Clinical Trial

Efficacy of Dupilumab Added to Medium Dose Inhaled Corticosteroid/Long-acting Beta-agonist (ICS/LABA) in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Adolescent and Adult Patients With Uncontrolled Asthma

Study acronym: AIM4:Next Step
Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
Summary
This study is researching a drug called dupilumab. The study is focused on patients who have uncontrolled asthma. Asthma is a condition where the airways narrow and swell, making it difficult to breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication. The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA. The study is also looking at: • What side effects may happen from taking dupilumab
Protocol Amendment History 5 changes
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-23
notable Enrollment reduced: 250 -> 120 participants 2026-05-23
notable Trial sites reduced: 84 -> 77 locations 2026-05-23
notable Primary completion pushed: 2026-12-31 -> 2027-04-24 2026-05-23
minor Completion pushed: 2026-12-31 -> 2027-04-24 2026-05-23
Trial Details
NCT Number NCT06572228
Lead Sponsor Regeneron Pharmaceuticals
Collaborators: Sanofi
Conditions Asthma
Enrollment 120 participants
Start Date 2024-08-26
Primary Completion 2027-04-24 (estimated)
Study Completion 2027-04-24 (estimated)
Updated on ClinicalTrials.gov 2026-05-22