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

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.

Timeline

Start

2021-12-16

Primary completion

2027-03-16

Completion

2029-06-08

Publications

• De Prado Gomez L, Pavord I, Busse W, Brightling CE, Wechsler ME, Rabe KF, Zhang M, Xing J, Jacob-Nara JA, Rowe PJ. Long-term effect of dupilumab on prevention of lung function decline in patients with uncontrolled moderate-to-severe asthma: ATLAS trial design. ERJ Open Res. 2023 Mar 6;9(2):00417-2022. doi: 10.1183/23120541.00417-2022. eCollection 2023 Mar.

Drugs

Indications