NL-OMON52084招募中2 期
A Phase 2a, open label, two-part study to evaluate the mechanism of action of itepekimab (anti-IL-33 mAb) on airway inflammation in patients with chronic obstructive lung disease (COPD) - PDY16967 Aerify3
Sanofi BV0 个研究点目标入组 3 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Participant must be 40 to 70 years of age inclusive
- •- Physician diagnosis of COPD for at least 1 year (based on the Global
- •Initiative for
- •Chronic Obstructive Lung Disease [GOLD] definition).
- •- Smoking history of >=10 pack-years
- •-- For former smokers: Participants who report that they are not currently
- •smoking, and
- •smoking cessation must have occurred >=6 months prior to Screening (Visit 1)
- •intention to quit permanently.
- •-- For current smokers (not eligible for Part A): Participants who report that
- •currently smoking tobacco (participant smoked at least 5 cigarettes per day on
- •during the past 7 days) at Screening (Visit 1) and at Baseline, and who are not
- •currently participating in, or planning to initiate, a smoking cessation
- •intervention at
- •Screening (Visit 1) or during the screening period.
- •- Participant-reported history of signs and symptoms of chronic bronchitis
- •productive cough for at least 3 months in the year before screening in a
- •participant in
- •whom other causes of chronic cough [eg, inadequately treated gastroesophageal
- •chronic rhinosinustis; or clinical diagnosis of bronchiectasis] have been
- •- Documented or self-reported history of exacerbation having had >=1 moderate or
- •exacerbation within the 5 years prior to Screening (Visit 1), with at least 1
- •exacerbation
- •treated with systemic corticosteroids:
- •-- Moderate exacerbations are defined as an acute worsening of respiratory
- •that requires either systemic corticosteroids (intramuscular [IM], intravenous
- •oral) and/or antibiotics.
- •-- Severe exacerbations are defined as AECOPD that require hospitalization or
- •observation for >24 hours in emergency department/urgent care facility.
- •- Participants treated with SoC controller therapy for >=3 months before
- •Screening (Visit 1)
- •and at a stable dose and regimen of controller therapy for at least 1 month
- •screening visit AND during the screening period, including either: triple
- •therapy with LAMA
- •+ LABA + ICS or double therapy with ICS + LABA or LABA + LAMA or ICS + LAMA, or
- •monotherapy with LABA or LAMA.
- •- Participants who have received appropriate vaccination according to local
- •recommendations against severe acute
- •respiratory syndrome coronavirus 2 (SARS-CoV-2), administered a minimum of 1
- •prior to Screening (Visit 1).
- •- Body mass index (BMI) >=18 kg/m2
- •- A female participant is eligible to participate if she is not pregnant, not
- •breastfeeding, and
- •at least one of the following conditions applies:
- •-- Not a women of child-bearing potential (WOCBP) or
- •-- A WOCBP who agrees to follow the contraceptive guidance during the
- •intervention
- •period and for at least 20 weeks after the last dose of study intervention.
排除标准
- •- Current diagnosis or previously confirmed diagnosis of asthma according to
- •Initiative for Asthma (GINA) guidelines unless asthma resolved before 18 years
- •of age and has not returned.
- •- For former smokers (Parts A and B): Active smoking or vaping of any products
- •nicotine, tetrahydrocannabinol [THC]) within 6 months prior to Screening (Visit
- •1) or during
- •the screening period.
- •For current smokers (Part B): vaping of any products (eg, nicotine, THC) within
- •prior to Screening (Visit 1) or during the screening period.
- •- Participants who are expected to be regularly exposed to environmental (ie,
- •hand) tobacco smoke in an indoor setting during the screening or treatment
- •(former smokers only)
- •- Clinically significant new abnormal electrocardiogram (ECG) within 6 months
- •before or at
- •Screening (Visit 1) that may affect the participant*s participation in the
- •- Clinically significant and current pulmonary disease other than COPD, eg,
- •sarcoidosis,
- •interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of
- •a-1 anti-trypsin
- •deficiency, or another diagnosed pulmonary disease.
- •- Diagnosis of cor pulmonale, evidence of right cardiac failure, or
- •moderate-to-severe
- •pulmonary hypertension.
- •- Participants who require more that 2L/min of long-term treatment with oxygen
- •at rest. Participants who use up to 4L/min of supplemental oxygen during
- •exercise may enroll. Oxygen during sleep is allowed.
- •- Participants who receive long-term treatment with oxygen or a low oxygen
- •saturation on
- •room air at rest.
- •- Hypercapnia that requires bi-level positive airway pressure (BiPAP).
- •- Moderate or severe exacerbation of COPD (AECOPD) within 8 weeks prior to
- •(Visit 1) or during the screening period.
- •- Prior history of pneumonectomy, lobectomy, segmentectomy, or therapeutic
- •bronchoscopy procedure (including bronchoscopic volume reduction).
- •Note: Prior history of surgical lung biopsy or wedge resection are not
- •exclusion criteria.
- •- Any surgery or major procedures (including those requiring conscious
- •sedation) planned
- •to occur during the study. Minor skin procedures are allowed.
- •- Unstable ischemic heart disease, including acute myocardial infarction within
- •before Screening (Visit 1), or unstable angina within 6 months before Screening
- •or during the screening period.
- •- Cardiac arrhythmias, including paroxysmal (eg, intermittent) atrial
- •fibrillation. Participants
- •with isolated premature ventricular contractions (PVCs) or premature atrial
- •contractions
- •(PACs) may be considered for inclusion.
- •- Cardiomyopathy, as defined by Stage III-IV (New York Heart Association)
- •cardiac failure,
- •or other relevant cardiovascular disorder that that may affect the
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