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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
StatusActive, Not Recruiting
PhasePhase 4
Started2024-08-26
View on ClinicalTrials.gov ↗

Amendment history

2026-05-20
critical
Study Status, Study Design, Contacts/Locations v23
Trial status changed: Recruiting → Active, Not Recruiting
Enrollment reduced: 250 → 120 participants
Trial sites reduced: 84 → 77 locations
Primary completion pushed: 2026-12-31 → 2027-04-24
Completion pushed: 2026-12-31 → 2027-04-24
2026-04-21
minor
Study Status, Contacts/Locations v22
Study sites84 entries, revised
Ark Clinical Research, - Long BeachLLC NorthShore UniversityEndeavor Health, SystemSkokie Campus Henry Ford Health SystemHospital
2026-04-16
minor
Study Status, Contacts/Locations v21
Study sitesdetails revised at 68 of 84 sites
2026-02-02
minor
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 84 sites
2025-12-18
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Study Status, Contacts/Locations v19
Study sites82→84
Show 18 earlier versions
2025-11-24
minor
Study Status, Contacts/Locations v18
Study sites82 entries, revised
Raffi Tachdjian MD, Inc.
2025-11-03
minor
Study Identification, Study Status, Contacts/Locations v17
Study sites82 entries, revised
Raffi Tachdjian MD incInc South Texas AllegryAllergy & Asthma Medical Professionals (STAAMP) Research
2025-10-22
minor
Study Status, Contacts/Locations v16
Study sites81→82
2025-09-19
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Study Status, Contacts/Locations v15
Study sites80→81
2025-07-11
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2025-06-18
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2025-06-09
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2025-04-22
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Study Status, Contacts/Locations, IPDSharing v11
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2025-04-08
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Study Status, Contacts/Locations v10
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2025-03-24
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Study Status, Contacts/Locations v9
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2025-03-05
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2025-02-19
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Study Status, Contacts/Locations v7
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2025-02-10
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2025-01-07
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2024-12-12
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Study Status, Arms and Interventions, Contacts/Locations v4
Study sites24→29
2024-11-22
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Study Status, Contacts/Locations v3
Study sites20→24
2024-11-14
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Study Status, Contacts/Locations v2
Study sites16→20
2024-10-18
notable
Not Yet Recruiting→Recruiting Study Status, Study Description, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-09-17→confirmed 2024-08-26
Study sites0→16
Study description+39 characters
This study is a Phase 3b in Canada Minors will not be enrolled in Denmark
2024-08-23
minor
Original filing
148 trials monitored
See 16 trials at risk
918 trials monitored
See 29 trials at risk
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
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