Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease
Led by Immunovant Sciences GmbH · Updated on 2026-06-08
210
Participants Needed
145
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and tolerability of IMVT-1402 in adults with Graves' disease who remain hyperthyroid despite taking antithyroid drugs. This phase 2b, randomized, double-blind, placebo-controlled study is conducted across multiple global centers to better understand treatment options for this condition. The study is led by Immunovant Sciences GmbH and focuses on adult patients aged 18 to 75 years. Participants will receive one of three study treatments for 26 weeks: IMVT-1402 at dose 1, IMVT-1402 at dose 2, or a placebo. Each participant is randomly assigned to one of these groups without knowing which treatment they receive, ensuring an unbiased assessment. The study aims to compare these treatments based on their ability to help participants become euthyroid and stop antithyroid drug use. During the study, participants will be closely monitored through regular visits where thyroid hormone levels, including triiodothyronine (T3) and free thyroxine (FT4), will be measured. The primary outcome is the percentage of participants who achieve normal thyroid function without antithyroid drugs by week 26. Secondary outcomes include additional hormone level measurements and seronegative status. Safety and tolerability are also assessed throughout the trial, which continues until May 2027.
CONDITIONS
Brief Title
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the trial requirements and provide written informed consent
- Male or female participants aged 18 years or older
- Diagnosis of Graves' disease and hyperthyroid despite antithyroid drug treatment
- Other specific inclusion criteria as defined in the protocol
You will not qualify if you...
- Previous successful treatment with radioactive iodine therapy or total thyroidectomy
- Autoimmune disease other than Graves' disease requiring treatment that poses undue risk
- Moderate-to-severe active thyroid eye disease requiring immediate surgery or planned therapy during the study
- Additional exclusion criteria as defined in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive either IMVT-1402 at one of two doses or a placebo for 26 weeks to assess efficacy, safety, and tolerability.
Multiple visits during treatment as scheduled by the trial
Trial Site Locations
Total: 145 locations
1
Site Number - 1015
Tucson, Arizona, United States, 85710
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2
Site Number -1014
Concord, California, United States, 94520
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3
Site Number - 1013
Aurora, Colorado, United States, 80045
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4
Site Number - 1024
Doral, Florida, United States, 33166
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5
Site Number - 1008
Hialeah, Florida, United States, 33016
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6
Site Number - 1000
Miami, Florida, United States, 33143
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7
Site Number - 1020
Columbus, Georgia, United States, 31904
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8
Site Number - 1022
Topeka, Kansas, United States, 66606
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9
Site Number - 1030
Louisville, Kentucky, United States, 40202
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10
Site Number - 1033
Jefferson City, Missouri, United States, 65109
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11
Site Number - 1004
Kansas City, Missouri, United States, 64110
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12
Site Number - 1019
St Louis, Missouri, United States, 63110
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13
Site Number - 1012
Reno, Nevada, United States, 89511
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14
Site Number - 1032
Long Island City, New York, United States, 11106
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15
Site Number - 1027
New Hyde Park, New York, United States, 11434
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16
Site Number - 1009
New York, New York, United States, 10022
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17
Site Number - 1018
Williamsville, New York, United States, 14221
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18
Site Number - 1010
Chapel Hill, North Carolina, United States, 27514
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19
Site Number - 1026
Hickory, North Carolina, United States, 28601
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20
Site Number - 1001
Morehead City, North Carolina, United States, 27577
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21
Site Number - 1034
Raleigh, North Carolina, United States, 27612
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22
Site Number - 1007
Oklahoma City, Oklahoma, United States, 73134
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23
Site Number - 1017
Memphis, Tennessee, United States, 38119
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24
Site Number - 1029
Dallas, Texas, United States, 75224
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25
Site Number - 1002
El Paso, Texas, United States, 79935
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26
Site Number - 1003
Fort Worth, Texas, United States, 76132
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27
Site Number - 1031
Houston, Texas, United States, 77030
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28
Site Number - 1028
Houston, Texas, United States, 77054
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29
Site Number -1023
Irving, Texas, United States, 75031
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30
Site Number - 1021
Irving, Texas, United States, 75039
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31
Site Number - 1025
McKinney, Texas, United States, 75069
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32
Site Number - 1011
San Antonio, Texas, United States, 78231
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33
Site Number - 1016
Norfolk, Virginia, United States, 23510
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34
Site Number - 5105
Sydney, New South Wales, Australia, 2050
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35
Site Number - 5103
Warrawong, New South Wales, Australia, 2502
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36
Site Number - 5101
Brisbane, Queensland, Australia, 4101
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37
Site Number - 5107
Douglas, Queensland, Australia, 4814
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38
Site Number - 5100
Southport, Queensland, Australia, 4222
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39
Site Number - 5102
Box Hill, Victoria, Australia, 3128
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40
Site Number - 5104
Geelong, Victoria, Australia, 3220
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41
Site Number - 5110
Parkville, Victoria, Australia, 3050
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42
Site Number - 5108
Perth, Australia, 6009
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43
Site Number - 5109
Saint Leonards, Australia, 2065
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44
Site Number - 5511
Fortaleza, Ceará, Brazil, 21941-913
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45
Site Number - 5513
Belo Horizonte, Minas Gerais, Brazil, 30150-320
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46
Site Number - 5500
Campinas, São Paulo, Brazil, 09060-870
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47
Site Number - 5505
Santo André, São Paulo, Brazil, 09060-870
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48
Site Number - 5502
Brasília, Brazil, 70200-730
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49
Site Number - 5503
Curitiba, Brazil, 80060-240
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50
Site Number - 5504
Curitiba, Brazil, 80810040
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51
Site Number - 5501
Porto Alegre, Brazil, 90035903
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52
Site Number - 5512
Rio de Janeiro, Brazil, 21941-913
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53
Site Number - 5506
São Paulo, Brazil, 01221-020
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54
Site Number - 5508
São Paulo, Brazil, 01228-000
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55
Site Number - 5510
São Paulo, Brazil, 05403-000
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56
Site Number - 5507
São Paulo, Brazil, 15500-003
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57
Site Number - 5509
São Paulo, Brazil, 17504-072
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58
Site Number - 5610
Sofia, Sofia-Grad, Bulgaria, 1431
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59
Site Number - 5613
Dobrich, Bulgaria, 7002
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60
Site Number - 5606
Plovdiv, Bulgaria, 4001
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61
Site Number - 5607
Plovdiv, Bulgaria, 4002
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62
Site Number - 5601
Sliven, Bulgaria, 8800
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63
Site Number - 5612
Smolyan, Bulgaria, 4700
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64
Site Number - 5604
Sofia, Bulgaria, 1233
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65
Site Number - 5609
Sofia, Bulgaria, 1431
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66
Site Number - 5608
Sofia, Bulgaria, 1680
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67
Site Number- 5605
Sofia, Bulgaria, 1750
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68
Site Number - 5602
Varna, Bulgaria, 9002
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69
Site Number - 5603
Varna, Bulgaria, 9020
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70
Site Number - 5611
Varna, Bulgaria, 9020
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71
Site Number - 5600
Yambol, Bulgaria, 8600
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72
Site Number - 3203
Náchod, Czechia, 547 01
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73
Site Number - 3201
Prague, Czechia, 149 00
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74
Site Number - 3200
Prague, Czechia, 181 00
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75
Site Number - 3202
Prague, Czechia, 190 14
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76
Site Number - 8004
Imereti, Georgia, 4600
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77
Site Number - 8003
Tbilisi, Georgia, 0114
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78
Site Number - 8000
Tbilisi, Georgia, 0145
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79
Site Number - 8002
Tbilisi, Georgia, 0159
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80
Site Number - 8001
Tbilisi, Georgia, 0160
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81
Site Number - 8005
Tbilisi, Georgia, 0186
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82
Site Number - 3902
Athens, Greece, 106 76
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83
Site Number - 3900
Athens, Greece, 115 27
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84
Site Number - 3901
Athens, Greece, 115 28
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85
Site Number - 4202
Ramat Gan, Central District, Israel, 5265601
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86
Site Number - 4205
Haifa, Haifa District, Israel, 3104802
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87
Site Number - 4203
Haifa, Haifa District, Israel, 3109601
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88
Site Number - 4209
Nahariya, Northern District, Israel, 2210001
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89
Site Number - 4206
Tzfat, Northern District, Israel, 1311001
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90
Site Number - 4211
Beersheba, Southern District, Israel, 8410101
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91
Site Number - 4201
Jerusalem, Israel, 9103102
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92
Site Number - 4204
Jerusalem, Israel, 9112001
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93
Site Number - 4210
Kfar Saba, Israel, 4428164
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94
Site Number - 4200
Petah Tikva, Israel, 4941492
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95
Site Number - 4208
Rehovot, Israel, 7661041
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96
Site Number - 4207
Tel Aviv, Israel, 6423906
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97
Site Number - 6005
Rozzano, Milan, Italy, 20089
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98
Site Number - 6004
Bergamo, Italy, 24127
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99
Site Number - 6003
Milan, Italy, 20132
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100
Site Number - 6006
Pavia, Italy, 27100
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101
Site Number - 6001
Rome, Italy, 135
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102
Site Number - 6002
Udine, Italy, 33100
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103
Site Number - 4011
Kitakyushu, Fukuoka, Japan, 807-8555
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104
Site Number - 4004
Kurume, Fukuoka, Japan, 830-0011
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105
Site Number - 4005
Minokamo, Gifu, Japan, 505-8510
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106
Site Number - 4008
Maebashi, Gunma, Japan, 371-8512
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107
Site Number - 4009
Yokohama, Kanagawa, Japan, 230-8765
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108
Site Number - 4003
Nankoku, Kochi, Japan, 791-0295
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109
Site Number - 4007
Kumamoto, Japan, 860-8556
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110
Site Number - 4006
Kyoto, Japan, 612-8555
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111
Site Number - 4600
Ogre, Latvia, LV-5001
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112
Site Number - 4602
Riga, Latvia, LV-1006
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113
Site Number - 4603
Riga, Latvia, LV-1050
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114
Site Number - 4604
Sigulda, Latvia, LV-2150
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115
Site Number - 4601
Ventspils, Latvia, LV-3601
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116
Site Number - 2003
Rotterdam, South Holland, Netherlands, 3045 PM
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117
Site Number - 2200
Rotterdam, South Holland, Netherlands, 3079 DZ
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118
Site Number - 2201
Rotterdam, South Holland, Netherlands, 3083 AN
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119
Site Number - 2202
Zwijndrecht, South Holland, Netherlands, 3318 AT
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120
Site Number - 3301
Auckland, New Zealand, 2025
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121
Site Number - 3300
Wellington, New Zealand, 6242
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122
Site Number - 3004
Bialystok, Podlaskie Voivodeship, Poland, 15-276
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123
Site Number - 3001
Szczecin, West Pomeranian Voivodeship, Poland, 71-252
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124
Site Number - 3002
Bydgoszcz, Poland, 85-605
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125
Site Number - 3010
Chorzów, Poland, 41-516
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126
Site Number - 3007
Kielce, Poland, 25-734
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127
Site Number - 3000
Lublin, Poland, 20-607
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128
Site Number - 3005
Olsztyn, Poland, 10-117
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129
Site Number - 3009
Opole, Poland, 45-301
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130
Site Number - 3006
Poznan, Poland, 60-693
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131
Site Number - 3008
Warsaw, Poland, 02-482
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132
Site Number - 3011
Warsaw, Poland, 02-507
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133
Site Nnumber - 3003
Wroclaw, Poland, 50-367
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134
Site Number - 4500
Daegu, South Korea, 42415
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135
Site Number - 4503
Goyang, South Korea, 410-77
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136
Site Number - 4504
Guri-si, South Korea, 11923
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137
Site Number - 4501
Seoul, South Korea, 02841
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138
Site Number - 4506
Seoul, South Korea, 03181
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139
Site Number - 4505
Seoul, South Korea, 05278
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140
Site Number - 7009
Cornwell, United Kingdom, TR1 3LJ
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141
Site Number - 7006
London, United Kingdom, SE1 9RT
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142
Site Number - 7001
London, United Kingdom, W2 1NY
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143
Site Number - 7003
Merthyr Tydfil, United Kingdom, CF72 8XR
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144
Site Number - 7010
Salford, United Kingdom, M6 8HD
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145
Site Number - 7008
Surrey, United Kingdom, GU2 7XX
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Research Team
C
Central Study Contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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