last updated
- 2026-04-16
Locations
249 sites across 23 countries: United States, Belgium, Brazil, Bulgaria, Canada, China, Greece, Hungary, India, Ireland, Mexico, Oman, Peru, Puerto Rico, Romania, Saudi Arabia, Slovakia, South Africa, South Korea, Taiwan, Turkey (Türkiye), United Arab Emirates, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05097287. Inclusion in this directory is not an endorsement.