Clincosm LogoSign in Get a demo

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

Sponsor
Sanofi (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04751487
Collaborator
Regeneron Pharmaceuticals (Industry)
1,170
Enrollment
207
Locations
5
Arms
40.6
Anticipated Duration (Months)
5.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Itepekimab SAR440340
  • Drug: Placebo
 Phase 3

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Feb 12, 2021
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Itepekimab Q2W in former smokers

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

Drug: Itepekimab SAR440340
Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
Other Names:
  • REGN3500

    		•
    Experimental: Itepekimab Q4W in former smokers

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

    Drug: Itepekimab SAR440340
    Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
    Other Names:
  • REGN3500

    		•
    Placebo Comparator: Placebo in former smokers

    SC administration of matching placebo Q2W for 52 weeks

    Drug: Placebo
    Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
    Experimental: Itepekimab Q2W in current smokers

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

    Drug: Itepekimab SAR440340
    Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
    Other Names:
  • REGN3500

    		•
    Placebo Comparator: Placebo in current smokers

    SC administration of matching placebo Q2W for 52 weeks

    Drug: Placebo
    Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous

    Outcome Measures

    Primary Outcome Measures

    1. Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) in former smokers [Baseline up to Week 52]

      Annualized rate of moderate or severe acute exacerbation of COPD (AECOPD) over the 52-week placebo-controlled treatment period.

    Secondary Outcome Measures

    1. Change from baseline in pre-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 52 in former smokers [Baseline to Week 52]

      FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

    2. Change from baseline in post-BD FEV1 at Week 52 in former smokers [Baseline to Week 52]

      FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

    3. Change from baseline in pre-BD FEV1 at Week 24 in former smokers [Baseline to Week 24]

      FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

    4. Time to first moderate or severe AECOPD in former smokers [Baseline through Week 52]

      Time to first moderate or severe AECOPD over the 52 week placebo-controlled treatment period.

    5. Annualized rate of severe AECOPD in former smokers [Baseline up to Week 52]

      Annualized rate of severe AECOPD over the 52 week placebo-controlled treatment period.

    6. Time to first severe AECOPD in former smokers [Baseline through Week 52]

      Time to first severe AECOPD over the 52-week placebo-controlled treatment period.

    7. Annualized rate of corticosteroid-treated AECOPD in former smokers [Baseline up to Week 52]

      Annualized rate of corticosteroid-treated AECOPD over the 52-week placebo-controlled treatment period.

    8. Change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score at Week 52 in former smokers [Baseline to Week 52]

      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.

    9. Rate of change in post-BD FEV1 (L) from baseline (post-BD FEV1 slope) in former smokers [Baseline up to Week 52]

    10. Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 52 in former smokers [Baseline to Week 52]

      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.

    11. Proportion of participants with a decrease from baseline of at least 4 points in SGRQ total score at Week 52 in former smokers [Baseline to Week 52]

      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.

    12. 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 [Baseline up to end of study (Week 72)]

    13. Incidence of potentially clinically significant laboratory test, vital signs, and electrocardiogram (ECGs) abnormalities in former smokers [Baseline up to end of study (Week 72)]

    14. Functional itepekimab concentrations in serum in former smokers [Baseline up to end of study (Week 72)]

    15. Incidence of treatment-emergent anti-itepekimab antibodies responses in former smokers [Baseline up to end of study (Week 72)]

    16. Annualized rate of moderate or severe AECOPD in current smokers [Baseline up to Week 52]

      Annualized rate of moderate or severe AECOPD over the 52 week placebo-controlled treatment period.

    17. Change from baseline in pre-BD FEV1 at Week 52 in current smokers [Baseline up to Week 52]

      FEV1 is the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

    18. Incidence of TEAEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation in current smokers [Baseline up to end of study (Week 72)]

    19. Incidence of potentially clinically significant laboratory, vital signs, and ECGs abnormalities in current smokers [Baseline up to end of study (Week 72)]

    20. Functional itepekimab concentrations in serum in current smokers [Baseline up to end of study (Week 72)]

    21. Incidence of treatment-emergent anti-itepekimab antibodies responses in current smokers [Baseline up to end of study (Week 72)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Palmtree Clinical Research-Site Number:8400184 Palm Springs California United States 92262
    2 Probe Clinical Research Corporation-Site Number:8400188 Riverside California United States 92501
    3 TriWest Research Associates-Site Number:8400185 San Diego California United States 92108
    4 Meris Clinical Research-Site Number:8400021 Brandon Florida United States 33594
    5 Omega Research-Site Number:8400031 DeBary Florida United States 32713
    6 Finlay Medical Research-Site Number:8400011 Greenacres City Florida United States 33467
    7 Advanced Pulmonary Research Institute-Site Number:8400018 Loxahatchee Groves Florida United States 33470
    8 Finlay Medical Research-Site Number:8400007 Miami Florida United States 33126
    9 Y and L Advance Health Care, Inc D/B/A Elite Clinical Res-Site Number:8400009 Miami Florida United States 33144
    10 Phoenix Medical Research-Site Number:8400019 Miami Florida United States 33165
    11 Renstar Medical Research-Site Number:8400015 Ocala Florida United States 34470
    12 Heuer M.D. Research-Site Number:8400016 Orlando Florida United States 32819
    13 Sarasota Memorial Health Care System Clinical ResearchCenter-Site Number:8400178 Sarasota Florida United States 34239
    14 Clinical Research Of West Florida Inc-Site Number:8400008 Tampa Florida United States 33603
    15 Genesis Clinical Research, LLC-Site Number:8400182 Tampa Florida United States 33603
    16 Agile Clinical Research Trial, LLC-Site Number:8400177 Atlanta Georgia United States 30328
    17 North Georgia Clinical Research-Site Number:8400013 Woodstock Georgia United States 30189
    18 Midwest Pulmonology, Critical Care and Sleep Associates-Site Number:8400033 Chicago Ridge Illinois United States 60415
    19 Revive Research Institute-Site Number:8400186 Lathrup Village Michigan United States 48076
    20 Sierra Clinical Research-Site Number:8400005 Las Vegas Nevada United States 89106
    21 Smart Medical Research-Site Number:8400191 Brooklyn New York United States 11236
    22 Schenectady Pulmonary and Critical Care Associates-Site Number:8400029 Schenectady New York United States 12308
    23 American Health Research-Site Number:8400002 Charlotte North Carolina United States 28277
    24 Advanced Respiratory and Sleep Medicine-Site Number:8400022 Huntersville North Carolina United States 28078
    25 Remington-Davis Inc-Site Number:8400004 Columbus Ohio United States 43215
    26 Toledo Institute of Clinical Research-Site Number:8400014 Toledo Ohio United States 43617
    27 OK Clinical Research LLC-Site Number:8400001 Edmond Oklahoma United States 73034
    28 Lowcountry Lung & Critical Care-Site Number:8400175 Charleston South Carolina United States 29406
    29 VitaLink Research- Gaffney-Site Number:8400003 Gaffney South Carolina United States 29340
    30 Health Concepts-Site Number:8400020 Rapid City South Dakota United States 57702
    31 Clinical Trials Center of Middle Tennessee-Site Number:8400025 Franklin Tennessee United States 37067
    32 TTS Research-Site Number:8400012 Boerne Texas United States 78006
    33 Sun Research Institute-Site Number:8400183 San Antonio Texas United States 78215
    34 Investigational Site Number :0320008 Caba Buenos Aires Argentina C1023AAB
    35 Investigational Site Number :0320001 Caba Buenos Aires Argentina C1414AIF
    36 Investigational Site Number :0320005 Pergamino Buenos Aires Argentina B2700CPM
    37 Investigational Site Number :0320007 Rosario Santa Fe Argentina 2000
    38 Investigational Site Number :0320003 Rosario Santa Fe Argentina S2000DBS
    39 Investigational Site Number :0320004 Rosario Santa Fe Argentina S2000JKR
    40 Investigational Site Number :0320002 Buenos Aires Argentina B1602DQD
    41 Investigational Site Number :0320006 Caba Argentina 1425DES
    42 Investigational Site Number :0760001 Porto Alegre Rio Grande Do Sul Brazil 90020-090
    43 Investigational Site Number :0760007 Porto Alegre Rio Grande Do Sul Brazil 90610-000
    44 Investigational Site Number :0760005 Botucatu Brazil 18618-687
    45 Investigational Site Number :1000008 Blagoevgrad Bulgaria
    46 Investigational Site Number :1000013 Dupnitsa Bulgaria 2600
    47 Investigational Site Number :1000004 Gabrovo Bulgaria 5300
    48 Investigational Site Number :1000009 Haskovo Bulgaria 6305
    49 Investigational Site Number :1000005 Montana Bulgaria 3400
    50 Investigational Site Number :1000002 Plovdiv Bulgaria 4002
    51 Investigational Site Number :1000012 Ruse Bulgaria 70000
    52 Investigational Site Number :1000003 Ruse Bulgaria 7002
    53 Investigational Site Number :1000001 Sofia Bulgaria 1142
    54 Investigational Site Number :1000006 Sofia Bulgaria 1680
    55 Investigational Site Number :1240006 Sherwood Park Alberta Canada T8H 0N2
    56 Investigational Site Number :1240014 Kelowna British Columbia Canada V1Y 4N7
    57 Investigational Site Number :1240016 Penticton British Columbia Canada V2A 5L5
    58 Investigational Site Number :1240012 Moncton New Brunswick Canada E1C2Z3
    59 Investigational Site Number :1240021 Ajax Ontario Canada L1S 2J5
    60 Investigational Site Number :1240020 Burlington Ontario Canada L7N 3V2
    61 Investigational Site Number :1240009 Toronto Ontario Canada M5T 3A9
    62 Investigational Site Number :1240018 Windsor Ontario Canada N8X 5A6
    63 Investigational Site Number :1240004 Sherbrooke Quebec Canada J1H 5N4
    64 Investigational Site Number :1240005 St-charles Borrommee Quebec Canada J6E 2B4
    65 Investigational Site Number :1240019 Terrebonne Quebec Canada J6V 2H2
    66 Investigational Site Number :1240001 Trois-Rivieres Quebec Canada G8T 7A1
    67 Investigational Site Number :1240002 Victoriaville Quebec Canada G6P 6P6
    68 Investigational Site Number :1240003 Quebec Canada G1N 4V3
    69 Investigational Site Number :1520002 Talca Maule Chile
    70 Investigational Site Number :1520001 Santiago Reg Metropolitana De Santiago Chile 7500692
    71 Investigational Site Number :1520003 Santiago Reg Metropolitana De Santiago Chile 7500698
    72 Investigational Site Number :1520005 Santiago Reg Metropolitana De Santiago Chile 8910131
    73 Investigational Site Number :1520006 Quillota Chile 2260877
    74 Investigational Site Number :2030001 Jindrichuv Hradec III Czechia 37701
    75 Investigational Site Number :2030009 Mesice Czechia 250 64
    76 Investigational Site Number :2030005 Mlada Boleslav Czechia 29301
    77 Investigational Site Number :2030008 Olomouc Czechia 779 00
    78 Investigational Site Number :2030004 Ostrava Czechia 70800
    79 Investigational Site Number :2030002 Praha 4 Czechia 140 46
    80 Investigational Site Number :2030006 Teplice Czechia 415 01
    81 Investigational Site Number :2030007 Varnsdorf Czechia 40747
    82 Investigational Site Number :2080001 Hvidovre Denmark 2650
    83 Investigational Site Number :2080003 Vejle Denmark 7100
    84 Investigational Site Number :2500001 Lyon France 69004
    85 Investigational Site Number :2500002 Montpellier France
    86 Investigational Site Number :2500003 Pessac France 33600
    87 Investigational Site Number :2500004 Reims France 51090
    88 Investigational Site Number :2760004 Berlin Germany 10787
    89 Investigational Site Number :2760005 Frankfurt am Main Germany 60596
    90 Investigational Site Number :2760002 Hamburg Germany 20354
    91 Investigational Site Number :2760006 Koblenz Germany 56068
    92 Investigational Site Number :2760007 Leipzig Germany 04347
    93 Investigational Site Number :2760003 Lübeck Germany 23552
    94 Investigational Site Number :2760001 Mainz Germany 55128
    95 Investigational Site Number :3480002 Balassagyarmat Hungary 2660
    96 Investigational Site Number :3480005 Edelény Hungary 3780
    97 Investigational Site Number :3480004 Hajdúnánás Hungary 4080
    98 Investigational Site Number :3480007 Nyíregyháza Hungary 4400
    99 Investigational Site Number :3480003 Püspökladány Hungary 4150
    100 Investigational Site Number :3480001 Százhalombatta Hungary 2440
    101 Investigational Site Number :3760003 Jerusalem Israel 91031
    102 Investigational Site Number :3760002 Jerusalem Israel 91120
    103 Investigational Site Number :3760001 Petah-Tikva Israel 49100
    104 Investigational Site Number :3760004 Rehovot Israel 76100
    105 Investigational Site Number :3920023 Nagoya-shi Aichi Japan 455-8530
    106 Investigational Site Number :3920020 Nagoya-shi Aichi Japan 457-8511
    107 Investigational Site Number :3920005 Fukuoka-shi Fukuoka Japan 815-0032
    108 Investigational Site Number :3920027 Fukuoka-shi Fukuoka Japan 819-8555
    109 Investigational Site Number :3920030 Kurume-shi Fukuoka Japan 830-0011
    110 Investigational Site Number :3920032 Yanagawa-shi Fukuoka Japan 832-0059
    111 Investigational Site Number :3920031 Gifu-shi Gifu Japan 500-8717
    112 Investigational Site Number :3920015 Mizunami-shi Gifu Japan 509-6134
    113 Investigational Site Number :3920010 Hiroshima-shi Hiroshima Japan 734-8530
    114 Investigational Site Number :3920021 Kure-shi Hiroshima Japan 737-0193
    115 Investigational Site Number :3920035 Kure-shi Hiroshima Japan 737-8505
    116 Investigational Site Number :3920004 Sapporo-shi Hokkaido Japan 006-0811
    117 Investigational Site Number :3920038 Sapporo-shi Hokkaido Japan 006-8555
    118 Investigational Site Number :3920013 Himeji-shi Hyogo Japan 670-0849
    119 Investigational Site Number :3920009 Sakaide-shi Kagawa Japan 762-8550
    120 Investigational Site Number :3920014 Takamatsu-shi Kagawa Japan 761-8073
    121 Investigational Site Number :3920033 Kawasaki-shi Kanagawa Japan 214-8525
    122 Investigational Site Number :3920011 Konan-ku, Yokohama-shi Kanagawa Japan 234-0054
    123 Investigational Site Number :3920039 Yokohama-shi Kanagawa Japan 223-0059
    124 Investigational Site Number :3920022 Yokohama-Shi Kanagawa Japan 227-8501
    125 Investigational Site Number :3920034 Ikoma-shi Nara Japan 630-0293
    126 Investigational Site Number :3920003 Osaka-shi Osaka Japan 530-8480
    127 Investigational Site Number :3920026 Osaka-shi Osaka Japan 545-8586
    128 Investigational Site Number :3920007 Sakai-shi Osaka Japan 591-8555
    129 Investigational Site Number :3920006 Yao-shi Osaka Japan 581-0011
    130 Investigational Site Number :3920028 Hamamatsu-shi Shizuoka Japan 430-8525
    131 Investigational Site Number :3920002 Hamamatsu-shi Shizuoka Japan 434-8511
    132 Investigational Site Number :3920036 Sano-shi Tochigi Japan 327-8511
    133 Investigational Site Number :3920040 Chuo-ku Tokyo Japan 103-0022
    134 Investigational Site Number :3920017 Chuo-ku Tokyo Japan 104-0031
    135 Investigational Site Number :3920024 Chuo-ku Tokyo Japan 104-0031
    136 Investigational Site Number :3920019 Itabashi-ku Tokyo Japan 173-8610
    137 Investigational Site Number :3920029 Kiyose-City Tokyo Japan 204-8522
    138 Investigational Site Number :3920001 Meguro-ku Tokyo Japan 153-8515
    139 Investigational Site Number :3920025 Shibuya-ku Tokyo Japan 150-8935
    140 Investigational Site Number :3920016 Shinagawa-ku Tokyo Japan 140-8522
    141 Investigational Site Number :3920037 Shinagawa-ku Tokyo Japan 142-8666
    142 Investigational Site Number :3920008 Hokkaido Japan 064-0915
    143 Investigational Site Number :4100002 Wonju Gangwon-do Korea, Republic of 26426
    144 Investigational Site Number :4100003 Incheon Incheon-gwangyeoksi Korea, Republic of 21431
    145 Investigational Site Number :4100004 Seoul Seoul-teukbyeolsi Korea, Republic of 05030
    146 Investigational Site Number :4100001 Seoul Korea, Republic of 06591
    147 Investigational Site Number :4840010 Aguascalientes Mexico 20230
    148 Investigational Site Number :4840003 Chihuahua Mexico 31000
    149 Investigational Site Number :4840007 Durango Mexico 34000
    150 Investigational Site Number :4840006 Mexico City Mexico 14050
    151 Investigational Site Number :4840001 Monterrey Mexico 64460
    152 Investigational Site Number :4840008 Monterrey Mexico 64710
    153 Investigational Site Number :4840009 Monterrey Mexico 64718
    154 Investigational Site Number :4840002 Monterrey Mexico 66465
    155 Investigational Site Number :4840004 Veracruz Mexico 91910
    156 Investigational Site Number :5280005 Arnhem Netherlands 6815 AD
    157 Investigational Site Number :5280006 Nijmegen Netherlands 6532 SZ
    158 Investigational Site Number :5280008 Zutphen Netherlands 7207 AE
    159 Investigational Site Number :5280004 Zwolle Netherlands 8025 AB
    160 Investigational Site Number :5780001 Lørenskog Norway 1478
    161 Investigational Site Number :6160006 Lublin Lubelskie Poland 20-089
    162 Investigational Site Number :6160005 Wolomin Mazowieckie Poland 05-200
    163 Investigational Site Number :6160008 Bialystok Podlaskie Poland 15-044
    164 Investigational Site Number :6160001 Bialystok Podlaskie Poland 15-351
    165 Investigational Site Number :6160003 Malbork Pomorskie Poland 82-200
    166 Investigational Site Number :6160002 Katowice Slaskie Poland 40-611
    167 Investigational Site Number :6160007 Piekary Slaskie Slaskie Poland 41-940
    168 Investigational Site Number :6200009 Almada Portugal 2801-951
    169 Investigational Site Number :6200006 Aveiro Portugal 3810-501
    170 Investigational Site Number :6200002 Braga Portugal 4710-243
    171 Investigational Site Number :6200011 Guarda Portugal 6301-857
    172 Investigational Site Number :6200001 Guimarães Portugal 4810-061
    173 Investigational Site Number :6200010 Matosinhos Portugal 4464-513
    174 BRCR Medical Center, Inc.-Site Number:8400190 Ponce Puerto Rico 00717-1322
    175 BRCR Medical Center-Site Number:8400180 San Juan Puerto Rico 00907
    176 Investigational Site Number :6430002 Moscow Russian Federation 105077
    177 Investigational Site Number :6430001 Moscow Russian Federation 115093
    178 Investigational Site Number :6430005 Moscow Russian Federation 115280
    179 Investigational Site Number :6430003 Saint-Petersburg Russian Federation 194354
    180 Investigational Site Number :6430004 St-Petersburg Russian Federation 193231
    181 Investigational Site Number :6430006 Ulyanovsk Russian Federation 432017
    182 Investigational Site Number :7100002 Bellville South Africa 7530
    183 Investigational Site Number :7100013 Benoni South Africa 1500
    184 Investigational Site Number :7100001 Cape Town South Africa 7700
    185 Investigational Site Number :7100005 Durban South Africa 4001
    186 Investigational Site Number :7100006 Durban South Africa 4071
    187 Investigational Site Number :7100004 Gatesville South Africa 7764
    188 Investigational Site Number :7100012 Middelburg South Africa 1055
    189 Investigational Site Number :7100009 Pretoria South Africa 0009
    190 Investigational Site Number :7240004 Palma de Mallorca Balears [Baleares] Spain 07120
    191 Investigational Site Number :7240006 Sant Boi de Llobregat Barcelona [Barcelona] Spain 08830
    192 Investigational Site Number :7240007 Madrid / Madrid Madrid, Comunidad De Spain 28040
    193 Investigational Site Number :7240008 Pozuelo De Alarcón Madrid Spain 28223
    194 Investigational Site Number :7240010 Cáceres Spain 10003
    195 Investigational Site Number :7240009 Lleida Spain 25198
    196 Investigational Site Number :7240003 Madrid Spain 28007
    197 Investigational Site Number :7240001 Málaga Spain 29010
    198 Investigational Site Number :7240002 Mérida Spain 06800
    199 Investigational Site Number :7920005 Balcali Adana Turkey 01330
    200 Investigational Site Number :7920001 Istanbul Turkey 34303
    201 Investigational Site Number :7920003 Izmir Turkey 35040
    202 Investigational Site Number :7920006 Kirikkale Turkey 71450
    203 Investigational Site Number :7920002 Mersin Turkey 33343
    204 Investigational Site Number :8260002 Chertsey Surrey United Kingdom KT16 0PZ
    205 Investigational Site Number :8260003 Bradford United Kingdom BD9 6RJ
    206 Investigational Site Number :8260005 Liverpool United Kingdom L143PE
    207 Investigational Site Number :8260001 Newcastle upon Tyne United Kingdom NE4 6BE

    Sponsors and Collaborators

    • Sanofi
    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT04751487
    Other Study ID Numbers:
    • EFC16819
    • 2020-001819-24
    • U1111-1250-2843
    First Posted:
    Feb 12, 2021
    Last Update Posted:
    Jul 27, 2022
    Last Verified:
    Jul 26, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Jul 27, 2022