drugset / Trial / 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

NCT06572228

Phase 4 Active not recruiting 120 enrolled Regeneron Pharmaceuticals Sanofi · collab
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2024-08-26
Primary completion
2027-04-24
Completion
2027-04-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Dupilumab Monoclonal antibody Subcutaneous
Background Fluticasone Other / unclassified Inhaled
Background Salmeterol Other / unclassified Inhaled

Indications