Status:
RECRUITING
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
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Asthma
Eligibility:
All Genders
12-80 years
Phase:
PHASE4
Brief 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 breat...
Detailed Description
This study is a Phase 3b in Canada Minors will not be enrolled in Denmark
Eligibility Criteria
Inclusion
- Key
- Diagnosis of asthma for ≥12 months, based on the Global Initiative for Asthma (GINA) 2023 guidance document
- 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
- 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
- Key
Exclusion
- 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)
- 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
- Weight is less than 30 kilograms
- 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
- NOTE: Other protocol-defined Inclusion/Exclusion criteria apply
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT06572228
Start Date
August 26 2024
End Date
December 31 2026
Last Update
December 22 2025
Active Locations (84)
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1
Kern Research, Inc
Bakersfield, California, United States, 93301
2
Modena Allergy & Asthma, Inc.
La Jolla, California, United States, 92037
3
Antelope Valley Clinical Trials
Lancaster, California, United States, 93534
4
Ark Clinical Research - Long Beach
Long Beach, California, United States, 90815