NCT06572228

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

AIM4: Next Step - Asthma Uncontrolled With ICS in Medium Dose (GINA 4): Next Step; Efficacy of Dupilumab Added to Medium Dose ICS/LABA in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Patients With Uncontrolled Asthma

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 80 Years
• Healthy volunteers: Not accepted

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

Detailed description

This study is a Phase 3b in Canada Minors will not be enrolled in Denmark

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	dupilumab	Administered by subcutaneous (SC) injection
DRUG	Matching Placebo	Administered by SC injection
DRUG	ICS/LABA	Administered at a blinded dose

Timeline

• Start date: 2024-08-26
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-08-27
• Last updated: 2026-02-03

Locations

84 sites across 6 countries: United States, Canada, Denmark, Germany, Poland, Puerto Rico

Regulatory

• FDA-regulated drug study