Mechanistic Study of the Effect of Itepekimab on Airway Inflammation in Patients With COPD (AERIFY-3)

  • STATUS
    Recruiting
  • End date
    Mar 20, 2025
  • participants needed
    60
  • sponsor
    Sanofi
Updated on 7 October 2022

Summary

This study is an exploratory, two-part, 12-week, Phase 2a study to evaluate the mechanism of action of Itepekimab and its impact on airway inflammation in former and current smokers with COPD, aged 40 to 70 years.

This study consists of participants who have been on a standard-of-care (SoC) triple (inhaled corticosteroid [ICS] + long-acting β2-agonist [LABA] + long-acting muscarinic antagonist [LAMA] or double (ICS + LABA) controller therapy for COPD for at least 3 months prior to Screening (Visit 1) with stable dose and regimen for controller therapy for ≥1 month prior to Screening (Visit 1) and during the screening period. Participants will stay on their established controller medications for COPD throughout the duration of the study, with the exception of systemic corticosteroids and/or antibiotics used for acute exacerbation of COPD (AECOPD).

The total study duration for each part (Part A and Part B) is approximately 36 weeks:

  • 4-week screening period
  • 12-week treatment period
  • 20-week followup period

Details
Condition Chronic Obstructive Pulmonary Disease
Treatment Itepekimab SAR440340
Clinical Study IdentifierNCT05326412
SponsorSanofi
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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) with an intention to quit permanently
For current smokers (not eligible for Part A): Participants who report that they are currently smoking tobacco (participant smoked at least 5 cigarettes per day on average 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 (chronic
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 reflux or chronic rhinosinusitis; or clinical diagnosis of
bronchiectasis] have been excluded)
Documented or self-reported history of exacerbation having had ≥1 moderate or severe exacerbation within the 2 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 symptoms that requires either systemic corticosteroids (intramuscular [IM], intravenous [IV], or 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
and at a stable dose and regimen of controller therapy for at least 1 month before the screening visit AND during the screening period, including either: triple therapy with LAMA + LABA + ICS or double therapy with ICS + LABA
Participants who have completed the vaccination regimen against severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2), administered a minimum of 6
weeks 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

Exclusion Criteria

Current diagnosis or previously confirmed diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines
For former smokers (Parts A and B): Active smoking or vaping of any products (eg, 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 6 months prior to Screening (Visit 1) or during the screening period
Participants who are expected to be regularly exposed to environmental (ie, 'second hand') tobacco smoke in an indoor setting during the screening or treatment periods (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 study
Clinically significant and current pulmonary disease other than COPD, eg, sarcoidosis, interstitial lung disease, bronchiectasis (clinical diagnosis), diagnosis of α1 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 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 Screening (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 1 year before Screening (Visit 1), or unstable angina within 6 months before Screening (Visit
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 participant's participation in the study
Any underlying disease requiring the use of prophylaxis for endocarditis
Uncontrolled hypertension (ie, systolic blood pressure [BP] >180 mm Hg or diastolic BP >110 mm Hg with or without use of antihypertensive 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 Guérin (BCG)-vaccination within 12 weeks before Screening (Visit 1)
History of human immunodeficiency virus (HIV) infection or positive HIV 1/2 serology at Screening (Visit 1)
Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection or contact with known exposure to COVID19 at Screening (Visit 1) or during the screening period; known history of COVID19 infection within 6 months before Screening (Visit 1); history of requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 12 months before Screening (Visit 1); participants who have had a COVID-19 infection before Screening (Visit 1) 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 antibacterial, antiviral, antifungal, antiparasitic, or antiprotozoal medications within 6 weeks before Screening (Visit 1) or during the screening period, significant viral infections within 6 weeks before Screening (Visit 1) or during the screening period that may not have been treated with antiviral treatment (eg, influenza receiving only symptomatic treatment)
Participants with active autoimmune disease or participants taking immunosuppressive therapy for autoimmune disease (eg, rheumato arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis)
History of malignancy within 5 years before Screening (Visit 1), or during the screening period, except completely treated in situ carcinoma of the cervix, completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin
Symptomatic herpes zoster within 3 months prior to screening
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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