AIM4: Next Step - Asthma Uncontrolled With ICS in Medium Dose (GINA 4): Next Step; Efficacy of Dupilumab Added to Medium Dose ICS/LABA in Comparison to ICS Dose Escalation to High Dose ICS/LABA in Patients With Uncontrolled Asthma
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 152
- 主要终点
- Annualized severe asthma exacerbation rate
研究概览
简要总结
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
详细描述
This study is a Phase 3b in Canada Minors will not be enrolled in Denmark
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Dupilumab + ICS/LABA
Randomized 1:1
干预措施: dupilumab (Drug)
Dupilumab + ICS/LABA
Randomized 1:1
干预措施: ICS/LABA (Drug)
Placebo + ICS/LABA
Randomized 1:1
干预措施: ICS/LABA (Drug)
Placebo + ICS/LABA
Randomized 1:1
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Annualized severe asthma exacerbation rate
时间窗: Baseline through Week 52
次要结局
- 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)(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)
研究者
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.