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

Prior treatment

• 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
• Current smoker or cessation of smoking within 6 months prior to visit 1 or previous smoker with a smoking history ≥10 pack-years
• 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
• 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

Other illness

• Diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases which may impair lung function and interfere with treatment assessments
• 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)

Other

• Weight is less than 30 kilograms
• Note: Other protocol-defined Exclusion criteria apply

• Participants must be 12 to 80 years of age inclusive at the time of signing the informed consent/assent form with a physician diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document
• Note: Other protocol-defined Inclusion criteria apply
• Existing treatment with medium dose ICS/LABA (>250 to 500 μg/day of fluticasone propionate DPI (dry powder inhaler) or equivalent, per GINA 2023 guidance document) for at least 3 months with a stable dose ≥1 month prior to visit 1
• Participants requiring a maximum of 3 controllers for their asthma will be considered eligible for this study
• Pre-bronchodilator FEV1, as defined in the protocol
• 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
• Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during the run-in period
• ACQ-5 score ≥1.5 at screening (visit 1)
• History of ≥1 severe exacerbation(s) in the previous year before visit 1, but not in the 30 days immediately preceding visit 1
• Biomarker criteria: Baseline blood eosinophil count ≥300 cells/μL at visit 1 (~90% of population), as defined in the protocol