Back to resultsStudy to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-2)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Itepekimab SAR440340
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
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:
- 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 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 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.
Sites / Locations
- Synexus Phoenix Central (Central Phoenix Medical Clinic)-Site Number:8400333Recruiting
- UCSF Fresno-Site Number:8400030Recruiting
- Palmtree Clinical Research-Site Number:8400184Recruiting
- Probe Clinical Research Corporation-Site Number:8400188Recruiting
- Allianz Research Institute Colorado-Site Number:8400061Recruiting
- Helix Biomedics, LLC-Site Number:8400049Recruiting
- Meris Clinical Research-Site Number:8400021Recruiting
- Innovative Research of West Florida, Inc-Site Number:8400041Recruiting
- Beautiful Minds Clinical Research Center-Site Number:8400352Recruiting
- Omega Research-Site Number:8400031Recruiting
- Sciences Connections, LLC-Site Number:8400045Recruiting
- North Florida/South Georgia Veterans Health System-Site Number:8400176Recruiting
- Finlay Medical Research-Site Number:8400011Recruiting
- Direct Helpers Medical Center Inc-Site Number:8400065Recruiting
- Multi-Specialty Research Associates, Inc-Site Number:8400044Recruiting
- Advanced Pulmonary Research Institute-Site Number:8400018Recruiting
- Columbus Clinical Services-Site Number:8400054Recruiting
- Finlay Medical Research-Site Number:8400007Recruiting
- Y and L Advance Health Care, Inc D/B/A Elite Clinical Res-Site Number:8400009Recruiting
- My Community Research Center-Site Number:8400060Recruiting
- Phoenix Medical Research-Site Number:8400019Recruiting
- Renstar Medical Research-Site Number:8400015Recruiting
- Central Florida Pulmonary Group, PA-Site Number:8400192Recruiting
- Heuer M.D. Research-Site Number:8400016Recruiting
- Oviedo Medical Research-Site Number:8400026Recruiting
- Pines Care Research Center LLC-Site Number:8400056Recruiting
- Sarasota Memorial Health Care System Clinical ResearchCenter-Site Number:8400178Recruiting
- Clinical Research Of West Florida Inc-Site Number:8400008Recruiting
- Genesis Clinical Research, LLC-Site Number:8400182Recruiting
- Medster Research, LLC-Site Number:8400051Recruiting
- North Georgia Clinical Research-Site Number:8400013
- Midwest Pulmonology, Critical Care and Sleep Associates-Site Number:8400033Recruiting
- Captain James A. Lovell Federal Health Care Center-Site Number:8400032Recruiting
- Illinois Lung Institute-Site Number:8400024Recruiting
- The Iowa Clinic-Site Number:8400034Recruiting
- Cotton O'Neil Garfield-Site Number:8400063Recruiting
- Lexington VA Health Care System-Site Number:8400036Recruiting
- Pulmonary & Critical Care-Site Number:8400047Recruiting
- 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
- Revive Research Institute-Site Number:8400186Recruiting
- Washington University School of Medicine-Site Number:8400035Recruiting
- Sierra Clinical Research-Site Number:8400005Recruiting
- Smart Medical Research-Site Number:8400191Recruiting
- VA Western New York Healthcare System-Site Number:8400050Recruiting
- New York - Presbyterian Queens-Site Number:8400028Recruiting
- IMA Clinical Research, LLC-Site Number:8400027Recruiting
- Schenectady Pulmonary and Critical Care Associates-Site Number:8400029Recruiting
- American Health Research-Site Number:8400002Recruiting
- Advanced Respiratory and Sleep Medicine-Site Number:8400022Recruiting
- University of Cincinnati-Site Number:8400042Recruiting
- Remington-Davis Inc-Site Number:8400004Recruiting
- Toledo Institute of Clinical Research-Site Number:8400014Recruiting
- OK Clinical Research LLC-Site Number:8400001Recruiting
- Kaiser Permanente Center for Health Research-Site Number:8400039Recruiting
- St. Luke's University Health Network-Site Number:8400187Recruiting
- Lowcountry Lung & Critical Care-Site Number:8400175Recruiting
- Medtrial, LLC-Site Number:8400048Recruiting
- VitaLink Research- Gaffney-Site Number:8400003Recruiting
- Clinical Trials Center of Middle Tennessee-Site Number:8400025Recruiting
- TTS Research-Site Number:8400012Recruiting
- United Memorial Medical Center (UMMC)-Site Number:8400193Recruiting
- FMC Science-Site Number:8400037Recruiting
- Sun Research Institute-Site Number:8400183Recruiting
- AES Salt Lake City-Site Number:8400332Recruiting
- The Rheumatology and Pulmonary Clinic-Site Number:8400053Recruiting
- Investigational Site Number :0320008Recruiting
- Investigational Site Number :0320001Recruiting
- Investigational Site Number :0320005Recruiting
- Investigational Site Number :0320002Recruiting
- Investigational Site Number :0320007Recruiting
- Investigational Site Number :0320003Recruiting
- Investigational Site Number :0320004Recruiting
- Investigational Site Number :0320006Recruiting
- Investigational Site Number :0760014Recruiting
- Investigational Site Number :0760012Recruiting
- Investigational Site Number :0760019Recruiting
- Investigational Site Number :0760001Recruiting
- Investigational Site Number :0760007Recruiting
- Investigational Site Number :0760006
- Investigational Site Number :0760005Recruiting
- Investigational Site Number :0760010Recruiting
- Investigational Site Number :0760013Recruiting
- Investigational Site Number :0760008Recruiting
- Investigational Site Number :1000008Recruiting
- Investigational Site Number :1000013Recruiting
- Investigational Site Number :1000004Recruiting
- Investigational Site Number :1000009Recruiting
- Investigational Site Number :1000005Recruiting
- Investigational Site Number :1000002Recruiting
- Investigational Site Number :1000012Recruiting
- Investigational Site Number :1000003Recruiting
- Investigational Site Number :1000001Recruiting
- Investigational Site Number :1000006Recruiting
- Investigational Site Number :1240006Recruiting
- Investigational Site Number :1240014Recruiting
- Investigational Site Number :1240016Recruiting
- Investigational Site Number :1240012Recruiting
- Investigational Site Number :1240021Recruiting
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- Investigational Site Number :1240009Recruiting
- Investigational Site Number :1240018Recruiting
- Investigational Site Number :1240004Recruiting
- Investigational Site Number :1240005Recruiting
- Investigational Site Number :1240019Recruiting
- Investigational Site Number :1240001Recruiting
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- Investigational Site Number :1240003Recruiting
- Investigational Site Number :1520002Recruiting
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- Investigational Site Number :2330001Recruiting
- Investigational Site Number :2500001Recruiting
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- Investigational Site Number :2680003Recruiting
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- Investigational Site Number :2680002Recruiting
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- Investigational Site Number :2760005Recruiting
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- Investigational Site Number :3920015Recruiting
- Investigational Site Number :3920010Recruiting
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- Investigational Site Number :3920035Recruiting
- Investigational Site Number :3920004Recruiting
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- Investigational Site Number :3920042Recruiting
- Investigational Site Number :3920013Recruiting
- Investigational Site Number :3920009Recruiting
- Investigational Site Number :3920014Recruiting
- Investigational Site Number :3920033Recruiting
- Investigational Site Number :3920011Recruiting
- Investigational Site Number :3920039Recruiting
- Investigational Site Number :3920022Recruiting
- Investigational Site Number :3920043Recruiting
- Investigational Site Number :3920034Recruiting
- Investigational Site Number :3920003Recruiting
- Investigational Site Number :3920026Recruiting
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- Investigational Site Number :3920028Recruiting
- Investigational Site Number :3920002Recruiting
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- Investigational Site Number :3920024Recruiting
- Investigational Site Number :3920019Recruiting
- Investigational Site Number :3920029Recruiting
- Investigational Site Number :3920001Recruiting
- Investigational Site Number :3920025Recruiting
- Investigational Site Number :3920016Recruiting
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- Investigational Site Number :3920041Recruiting
- Investigational Site Number :4100002Recruiting
- Investigational Site Number :4100003Recruiting
- Investigational Site Number :4100004Recruiting
- Investigational Site Number :4100001Recruiting
- Investigational Site Number :4280001Recruiting
- Investigational Site Number :4400002Recruiting
- Investigational Site Number :4840008Recruiting
- Investigational Site Number :4840009Recruiting
- Investigational Site Number :4840002Recruiting
- Investigational Site Number :4840010Recruiting
- Investigational Site Number :4840003Recruiting
- Investigational Site Number :4840012Recruiting
- Investigational Site Number :4840007Recruiting
- Investigational Site Number :4840006Recruiting
- Investigational Site Number :4840001Recruiting
- Investigational Site Number :4840004Recruiting
- Investigational Site Number :4840015Recruiting
- Investigational Site Number :5280005Recruiting
- Investigational Site Number :5280006Recruiting
- Investigational Site Number :5280008Recruiting
- Investigational Site Number :5280004Recruiting
- Investigational Site Number :5780001Recruiting
- Investigational Site Number :6160005Recruiting
- Investigational Site Number :6160008Recruiting
- Investigational Site Number :6160001Recruiting
- Investigational Site Number :6160003Recruiting
- Investigational Site Number :6160002Recruiting
- Investigational Site Number :6160009Recruiting
- Investigational Site Number :6200009Recruiting
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- Investigational Site Number :6200011Recruiting
- Investigational Site Number :6200001Recruiting
- Investigational Site Number :6200010Recruiting
- Investigational Site Number :6200003Recruiting
- Cardiopulmonary Research-Site Number:8400040Recruiting
- BRCR Medical Center, Inc.-Site Number:8400190Recruiting
- BRCR Medical Center-Site Number:8400180Recruiting
- Inspire Pulmonary & Sleep Medicine Specialists-Site Number:8400232Recruiting
- Investigational Site Number :6430002
- Investigational Site Number :6430001
- Investigational Site Number :6430005Recruiting
- Investigational Site Number :6430003
- Investigational Site Number :6430004
- Investigational Site Number :6430006
- Investigational Site Number :7100013Recruiting
- Investigational Site Number :7100010Recruiting
- Investigational Site Number :7100002Recruiting
- Investigational Site Number :7100001Recruiting
- Investigational Site Number :7100015Recruiting
- Investigational Site Number :7100005Recruiting
- Investigational Site Number :7100017Recruiting
- Investigational Site Number :7100006Recruiting
- Investigational Site Number :7100016Recruiting
- Investigational Site Number :7100004Recruiting
- Investigational Site Number :7100012Recruiting
- Investigational Site Number :7100003Recruiting
- Investigational Site Number :7100009Recruiting
- Investigational Site Number :7240004Recruiting
- Investigational Site Number :7240006Recruiting
- Investigational Site Number :7240002Recruiting
- Investigational Site Number :7240009Recruiting
- Investigational Site Number :7240007Recruiting
- Investigational Site Number :7240011Recruiting
- Investigational Site Number :7240008Recruiting
- Investigational Site Number :7240010Recruiting
- Investigational Site Number :7240003Recruiting
- Investigational Site Number :7240001Recruiting
- Investigational Site Number :8260002Recruiting
- Investigational Site Number :8260003Recruiting
- Investigational Site Number :8260005Recruiting
- Investigational Site Number :8260001Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Itepekimab Q2W in former smokers
Itepekimab Q4W in former smokers
Placebo in former smokers
Itepekimab Q2W in current smokers
Placebo in current smokers
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
SC administration of Itepekimab every 2 weeks (Q2W) for 52 weeks
SC administration of matching placebo Q2W for 52 weeks
Outcomes
Primary Outcome Measures
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) in former smokers
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the placebo-controlled treatment period.
Secondary Outcome Measures
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) in former smokers
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 in former smokers
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 in former smokers
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 in former smokers
Time to first moderate or severe AECOPD over the placebo-controlled treatment period.
Annualized rate of severe AECOPD in former smokers
Annualized rate of severe AECOPD over the placebo-controlled treatment period.
Time to first severe AECOPD in former smokers
Time to first severe AECOPD over the placebo-controlled treatment period.
Annualized rate of corticosteroid-treated AECOPD in former smokers
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 in former smokers
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) in former smokers
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score in former smokers
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 in former smokers
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 in former smokers
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities in former smokers
Functional itepekimab concentrations in serum in former smokers
Incidence of treatment-emergent anti-itepekimab antibodies responses in former smokers
Annualized rate of moderate or severe AECOPD in current smokers
Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period.
Change from baseline in pre-BD FEV1 in current smokers
FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation in current smokers
Incidence of potentially clinically significant laboratory, vital signs, and ECGs abnormalities in current smokers
Functional itepekimab concentrations in serum in current smokers
Incidence of treatment-emergent anti-itepekimab antibodies responses in current smokers
Full Information
NCT ID
NCT04751487
First Posted
February 8, 2021
Last Updated
August 16, 2023
Sponsor
Sanofi
Collaborators
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT04751487
Brief Title
Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD) (AERIFY-2)
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
August 16, 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
October 17, 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:
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
Detailed Description
The study duration per participant:
Screening period is 3-5 weeks
Randomized investigational medicinal product (IMP) treatment period is 52 weeks for first cohort of randomized former smoker participants [approximately 930] and cohort of current smokers [approximately 280], and 24 to 52 weeks for potential additional randomized former smoker participants
Post-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
1210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Itepekimab Q2W in former smokers
Arm Type
Experimental
Arm Description
Subcutaneous (SC) administration of Itepekimab every 2 weeks (Q2W) for up to 52 weeks
Arm Title
Itepekimab Q4W in former smokers
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 in former smokers
Arm Type
Placebo Comparator
Arm Description
SC administration of matching placebo Q2W for up to 52 weeks
Arm Title
Itepekimab Q2W in current smokers
Arm Type
Experimental
Arm Description
SC administration of Itepekimab every 2 weeks (Q2W) for 52 weeks
Arm Title
Placebo in current smokers
Arm Type
Placebo Comparator
Arm Description
SC administration of matching placebo Q2W for 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) in former smokers
Description
Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the placebo-controlled treatment period.
Time Frame
Baseline up to End Of Treatment (EOT) (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Secondary Outcome Measure Information:
Title
Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) in former smokers
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 in former smokers
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 in former smokers
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 in former smokers
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, 24 to 52 weeks for potential additional randomized former smoker participants)
Title
Annualized rate of severe AECOPD in former smokers
Description
Annualized rate of severe AECOPD over the placebo-controlled treatment period.
Time Frame
Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Title
Time to first severe AECOPD in former smokers
Description
Time to first severe AECOPD over the placebo-controlled treatment period.
Time Frame
Baseline through EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Title
Annualized rate of corticosteroid-treated AECOPD in former smokers
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, 24 to 52 weeks for potential additional randomized former smoker participants)
Title
Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score in former smokers
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) in former smokers
Time Frame
Baseline up to EOT (Week 52 for initial randomized participants, 24 to 52 weeks for potential additional randomized former smoker participants)
Title
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score in former smokers
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 in former smokers
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 in former smokers
Time Frame
Baseline up to End Of Study (EOS) (Week 72 for initial randomized participants, 44 to 72 weeks for potential additional randomized former smoker participants)
Title
Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities in former smokers
Time Frame
Baseline up to EOS (Week 72 for initial randomized participants, 44 to 72 weeks for potential additional randomized former smoker participants)
Title
Functional itepekimab concentrations in serum in former smokers
Time Frame
Baseline up to EOS (Week 72 for initial randomized participants, 44 to 72 weeks for potential additional randomized former smoker participants)
Title
Incidence of treatment-emergent anti-itepekimab antibodies responses in former smokers
Time Frame
Baseline up to EOS (Week 72 for initial randomized participants, 44 to 72 weeks for potential additional randomized former smoker participants)
Title
Annualized rate of moderate or severe AECOPD in current smokers
Description
Annualized rate of moderate or severe AECOPD over the placebo-controlled treatment period.
Time Frame
Baseline up to Week 52
Title
Change from baseline in pre-BD FEV1 in current smokers
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 Week 24 and Week 52
Title
Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation in current smokers
Time Frame
Baseline up to EOS (Week 72)
Title
Incidence of potentially clinically significant laboratory, vital signs, and ECGs abnormalities in current smokers
Time Frame
Baseline up to EOS (Week 72)
Title
Functional itepekimab concentrations in serum in current smokers
Time Frame
Baseline up to EOS (Week 72)
Title
Incidence of treatment-emergent anti-itepekimab antibodies responses in current smokers
Time Frame
Baseline up to EOS (Week 72)
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:
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, 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.
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 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 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 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
Synexus Phoenix Central (Central Phoenix Medical Clinic)-Site Number:8400333
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Individual Site Status
Recruiting
Facility Name
UCSF Fresno-Site Number:8400030
City
Fresno
State/Province
California
ZIP/Postal Code
93701
Country
United States
Individual Site Status
Recruiting
Facility Name
Palmtree Clinical Research-Site Number:8400184
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Individual Site Status
Recruiting
Facility Name
Probe Clinical Research Corporation-Site Number:8400188
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Individual Site Status
Recruiting
Facility Name
Allianz Research Institute Colorado-Site Number:8400061
City
Denver
State/Province
Colorado
ZIP/Postal Code
80219
Country
United States
Individual Site Status
Recruiting
Facility Name
Helix Biomedics, LLC-Site Number:8400049
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Individual Site Status
Recruiting
Facility Name
Meris Clinical Research-Site Number:8400021
City
Brandon
State/Province
Florida
ZIP/Postal Code
33594
Country
United States
Individual Site Status
Recruiting
Facility Name
Innovative Research of West Florida, Inc-Site Number:8400041
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Individual Site Status
Recruiting
Facility Name
Beautiful Minds Clinical Research Center-Site Number:8400352
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33157
Country
United States
Individual Site Status
Recruiting
Facility Name
Omega Research-Site Number:8400031
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Individual Site Status
Recruiting
Facility Name
Sciences Connections, LLC-Site Number:8400045
City
Doral
State/Province
Florida
ZIP/Postal Code
33178
Country
United States
Individual Site Status
Recruiting
Facility Name
North Florida/South Georgia Veterans Health System-Site Number:8400176
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Individual Site Status
Recruiting
Facility Name
Finlay Medical Research-Site Number:8400011
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Recruiting
Facility Name
Direct Helpers Medical Center Inc-Site Number:8400065
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Individual Site Status
Recruiting
Facility Name
Multi-Specialty Research Associates, Inc-Site Number:8400044
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Pulmonary Research Institute-Site Number:8400018
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbus Clinical Services-Site Number:8400054
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Name
Finlay Medical Research-Site Number:8400007
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Name
Y and L Advance Health Care, Inc D/B/A Elite Clinical Res-Site Number:8400009
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Individual Site Status
Recruiting
Facility Name
My Community Research Center-Site Number:8400060
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Name
Phoenix Medical Research-Site Number:8400019
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Individual Site Status
Recruiting
Facility Name
Renstar Medical Research-Site Number:8400015
City
Ocala
State/Province
Florida
ZIP/Postal Code
34470
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Florida Pulmonary Group, PA-Site Number:8400192
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
Heuer M.D. Research-Site Number:8400016
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Individual Site Status
Recruiting
Facility Name
Oviedo Medical Research-Site Number:8400026
City
Oviedo
State/Province
Florida
ZIP/Postal Code
32765
Country
United States
Individual Site Status
Recruiting
Facility Name
Pines Care Research Center LLC-Site Number:8400056
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarasota Memorial Health Care System Clinical ResearchCenter-Site Number:8400178
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Of West Florida Inc-Site Number:8400008
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesis Clinical Research, LLC-Site Number:8400182
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Recruiting
Facility Name
Medster Research, LLC-Site Number:8400051
City
Valdosta
State/Province
Georgia
ZIP/Postal Code
31605
Country
United States
Individual Site Status
Recruiting
Facility Name
North Georgia Clinical Research-Site Number:8400013
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Individual Site Status
Completed
Facility Name
Midwest Pulmonology, Critical Care and Sleep Associates-Site Number:8400033
City
Chicago Ridge
State/Province
Illinois
ZIP/Postal Code
60415
Country
United States
Individual Site Status
Recruiting
Facility Name
Captain James A. Lovell Federal Health Care Center-Site Number:8400032
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Individual Site Status
Recruiting
Facility Name
Illinois Lung Institute-Site Number:8400024
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61605
Country
United States
Individual Site Status
Recruiting
Facility Name
The Iowa Clinic-Site Number:8400034
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Individual Site Status
Recruiting
Facility Name
Cotton O'Neil Garfield-Site Number:8400063
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Recruiting
Facility Name
Lexington VA Health Care System-Site Number:8400036
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502
Country
United States
Individual Site Status
Recruiting
Facility Name
Pulmonary & Critical Care-Site Number:8400047
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
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
Revive Research Institute-Site Number:8400186
City
Lathrup Village
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine-Site Number:8400035
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Sierra Clinical Research-Site Number:8400005
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Individual Site Status
Recruiting
Facility Name
Smart Medical Research-Site Number:8400191
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11230
Country
United States
Individual Site Status
Recruiting
Facility Name
VA Western New York Healthcare System-Site Number:8400050
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Individual Site Status
Recruiting
Facility Name
New York - Presbyterian Queens-Site Number:8400028
City
Flushing
State/Province
New York
ZIP/Postal Code
11355
Country
United States
Individual Site Status
Recruiting
Facility Name
IMA Clinical Research, LLC-Site Number:8400027
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Individual Site Status
Recruiting
Facility Name
Schenectady Pulmonary and Critical Care Associates-Site Number:8400029
City
Schenectady
State/Province
New York
ZIP/Postal Code
12308
Country
United States
Individual Site Status
Recruiting
Facility Name
American Health Research-Site Number:8400002
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Respiratory and Sleep Medicine-Site Number:8400022
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Cincinnati-Site Number:8400042
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Name
Remington-Davis Inc-Site Number:8400004
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Individual Site Status
Recruiting
Facility Name
Toledo Institute of Clinical Research-Site Number:8400014
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Individual Site Status
Recruiting
Facility Name
OK Clinical Research LLC-Site Number:8400001
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Individual Site Status
Recruiting
Facility Name
Kaiser Permanente Center for Health Research-Site Number:8400039
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Luke's University Health Network-Site Number:8400187
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Individual Site Status
Recruiting
Facility Name
Lowcountry Lung & Critical Care-Site Number:8400175
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Individual Site Status
Recruiting
Facility Name
Medtrial, LLC-Site Number:8400048
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Individual Site Status
Recruiting
Facility Name
VitaLink Research- Gaffney-Site Number:8400003
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29340
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Trials Center of Middle Tennessee-Site Number:8400025
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Recruiting
Facility Name
TTS Research-Site Number:8400012
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Individual Site Status
Recruiting
Facility Name
United Memorial Medical Center (UMMC)-Site Number:8400193
City
Houston
State/Province
Texas
ZIP/Postal Code
77091
Country
United States
Individual Site Status
Recruiting
Facility Name
FMC Science-Site Number:8400037
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550-1820
Country
United States
Individual Site Status
Recruiting
Facility Name
Sun Research Institute-Site Number:8400183
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Recruiting
Facility Name
AES Salt Lake City-Site Number:8400332
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Individual Site Status
Recruiting
Facility Name
The Rheumatology and Pulmonary Clinic-Site Number:8400053
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320008
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1023AAB
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320001
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320005
City
Pergamino
State/Province
Buenos Aires
ZIP/Postal Code
B2700CPM
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320002
City
Florida
State/Province
Ciudad De Buenos Aires
ZIP/Postal Code
B1602DQD
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320007
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320003
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000DBS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320004
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
S2000JKR
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0320006
City
Caba
ZIP/Postal Code
1425DES
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760014
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760012
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80060-240
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760019
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59062-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760001
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760007
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760006
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
91350-200
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Investigational Site Number :0760005
City
Botucatu
State/Province
São Paulo
ZIP/Postal Code
18618-687
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760010
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13059900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760013
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :0760008
City
Sorocaba
State/Province
São Paulo
ZIP/Postal Code
18040-425
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000008
City
Blagoevgrad
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000013
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000004
City
Gabrovo
ZIP/Postal Code
5300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000009
City
Haskovo
ZIP/Postal Code
6305
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000005
City
Montana
ZIP/Postal Code
3400
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000002
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000012
City
Ruse
ZIP/Postal Code
70000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000003
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000001
City
Sofia
ZIP/Postal Code
1142
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1000006
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240006
City
Sherwood Park
State/Province
Alberta
ZIP/Postal Code
T8H 0N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240014
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 4N7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240016
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 5L5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240012
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C2Z3
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240021
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240020
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7N 3V2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240009
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 3A9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240018
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240004
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240005
City
St-charles Borrommee
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240019
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240001
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240002
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1240003
City
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
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 :1520007
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500010
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520008
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500587
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 :1520003
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
7500698
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520005
City
Santiago
State/Province
Reg Metropolitana De Santiago
ZIP/Postal Code
8910131
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :1520006
City
Quillota
State/Province
Valparaíso
ZIP/Postal Code
2260877
Country
Chile
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2080001
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2080003
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2330001
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500001
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500002
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500003
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2500004
City
Reims
ZIP/Postal Code
51090
Country
France
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2680003
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2680001
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2680002
City
Tbilisi
ZIP/Postal Code
0168
Country
Georgia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760004
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760005
City
Frankfurt am Main
ZIP/Postal Code
60596
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760002
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760006
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760007
City
Leipzig
ZIP/Postal Code
04347
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760003
City
Lübeck
ZIP/Postal Code
23552
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :2760001
City
Mainz
ZIP/Postal Code
55128
Country
Germany
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480002
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480009
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480005
City
Edelény
ZIP/Postal Code
3780
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480004
City
Hajdunánás
ZIP/Postal Code
4080
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480007
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480003
City
Puspokladany
ZIP/Postal Code
4150
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480012
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3480001
City
Százhalombatta
ZIP/Postal Code
2440
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560001
City
Chandigarh
ZIP/Postal Code
160012
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560014
City
India
ZIP/Postal Code
440010
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560013
City
Jaipur
ZIP/Postal Code
302023
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560010
City
Kolkata
ZIP/Postal Code
700107
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560005
City
Nagpur
ZIP/Postal Code
440015
Country
India
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3560009
City
Nashik
ZIP/Postal Code
422007
Country
India
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 :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 :3920023
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920020
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920005
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
815-0032
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920027
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
819-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920030
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920032
City
Yanagawa-shi
State/Province
Fukuoka
ZIP/Postal Code
832-0059
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920031
City
Gifu-shi
State/Province
Gifu
ZIP/Postal Code
500-8717
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920015
City
Mizunami-shi
State/Province
Gifu
ZIP/Postal Code
509-6134
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920010
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8530
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920021
City
Kure-shi
State/Province
Hiroshima
ZIP/Postal Code
737-0193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920035
City
Kure-shi
State/Province
Hiroshima
ZIP/Postal Code
737-8505
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920004
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
006-0811
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920038
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920008
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0034
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920042
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
064-0804
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920013
City
Himeji-shi
State/Province
Hyogo
ZIP/Postal Code
670-0849
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920009
City
Sakaide-shi
State/Province
Kagawa
ZIP/Postal Code
762-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920014
City
Takamatsu-shi
State/Province
Kagawa
ZIP/Postal Code
761-8073
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920033
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
214-8525
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920011
City
Konan-ku, Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
234-0054
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920039
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
223-0059
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920022
City
Yokohama-Shi
State/Province
Kanagawa
ZIP/Postal Code
227-8501
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920043
City
Matsusaka-shi
State/Province
Mie
ZIP/Postal Code
515-8544
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920034
City
Ikoma-shi
State/Province
Nara
ZIP/Postal Code
630-0293
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920003
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
530-8480
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920026
City
Osaka-shi
State/Province
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920007
City
Sakai-shi
State/Province
Osaka
ZIP/Postal Code
591-8555
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920006
City
Yao-shi
State/Province
Osaka
ZIP/Postal Code
581-0011
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920028
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
430-8525
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920002
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
434-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920036
City
Sano-shi
State/Province
Tochigi
ZIP/Postal Code
327-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920040
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
103-0022
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920017
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920024
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920019
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-8610
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920029
City
Kiyose-City
State/Province
Tokyo
ZIP/Postal Code
204-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920001
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
153-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920025
City
Shibuya-ku
State/Province
Tokyo
ZIP/Postal Code
150-8935
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920016
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
140-8522
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920037
City
Shinagawa-ku
State/Province
Tokyo
ZIP/Postal Code
142-8666
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :3920041
City
Toshima-ku
State/Province
Tokyo
ZIP/Postal Code
170-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100002
City
Wonju
State/Province
Gangwon-do
ZIP/Postal Code
26426
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100003
City
Incheon
State/Province
Incheon-gwangyeoksi
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100004
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4100001
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4280001
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4400002
City
Kaunas
ZIP/Postal Code
49449
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840008
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840009
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64718
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840002
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
66465
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840010
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840003
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840012
City
Durango, Durango
ZIP/Postal Code
34080
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840007
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840006
City
Mexico City
ZIP/Postal Code
14050
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840001
City
Monterrey, Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840004
City
Veracruz
ZIP/Postal Code
91910
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :4840015
City
Yucatan
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5280005
City
Arnhem
ZIP/Postal Code
6815 AD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5280006
City
Nijmegen
ZIP/Postal Code
6532 SZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5280008
City
Zutphen
ZIP/Postal Code
7207 AE
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5280004
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :5780001
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160005
City
Wolomin
State/Province
Mazowieckie
ZIP/Postal Code
05-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160008
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-044
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160001
City
Bialystok
State/Province
Podlaskie
ZIP/Postal Code
15-351
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160003
City
Malbork
State/Province
Pomorskie
ZIP/Postal Code
82-200
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160002
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-611
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6160009
City
Ostrowiec Swietokrzyski
State/Province
Swietokrzyskie
ZIP/Postal Code
27-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200009
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200006
City
Aveiro
ZIP/Postal Code
3810-501
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200002
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200011
City
Guarda
ZIP/Postal Code
6301-857
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200001
City
Guimarães
ZIP/Postal Code
4810-061
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200010
City
Matosinhos
ZIP/Postal Code
4464-513
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6200003
City
Porto
ZIP/Postal Code
4202-451
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Cardiopulmonary Research-Site Number:8400040
City
Guaynabo
ZIP/Postal Code
00968
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
BRCR Medical Center, Inc.-Site Number:8400190
City
Ponce
ZIP/Postal Code
00717-1322
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
BRCR Medical Center-Site Number:8400180
City
San Juan
ZIP/Postal Code
00907
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Inspire Pulmonary & Sleep Medicine Specialists-Site Number:8400232
City
Temecula
ZIP/Postal Code
92590
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6430002
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430001
City
Moscow
ZIP/Postal Code
115093
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430005
City
Moscow
ZIP/Postal Code
115280
Country
Russian Federation
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :6430003
City
Saint-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430004
City
St-Petersburg
ZIP/Postal Code
193231
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :6430006
City
Ulyanovsk
ZIP/Postal Code
432017
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Investigational Site Number :7100013
City
Benoni
ZIP/Postal Code
1500
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100010
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100002
City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100001
City
Cape Town
ZIP/Postal Code
7937
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100015
City
Chatsworth
ZIP/Postal Code
4091
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100005
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100017
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100006
City
Durban
ZIP/Postal Code
4071
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100016
City
Durban
ZIP/Postal Code
4302
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100004
City
Gatesville
ZIP/Postal Code
7764
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100012
City
Middelburg
ZIP/Postal Code
1055
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100003
City
Parow
ZIP/Postal Code
7500
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7100009
City
Pretoria
ZIP/Postal Code
0145
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240004
City
Palma de Mallorca
State/Province
Balears [Baleares]
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240006
City
Sant Boi de Llobregat
State/Province
Barcelona [Barcelona]
ZIP/Postal Code
08830
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240002
City
Mérida / Badajoz
State/Province
Extremadura
ZIP/Postal Code
06800
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240009
City
Lleida / Lleida
State/Province
Lleida [Lérida]
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240007
City
Madrid / Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240011
City
Madrid
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240008
City
Pozuelo De Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240010
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240003
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :7240001
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260002
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260003
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260005
City
Liverpool
ZIP/Postal Code
L143PE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Investigational Site Number :8260001
City
Newcastle upon Tyne
ZIP/Postal Code
NE4 6BE
Country
United Kingdom
Individual Site Status
Recruiting
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) (AERIFY-2)
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