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Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-1)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Itepekimab SAR440340
Placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, but who are not currently smoking, and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently.
  • 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.
  • Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol [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 α-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-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 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 sScreening (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.

Sites / Locations

  • University of Alabama at Birmingham-Site Number:8400012Recruiting
  • Jasper Summit Research-Site Number:8400178Recruiting
  • MedPharmics, LLC-Site Number:8400185Recruiting
  • Chandler Clinical Trials (Elite Clinical Network)-Site Number:8400034Recruiting
  • Noble Clinical Research-Site Number:8400182Recruiting
  • Modena Allergy + Asthma-Site Number:8400036Recruiting
  • Downtown LA Research Center Inc.-Site Number:8400027Recruiting
  • MACRO Trials-Site Number:8400030Recruiting
  • Antelope Valley Clinical Trials-Site Number:8400003
  • Alpine Clinical Research Center-Site Number:8400180Recruiting
  • Innovative Clinical Research-Site Number:8400017Recruiting
  • Clin Research W Florida-Site Number:8400004Recruiting
  • Beautiful Minds Clinical Research Center-Site Number:8400037Recruiting
  • Indago Research and Health Center-Site Number:8400187Recruiting
  • Deluxe Health Center-Site Number:8400188Recruiting
  • University of Miami/Miami VA Medical Center-Site Number:8400026Recruiting
  • DL Research Solutions Inc-Site Number:8400033Recruiting
  • Research Institute of South Florida,Inc-Site Number:8400006Recruiting
  • Reed Medical Research-Site Number:8400032Recruiting
  • Florida Institute for Clinical Research-Site Number:8400013Recruiting
  • Broward Pulmonary and Sleep Specialists-Site Number:8400031Recruiting
  • Coastal Medical Research Institute-Site Number:8400044Recruiting
  • Pasadena Center for Medical Research-Site Number:8400043Recruiting
  • Appalachian Clinical Research-Site Number:8400024Recruiting
  • Alpha Clinical Research Georgia-Site Number:8400190Recruiting
  • Covenant Pulmonary Critical Care-Site Number:8400183Recruiting
  • David Kavtaradze MD, Inc.-Site Number:8400029Recruiting
  • Gwinnett Biomedical Research-Site Number:8400007Recruiting
  • GenHarp Clinical Solutions-Site Number:8400028Recruiting
  • Benchmark Research-Site Number:8400193Recruiting
  • Paul Shapero, PC-Site Number:8400016Recruiting
  • Care Access-Site Number:8400275Recruiting
  • Care Access-Site Number:8400276Recruiting
  • Care Access-Site Number:8400277Recruiting
  • Care Access-Site Number:8400278Recruiting
  • Care Access-Site Number:8400281Recruiting
  • Revival Research Institute, LLC-Site Number:8400191Recruiting
  • Midwest Chest Consultants, P.C.-Site Number:8400002Recruiting
  • Hendeson Clinical Trials-Site Number:8400365Recruiting
  • Northwell/ Lenox Hill Hospital-Site Number:8400019Recruiting
  • Gastonia Pharmaceutical Research-Site Number:8400010
  • East Carolina University Brody School Of Medicine-Site Number:8400022Recruiting
  • Carolina Research Center-Site Number:8400005Recruiting
  • Accellacare-Site Number:8400001Recruiting
  • Southeastern Research Center-Site Number:8400011Recruiting
  • Bernstein Clinical Research Center-Site Number:8400014Recruiting
  • WellNow Urgent Care and Research-Site Number:8400039Recruiting
  • Clinical Research of Central PA-Site Number:8400023
  • Bogan Sleep Consultants-Site Number:8400181
  • Clinical Research of Rock Hill-Site Number:8400008Recruiting
  • Clinrx Research-Site Number:8400021Recruiting
  • Austin Pulmonary Consultants-Site Number:8400035Recruiting
  • Corsicana Medical Research, LLC-Site Number:8400018Recruiting
  • Texas Tech University Health Sciences Center-Site Number:8400189Recruiting
  • The Methodist Hospital Research Institute-Site Number:8400194Recruiting
  • Biopharma Informatic - Cardiff Avenue - PPDS-Site Number:8400038Recruiting
  • DM Clinical Research-Site Number:8400179Recruiting
  • Metroplex Pulmonary and Sleep Center-Site Number:8400015Recruiting
  • Advance Lung and Sleep Center-Site Number:8400040Recruiting
  • Sherman Clinical Research-Site Number:8400009Recruiting
  • Clearlake Specialties-Site Number:8400025Recruiting
  • Investigational Site Number :0320001Recruiting
  • Investigational Site Number :0320002Recruiting
  • Investigational Site Number :0320003Recruiting
  • Investigational Site Number :0320004Recruiting
  • Investigational Site Number :1000005Recruiting
  • Investigational Site Number :1000001Recruiting
  • Investigational Site Number :1000004Recruiting
  • Investigational Site Number :1000002Recruiting
  • Investigational Site Number :1000003Recruiting
  • Investigational Site Number :1520008Recruiting
  • Investigational Site Number :1520007Recruiting
  • Investigational Site Number :1520002Recruiting
  • Investigational Site Number :1520009Recruiting
  • Investigational Site Number :1520003Recruiting
  • Investigational Site Number :1520001Recruiting
  • Investigational Site Number :1520006Recruiting
  • Investigational Site Number :1520004Recruiting
  • Investigational Site Number :1520005Recruiting
  • Investigational Site Number :1560003Recruiting
  • Investigational Site Number :1560004Recruiting
  • Investigational Site Number :1560030Recruiting
  • Investigational Site Number :1560014Recruiting
  • Investigational Site Number :1560002Recruiting
  • Investigational Site Number :1560012Recruiting
  • Investigational Site Number :1560013Recruiting
  • Investigational Site Number :1560047Recruiting
  • Investigational Site Number :1560001Recruiting
  • Investigational Site Number :1560040Recruiting
  • Investigational Site Number :1560032Recruiting
  • Investigational Site Number :1560006Recruiting
  • Investigational Site Number :1560025Recruiting
  • Investigational Site Number :1560036Recruiting
  • Investigational Site Number :1560022Recruiting
  • Investigational Site Number :1560039Recruiting
  • Investigational Site Number :1560017Recruiting
  • Investigational Site Number :1560008Recruiting
  • Investigational Site Number :1560010Recruiting
  • Investigational Site Number :1560044Recruiting
  • Investigational Site Number :1560027Recruiting
  • Investigational Site Number :1560031Recruiting
  • Investigational Site Number :1560038Recruiting
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  • Investigational Site Number :1560023Recruiting
  • Investigational Site Number :1560015Recruiting
  • Investigational Site Number :1560043Recruiting
  • Investigational Site Number :1560034Recruiting
  • Investigational Site Number :1560009Recruiting
  • Investigational Site Number :1560045Recruiting
  • Investigational Site Number :1560005Recruiting
  • Investigational Site Number :1560020Recruiting
  • Investigational Site Number :1560028Recruiting
  • Investigational Site Number :1560024Recruiting
  • Investigational Site Number :1560019Recruiting
  • Investigational Site Number :1560029Recruiting
  • Investigational Site Number :1560016Recruiting
  • Investigational Site Number :1560046Recruiting
  • Investigational Site Number :1560007Recruiting
  • Investigational Site Number :1560026Recruiting
  • Investigational Site Number :1560041Recruiting
  • Investigational Site Number :1560042Recruiting
  • Investigational Site Number :1560048Recruiting
  • Investigational Site Number :2680002Recruiting
  • Investigational Site Number :2680003Recruiting
  • Investigational Site Number :2680001Recruiting
  • Investigational Site Number :3000005Recruiting
  • Investigational Site Number :3000006Recruiting
  • Investigational Site Number :3000004Recruiting
  • Investigational Site Number :3000001Recruiting
  • Investigational Site Number :3000007Recruiting
  • Investigational Site Number :3000008Recruiting
  • Investigational Site Number :3000002Recruiting
  • Investigational Site Number :3480004Recruiting
  • Investigational Site Number :3480001Recruiting
  • Investigational Site Number :3480002Recruiting
  • Investigational Site Number :3480003Recruiting
  • Investigational Site Number :3560002Recruiting
  • Investigational Site Number :3560005Recruiting
  • Investigational Site Number :3560004Recruiting
  • Investigational Site Number :3560008Recruiting
  • Investigational Site Number :3560001Recruiting
  • Investigational Site Number :3560007Recruiting
  • Investigational Site Number :3560003Recruiting
  • Investigational Site Number :3760008Recruiting
  • Investigational Site Number :3760003Recruiting
  • Investigational Site Number :3760002Recruiting
  • Investigational Site Number :3760006Recruiting
  • Investigational Site Number :3760001Recruiting
  • Investigational Site Number :3760004Recruiting
  • Investigational Site Number :3760007Recruiting
  • Investigational Site Number :3800003Recruiting
  • Investigational Site Number :3800004Recruiting
  • Investigational Site Number :3800005Recruiting
  • Investigational Site Number :3800001Recruiting
  • Investigational Site Number :3800007Recruiting
  • Investigational Site Number :4840001Recruiting
  • Investigational Site Number :4840007Recruiting
  • Investigational Site Number :4840002Recruiting
  • Investigational Site Number :4840003Recruiting
  • Investigational Site Number :4840004Recruiting
  • Investigational Site Number :6160004Recruiting
  • Investigational Site Number :6160003Recruiting
  • Investigational Site Number :6160001Recruiting
  • Investigational Site Number :6160002Recruiting
  • Investigational Site Number :6420005Recruiting
  • Investigational Site Number :6420006Recruiting
  • Investigational Site Number :6420012Recruiting
  • Investigational Site Number :6420002Recruiting
  • Investigational Site Number :6420007Recruiting
  • Investigational Site Number :6420010Recruiting
  • Investigational Site Number :6420001Recruiting
  • Investigational Site Number :6420009Recruiting
  • Investigational Site Number :6420003Recruiting
  • Investigational Site Number :6430001
  • Investigational Site Number :6430003
  • Investigational Site Number :6430002
  • Investigational Site Number :6430005
  • Investigational Site Number :6430006
  • Investigational Site Number :7030009Recruiting
  • Investigational Site Number :7030007Recruiting
  • Investigational Site Number :7030003Recruiting
  • Investigational Site Number :7030011Recruiting
  • Investigational Site Number :7030002Recruiting
  • Investigational Site Number :7030001Recruiting
  • Investigational Site Number :1580005Recruiting
  • Investigational Site Number :1580002Recruiting
  • Investigational Site Number :1580007Recruiting
  • Investigational Site Number :1580006Recruiting
  • Investigational Site Number :1580004Recruiting
  • Investigational Site Number :1580003Recruiting
  • Investigational Site Number :1580008Recruiting
  • Investigational Site Number :8040003Recruiting
  • Investigational Site Number :8040007
  • Investigational Site Number :8040008
  • Investigational Site Number :8040006
  • Investigational Site Number :8040004
  • Investigational Site Number :8040001Recruiting
  • Investigational Site Number :8040005Recruiting
  • Investigational Site Number :8040011

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Itepekimab Q2W

Itepekimab Q4W

Placebo

Arm Description

Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks

SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP

SC administration of matching placebo Q2W for up to 52 weeks

Outcomes

Primary Outcome Measures

Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD)
Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period

Secondary Outcome Measures

Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change from baseline in post-BD FEV1
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change from baseline in pre-BD FEV1
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time to first moderate or severe AECOPD
Time to first moderate or severe AECOPD over the placebo-controlled treatment period
Annualized rate of severe AECOPD
Annualized rate of severe AECOPD over the placebo-controlled treatment period
Time to first severe AECOPD
Time to first severe AECOPD over the placebo-controlled treatment period.
Annualized rate of corticosteroid-treated AECOPD
Annualized rate of corticosteroid-treated AECOPD over the placebo-controlled treatment period.
Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score
The E-RS: COPD is administered as a part of the 14-item EXACT questionnaire and is completed on a daily basis.The 11-item E-RS:COPD assesses severity of respiratory symptoms overall and severity of individual symptoms such as breathlessness, cough and sputum, and chest symptoms The total score of E-RS:COPD ranges from 0 to 40, with higher values indicating more severe respiratory symptoms.
Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope)
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change from baseline in St. George''s Respiratory Questionnaire (SGRQ) total score
The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score
The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities
Functional itepekimab concentrations in serum
Incidence of treatment-emergent anti-itepekimab antibodies responses

Full Information

First Posted
December 30, 2020
Last Updated
September 29, 2023
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04701983
Brief Title
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
AERIFY-1
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 29, 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2020 (Actual)
Primary Completion Date
June 27, 2025 (Anticipated)
Study Completion Date
November 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary Objective: 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: 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
Detailed Description
The study duration per participant: Screening period is 3-5 weeks Placebo-controlled treatment period is 52 weeks for first approximately 960 randomized participants, and 24 to 52 weeks for potential additional randomized participants Post-investigational medicinal product (IMP) treatment follow-up period is 20 weeks

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
960 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Itepekimab Q2W
Arm Type
Experimental
Arm Description
Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
Arm Title
Itepekimab Q4W
Arm Type
Experimental
Arm Description
SC administration of Itepekimab every 4 weeks (Q4W) for up to 52 weeks, with alternating SC administration of matching placebo at the 2-week interval between active IMP
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
SC administration of matching placebo Q2W for up to 52 weeks
Intervention Type
Drug
Intervention Name(s)
Itepekimab SAR440340
Other Intervention Name(s)
REGN3500
Intervention Description
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD)
Description
Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period
Time Frame
Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Secondary Outcome Measure Information:
Title
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
Description
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time Frame
Baseline to Week 24
Title
Change from baseline in post-BD FEV1
Description
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time Frame
Baseline to Week 24 and Week 52
Title
Change from baseline in pre-BD FEV1
Description
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time Frame
Baseline to Week 52
Title
Time to first moderate or severe AECOPD
Description
Time to first moderate or severe AECOPD over the placebo-controlled treatment period
Time Frame
Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Title
Annualized rate of severe AECOPD
Description
Annualized rate of severe AECOPD over the placebo-controlled treatment period
Time Frame
Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Title
Time to first severe AECOPD
Description
Time to first severe AECOPD over the placebo-controlled treatment period.
Time Frame
Baseline through EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Title
Annualized rate of corticosteroid-treated AECOPD
Description
Annualized rate of corticosteroid-treated AECOPD over the placebo-controlled treatment period.
Time Frame
Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Title
Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score
Description
The E-RS: COPD is administered as a part of the 14-item EXACT questionnaire and is completed on a daily basis.The 11-item E-RS:COPD assesses severity of respiratory symptoms overall and severity of individual symptoms such as breathlessness, cough and sputum, and chest symptoms The total score of E-RS:COPD ranges from 0 to 40, with higher values indicating more severe respiratory symptoms.
Time Frame
Baseline to Week 24 and Week 52
Title
Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope)
Description
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time Frame
Baseline up to EOT (Week 52 for initial randomized participants, Week 24 to 52 for potential additional randomized participants)
Title
Change from baseline in St. George''s Respiratory Questionnaire (SGRQ) total score
Description
The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
Time Frame
Baseline to Week 24 and Week 52
Title
Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score
Description
The SGRQ is a 50-item questionnaire designed to measure and quantify health status in adult participants with chronic airflow limitation. A global score ranges from 0 to 100. Scores by dimension are calculated for 3 domains: Symptoms, Activity and Impacts (Psycho-social) as well as a total score. A lower score indicates better quality of life.
Time Frame
Baseline to Week 24 and Week 52
Title
Incidence of treatment-emergent adverse events (TEAEs), adverse event of special interests (AESIs), serious adverse events (SAEs), and adverse events (AEs) leading to permanent treatment discontinuation
Time Frame
Baseline up to End Of Study (EOS) (Week 72 for initial randomized participants, Week 44 to 72 for potential additional randomized participants)
Title
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities
Time Frame
Baseline up to EOS (Week 72 for initial randomized participants, Week 44 to 72 for potential additional randomized participants)
Title
Functional itepekimab concentrations in serum
Time Frame
Baseline up to EOS (Week 72 for initial randomized participants, Week 44 to 72 for potential additional randomized participants)
Title
Incidence of treatment-emergent anti-itepekimab antibodies responses
Time Frame
Baseline up to EOS (Week 72 for initial randomized participants, Week 44 to 72 for potential additional randomized participants)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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, but who are not currently smoking, and smoking cessation must have occurred ≥6 months prior to Screening (Visit 1A) with an intention to quit permanently. 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, or BMI ≥16.0 kg/m^2 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. Exclusion criteria: Current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma unless asthma resolved before 18 years of age and has not recurred. Active smoking or vaping of any products (eg, nicotine, tetrahydrocannabinol [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 α-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-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 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 sScreening (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 antibacterial, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Transparency email recommended (Toll free number for US & Canada)
Phone
800-633-1610
Ext
option 6
Email
Contact-US@sanofi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham-Site Number:8400012
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
34294
Country
United States
Individual Site Status
Recruiting
Facility Name
Jasper Summit Research-Site Number:8400178
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Individual Site Status
Recruiting
Facility Name
MedPharmics, LLC-Site Number:8400185
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Recruiting
Facility Name
Chandler Clinical Trials (Elite Clinical Network)-Site Number:8400034
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85286
Country
United States
Individual Site Status
Recruiting
Facility Name
Noble Clinical Research-Site Number:8400182
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704-7876
Country
United States
Individual Site Status
Recruiting
Facility Name
Modena Allergy + Asthma-Site Number:8400036
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
Downtown LA Research Center Inc.-Site Number:8400027
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Name
MACRO Trials-Site Number:8400030
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
Antelope Valley Clinical Trials-Site Number:8400003
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Alpine Clinical Research Center-Site Number:8400180
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Individual Site Status
Recruiting
Facility Name
Innovative Clinical Research-Site Number:8400017
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Individual Site Status
Recruiting
Facility Name
Clin Research W Florida-Site Number:8400004
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Beautiful Minds Clinical Research Center-Site Number:8400037
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Recruiting
Facility Name
Indago Research and Health Center-Site Number:8400187
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Deluxe Health Center-Site Number:8400188
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Miami/Miami VA Medical Center-Site Number:8400026
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
DL Research Solutions Inc-Site Number:8400033
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Institute of South Florida,Inc-Site Number:8400006
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Name
Reed Medical Research-Site Number:8400032
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Institute for Clinical Research-Site Number:8400013
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825-4454
Country
United States
Individual Site Status
Recruiting
Facility Name
Broward Pulmonary and Sleep Specialists-Site Number:8400031
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Name
Coastal Medical Research Institute-Site Number:8400044
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Individual Site Status
Recruiting
Facility Name
Pasadena Center for Medical Research-Site Number:8400043
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33710
Country
United States
Individual Site Status
Recruiting
Facility Name
Appalachian Clinical Research-Site Number:8400024
City
Adairsville
State/Province
Georgia
ZIP/Postal Code
30103
Country
United States
Individual Site Status
Recruiting
Facility Name
Alpha Clinical Research Georgia-Site Number:8400190
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30311
Country
United States
Individual Site Status
Recruiting
Facility Name
Covenant Pulmonary Critical Care-Site Number:8400183
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30344
Country
United States
Individual Site Status
Recruiting
Facility Name
David Kavtaradze MD, Inc.-Site Number:8400029
City
Cordele
State/Province
Georgia
ZIP/Postal Code
31015
Country
United States
Individual Site Status
Recruiting
Facility Name
Gwinnett Biomedical Research-Site Number:8400007
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Individual Site Status
Recruiting
Facility Name
GenHarp Clinical Solutions-Site Number:8400028
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Individual Site Status
Recruiting
Facility Name
Benchmark Research-Site Number:8400193
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Individual Site Status
Recruiting
Facility Name
Paul Shapero, PC-Site Number:8400016
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access-Site Number:8400275
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02110
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access-Site Number:8400276
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02110
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access-Site Number:8400277
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02110
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access-Site Number:8400278
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02110
Country
United States
Individual Site Status
Recruiting
Facility Name
Care Access-Site Number:8400281
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02110
Country
United States
Individual Site Status
Recruiting
Facility Name
Revival Research Institute, LLC-Site Number:8400191
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48126
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Chest Consultants, P.C.-Site Number:8400002
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Individual Site Status
Recruiting
Facility Name
Hendeson Clinical Trials-Site Number:8400365
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwell/ Lenox Hill Hospital-Site Number:8400019
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastonia Pharmaceutical Research-Site Number:8400010
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Individual Site Status
Completed
Facility Name
East Carolina University Brody School Of Medicine-Site Number:8400022
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Research Center-Site Number:8400005
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Individual Site Status
Recruiting
Facility Name
Accellacare-Site Number:8400001
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Individual Site Status
Recruiting
Facility Name
Southeastern Research Center-Site Number:8400011
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Bernstein Clinical Research Center-Site Number:8400014
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Recruiting
Facility Name
WellNow Urgent Care and Research-Site Number:8400039
City
Springdale
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of Central PA-Site Number:8400023
City
DuBois
State/Province
Pennsylvania
ZIP/Postal Code
15801
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Bogan Sleep Consultants-Site Number:8400181
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Clinical Research of Rock Hill-Site Number:8400008
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinrx Research-Site Number:8400021
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Pulmonary Consultants-Site Number:8400035
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Individual Site Status
Recruiting
Facility Name
Corsicana Medical Research, LLC-Site Number:8400018
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Tech University Health Sciences Center-Site Number:8400189
City
El Paso
State/Province
Texas
ZIP/Postal Code
79911
Country
United States
Individual Site Status
Recruiting
Facility Name
The Methodist Hospital Research Institute-Site Number:8400194
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Biopharma Informatic - Cardiff Avenue - PPDS-Site Number:8400038
City
Houston
State/Province
Texas
ZIP/Postal Code
77043-2742
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research-Site Number:8400179
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Individual Site Status
Recruiting
Facility Name
Metroplex Pulmonary and Sleep Center-Site Number:8400015
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Individual Site Status
Recruiting
Facility Name
Advance Lung and Sleep Center-Site Number:8400040
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Individual Site Status
Recruiting
Facility Name
Sherman Clinical Research-Site Number:8400009
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Individual Site Status
Recruiting
Facility Name
Clearlake Specialties-Site Number:8400025
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320001
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425BEN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320002
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1425FVH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320003
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DEJ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320004
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000005
City
Dimitrovgrad
ZIP/Postal Code
6400
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000001
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000004
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000002
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000003
City
Stara Zagora
ZIP/Postal Code
6001
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520008
City
Temuco
State/Province
La Araucanía
ZIP/Postal Code
4781173
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520007
City
Curicó
State/Province
Maule
ZIP/Postal Code
3341643
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520002
City
Talca
State/Province
Maule
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520009
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500010
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520003
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500571
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520001
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500692
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520006
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500698
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520004
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8910131
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520005
City
Quillota
State/Province
Valparaíso
ZIP/Postal Code
2260877
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560003
City
Baotou
ZIP/Postal Code
014010
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560004
City
Beijing
ZIP/Postal Code
100020
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560030
City
Beijing
ZIP/Postal Code
100038
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560014
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560002
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560012
City
Changsha
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560013
City
Changsha
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560047
City
Changsha
ZIP/Postal Code
410023
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560001
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560040
City
Chengdu
ZIP/Postal Code
611130
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560032
City
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560006
City
Guangzhou
ZIP/Postal Code
510150
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560025
City
Guangzhou
ZIP/Postal Code
510163
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560036
City
Haikou
ZIP/Postal Code
570216
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560022
City
Hangzhou
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560039
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560017
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560008
City
Hohhot
ZIP/Postal Code
010017
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560010
City
Hohhot
ZIP/Postal Code
010050
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560044
City
Jinan
ZIP/Postal Code
250013
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560027
City
Jinan
ZIP/Postal Code
250014
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560031
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560038
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560035
City
Nanjing
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560023
City
Nanning
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560015
City
Pingxiang
ZIP/Postal Code
337055
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560043
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560034
City
Shanghai
ZIP/Postal Code
200240
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560009
City
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560045
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560005
City
Shenyang
ZIP/Postal Code
110004
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560020
City
Shenzhen
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560028
City
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560024
City
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560019
City
Wenzhou
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560029
City
Wuhan
ZIP/Postal Code
430014
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560016
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560046
City
Xiangtan
ZIP/Postal Code
411100
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560007
City
Xuzhou
ZIP/Postal Code
221002
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560026
City
Yangzhou
ZIP/Postal Code
225001
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560041
City
Zhanjiang
ZIP/Postal Code
524001
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560042
City
Zhengzhou
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1560048
City
Zhongshan
ZIP/Postal Code
528403
Country
China
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2680002
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2680003
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2680001
City
Tbilisi
ZIP/Postal Code
159
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000005
City
Athens
ZIP/Postal Code
106 76
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000006
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000004
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000001
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000007
City
Larissa
ZIP/Postal Code
41500
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000008
City
Palaio Faliro, Athens
ZIP/Postal Code
17562
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3000002
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480004
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480001
City
Gödöllö
ZIP/Postal Code
2100
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480002
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480003
City
Pécs
ZIP/Postal Code
7635
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560002
City
Coimbatore
ZIP/Postal Code
641028
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560005
City
Hyderabad
ZIP/Postal Code
500 084
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560004
City
Jaipur
ZIP/Postal Code
302039
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560008
City
Jaipur
ZIP/Postal Code
392017
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560001
City
Kozhikode
ZIP/Postal Code
673008
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560007
City
Mumbai
ZIP/Postal Code
400078
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560003
City
Nagpur
ZIP/Postal Code
441203
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760008
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760003
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760002
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760006
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760001
City
Petah-Tikva
ZIP/Postal Code
49100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760004
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3760007
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800003
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800004
City
Foggia
State/Province
Puglia
ZIP/Postal Code
71122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800005
City
Catania
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800001
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3800007
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840001
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840007
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62250
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840002
City
Cdmx
State/Province
México
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840003
City
San Juan del Rio
State/Province
Querétaro
ZIP/Postal Code
76800
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840004
City
Benito Juarez
ZIP/Postal Code
03100
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160004
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-088
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160003
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-777
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160001
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-044
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160002
City
Ostrowiec Swietokrzyski
State/Province
Swietokrzyskie
ZIP/Postal Code
27-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420005
City
Bragadiru
ZIP/Postal Code
769764
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420006
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420012
City
Bucaresti
ZIP/Postal Code
010192
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420002
City
Cluj-Napoca
ZIP/Postal Code
400275
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420007
City
Codlea
ZIP/Postal Code
505100
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420010
City
Deva
ZIP/Postal Code
330162
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420001
City
Iasi
ZIP/Postal Code
700732
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420009
City
Oradea
ZIP/Postal Code
410163
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6420003
City
Timisoara
ZIP/Postal Code
300134
Country
Romania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6430001
City
Moscow
ZIP/Postal Code
115093
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430003
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430002
City
Moscow
ZIP/Postal Code
117546
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430005
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430006
City
St-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :7030009
City
Bardejov
ZIP/Postal Code
08501
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7030007
City
Humenne
ZIP/Postal Code
066 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7030003
City
Levice
ZIP/Postal Code
93401
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7030011
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7030002
City
Poprad
ZIP/Postal Code
058 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7030001
City
Spisska Nova Ves
ZIP/Postal Code
05201
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1580005
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1580002
City
New Taipei City
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1580007
City
Taichung
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1580006
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1580004
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1580003
City
Taipei
ZIP/Postal Code
11031
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1580008
City
Yunlin
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8040003
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8040007
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :8040008
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Individual Site Status
Completed
Facility Name
Investigational Site Number :8040006
City
Kharkiv
ZIP/Postal Code
61166
Country
Ukraine
Individual Site Status
Completed
Facility Name
Investigational Site Number :8040004
City
Kyiv
ZIP/Postal Code
01023
Country
Ukraine
Individual Site Status
Completed
Facility Name
Investigational Site Number :8040001
City
Kyiv
ZIP/Postal Code
01033
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8040005
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8040011
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Learn more about this trial

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

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