Actively Recruiting
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
Led by Sanofi · Updated on 2026-04-16
1147
Participants Needed
236
Research Sites
153 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a parallel-group, Phase 2, randomized, double-blind, placebo-controlled, 2-arm study for the treatment of asthma. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous (SC) lunsekimig compared with placebo in male and female participants (aged 18 to 80 years, inclusive) with asthma, who are not currently eligible for biologic treatments. Study details include: * The study duration will be approximately 64 weeks for participants not transitioning into the LTS study and approximately 60 weeks for participants transitioning into the LTS study. * The investigational treatment duration will be up to approximately 52 weeks. * The number of visits will be 18.
CONDITIONS
Official Title
Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Physician-diagnosed mild-to-moderate asthma for more than 12 months based on GINA guidelines
- At least 1 asthma exacerbation in the year prior to screening
- Pre-bronchodilator FEV1 equal or greater than 40% of predicted normal at screening
You will not qualify if you...
- Severe lung diseases other than asthma, such as COPD, bronchiectasis, or idiopathic pulmonary fibrosis
- Asthma deterioration requiring emergency treatment, hospitalization, or systemic steroids within 1 month before screening
- Upper or lower respiratory tract infection within 4 weeks prior to screening
- Significant current immunosuppression or history of invasive opportunistic or helminthic infections
- Infection requiring systemic anti-infective treatment within 2 weeks before or during screening
- Active or latent tuberculosis, history of incompletely treated tuberculosis, or high risk of contracting tuberculosis
- Severe concomitant illnesses that may interfere with participation (eg, hypertension, renal disease, neurological conditions, heart failure, pulmonary disease)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 236 locations
1
The Center for Clinical Trials - Saraland- Site Number : 8400096
Saraland, Alabama, United States, 36571
Actively Recruiting
2
Chandler Clinical Research Trials- Site Number : 8400075
Chandler, Arizona, United States, 85224
Actively Recruiting
3
Epic Medical Research - Sun City- Site Number : 8400052
Sun City, Arizona, United States, 85351
Actively Recruiting
4
Tucson Clinical Research Institute- Site Number : 8400085
Tucson, Arizona, United States, 85712
Actively Recruiting
5
Ark Clinical Research- Site Number : 8400097
Long Beach, California, United States, 90815
Actively Recruiting
6
Downtown L.A. Research Center- Site Number : 8400080
Los Angeles, California, United States, 90017
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7
Carbon Health - North Hollywood - NoHo West- Site Number : 8400061
North Hollywood, California, United States, 91606
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8
Carbon Health - San Mateo - Hillsdale Mall- Site Number : 8400062
San Mateo, California, United States, 94403
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9
Stanford University Medical Center- Site Number : 8400108
Stanford, California, United States, 94305
Actively Recruiting
10
Modena Allergy And Asthma- Site Number : 8400068
Torrance, California, United States, 90505
Actively Recruiting
11
Howard University Hospital- Site Number : 8400107
Washington D.C., District of Columbia, United States, 20060
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12
Helix Biomedics- Site Number : 8400005
Boynton Beach, Florida, United States, 33435
Actively Recruiting
13
Beautiful Minds Clinical Research Center- Site Number : 8400019
Cutler Bay, Florida, United States, 33157
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14
Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8400082
DeBary, Florida, United States, 32713
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15
Alfa Medical Research- Site Number : 8400071
Hollywood, Florida, United States, 33024
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16
Royal Clinical Trials - Inverness- Site Number : 8400067
Inverness, Florida, United States, 34453
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17
Premier Medical Associates- Site Number : 8400077
Lady Lake, Florida, United States, 32159
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18
D&H Pompano Research Center- Site Number : 8400072
Margate, Florida, United States, 33063
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19
Research Institute of South Florida- Site Number : 8400023
Miami, Florida, United States, 33173
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20
Innovations Biotech- Site Number : 8400044
Miami, Florida, United States, 33186
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21
Tellabio International Research Services- Site Number : 8400083
Pembroke Pines, Florida, United States, 33025
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22
Avanza Medical Research Center- Site Number : 8400056
Pensacola, Florida, United States, 32503
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23
Hull and Hull Medical Specialists- Site Number : 8400079
Plantation, Florida, United States, 33324
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24
Ilumina Medical Research- Site Number : 8400095
Saint Cloud, Florida, United States, 34769
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25
Private Practice - Dr. David Kavtaradze- Site Number : 8400081
Cordele, Georgia, United States, 31015
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26
EmVenio Research - Riverdale- Site Number : 8400109
Riverdale, Georgia, United States, 30274
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27
Christie Clinic in Champaign on University- Site Number : 8400003
Champaign, Illinois, United States, 61820
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28
University of Kansas Medical Center (KUMC)- Site Number : 8400105
Westwood, Kansas, United States, 66205-2003
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29
Velocity Clinical Research - Rockville (formerly Meridian Clinical Research)- Site Number : 8400036
Rockville, Maryland, United States, 20854
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30
Javara - Privia Medical Group - Silver Spring Lockwood- Site Number : 8400042
Silver Spring, Maryland, United States, 20901
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31
University of Michigan Health System - Ann Arbor- Site Number : 8400014
Ann Arbor, Michigan, United States, 48109
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32
Clarkston Medical Group- Site Number : 8400054
Clarkston, Michigan, United States, 48346
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33
Javara - Mankato Clinic- Site Number : 8400001
Mankato, Minnesota, United States, 56001
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34
Mayo Clinic in Rochester - Minnesota- Site Number : 8400057
Rochester, Minnesota, United States, 55905
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35
Hannibal Regional Healthcare System- Site Number : 8400078
Hannibal, Missouri, United States, 63401
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36
Icahn School of Medicine at Mount Sinai (ISMMS) - Mount Sinai Doctors- Site Number : 8400069
New York, New York, United States, 10011
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37
Pioneer Clinical Research - New York- Site Number : 8400092
New York, New York, United States, 10016
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38
Piedmont Healthcare - Family Medicine- Site Number : 8400064
Statesville, North Carolina, United States, 28625
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39
Cleveland Clinic - Cleveland- Site Number : 8400106
Cleveland, Ohio, United States, 44195
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40
Asthma & Allergy Center - Toledo- Site Number : 8400020
Toledo, Ohio, United States, 43617
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41
OK Clinical Research- Site Number : 8400060
Edmond, Oklahoma, United States, 73034
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42
Clinical Research Associates of Central PA- Site Number : 8400013
DuBois, Pennsylvania, United States, 15801
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43
Thomas Jefferson University Hospital- Site Number : 8400110
Philadelphia, Pennsylvania, United States, 19107
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44
Allergic Disease and Asthma Center (ADAC)- Site Number : 8400070
Greenville, South Carolina, United States, 29607
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45
Orion Clinical Research
Austin, Texas, United States, 78759
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46
South Texas Medical Research Institute - TTS Research- Site Number : 8400015
Boerne, Texas, United States, 78006
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47
Epic Medical Research - De Soto- Site Number : 8400051
DeSoto, Texas, United States, 75115
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48
Axsendo Clinical Research - Houston- Site Number : 8400065
Houston, Texas, United States, 77058
Completed
49
Metroplex Pulmonary and Sleep Center- Site Number : 8400012
McKinney, Texas, United States, 75069
Actively Recruiting
50
STAAMP Research - San Antonio- Site Number : 8400059
San Antonio, Texas, United States, 78229
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51
Bandera Family Health Care - San Antonio- Site Number : 8400049
San Antonio, Texas, United States, 78249
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52
Javara - San Marcos - Redwood Road- Site Number : 8400040
San Marcos, Texas, United States, 78666
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53
Simcare Medical Research- Site Number : 8400102
Sugar Land, Texas, United States, 77478
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54
Children's Wisconsin- Site Number : 8400073
Milwaukee, Wisconsin, United States, 53226
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55
Investigational Site Number : 0320007
Berazategui, Buenos Aires, Argentina, 1886
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56
Investigational Site Number : 0320011
La Plata, Buenos Aires, Argentina, 1900
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57
Investigational Site Number : 0320013
Lobos, Buenos Aires, Argentina, 7240
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58
Investigational Site Number : 0320006
Rosario, Santa Fe Province, Argentina, 2000
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59
Investigational Site Number : 0320010
Rosario, Santa Fe Province, Argentina, 2000
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60
Investigational Site Number : 0320016
Rosario, Santa Fe Province, Argentina, 2000
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61
Investigational Site Number : 0320003
San Miguel de Tucumán, Tucumán Province, Argentina, 4000
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62
Investigational Site Number : 0320005
Buenos Aires, Argentina, 1121
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63
Investigational Site Number : 0320012
Buenos Aires, Argentina, 1122
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64
Investigational Site Number : 0320002
Buenos Aires, Argentina, 1414
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65
Investigational Site Number : 0320001
Buenos Aires, Argentina, 1425
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66
Investigational Site Number : 0320004
Buenos Aires, Argentina, 1425
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67
Investigational Site Number : 0320008
Corrientes, Argentina, 3400
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68
Investigational Site Number : 0320014
Mendoza, Argentina, 5500
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69
Investigational Site Number : 0320015
Mendoza, Argentina, 5500
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70
Investigational Site Number : 0320009
Santa Fe, Argentina, 3000
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71
Investigational Site Number : 0560001
Ghent, Belgium, 9000
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72
Investigational Site Number : 0560003
Liège, Belgium, 4000
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73
Investigational Site Number : 0560002
Mechelen, Belgium, 2800
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74
Associacao Proar- Site Number : 0760002
Salvador, Estado de Bahia, Brazil, 40060-330
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75
Universidade Federal de Goias- Site Number : 0760011
Goiânia, Goiás, Brazil, 74605-020
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76
Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760006
Curitiba, Paraná, Brazil, 80060-900
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77
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760001
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
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78
WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760003
Porto Alegre, Rio Grande do Sul, Brazil, 91010-006
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79
Incor - Instituto do Coracao- Site Number : 0760004
São Paulo, Brazil, 05403-900
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80
Investigational Site Number : 1240011
Kelowna, British Columbia, Canada, V1Y 4N7
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81
Investigational Site Number : 1240012
West Vancouver, British Columbia, Canada, V7T 2Z3
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82
Investigational Site Number : 1240013
Ajax, Ontario, Canada, L1S 2J5
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83
Investigational Site Number : 1240003
Guelph, Ontario, Canada, N1H 6J2
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84
Investigational Site Number : 1240006
Stoney Creek, Ontario, Canada, L8G 2V6
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85
Investigational Site Number : 1240008
Toronto, Ontario, Canada, M4G 3E8
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86
Investigational Site Number : 1240014
Montreal, Quebec, Canada, H2X 3E4
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87
Investigational Site Number : 1240002
Sherbrooke, Quebec, Canada, J1H 5N4
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88
Investigational Site Number : 1520008
Concepción, Biobio, Chile, 4070094
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89
Investigational Site Number : 1520002
Talca, Maule Region, Chile, 3465584
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90
Investigational Site Number : 1520009
Lo Barnechea, Reg Metropolitana de Santiago, Chile, 7691236
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91
Investigational Site Number : 1520010
Recoleta, Reg Metropolitana de Santiago, Chile, 8420000
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92
Investigational Site Number : 1520006
Santiago, Reg Metropolitana de Santiago, Chile, 7500587
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93
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, Chile, 7500692
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94
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, Chile, 7500698
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95
Investigational Site Number : 1520005
Quillota, Valparaiso, Chile, 2260877
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96
Investigational Site Number : 1520004
Viña del Mar, Valparaiso, Chile, 2531172
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97
Investigational Site Number : 1520007
Viña del Mar, Valparaiso, Chile, 2540364
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98
Investigational Site Number : 1560027
Beijing, China, 100029
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99
Investigational Site Number : 1560005
Changchun, China, 130021
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100
Investigational Site Number : 1560021
Chengde, China, 067020
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101
Investigational Site Number : 1560039
Chengdu, China, 611130
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102
Investigational Site Number : 1560028
Foshan, China, 528399
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103
Investigational Site Number : 1560010
Guangzhou, China, 510000
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104
Investigational Site Number : 1560033
Guangzhou, China, 510180
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105
Investigational Site Number : 1560037
Guiyang, China, 550002
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106
Investigational Site Number : 1560042
Hangzhou, China, 310005
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107
Investigational Site Number : 1560009
Hebei, China, 050051
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108
Investigational Site Number : 1560040
Hefei, China, 230032
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109
Investigational Site Number : 1560006
Hohhot, China, 010050
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110
Investigational Site Number : 1560007
Hohhot, China, 010070
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111
Investigational Site Number : 1560029
Huizhou, China, 516001
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112
Investigational Site Number : 1560011
Huizhou, China, 516002
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113
Investigational Site Number : 1560025
Jiazhuang, China, 050000
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114
Investigational Site Number : 1560034
Jinan, China, 250001
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115
Investigational Site Number : 1560038
Jinan, China, 250014
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116
Investigational Site Number : 1560030
Lanzhou, China, 730000
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117
Investigational Site Number : 1560018
Luoyang, China, 471003
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118
Investigational Site Number : 1560003
Nanchang, China, 330006
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119
Investigational Site Number : 1560014
Ningbo, China, 315010
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120
Investigational Site Number : 1560001
Shanghai, China, 200080
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121
Investigational Site Number : 1560043
Shanghai, China, 200433
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122
Investigational Site Number : 1560016
Shenyang, China, 110004
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123
Investigational Site Number : 1560019
Suzhou, China, 215002
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124
Investigational Site Number : 1560008
Suzhou, China, 215006
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125
Investigational Site Number : 1560017
Taiyuan, China, 030001
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126
Investigational Site Number : 1560035
Taiyuan, China, 030032
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127
Investigational Site Number : 1560002
Tianjin, China, 300121
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128
Investigational Site Number : 1560013
Tianjin, China, 300211
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129
Investigational Site Number : 1560022
Wuhan, China, 430030
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130
Investigational Site Number : 1560036
Xi'an, China, 710004
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131
Investigational Site Number : 1560032
Xi'an, China, 710061
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132
Investigational Site Number : 1560044
Xianyang, China, 712000
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133
Investigational Site Number : 1560012
Xuzhou, China, 221006
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134
Investigational Site Number : 1560047
Yangzhou, China, 225000
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135
Investigational Site Number : 1560023
Zhengzhou, China, 450003
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136
Investigational Site Number : 1560026
Zhengzhou, China, 450007
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137
Investigational Site Number : 1560045
Zigong, China, 643000
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138
Investigational Site Number : 2080001
Hvidovre, Denmark, 2650
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139
Investigational Site Number : 2080002
Vejle, Denmark, 7100
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140
Investigational Site Number : 2500007
Amiens, France, 80000
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141
Investigational Site Number : 2500004
Lyon, France, 69004
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142
Investigational Site Number : 2500003
Montpellier, France, 34090
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143
Investigational Site Number : 2500005
Pessac, France, 33604
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144
Investigational Site Number : 2500001
Strasbourg, France, 67000
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145
Investigational Site Number : 2500002
Toulouse, France, 31059
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146
Investigational Site Number : 2760006
Ahrensburg, Germany, 22926
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147
Investigational Site Number : 2760002
Bendorf, Germany, 56170
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148
Investigational Site Number : 2760007
Berlin, Germany, 12159
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149
Investigational Site Number : 6420001
Düsseldorf, Germany, 40225
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150
Investigational Site Number : 2760004
Frankfurt, Germany, 60596
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151
Investigational Site Number : 2760008
Frankfurt, Germany, 60596
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152
Investigational Site Number : 2760001
Leipzig, Germany, 04347
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153
Investigational Site Number : 2760005
Mainz, Germany, 55128
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154
Investigational Site Number : 3480006
Debrecen, Hungary, 4032
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155
Investigational Site Number : 3480002
Gödöllő, Hungary, 2100
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156
Investigational Site Number : 3480003
Hajdúnánás, Hungary, 4080
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157
Investigational Site Number : 3480004
Mosonmagyaróvár, Hungary, 9200
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158
Investigational Site Number : 3480005
Pécs, Hungary, 7635
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159
Investigational Site Number : 3480001
Püspökladány, Hungary, 4150
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160
Investigational Site Number : 2500006
Mumbai, India, 400026
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161
Investigational Site Number : 3760006
Haifa, Israel, 3436212
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162
Investigational Site Number : 3760003
Jerusalem, Israel, 9103102
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163
Investigational Site Number : 3760002
Jerusalem, Israel, 9112001
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164
Investigational Site Number : 3760005
Petah Tikva, Israel, 4941492
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165
Investigational Site Number : 3760001
Rehovot, Israel, 7610001
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166
Investigational Site Number : 3760004
Tel Aviv, Israel, 6423906
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167
Investigational Site Number : 3800008
Torette, Ancona, Italy, 60020
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168
Investigational Site Number : 3800006
Monserrato, Cagliari, Italy, 09042
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169
Investigational Site Number : 3800001
Cona, Ferrara, Italy, 44124
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170
Investigational Site Number : 3800009
Genoa, Genova, Italy, 16132
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171
Investigational Site Number : 3800004
Milan, Milano, Italy, 20122
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172
Investigational Site Number : 3800003
Rozzano, Milano, Italy, 20089
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173
Investigational Site Number : 3800010
Rome, Roma, Italy, 00168
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174
Investigational Site Number : 3800012
Tradate, Varese, Italy, 21049
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175
Investigational Site Number : 3800007
Bergamo, Italy, 24127
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176
Investigational Site Number : 3800005
Modena, Italy, 41125
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177
Investigational Site Number : 3800013
Palermo, Italy, 90127
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178
Investigational Site Number : 3800011
Reggio Emilia, Italy, 42123
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179
Investigational Site Number : 3920002
Shinagawa, Tokyo, Japan, 142-8666
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180
Investigational Site Number : 3920001
Ube, Yamaguchi, Japan, 755-8505
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181
Investigational Site Number : 3920004
Tokyo, Japan, 162-8666
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182
Investigational Site Number : 4840001
Guadalajara, Jalisco, Mexico, 44100
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183
Investigational Site Number : 4840007
Guadalajara, Jalisco, Mexico, 44200
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184
Investigational Site Number : 4840005
Monterrey, Nuevo León, Mexico, 66465
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185
Investigational Site Number : 4840006
San Juan del Río, Querétaro, Mexico, 76800
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186
Investigational Site Number : 4840002
Chihuahua City, Mexico, 31000
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187
Investigational Site Number : 6160005
Poznan, Greater Poland Voivodeship, Poland, 60-309
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188
Investigational Site Number : 6160001
Poznan, Greater Poland Voivodeship, Poland, 60-693
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189
Investigational Site Number : 6160008
Lodz, Lódzkie, Poland, 02-213
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190
Investigational Site Number : 6160002
Bialystok, Podlaskie Voivodeship, Poland, 15-044
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191
Investigational Site Number : 6160004
Chęciny, Poland, 26-060
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192
Investigational Site Number : 6160009
Katowice, Poland, 40-600
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193
Investigational Site Number : 6160003
Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland, 27-400
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194
Investigational Site Number : 6420002
Cluj-Napoca, Romania, 400006
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195
Investigational Site Number : 7100004
Benoni, South Africa, 1500
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196
Investigational Site Number : 7100005
Benoni, South Africa, 1500
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197
Investigational Site Number : 7100002
Cape Town, South Africa, 7530
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198
Investigational Site Number : 7100003
Durban, South Africa, 3630
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199
Investigational Site Number : 7100006
Durban, South Africa, 4001
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200
Investigational Site Number : 7100007
Johannesburg, South Africa, 1821
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201
Investigational Site Number : 7240005
Santiago de Compostela, A Coruña [La Coruña], Spain, 15702
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202
Investigational Site Number : 7240010
Badalona, Barcelona [Barcelona], Spain, 08916
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203
Investigational Site Number : 7240009
Barcelona, Barcelona [Barcelona], Spain, 08017
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204
Investigational Site Number : 7240015
Barcelona, Barcelona [Barcelona], Spain, 08035
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205
Investigational Site Number : 7240017
Santander, Cantabria, Spain, 39008
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206
Investigational Site Number : 7240016
Girona, Girona [Gerona], Spain, 17005
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207
Investigational Site Number : 7240018
Benalmádena, Málaga, Spain, 29631
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208
Investigational Site Number : 7240013
Madrid, Spain, 28003
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209
Investigational Site Number : 7240008
Madrid, Spain, 28007
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210
Investigational Site Number : 7240011
Madrid, Spain, 28010
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211
Investigational Site Number : 7240002
Madrid, Spain, 28041
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212
Investigational Site Number : 7240007
Madrid, Spain, 28046
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213
Investigational Site Number : 7240004
Málaga, Spain, 29010
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214
Investigational Site Number : 7240006
Málaga, Spain, 29010
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215
Investigational Site Number : 7240001
Palma, Spain, 07120
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216
Investigational Site Number : 7240014
Seville, Spain, 41012
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217
Investigational Site Number : 7520003
Gothenburg, Sweden, 413 45
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218
Investigational Site Number : 7520002
Lund, Sweden, 221 85
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219
Investigational Site Number : 7520001
Solna, Sweden, 171 64
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220
Investigational Site Number : 1580002
Hualien City, Taiwan, 970
Actively Recruiting
221
Investigational Site Number : 1580005
Kaohsiung City, Taiwan, 807
Actively Recruiting
222
Investigational Site Number : 1580006
Taichung, Taiwan, 404
Actively Recruiting
223
Investigational Site Number : 1580007
Taichung, Taiwan, 407
Actively Recruiting
224
Investigational Site Number : 1580004
Taipei, Taiwan, 100
Actively Recruiting
225
Investigational Site Number : 1580003
Taipei, Taiwan, 110
Actively Recruiting
226
Investigational Site Number : 1580001
Taoyuan City, Taiwan, 333
Actively Recruiting
227
Investigational Site Number : 7920003
Kayseri, Turkey (Türkiye), 38039
Actively Recruiting
228
Investigational Site Number : 7920002
Kirikkale, Turkey (Türkiye), 71100
Actively Recruiting
229
Investigational Site Number : 7920001
Mersin, Turkey (Türkiye), 33070
Actively Recruiting
230
Investigational Site Number : 8260009
Ruislip, Hillingdon, United Kingdom, HA4 8NX
Actively Recruiting
231
Investigational Site Number : 8260007
Corby, Northamptonshire, United Kingdom, NN17 2UN
Actively Recruiting
232
Investigational Site Number : 8260006
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
Actively Recruiting
233
Investigational Site Number : 8260008
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Actively Recruiting
234
Investigational Site Number : 8260005
Barnsley, United Kingdom, S75 2EP
Actively Recruiting
235
Investigational Site Number : 8260003
Bradford, United Kingdom, BD9 6RJ
Actively Recruiting
236
Investigational Site Number : 8260001
London, United Kingdom, W1G 8HU
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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