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临床试验/NL-OMON54121
NL-OMON54121招募中3 期

Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) - EFC16819 Aerify2

Sanofi B.V.0 个研究点目标入组 10 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
3 期
状态
招募中
发起方
Sanofi B.V.
入组人数
10
研究概览入排标准研究者记录与标识符相似试验

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 85 years of age inclusive.
  • •- Physician diagnosis of COPD for at least 1 year (based on 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 1A)
  • •intention to quit permanently.
  • •-- For current smokers: participants who report that they are currently smoking
  • •(participant smoked at least 1 cigarette per day on average during the past 7
  • •Screening (Visit 1A) and who are not currently participating in or planning to
  • •smoking cessation intervention at Screening (Visit 1A) or during Screening
  • •- Participants with moderate-to-severe COPD
  • •- Participant-reported history of signs and symptoms of chronic bronchitis
  • •productive cough for at least 3 months in the year prior to Screening in a
  • •participant in
  • •whom other causes of chronic cough [eg, inadequately treated gastroesophageal
  • •chronic rhinosinusitis; or clinical diagnosis of bronchiectasis] has been
  • •- Documented history of high exacerbation risk defined as having had >=2
  • •moderate or >=1
  • •severe exacerbations within the year prior to Screening (Visit 1A), with at
  • •exacerbation treated with systemic corticosteroids. At least one exacerbation
  • •occurred while participants were on their current controller therapy:
  • •-- Moderate exacerbations will be recorded by the Investigator and are defined
  • •worsening of respiratory symptoms that requires either systemic corticosteroids
  • •(IM, IV, or
  • •oral) and/or antibiotics.
  • •-- Severe exacerbations will be recorded by the Investigator and are defined as
  • •that require hospitalization or observation for >24 hours in emergency
  • •department/urgent
  • •care facility.
  • •- Participants with standard of care controller therapy, for >=3 months prior to
  • •(Visit 1A) and at a stable dose of controller therapy for at least 1 month
  • •prior to the
  • •Screening, including either: inhaled corticosteroid (ICS) + long-acting
  • •beta-agonist
  • •(LABA), long-acting muscarinic antagonist (LAMA) + LABA or LAMA + LABA + ICS.
  • •- Body mass index (BMI) >=18.0 kg/m^2, or BMI >=16.0 kg/m2 for participants
  • •enrolled in
  • •East-Asian countries.
  • •- Female participant 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 of asthma according to the Global Initiative for Asthma
  • •guidelines, or documented history of asthma unless asthma resolved before 18
  • •age and has not recurred.
  • •- For former smokers: Active smoking or vaping of any products (eg, nicotine,
  • •tetrahydrocannabinol [THC]) within 6 months prior to Screening (Visit 1A).
  • •For current smokers: vaping of any products (eg, nicotine, THC) within 6 months
  • •Screening (Visit 1A).
  • •- Clinically significant new abnormal electrocardiogram (ECG) within 6 months
  • •prior to, or
  • •at Screening (Visit 1A) 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.
  • •- Hypercapnia requiring bilevel positive airway pressure (BiPAP).
  • •- Moderate or severe exacerbation of COPD (AECOPD) within 4 weeks prior to
  • •(Visit 1A).
  • •- Prior history of / planned: lung pneumonectomy for any reason, or lung volume
  • •procedures (including bronchoscopic volume reduction) for COPD. Note: Surgical
  • •or segmentectomy, or wedge resection, or lobectomy for other diseases would not
  • •- Unstable ischemic heart disease, including acute myocardial infarction within
  • •year prior to Screening, or unstable angina in the 6 months prior to Screening
  • •(Visit 1A).
  • •- Cardiac arrhythmias including paroxysmal (eg, intermittent) atrial
  • •fibrillation.
  • •- Uncontrolled hypertension (ie, systolic blood pressure [BP] >180 mm Hg or
  • •diastolic BP
  • •>110 mm Hg with or without use of anti-hypertensive therapy).
  • •- Participants with active tuberculosis (TB), latent TB, a history of
  • •incompletely treated TB,
  • •suspected extrapulmonary TB infection (TBI), or who are at high risk of
  • •contracting TB
  • •(such as close contact with individuals with active or latent TB) or received
  • •Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening (Visit 1A).
  • •- History of human immunodeficiency virus (HIV) infection or positive HIV 1/2
  • •serology at
  • •Screening (Visit 1A).
  • •- Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or
  • •with known exposure to COVID-19 at Screening (Visit 1A); known history of
  • •infection within 4 weeks prior to Screening (Visit 1A); history of requiring
  • •ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19
  • •within 3 months prior to Screening (Visit 1A); participants who have had a
  • •infection prior Screening (Visit 1A) who have not yet sufficiently recovered to
  • •participate in
  • •the procedures of a clinical trial.
  • •- Evidence of acute or chronic infection requiring systemic treatment with anti
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研究者

发起方
Sanofi B.V.

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