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

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 fluticasonepropionate DPI or equivalent, per GINA 2023 guidance document) for at least 3 monthswith a stable dose ≥1 month prior to visit 1

3. Participants requiring a maximum of 3 controllers for their asthma will beconsidered 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% reductionin the FEV1, as defined in the protocol

6. Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during therun-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 inthe 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 diseaseswhich 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 significantfindings 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 monthprior 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 previoussmoker with a smoking history ≥10 pack-years

6. Severe concomitant illness(es) that, in the Investigator's judgment, would adverselyaffect 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 tothe screening visit (visit 1) through the duration of the run-in period

NOTE: Other protocol-defined Inclusion/Exclusion criteria apply