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Study details
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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

Regeneron Pharmaceuticals
NCT IDNCT06572228ClinicalTrials.gov data as of Apr 2026
Phase

Phase 4

Target enrollment

250

Study length

about 2.3 years

Ages

12–80

Locations

55 sites in CA, CO, FL +20

What this study is about

This trial is testing whether adding dupilumab to a medium dose inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) is more effective than increasing the dose of the inhaled corticosteroid/long-acting beta-agonist (ICS/LABA). It involves adults and adolescents with uncontrolled asthma who are not responding well to their current asthma medications. The goal is to determine which treatment approach provides better control of asthma symptoms.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take ICS/LABA
  • 2.Take Matching Placebo
  • 3.Take dupilumab

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Standard

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

dupilumab

Endpoints

Secondary: Change in FEV1: FVC ratio, Change in percent predicted FEV1, Change in post-bronchodilator FEV1, Change in pre-bronchodilator FEV1, Change in pre-bronchodilator Forced expiratory volume in the first second (FEV1), Incidence of Treatment-emergent adverse event (TEAEs)

Body systems

Respiratory