Clinical Trial

Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

Study acronym: ATLAS
Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 changes
critical Trial status changed: RECRUITING → ACTIVE_NOT_RECRUITING 2026-04-17
notable Primary completion moved earlier: 2027-05-31 -> 2027-03-16 2026-04-17
minor Completion moved earlier: 2029-08-21 -> 2029-06-08 2026-04-17
Trial Details
NCT Number NCT05097287
Lead Sponsor Sanofi
Collaborators: Regeneron Pharmaceuticals
Conditions Asthma
Enrollment 1,339 participants
Start Date 2021-12-16
Primary Completion 2027-03-16 (estimated)
Study Completion 2029-06-08 (estimated)
Updated on ClinicalTrials.gov 2026-04-16