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

Launched by REGENERON PHARMACEUTICALS · Aug 23, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called dupilumab for patients with uncontrolled asthma, which means they still experience frequent symptoms despite using their current asthma treatments. The study aims to find out if adding dupilumab to a medium dose of inhaled asthma medication (a combination of corticosteroids and a long-acting beta-agonist) is more effective than simply increasing the dose of inhaled medication to a higher level. Participants may also receive an additional asthma medication if they are already using it. The trial will also monitor any side effects that might occur from taking dupilumab.

To be eligible for the study, participants should be adolescents or adults aged 12 and older who have had asthma for at least a year and are currently on a stable medium dose of inhaled medication for at least three months. They should also have experienced at least one severe asthma flare-up in the past year. Participants can expect regular check-ins during the study, where their asthma control and overall health will be monitored closely. This research is important as it may help find better treatment options for those struggling to manage their asthma symptoms.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • 1. Diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document
• • 2. Existing treatment with medium dose ICS/LABA (\>250 to 500 μg/day of fluticasone propionate DPI or equivalent, per GINA 2023 guidance document) for at least 3 months with a stable dose ≥1 month prior to visit 1
• • 3. Participants requiring a maximum of 3 controllers for their asthma will be considered eligible for this study
• • 4. Pre-bronchodilator FEV1, as defined in the protocol
• • 5. Reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 μg albuterol/salbutamol at screening OR a documented history of ≥20% reduction in the FEV1, as defined in the protocol
• • 6. Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during the run-in period
• • 7. ACQ-5 score ≥1.5 at screening (visit 1)
• • 8. History of ≥1 severe exacerbation(s) in the previous year before visit 1, but not in the 30 days immediately preceding visit 1
• • 9. Biomarker criteria: Baseline blood eosinophil count ≥300 cells/μL at visit 1 (\~90% of population), as defined in the protocol
• Key Exclusion Criteria:
• • 1. Diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases which may impair lung function and interfere with treatment assessments
• • 2. Clinical evidence of lung disease(s) other than asthma or imaging (Chest X-ray, computed tomography (CT), magnetic resonance imaging \[MRI\]) with significant findings within 12 months of visit 1 and up to and including the baseline visit (visit 3)
• • 3. A participant who experiences a severe asthma exacerbation at any time from 1 month prior to the screening visit (visit 1) up to and including the baseline visit (visit 3), as defined in the protocol
• • 4. Weight is less than 30 kilograms
• • 5. Current smoker or cessation of smoking within 6 months prior to visit 1 or previous smoker with a smoking history ≥10 pack-years
• • 6. Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study, as defined in the protocol
• • 7. Participants cannot be on systemic corticosteroids at any time from 1 month prior to the screening visit (visit 1) through the duration of the run-in period
• • NOTE: Other protocol-defined Inclusion/Exclusion criteria apply