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NOTUS: Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate to Severe COPD With Type 2 Inflammation

Sponsor
Sanofi (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04456673
Collaborator
Regeneron Pharmaceuticals (Industry)
924
Enrollment
335
Locations
2
Arms
40.2
Anticipated Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Primary Objective:

To evaluate the efficacy of dupilumab administered every 2 weeks in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD) as measured by

  • Annualized rate of acute moderate or severe COPD exacerbation (AECOPD)
Secondary Objectives:

To evaluate the effect of dupilumab administered every 2 weeks on

  • Pre-bronchodilator forced expiratory volume in 1 second (FEV1) over 12 weeks compared to placebo

  • Health related quality of life, assessed by the change from baseline to Week 52 in the St. George's Respiratory Questionnaire (SGRQ)

  • Pre-bronchodilator FEV1 over 52 weeks compared to placebo

  • Lung function assessments

  • Moderate and severe COPD exacerbations

  • To evaluate safety and tolerability

  • To evaluate dupilumab systemic exposure and incidence of antidrug antibodies (ADA)

Condition or Disease Intervention/Treatment Phase
  • Drug: Dupilumab SAR231893
  • Drug: Inhaled Corticosteroid
  • Drug: Inhaled Long-Acting Beta Agonist
  • Drug: Inhaled Long-Acting Muscarinic Antagonist
  • Drug: Placebo
 Phase 3

Detailed Description

Approximately 68 weeks including a 4-week screening period, a 52-week treatment period, and 12 weeks of follow-up

Study Design

Study Type:
Interventional
Anticipated Enrollment :
924 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) With Type 2 Inflammation
Actual Study Start Date :
Jun 12, 2020
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Oct 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dupilumab

Dupilumab administered every 2 weeks

Drug: Dupilumab SAR231893
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Other Names:
  • Dupixent

    • Drug: Inhaled Corticosteroid
    Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

    Drug: Inhaled Long-Acting Beta Agonist
    Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

    Drug: Inhaled Long-Acting Muscarinic Antagonist
    Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation
    Placebo Comparator: Placebo

    Placebo dose administered every 2 weeks

    Drug: Inhaled Corticosteroid
    Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

    Drug: Inhaled Long-Acting Beta Agonist
    Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

    Drug: Inhaled Long-Acting Muscarinic Antagonist
    Pharmaceutical form: Inhaled Powder Route of administration: Oral inhalation

    Drug: Placebo
    Pharmaceutical form: Solution for injection Route of administration: Subcutaneous

    Outcome Measures

    Primary Outcome Measures

    1. Annual rate of acute COPD exacerbation (AECOPD) [Baseline to week 52]

      Annualized rate of moderate or severe COPD exacerbations over the 52-week treatment period compared to placebo

    Secondary Outcome Measures

    1. Change in pre-bronchodilator FEV1 [Baseline to week 12]

      Change in pre-bronchodilator FEV1 from baseline to Week 12 compared to placebo

    2. Change in SGRQ [Baseline to week 52]

      Change from baseline to Week 52 in SGRQ total score compared to placebo

    3. Improvement in SGRQ [Baseline to week 52]

      Proportion of patients with SGRQ improvement ≥4 points at Week 52

    4. Change in pre-bronchodilator FEV1 from baseline to Week 52 [Baseline to week 52]

      Change in pre-bronchodilator FEV1 from baseline to Week 52 compared to placebo

    5. Change in pre-bronchodilator FEV1 from baseline to time points up to Week 44 [Baseline to weeks 2, 4, 8, 24, 36, 44]

      Change in pre-bronchodilator FEV1 from baseline to weeks other than 12 and 52 (i.e. Weeks 2, 4, 8, 24, 36, and 44) compared to placebo

    6. Change in post-bronchodilator FEV1 lung function [Baseline to weeks 2, 4, 8, 12, 24, 36, 52]

      Change in post-bronchodilator FEV1 from baseline at Weeks 2, 4, 8, 12, 24, 36 and 52 compared to placebo

    7. Change in forced expiratory flow (FEF) 25-75% [Baseline to weeks 2, 4, 8, 12, 24, 36, 44, 52]

      Change in FEF 25-75% from baseline to Weeks 2, 4, 8, 12, 24, 36, 44 and 52

    8. Annualized rate of severe AECOPD [Baseline through week 52]

      Annualized rate of severe COPD exacerbations compared to placebo over the 52-week treatment period

    9. Time to first AECOPD [Baseline through week 52]

      Time to first moderate or severe COPD exacerbation compared with placebo during the 52-week treatment period

    10. Adverse events [Baseline through week 64]

      Number of adverse events (AEs)/treatment-emergent adverse events (TEAEs)

    11. Potentially clinically significant abnormality (PCSA) in laboratory tests [Baseline through week 64]

      Percentage of patients with at least one incidence of PCSA

    12. Anti-drug antibodies [Baseline through week 64]

      Incidence of anti-drug antibodies against dupilumab

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Inclusion criteria:

    • Participants with a physician diagnosis of COPD who meet the following criteria at screening:

    • Current or former smokers with a smoking history of ≥10 pack-years.

    • Moderate-to-severe COPD (post-bronchodilator FEV1/ forced vital capacity [FVC] ratio <0.70 and post-bronchodilator FEV1 % predicted >30% and ≤70%).

    • Medical Research Council (MRC) Dyspnea Scale grade ≥2.

    • Patient-reported history of signs and symptoms of chronic bronchitis (chronic productive cough) for 3 months in the year up to screening in the absence of other known causes of chronic cough.

    • Documented history of high exacerbation risk defined as exacerbation history of ≥2 moderate or ≥1 severe within the year prior to inclusion. At least one exacerbation should have occurred while the patient was taking inhaled corticosteroid (ICS)/long acting beta agonist (LABA)/long acting muscarinic antagonist (LAMA) (or LABA/LAMA if ICS is contraindicated). Moderate exacerbations are recorded by the investigator and defined as AECOPD that require either systemic corticosteroids (intramuscular, intravenous, or oral) and/or antibiotics. One of the two required moderate exacerbations has to require the use of systemic corticosteroids. Severe exacerbations are recorded by the investigator and defined as AECOPD requiring hospitalization or observation > 24 hours in emergency department/urgent care facility.

    • Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to Visit 1; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.

    • Evidence of Type 2 inflammation: Patients with blood eosinophils ≥300 cells/microliter at Visit 1.

    Exclusion Criteria:
    Exclusion criteria:

    • COPD diagnosis for less than 12 months prior to randomization.

    • Participants with current diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines, or documented history of asthma.

    • Significant pulmonary disease other than COPD (e.g., lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome etc) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts.

    • Cor pulmonale, evidence of right cardiac failure.

    • Long-term treatment with oxygen >4.0 L/min OR if a participant requires more than 2.0 L/min in order to maintain oxygen saturation >88%

    • Hypercapnia requiring Bi-level ventilation.

    • AECOPD as defined in inclusion criteria within 4 weeks prior to screening, or during the screening period.

    • Respiratory tract infection within 4 weeks prior to screening, or during the screening period.

    • History of, or planned pneumonectomy or lung volume reduction surgery. Patients who are participating in the acute phase of a pulmonary rehabilitation program, ie, who started rehabilitation <4 weeks prior to screening (Note: patients in the maintenance phase of a rehabilitation program can be included).

    • Diagnosis of α-1 anti-trypsin deficiency.

    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 Investigational Site Number :8400095 Cullman Alabama United States 35055
    2 Investigational Site Number :8400090 Jasper Alabama United States 35501
    3 Investigational Site Number :8400116 Scottsboro Alabama United States 35768
    4 Investigational Site Number :8400061 Peoria Arizona United States 85381
    5 Investigational Site Number :8400093 Phoenix Arizona United States 85014
    6 Investigational Site Number :8400107 Phoenix Arizona United States 85051
    7 Investigational Site Number :8400065 Tempe Arizona United States 85283
    8 Investigational Site Number :8400022 Little Rock Arkansas United States 72209
    9 Investigational Site Number :8400031 Bakersfield California United States 93301
    10 Investigational Site Number :8400051 Huntington Beach California United States 92647
    11 Investigational Site Number :8400032 Newport Beach California United States 92663
    12 Investigational Site Number :8400063 Rancho Cucamonga California United States 91730
    13 Investigational Site Number :8400094 San Diego California United States 92119
    14 Investigational Site Number :8400015 San Diego California United States 92120
    15 Investigational Site Number :8400007 Westminster California United States 92683
    16 Investigational Site Number :8400018 Lafayette Colorado United States 80026
    17 Investigational Site Number :8400102 Altamonte Springs Florida United States 32701
    18 Investigational Site Number :8400035 Boynton Beach Florida United States 33435
    19 Investigational Site Number :8400043 Boynton Beach Florida United States 33437
    20 Investigational Site Number :8400111 Bradenton Florida United States 34208
    21 Investigational Site Number :8400092 Cape Coral Florida United States 33991
    22 Investigational Site Number :8400020 Clearwater Florida United States 33765
    23 Investigational Site Number :8400081 Cutler Bay Florida United States 33157
    24 Investigational Site Number :8400021 DeBary Florida United States 32713
    25 Investigational Site Number :8400060 DeLand Florida United States 32720
    26 Investigational Site Number :8400039 Fort Lauderdale Florida United States 33308
    27 Investigational Site Number :8400047 Fort Myers Florida United States 33907
    28 Investigational Site Number :8400071 Greenacres City Florida United States 33467
    29 Investigational Site Number :8400079 Hialeah Florida United States 33012
    30 Investigational Site Number :8400100 Loxahatchee Groves Florida United States 33470
    31 Investigational Site Number :8400089 Miami Florida United States 33155
    32 Investigational Site Number :8400012 Miami Florida United States 33165
    33 Investigational Site Number :8400062 Miami Florida United States 33174
    34 Investigational Site Number :8400123 Miami Florida United States 33176
    35 Investigational Site Number :8400075 Miami Florida United States 33184
    36 Investigational Site Number :8400101 Orlando Florida United States 32825
    37 Investigational Site Number :8400114 Palmetto Bay Florida United States 33157
    38 Investigational Site Number :8400077 Plant City Florida United States 33563
    39 Investigational Site Number :8400013 Saint Petersburg Florida United States 33704
    40 Investigational Site Number :8400001 Winter Park Florida United States 32789
    41 Investigational Site Number :8400048 Adairsville Georgia United States 30103
    42 Investigational Site Number :8400099 Atlanta Georgia United States 30345
    43 Investigational Site Number :8400045 Blue Ridge Georgia United States 30513
    44 Investigational Site Number :8400058 Columbus Georgia United States 31902
    45 Investigational Site Number :8400064 Conyers Georgia United States 30094
    46 Investigational Site Number :8400052 Lawrenceville Georgia United States 30046
    47 Investigational Site Number :8400003 Rincon Georgia United States 31326
    48 Investigational Site Number :8400078 Suwanee Georgia United States 30024
    49 Investigational Site Number :8400119 Evansville Indiana United States 47715
    50 Investigational Site Number :8400118 Crowley Louisiana United States 70526
    51 Investigational Site Number :8400050 Fall River Massachusetts United States 02723
    52 Investigational Site Number :8400004 South Dartmouth Massachusetts United States 02747
    53 Investigational Site Number :8400053 Detroit Michigan United States 48202
    54 Investigational Site Number :8400120 Lathrup Village Michigan United States 48076
    55 Investigational Site Number :8400034 Rochester Michigan United States 48307
    56 Investigational Site Number :8400057 Saginaw Michigan United States 48638
    57 Investigational Site Number :8400096 Southfield Michigan United States 48055
    58 Investigational Site Number :8400017 Chesterfield Missouri United States 63017-3625
    59 Investigational Site Number :8400019 Missoula Montana United States 59808
    60 Investigational Site Number :8400016 Lincoln Nebraska United States 68510
    61 Investigational Site Number :8400073 Omaha Nebraska United States 68114
    62 Investigational Site Number :8400008 Manasquan New Jersey United States 08736-2609
    63 Investigational Site Number :8400054 Mineola New York United States 11501-3893
    64 Investigational Site Number :8400037 New Windsor New York United States 12553-7754
    65 Investigational Site Number :8400044 Westfield New York United States 14787
    66 Investigational Site Number :8400076 Charlotte North Carolina United States 28210
    67 Investigational Site Number :8400042 Charlotte North Carolina United States 28277
    68 Investigational Site Number :8400010 Gastonia North Carolina United States 28054
    69 Investigational Site Number :8400087 Monroe North Carolina United States 28112
    70 Investigational Site Number :8400006 Mooresville North Carolina United States 28117
    71 Investigational Site Number :8400117 Mooresville North Carolina United States 28117
    72 Investigational Site Number :8400025 New Bern North Carolina United States 28562
    73 Investigational Site Number :8400068 Winston-Salem North Carolina United States 27103
    74 Investigational Site Number :8400082 Columbus Ohio United States 43235
    75 Investigational Site Number :8400024 Toledo Ohio United States 43617
    76 Investigational Site Number :8400009 DuBois Pennsylvania United States 15801
    77 Investigational Site Number :8400046 Erie Pennsylvania United States 16508
    78 Investigational Site Number :8400049 Scottdale Pennsylvania United States 15683
    79 Investigational Site Number :8400026 Clinton South Carolina United States 29325
    80 Investigational Site Number :8400105 Lancaster South Carolina United States 29720
    81 Investigational Site Number :8400027 Rapid City South Dakota United States 57702
    82 Investigational Site Number :8400066 Franklin Tennessee United States 37067
    83 Investigational Site Number :8400110 Johnson City Tennessee United States 37601
    84 Investigational Site Number :8400108 Amarillo Texas United States 79106
    85 Investigational Site Number :8400059 Carrollton Texas United States 75007
    86 Investigational Site Number :8400011 Cypress Texas United States 77429
    87 Investigational Site Number :8400091 Houston Texas United States 77004
    88 Investigational Site Number :8400055 Houston Texas United States 77084
    89 Investigational Site Number :8400070 Houston Texas United States 77099
    90 Investigational Site Number :8400029 Lampasas Texas United States 76550-1820
    91 Investigational Site Number :8400028 Longview Texas United States 75605
    92 Investigational Site Number :8400069 Plano Texas United States 75024
    93 Investigational Site Number :8400038 San Antonio Texas United States 78229
    94 Investigational Site Number :8400080 San Antonio Texas United States 78258
    95 Investigational Site Number :8400115 Sugar Land Texas United States 77479
    96 Investigational Site Number :8400030 Abingdon Virginia United States 24210
    97 Investigational Site Number :8400056 Norfolk Virginia United States 23507
    98 Investigational Site Number :8400040 Richmond Virginia United States 23236
    99 Investigational Site Number :8400088 Greenfield Wisconsin United States 53228
    100 Investigational Site Number :0320007 Berazategui Buenos Aires Argentina CP 1884
    101 Investigational Site Number :0320006 Caba Buenos Aires Argentina C1122AAK
    102 Investigational Site Number :0320004 Caba Buenos Aires Argentina C1414AIF
    103 Investigational Site Number :0320001 Caba Buenos Aires Argentina C1425BEN
    104 Investigational Site Number :0320003 Caba Buenos Aires Argentina C1425FVH
    105 Investigational Site Number :0320010 La Plata Buenos Aires Argentina B1900BNN
    106 Investigational Site Number :0320005 Quilmes Ciudad De Buenos Aires Argentina B1878FNR
    107 Investigational Site Number :0320011 Cordoba Córdoba Argentina X5003DCE
    108 Investigational Site Number :0320008 Rosario Santa Fe Argentina S2000DEJ
    109 Investigational Site Number :0320009 Rosario Santa Fe Argentina S2002OJP
    110 Investigational Site Number :0320002 Buenos Aires Argentina C1121ABE
    111 Investigational Site Number :0320012 Launs Este Argentina B1824KAJ
    112 Investigational Site Number :0360003 Westmead New South Wales Australia 2145
    113 Investigational Site Number :0360006 Box Hill Victoria Australia 3128
    114 Investigational Site Number :0360005 Clayton Victoria Australia 3168
    115 Investigational Site Number :0360001 Murdoch Western Australia Australia 6150
    116 Investigational Site Number :0560002 Edegem Belgium 2650
    117 Investigational Site Number :0560001 Leuven Belgium 3000
    118 Investigational Site Number :0560003 Liege Belgium 4000
    119 Investigational Site Number :0560004 Mechelen Belgium 2800
    120 Investigational Site Number :0760008 Passo Fundo Rio Grande Do Sul Brazil 99010-120
    121 Investigational Site Number :0760001 Porto Alegre Rio Grande Do Sul Brazil 90160-090
    122 Investigational Site Number :0760006 Blumenau Santa Catarina Brazil 89030-100
    123 Investigational Site Number :0760016 Botucatu São Paulo Brazil 18618-970
    124 Investigational Site Number :0760015 Campinas São Paulo Brazil 13059900
    125 Investigational Site Number :0760007 Santo Andre São Paulo Brazil 09060-870
    126 Investigational Site Number :0760012 Sao Paulo São Paulo Brazil 01229-010
    127 Investigational Site Number :0760002 Sao Paulo São Paulo Brazil 05403-900
    128 Investigational Site Number :0760009 Sorocaba São Paulo Brazil 18040-425
    129 Investigational Site Number :0760003 São Paulo Brazil 01.228-000
    130 Investigational Site Number :1005021 Dupnitsa Bulgaria 2600
    131 Investigational Site Number :1005012 Haskovo Bulgaria 6305
    132 Investigational Site Number :1005011 Montana Bulgaria 3400
    133 Investigational Site Number :1005008 Plovdiv Bulgaria 4002
    134 Investigational Site Number :1005015 Ruse Bulgaria 70000
    135 Investigational Site Number :1005013 Ruse Bulgaria 7002
    136 Investigational Site Number :1005018 Sofia Bulgaria 1000
    137 Investigational Site Number :1005003 Sofia Bulgaria 1142
    138 Investigational Site Number :1005001 Sofia Bulgaria 1233
    139 Investigational Site Number :1005006 Sofia Bulgaria 1233
    140 Investigational Site Number :1005002 Sofia Bulgaria 1407
    141 Investigational Site Number :1005009 Sofia Bulgaria 1680
    142 Investigational Site Number :1005024 Stara Zagora Bulgaria 6000
    143 Investigational Site Number :1005004 Stara Zagora Bulgaria 6001
    144 Investigational Site Number :1005023 Veliko Tyrnovo Bulgaria 5000
    145 Investigational Site Number :1005019 Vidin Bulgaria 3700
    146 Investigational Site Number :1005020 Vratsa Bulgaria 3000
    147 Investigational Site Number :1240014 Moncton New Brunswick Canada E1G 5C4
    148 Investigational Site Number :1240010 Ajax Ontario Canada L1S 2J5
    149 Investigational Site Number :1240008 London Ontario Canada N5W 6A2
    150 Investigational Site Number :1240009 Sarnia Ontario Canada N7T 4X3
    151 Investigational Site Number :1240007 Windsor Ontario Canada N8X 1T3
    152 Investigational Site Number :1240004 Montreal Quebec Canada H3T 1E2
    153 Investigational Site Number :1240012 Québec Quebec Canada G1V 4W2
    154 Investigational Site Number :1240001 Quebec Canada G1G 3Y8
    155 Investigational Site Number :1240005 Quebec Canada G2J 0C4
    156 Investigational Site Number :1520009 Valdivia Los Ríos Chile 5110683
    157 Investigational Site Number :1520006 Curicó Maule Chile 3341643
    158 Investigational Site Number :1520001 Talca Maule Chile
    159 Investigational Site Number :1520007 Santiago Reg Metropolitana De Santiago Chile 7500571
    160 Investigational Site Number :1520003 Santiago Reg Metropolitana De Santiago Chile 7500692
    161 Investigational Site Number :1520002 Santiago Reg Metropolitana De Santiago Chile 8910131
    162 Investigational Site Number :1520004 Quillota Valparaíso Chile 2260877
    163 Investigational Site Number :1700002 Bogota Colombia 11001000
    164 Investigational Site Number :1700005 Manizales Colombia 170004
    165 Investigational Site Number :2030004 Jihlava Czechia 58633
    166 Investigational Site Number :2030001 Jindrichuv Hradec III Czechia 37701
    167 Investigational Site Number :2030007 Kralupy nad Vltavou Czechia 278 01
    168 Investigational Site Number :2030003 Miroslav Czechia 67172
    169 Investigational Site Number :2030002 Strakonice Czechia 38601
    170 Investigational Site Number :2500009 Bayonne France 64100
    171 Investigational Site Number :2500010 Besancon France 25030
    172 Investigational Site Number :2500002 Dijon France 21079
    173 Investigational Site Number :2500005 Lyon France 69004
    174 Investigational Site Number :2500013 Marseille France 13003
    175 Investigational Site Number :2500004 Marseille France 13015
    176 Investigational Site Number :2500003 Montpellier France 34295
    177 Investigational Site Number :2500001 Nantes France 44093
    178 Investigational Site Number :2500007 Paris France 75014
    179 Investigational Site Number :2500008 Paris France 75015
    180 Investigational Site Number :2500006 Pessac France 33600
    181 Investigational Site Number :2760015 Berlin Germany 10117
    182 Investigational Site Number :2760017 Darmstadt Germany 64283
    183 Investigational Site Number :2760009 Frankfurt am Main Germany 60596
    184 Investigational Site Number :2760002 Hamburg Germany 20354
    185 Investigational Site Number :2760003 Hannover Germany 30173
    186 Investigational Site Number :2760007 Koblenz Germany 56068
    187 Investigational Site Number :2760011 Leipzig Germany 04347
    188 Investigational Site Number :2760010 Lübeck Germany 23552
    189 Investigational Site Number :2760012 Mainz Germany 55128
    190 Investigational Site Number :2760008 Marburg Germany 35043
    191 Investigational Site Number :2760020 Peine Germany 31224
    192 Investigational Site Number :2760016 Rosenheim Germany 83022
    193 Investigational Site Number :2760013 Schwerin Germany 19055
    194 Investigational Site Number :2760018 Wiesbaden Germany 65183
    195 Investigational Site Number :3000001 Athens Greece 11527
    196 Investigational Site Number :3000005 Athens Greece 12462
    197 Investigational Site Number :3000006 Athens Greece
    198 Investigational Site Number :3000003 Heraklion Greece 71110
    199 Investigational Site Number :3000002 Ioannina Greece 455 00
    200 Investigational Site Number :3000007 Palaio Faliro, Athens Greece 17562
    201 Investigational Site Number :3000004 Thessaloniki Greece 57010
    202 Investigational Site Number :3480003 Edelény Hungary 3780
    203 Investigational Site Number :3480004 Gödöllö Hungary 2100
    204 Investigational Site Number :3480002 Hajdunánás Hungary 4080
    205 Investigational Site Number :3480005 Szombathely Hungary 9700
    206 Investigational Site Number :3480001 Százhalombatta Hungary 2440
    207 Investigational Site Number :4280008 Balvi Latvia LV-4501
    208 Investigational Site Number :4280007 Rezekne Latvia LV - 4601
    209 Investigational Site Number :4280001 Riga Latvia LV -1010
    210 Investigational Site Number :4280005 Riga Latvia LV -1010
    211 Investigational Site Number :4280006 Riga Latvia LV -1021
    212 Investigational Site Number :4280002 Riga Latvia LV-1002
    213 Investigational Site Number :4280003 Riga Latvia LV-1038
    214 Investigational Site Number :4400001 Kaunas Lithuania 44320
    215 Investigational Site Number :4400003 Kaunas Lithuania 49449
    216 Investigational Site Number :4400008 Kaunas Lithuania 50161
    217 Investigational Site Number :4400007 Klaipeda Lithuania 92231
    218 Investigational Site Number :4400004 Vilnius Lithuania 01117
    219 Investigational Site Number :4400005 Vilnius Lithuania 04130
    220 Investigational Site Number :4840008 Benito Juarez Ciudad De Mexico Mexico 03100
    221 Investigational Site Number :4840002 Guadalajara Jalisco Mexico 44100
    222 Investigational Site Number :4840011 Zapopan Jalisco Mexico 45070
    223 Investigational Site Number :4840004 Monterrey Nuevo León Mexico 64710
    224 Investigational Site Number :4840010 Chihuahua Mexico 31000
    225 Investigational Site Number :4840007 Mexico City Mexico 14050
    226 Investigational Site Number :4840009 Mexico Mexico 67000
    227 Investigational Site Number :4840005 Veracruz Mexico 91910
    228 Investigational Site Number :5280005 Arnhem Netherlands 6815 AD
    229 Investigational Site Number :5280001 Breda Netherlands 4818 CK
    230 Investigational Site Number :5280010 Dordrecht Netherlands 3318 AT
    231 Investigational Site Number :5280009 Harderwijk Netherlands 3844 DG
    232 Investigational Site Number :5280007 Heerlen Netherlands 6419 PC
    233 Investigational Site Number :5280002 Leeuwarden Netherlands 8934 AD
    234 Investigational Site Number :5280006 Nijmegen Netherlands 6532 SZ
    235 Investigational Site Number :5280011 Roermond Netherlands 6043 CV
    236 Investigational Site Number :5280008 Zutphen Netherlands 7207 AE
    237 Investigational Site Number :5280004 Zwolle Netherlands 8025 AB
    238 Investigational Site Number :6040003 Chancay Peru
    239 Investigational Site Number :6040002 Lima Lima Peru Lima 01
    240 Investigational Site Number :6040006 Lima Peru 021
    241 Investigational Site Number :6040004 Lima Peru 15004
    242 Investigational Site Number :6040001 Lima Peru LIMA 31
    243 Investigational Site Number :6040005 Piura Peru 20000
    244 Investigational Site Number :6160009 Grudziadz Kujawsko-pomorskie Poland 86-300
    245 Investigational Site Number :6160007 Krakow Malopolskie Poland 31-559
    246 Investigational Site Number :6160015 Grodzisk Mazowiecki Mazowieckie Poland 05-825
    247 Investigational Site Number :6160010 Rzeszow Podkarpackie Poland 35-205
    248 Investigational Site Number :6160008 Bialystok Podlaskie Poland 15-044
    249 Investigational Site Number :6160018 Katowice Slaskie Poland 40-611
    250 Investigational Site Number :6160011 Katowice Slaskie Poland 40-648
    251 Investigational Site Number :6160014 Elblag Warminsko-mazurskie Poland 82-300
    252 Investigational Site Number :6160019 Krakow Poland 30-033
    253 Investigational Site Number :6200007 Almada Portugal 2801-951
    254 Investigational Site Number :6200006 Aveiro Portugal 3810-501
    255 Investigational Site Number :6200008 Coimbra Portugal 3000-075
    256 Investigational Site Number :6200011 Covilhã Portugal 6200-251
    257 Investigational Site Number :6200002 Guimarães Portugal 4810-061
    258 Investigational Site Number :6200005 Leiria Portugal 2410-197
    259 Investigational Site Number :6200009 Lisboa Portugal 1769
    260 Investigational Site Number :6200012 Matosinhos Portugal 4464-513
    261 Investigational Site Number :6200003 Porto Portugal 4099-001
    262 Investigational Site Number :6200004 Porto Portugal 4200-319
    263 Investigational Site Number :6425004 Bacau Romania 600252
    264 Investigational Site Number :6425003 Cluj-Napoca Romania 400275
    265 Investigational Site Number :6425005 Constanta Romania 900002
    266 Investigational Site Number :6425002 Iasi Romania 700732
    267 Investigational Site Number :6425006 Pitesti Romania 110117
    268 Investigational Site Number :6425001 Timisoara Romania 300134
    269 Investigational Site Number :6430011 Chelyabinsk Russian Federation 454091
    270 Investigational Site Number :6430001 Moscow Russian Federation 115093
    271 Investigational Site Number :6430003 Moscow Russian Federation 115280
    272 Investigational Site Number :6430002 Moscow Russian Federation 125284
    273 Investigational Site Number :6430009 Nizhny Novgorod Russian Federation 603126
    274 Investigational Site Number :6430010 Ryazan Russian Federation
    275 Investigational Site Number :6430013 Saint Petersburg Russian Federation 198328
    276 Investigational Site Number :6430014 Saint Petersburg Russian Federation 928260
    277 Investigational Site Number :6430004 St-Petersburg Russian Federation 194354
    278 Investigational Site Number :6430012 Stavropol Russian Federation 355020
    279 Investigational Site Number :6430006 Tomsk Russian Federation 634034
    280 Investigational Site Number :6430008 Ulyanovsk Russian Federation 432017
    281 Investigational Site Number :6430005 Voronezh Russian Federation 394066
    282 Investigational Site Number :6880005 Belgrade Serbia 11000
    283 Investigational Site Number :6880006 Belgrade Serbia 11000
    284 Investigational Site Number :6880007 Belgrade Serbia 11000
    285 Investigational Site Number :6880003 Kragujevac Serbia 34000
    286 Investigational Site Number :6880001 Sremska Kamenica Serbia 21204
    287 Investigational Site Number :6880002 Valjevo Serbia 14000
    288 Investigational Site Number :7030007 Banska Bystrica Slovakia 97517
    289 Investigational Site Number :7030006 Humenne Slovakia 066 01
    290 Investigational Site Number :7030005 Kosice Slovakia 040 01
    291 Investigational Site Number :7030003 Levice Slovakia 93401
    292 Investigational Site Number :7030001 Poprad Slovakia 058 01
    293 Investigational Site Number :7030002 Spisska Nova Ves Slovakia 05201
    294 Investigational Site Number :7100004 Cape Town South Africa 7500
    295 Investigational Site Number :7100014 Chatsworth South Africa 4091
    296 Investigational Site Number :7100001 Durban South Africa 4001
    297 Investigational Site Number :7100013 Durban South Africa 4001
    298 Investigational Site Number :7100003 Durban South Africa 4071
    299 Investigational Site Number :7100002 Gatesville South Africa 7764
    300 Investigational Site Number :7100009 Johannesburg South Africa 0157
    301 Investigational Site Number :7100012 Middelburg South Africa 1050
    302 Investigational Site Number :7100006 Parow South Africa 7500
    303 Investigational Site Number :7100005 Pretoria South Africa 0157
    304 Investigational Site Number :7100008 Somerset West South Africa 7130
    305 Investigational Site Number :7100011 Vereeniging South Africa 1935
    306 Investigational Site Number :7240007 Oviedo Asturias Spain 33011
    307 Investigational Site Number :7240009 Badalona Barcelona [Barcelona] Spain 08916
    308 Investigational Site Number :7240001 Barcelona Barcelona [Barcelona] Spain 08003
    309 Investigational Site Number :7240002 Barcelona Barcelona [Barcelona] Spain 08023
    310 Investigational Site Number :7240006 Madrid Madrid, Comunidad De Spain 28040
    311 Investigational Site Number :7240003 Madrid Madrid, Comunidad De Spain 28046
    312 Investigational Site Number :7240008 Valencia Valenciana, Comunidad Spain 46017
    313 Investigational Site Number :7240010 Málaga Spain 29010
    314 Investigational Site Number :7240011 Zaragoza Spain 50009
    315 Investigational Site Number :8040011 Chernivtsi Ukraine 58001
    316 Investigational Site Number :8040002 Ivano-Frankivsk Ukraine 76018
    317 Investigational Site Number :8040003 Ivano-Frankivsk Ukraine 76018
    318 Investigational Site Number :8040001 Kharkiv Ukraine 61124
    319 Investigational Site Number :8040007 Kyiv Ukraine 01033
    320 Investigational Site Number :8040004 Kyiv Ukraine 03049
    321 Investigational Site Number :8040006 Lviv Ukraine 79011
    322 Investigational Site Number :8040010 Ternopil Ukraine 46000
    323 Investigational Site Number :8040008 Zaporizhzhia Ukraine 69076
    324 Investigational Site Number :8040009 Zaporizhzhya Ukraine 69600
    325 Investigational Site Number :8260003 Cambridge Cambridgeshire United Kingdom CB2 2QQ
    326 Investigational Site Number :8260002 Blackpool Lancashire United Kingdom FY3 7DQ
    327 Investigational Site Number :8260006 Swansea Neath Port Talbot United Kingdom SA2 8QA
    328 Investigational Site Number :8260007 North Shields Newcastle Upon Tyne United Kingdom NE29 8NH
    329 Investigational Site Number :8260004 South Shields Newcastle Upon Tyne United Kingdom NE34 0PL
    330 Investigational Site Number :8260013 Nottingham Nottinghamshire United Kingdom NG5 1PB
    331 Investigational Site Number :8260012 Aylesbury United Kingdom HP218AL
    332 Investigational Site Number :8260001 Bradford United Kingdom BD9 6RJ
    333 Investigational Site Number :8260005 Bristol United Kingdom BS10 5NB
    334 Investigational Site Number :8260011 Chippenham United Kingdom SN15 2SB
    335 Investigational Site Number :8260015 Derby United Kingdom DE223NE

    Sponsors and Collaborators

    • Sanofi
    • Regeneron Pharmaceuticals

    Investigators

    • Study Director: Clinical Sciences & Operations, Sanofi

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Sanofi
    ClinicalTrials.gov Identifier:
    NCT04456673
    Other Study ID Numbers:
    • EFC15805
    • 2018-001954-91
    • U1111-1211-8837
    First Posted:
    Jul 2, 2020
    Last Update Posted:
    Jun 15, 2022
    Last Verified:
    Jun 14, 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
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Inflammation
    Cholinergic Agents
    Muscarinic Antagonists

    Study Results

    No Results Posted as of Jun 15, 2022