Study to Assess the Efficacy Safety and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-2)

  • STATUS
    Recruiting
  • End date
    Jul 25, 2024
  • participants needed
    1170
  • sponsor
    Sanofi
Updated on 25 April 2021

Summary

Primary Objective:

Primary population (former smokers cohort):

  • Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD

Secondary Objectives:

Primary population (former smokers cohort):

  • Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD
  • Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD
  • Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD
  • Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD
  • Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD

Secondary population (current smokers cohort)

  • Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD
  • Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD
  • Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD
  • Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD
  • Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD

Description

The study duration per participant is approximatively 76 weeks including a 3-to-5-week screening period, a 52-week treatment period on investigational medicinal product (IMP) and a 20-week post-IMP treatment follow-up period.

Details
Condition Chronic Obstructive Lung Disease, COPD (Chronic Obstructive Pulmonary Disease), chronic obstructive pulmonary disease, COPD, chronic obstructive pulmonary disease (copd)
Treatment Placebo, Itepekimab SAR440340
Clinical Study IdentifierNCT04751487
SponsorSanofi
Last Modified on25 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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) with an intention to quit permanently
For current smokers: participants who report that they are currently smoking tobacco (participant smoked at least 1 cigarette per day on average during the past 7 days) at Screening (Visit 1A) and who are not currently participating in or planning to initiate a smoking cessation intervention at Screening (Visit 1A) or during Screening period
Participants with moderate-to-severe COPD
Participant-reported history of signs and symptoms of chronic bronchitis (chronic 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 reflux or chronic rhinosinusitis; or clinical diagnosis of bronchiectasis] has been excluded)
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 least 1 exacerbation treated with systemic corticosteroids. At least one exacerbation must have occurred while participants were on their current controller therapy
Moderate exacerbations will be recorded by the Investigator and are defined as acute 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 AECOPD 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 Screening (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
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. -

Exclusion Criteria

Current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma
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 prior to 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 study
Clinically significant and current pulmonary disease other than COPD, eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of -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 Screening (Visit 1A)
Prior history of / planned: lung pneumonectomy for any reason, or lung volume reduction procedures (including bronchoscopic volume reduction) for COPD. Note: Surgical biopsy, or segmentectomy, or wedge resection, or lobectomy for other diseases would not be excluded
Unstable ischemic heart disease, including acute myocardial infarction within the past 1 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 Bacillus Calmette-Gurin (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 in contact with known exposure to COVID-19 at Screening (Visit 1A); known history of COVID-19 infection within 4 weeks prior to Screening (Visit 1A); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening (Visit 1A); participants who have had a COVID-19 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 bacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications within 4 weeks before Screening (Visit 1A), significant viral infections within 4 weeks before Screening (Visit 1A) that may not have been treated with antiviral treatment (eg, influenza receiving only symptomatic treatment)
Participants with active autoimmune disease or participants using immunosuppressive therapy for autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis
History of malignancy within 5 years before Screening (Visit 1A), except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin
Previous use of itepekimab
The above information is not intended to contain all considerations relevant
to a patient's potential participation in a clinical trial
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