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
- Conditions
- Asthma
- Registration Number
- NCT06572228
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 250
Key Inclusion Criteria:<br><br> 1. Diagnosis of asthma for =12 months, based on the Global Initiative for Asthma (GINA)<br> 2023 guidance document<br><br> 2. Existing treatment with medium dose ICS/LABA (>250 to 500 µg/day of fluticasone<br> propionate DPI or equivalent, per GINA 2023 guidance document) for at least 3 months<br> with a stable dose =1 month prior to visit 1<br><br> 3. Participants requiring a maximum of 3 controllers for their asthma will be<br> considered eligible for this study<br><br> 4. Pre-bronchodilator FEV1, as defined in the protocol<br><br> 5. Reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to<br> 400 µg albuterol/salbutamol at screening OR a documented history of =20% reduction<br> in the FEV1, as defined in the protocol<br><br> 6. Demonstrated adherence to medium dose ICS/LABA on at least 80% of days during the<br> run-in period<br><br> 7. ACQ-5 score =1.5 at screening (visit 1)<br><br> 8. History of =1 severe exacerbation(s) in the previous year before visit 1, but not in<br> the 30 days immediately preceding visit 1<br><br> 9. Biomarker criteria: Baseline blood eosinophil count =300 cells/µL at visit 1 (~90%<br> of population), as defined in the protocol<br><br>Key Exclusion Criteria:<br><br> 1. Diagnosis of chronic obstructive pulmonary disease (COPD) or other lung diseases<br> which may impair lung function and interfere with treatment assessments<br><br> 2. Clinical evidence of lung disease(s) other than asthma or imaging (Chest X-ray,<br> computed tomography (CT), magnetic resonance imaging [MRI]) with significant<br> findings within 12 months of visit 1 and up to and including the baseline visit<br> (visit 3)<br><br> 3. A participant who experiences a severe asthma exacerbation at any time from 1 month<br> prior to the screening visit (visit 1) up to and including the baseline visit (visit<br> 3), as defined in the protocol<br><br> 4. Weight is less than 30 kilograms<br><br> 5. Current smoker or cessation of smoking within 6 months prior to visit 1 or previous<br> smoker with a smoking history =10 pack-years<br><br> 6. Severe concomitant illness(es) that, in the Investigator's judgment, would adversely<br> affect the participant's participation in the study, as defined in the protocol<br><br> 7. Participants cannot be on systemic corticosteroids at any time from 1 month prior to<br> the screening visit (visit 1) through the duration of the run-in period<br><br>NOTE: Other protocol-defined Inclusion/Exclusion criteria apply
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Annualized severe asthma exacerbation rate
- Secondary Outcome Measures
Name Time Method Change in pre-bronchodilator Forced expiratory volume in the first second (FEV1);Annualized cumulative dose of systemic corticosteroid exposure to treat severe asthma exacerbations;Change in Asthma Control Questionnaire (ACQ-5);Proportion of participants achieving ACQ-5 <1.5;Change in pre-bronchodilator FEV1;Change in percent predicted FEV1;Change in peak expiratory flow (PEF);Change in forced vital capacity (FVC);Change in forced expiratory flow (FEF) 25-75%;Change in FEV1: FVC ratio;Change in post-bronchodilator FEV1;Time to first severe exacerbation event;Proportion of participants achieving a 0.5-point improvement minimal clinically important difference (MCID) in ACQ-5;Incidence of Treatment-emergent adverse event (TEAEs)