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
NCT Number: NCT06572228
Acronym: AIM4:Next Step
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Asthma
Interventions: DRUG: dupilumab|DRUG: Matching Placebo|DRUG: ICS/LABA
Sponsor: Regeneron Pharmaceuticals
Collaborators: Sanofi
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 250
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-17
Completion Date: 2026-12-31

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 breathe. Uncontrolled asthma means that patients are still having frequent symptoms while taking their current asthma medication.

The aim of the study is to see which regimen is more effective: taking dupilumab with an inhaled asthma medication or only taking a higher dose of the inhaled asthma medication. The type of asthma medication that will be used is a combination inhaled corticosteroid and long-acting beta-agonist (referred to as an ICS/LABA). Some patients may also receive an additional asthma medication called a long-acting muscarinic antagonist (referred to as a LAMA) if they are already receiving a LAMA.

The study is also looking at:

• What side effects may happen from taking dupilumab

Primary Outcome Measures: Annualized severe asthma exacerbation rate, Baseline through Week 52
Secondary Outcome Measures: Change in pre-bronchodilator Forced expiratory volume in the first second (FEV1), Baseline to week 12|Annualized cumulative dose of systemic corticosteroid exposure to treat severe asthma exacerbations, Baseline to week 52|Change in Asthma Control Questionnaire (ACQ-5), The ACQ-5 has 5 items that assess the most common asthma symptoms: 1. Frequency in past week awoken by asthma during the night, 2. Severity of asthma symptoms in the morning, 3. Limitation of daily activities due to asthma, 4. Shortness of breath due to asthma and 5. Wheeze. Participants are asked to recall how their asthma has been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The ACQ-5 global score is the mean of the 5 questions and, therefore, between 0 (totally controlled) and 6 (severely uncontrolled). Higher score indicates lower asthma control., Baseline to week 12|Proportion of participants achieving ACQ-5 <1.5, At week 12|Change in pre-bronchodilator FEV1, Baseline up to week 52|Change in percent predicted FEV1, Baseline up to week 52|Change in peak expiratory flow (PEF), Baseline up to week 52|Change in forced vital capacity (FVC), Baseline up to week 52|Change in forced expiratory flow (FEF) 25-75%, Baseline up to week 52|Change in FEV1: FVC ratio, Baseline up to week 52|Change in post-bronchodilator FEV1, Baseline up to week 52|Time to first severe exacerbation event, Up to week 52|Proportion of participants achieving a 0.5-point improvement minimal clinically important difference (MCID) in ACQ-5, Up to week 52|Incidence of Treatment-emergent adverse event (TEAEs), Up to week 52