2024-510641-33-00已完成2 期
A randomized, double-blind, placebo-controlled, parallel-group, dose ranging study to assess the efficacy, safety, and tolerability of subcutaneous amlitelimab in adult participants with moderate-to-severe asthma. DRI17509
Sanofi-Aventis Recherche & Developpement17 个研究点 分布在 3 个国家目标入组 104 人开始时间: 2024年5月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 17
- 主要终点
- Annualized rate of severe exacerbation events over 48 weeks
研究概览
简要总结
To evaluate the efficacy of different doses of amlitelimab compared to placebo in participants with moderate-to-severe, uncontrolled asthma
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •The participant must be between the ages of 18 and 75 inclusive at the time of signing the informed consent.
- •Moderate to severe asthma diagnosed by a physician for ≥ 12 months according to stages 4 and 5 of the Global Initiative for Asthma (GINA ).
- •Participants on existing therapy with medium to high doses of ICS (≥500 μg fluticasone propionate daily or comparable ICS dose in combination with at least one additional controller (e.g., long-acting beta agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic Antagonist [LAMA], methylxanthines) for at least 3 months.
- •≥ 1 severe asthma exacerbation in the past year, with at least one exacerbation during treatment with medium to high doses of ICS (≥ 500 μg fluticasone propionate daily or one dose of ICS comparable).
- •Participants with pre-BD forced expiratory volume in 1 second (FEV1) > 40% and < 80% of predicted normal at the screening visit.
- •5-item ACQ-5 score >1.5 at randomization.
- •Participants with at least 12% reversibility and 200 mL post-BD FEV after administration of albuterol/salbutamol or levalbuterol/levosalbutamol at screening or documented history of a reversibility test.
- •Weight ≥40 kg and ≤150 kg at the randomization visit.
排除标准
- •Chronic lung disease other than asthma.
- •Hepatitis B, C or HIV.
- •Pregnant or breastfeeding.
- •History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
- •Any prior use of anti-OX40 or anti-OX40L mAb, including amlitelimab
- •Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
- •Current or former smoker including active vaping of any products and/or marijuana with cessation within 6 months of screening or history of >10 pack-years.
- •Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 1 month prior to screening.
- •Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening; COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
- •Active infection or history of clinically significant infection
- •Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
- •Active or latent tuberculosis (TB)
- •A history of malignancy of any type (excluding basal and squamous cell skin cancer and in situ cervical carcinoma that has been excised and cured >3 years prior to baseline).
- •History of solid organ transplant.
结局指标
主要结局
Annualized rate of severe exacerbation events over 48 weeks
Annualized rate of severe exacerbation events over 48 weeks
次要结局
- Change from baseline in pre-bronchodilator (BD) FEV1 at Week 48
- Change from baseline in Asthma Control Questionnaire 5 (ACQ-5) score at Week 48
- Change from baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score at Week 48
- Change from baseline in post-BD FEV1 at Week 48
- The absolute change in the percent predicted FEV1 from baseline to Week 48 (pre-BD and post-BD)
- Change from baseline in ACQ-5 score at Weeks 2, 4, 8, 12, 24, 36, and 60
- Time to first severe exacerbation event
- Change from baseline in pre-BD and post-BD FEV1
- Change from baseline in peak expiratory flow (PEF) and forced expiratory flow (FEF) 25-75%
- Change from baseline in forced vital capacity (FVC)
- Change from baseline in FeNO at Weeks 2, 4, 8, 12, 16, 24, 36, 48 and 60
- Annualized rate of loss of asthma control (LOAC) events during 48 weeks of treatment
- Time to first LOAC event
- Change from baseline in the Asthma Daytime Symptom Diary (ADSD) 6-item daily morning score and in the Asthma Nighttime Symptom Diary (ANSD) 6-item daily evening scores at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
- Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit during 48 weeks of treatment
- Change from baseline in the numbers of inhalations/day of SABA or low-dose ICS/formoterol for symptom relief at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
- Serum amlitelimab concentrations measured throughout the study
- Incidence of anti-amlitelimab antibody positive response
- Percentage of participants with treatment-emergent adverse events (TEAEs), including local reactions, AEs of special interest (AESIs), serious adverse events (SAEs)
- Incidence of potentially clinically significant laboratory test, vital signs, and ECG abnormalities in the treatment period
- Change from baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score at Weeks 2, 4, 8, 12, 24, 36, and 60
- Change from baseline in St. George’s Respiratory Questionnaire (SGRQ) at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
- Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 48
- Change from baseline in ACQ-6 score and ACQ-7 at Weeks 2, 4, 8, 12, 24, 36, 48, and 60
研究者
Clinical Sciences and Operations
Scientific
Sanofi-Aventis Recherche & Developpement
研究点 (17)
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