A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Phase 2
Contacts and Locations
Study Contact
Study Contact
- Name: Central Study Contact
- Phone Number: 18007970414
- Email: clinicaltrials@immunovant.com
Study Locations
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Perth, Australia, 6009
- Recruiting
- Site Number - 5108
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Saint Leonards, Australia, 2065
- Recruiting
- Site Number - 5109
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New South Wales
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Sydney, New South Wales, Australia, 2050
- Recruiting
- Site Number - 5105
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Warrawong, New South Wales, Australia, 2502
- Recruiting
- Site Number - 5103
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Queensland
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Brisbane, Queensland, Australia, 4101
- Recruiting
- Site Number - 5101
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Douglas, Queensland, Australia, 4814
- Recruiting
- Site Number - 5107
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Southport, Queensland, Australia, 4222
- Recruiting
- Site Number - 5100
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Victoria
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Box Hill, Victoria, Australia, 3128
- Recruiting
- Site Number - 5102
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Geelong, Victoria, Australia, 3220
- Recruiting
- Site Number - 5104
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Parkville, Victoria, Australia, 3050
- Recruiting
- Site Number - 5110
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Brasília, Brazil, 70200-730
- Recruiting
- Site Number - 5502
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Curitiba, Brazil, 80060-240
- Recruiting
- Site Number - 5503
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Curitiba, Brazil, 80810040
- Recruiting
- Site Number - 5504
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Porto Alegre, Brazil, 90035903
- Recruiting
- Site Number - 5501
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Rio de Janeiro, Brazil, 21941-913
- Recruiting
- Site Number - 5512
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São Paulo, Brazil, 01228-000
- Recruiting
- Site Number - 5508
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São Paulo, Brazil, 01221-020
- Recruiting
- Site Number - 5506
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São Paulo, Brazil, 05403-000
- Recruiting
- Site Number - 5510
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São Paulo, Brazil, 15500-003
- Recruiting
- Site Number - 5507
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São Paulo, Brazil, 17504-072
- Recruiting
- Site Number - 5509
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Ceará
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Fortaleza, Ceará, Brazil, 21941-913
- Recruiting
- Site Number - 5511
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30150-320
- Recruiting
- Site Number - 5513
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São Paulo
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Campinas, São Paulo, Brazil, 09060-870
- Recruiting
- Site Number - 5500
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Santo André, São Paulo, Brazil, 09060-870
- Recruiting
- Site Number - 5505
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Dobrich, Bulgaria, 7002
- Recruiting
- Site Number - 5613
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Plovdiv, Bulgaria, 4001
- Recruiting
- Site Number - 5606
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Plovdiv, Bulgaria, 4002
- Recruiting
- Site Number - 5607
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Sliven, Bulgaria, 8800
- Recruiting
- Site Number - 5601
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Smolyan, Bulgaria, 4700
- Recruiting
- Site Number - 5612
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Sofia, Bulgaria, 1233
- Recruiting
- Site Number - 5604
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Sofia, Bulgaria, 1431
- Recruiting
- Site Number - 5609
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Sofia, Bulgaria, 1680
- Recruiting
- Site Number - 5608
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Sofia, Bulgaria, 1750
- Recruiting
- Site Number- 5605
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Varna, Bulgaria, 9002
- Recruiting
- Site Number - 5602
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Varna, Bulgaria, 9020
- Recruiting
- Site Number - 5603
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Varna, Bulgaria, 9020
- Recruiting
- Site Number - 5611
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Yambol, Bulgaria, 8600
- Recruiting
- Site Number - 5600
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Sofia-Grad
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Sofia, Sofia-Grad, Bulgaria, 1431
- Recruiting
- Site Number - 5610
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Náchod, Czechia, 547 01
- Recruiting
- Site Number - 3203
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Prague, Czechia, 149 00
- Recruiting
- Site Number - 3201
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Prague, Czechia, 181 00
- Recruiting
- Site Number - 3200
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Prague, Czechia, 190 14
- Recruiting
- Site Number - 3202
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Imereti, Georgia, 4600
- Recruiting
- Site Number - 8004
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Tbilisi, Georgia, 0160
- Recruiting
- Site Number - 8001
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Tbilisi, Georgia, 0114
- Recruiting
- Site Number - 8003
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Tbilisi, Georgia, 0145
- Recruiting
- Site Number - 8000
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Tbilisi, Georgia, 0159
- Recruiting
- Site Number - 8002
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Tbilisi, Georgia, 0186
- Recruiting
- Site Number - 8005
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Athens, Greece, 106 76
- Recruiting
- Site Number - 3902
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Athens, Greece, 115 27
- Recruiting
- Site Number - 3900
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Athens, Greece, 115 28
- Recruiting
- Site Number - 3901
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Jerusalem, Israel, 9103102
- Recruiting
- Site Number - 4201
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Jerusalem, Israel, 9112001
- Recruiting
- Site Number - 4204
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Kfar Saba, Israel, 4428164
- Recruiting
- Site Number - 4210
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Petah Tikva, Israel, 4941492
- Recruiting
- Site Number - 4200
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Rehovot, Israel, 7661041
- Recruiting
- Site Number - 4208
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Tel Aviv, Israel, 6423906
- Recruiting
- Site Number - 4207
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Central District
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Ramat Gan, Central District, Israel, 5265601
- Recruiting
- Site Number - 4202
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Haifa District
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Haifa, Haifa District, Israel, 3104802
- Recruiting
- Site Number - 4205
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Haifa, Haifa District, Israel, 3109601
- Recruiting
- Site Number - 4203
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Northern District
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Nahariya, Northern District, Israel, 2210001
- Recruiting
- Site Number - 4209
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Tzfat, Northern District, Israel, 1311001
- Recruiting
- Site Number - 4206
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Southern District
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Beersheba, Southern District, Israel, 8410101
- Recruiting
- Site Number - 4211
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Bergamo, Italy, 24127
- Recruiting
- Site Number - 6004
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Milan, Italy, 20132
- Recruiting
- Site Number - 6003
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Pavia, Italy, 27100
- Recruiting
- Site Number - 6006
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Rome, Italy, 135
- Recruiting
- Site Number - 6001
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Udine, Italy, 33100
- Recruiting
- Site Number - 6002
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Milan
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Rozzano, Milan, Italy, 20089
- Recruiting
- Site Number - 6005
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Kumamoto, Japan, 860-8556
- Recruiting
- Site Number - 4007
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Kyoto, Japan, 612-8555
- Recruiting
- Site Number - 4006
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Fukuoka
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Kitakyushu, Fukuoka, Japan, 807-8555
- Recruiting
- Site Number - 4011
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Kurume, Fukuoka, Japan, 830-0011
- Recruiting
- Site Number - 4004
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Gifu
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Minokamo, Gifu, Japan, 505-8510
- Recruiting
- Site Number - 4005
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Gunma
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Maebashi, Gunma, Japan, 371-8512
- Recruiting
- Site Number - 4008
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Kanagawa
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Yokohama, Kanagawa, Japan, 230-8765
- Recruiting
- Site Number - 4009
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Kochi
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Nankoku, Kochi, Japan, 791-0295
- Recruiting
- Site Number - 4003
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Ogre, Latvia, LV-5001
- Recruiting
- Site Number - 4600
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Riga, Latvia, LV-1006
- Recruiting
- Site Number - 4602
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Riga, Latvia, LV-1050
- Recruiting
- Site Number - 4603
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Sigulda, Latvia, LV-2150
- Recruiting
- Site Number - 4604
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Ventspils, Latvia, LV-3601
- Recruiting
- Site Number - 4601
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South Holland
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Rotterdam, South Holland, Netherlands, 3079 DZ
- Recruiting
- Site Number - 2200
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Rotterdam, South Holland, Netherlands, 3083 AN
- Recruiting
- Site Number - 2201
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Rotterdam, South Holland, Netherlands, 3045 PM
- Recruiting
- Site Number - 2003
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Zwijndrecht, South Holland, Netherlands, 3318 AT
- Recruiting
- Site Number - 2202
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Auckland, New Zealand, 2025
- Recruiting
- Site Number - 3301
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Wellington, New Zealand, 6242
- Recruiting
- Site Number - 3300
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Bydgoszcz, Poland, 85-605
- Recruiting
- Site Number - 3002
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Chorzów, Poland, 41-516
- Recruiting
- Site Number - 3010
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Kielce, Poland, 25-734
- Recruiting
- Site Number - 3007
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Lublin, Poland, 20-607
- Recruiting
- Site Number - 3000
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Olsztyn, Poland, 10-117
- Recruiting
- Site Number - 3005
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Opole, Poland, 45-301
- Recruiting
- Site Number - 3009
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Poznan, Poland, 60-693
- Recruiting
- Site Number - 3006
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Warsaw, Poland, 02-482
- Recruiting
- Site Number - 3008
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Warsaw, Poland, 02-507
- Recruiting
- Site Number - 3011
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Wroclaw, Poland, 50-367
- Recruiting
- Site Nnumber - 3003
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Poland, 15-276
- Recruiting
- Site Number - 3004
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West Pomeranian Voivodeship
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Szczecin, West Pomeranian Voivodeship, Poland, 71-252
- Recruiting
- Site Number - 3001
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Daegu, South Korea, 42415
- Recruiting
- Site Number - 4500
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Goyang, South Korea, 410-77
- Recruiting
- Site Number - 4503
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Guri-si, South Korea, 11923
- Recruiting
- Site Number - 4504
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Seoul, South Korea, 02841
- Recruiting
- Site Number - 4501
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Seoul, South Korea, 03181
- Recruiting
- Site Number - 4506
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Seoul, South Korea, 05278
- Recruiting
- Site Number - 4505
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Cornwell, United Kingdom, TR1 3LJ
- Recruiting
- Site Number - 7009
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London, United Kingdom, W2 1NY
- Recruiting
- Site Number - 7001
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London, United Kingdom, SE1 9RT
- Recruiting
- Site Number - 7006
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Merthyr Tydfil, United Kingdom, CF72 8XR
- Recruiting
- Site Number - 7003
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Salford, United Kingdom, M6 8HD
- Recruiting
- Site Number - 7010
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Surrey, United Kingdom, GU2 7XX
- Recruiting
- Site Number - 7008
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Arizona
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Tucson, Arizona, United States, 85710
- Recruiting
- Site Number - 1015
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California
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Concord, California, United States, 94520
- Recruiting
- Site Number -1014
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- Site Number - 1013
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Florida
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Doral, Florida, United States, 33166
- Recruiting
- Site Number - 1024
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Hialeah, Florida, United States, 33016
- Recruiting
- Site Number - 1008
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Miami, Florida, United States, 33143
- Recruiting
- Site Number - 1000
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Georgia
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Columbus, Georgia, United States, 31904
- Recruiting
- Site Number - 1020
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Kansas
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Topeka, Kansas, United States, 66606
- Recruiting
- Site Number - 1022
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Kentucky
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Louisville, Kentucky, United States, 40202
- Recruiting
- Site Number - 1030
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Missouri
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Jefferson City, Missouri, United States, 65109
- Recruiting
- Site Number - 1033
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Kansas City, Missouri, United States, 64110
- Recruiting
- Site Number - 1004
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St Louis, Missouri, United States, 63110
- Recruiting
- Site Number - 1019
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Nevada
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Reno, Nevada, United States, 89511
- Recruiting
- Site Number - 1012
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New York
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Long Island City, New York, United States, 11106
- Recruiting
- Site Number - 1032
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New Hyde Park, New York, United States, 11434
- Recruiting
- Site Number - 1027
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New York, New York, United States, 10022
- Recruiting
- Site Number - 1009
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Williamsville, New York, United States, 14221
- Recruiting
- Site Number - 1018
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North Carolina
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Chapel Hill, North Carolina, United States, 27514
- Recruiting
- Site Number - 1010
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Hickory, North Carolina, United States, 28601
- Recruiting
- Site Number - 1026
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Morehead City, North Carolina, United States, 27577
- Recruiting
- Site Number - 1001
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Raleigh, North Carolina, United States, 27612
- Recruiting
- Site Number - 1034
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73134
- Recruiting
- Site Number - 1007
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Tennessee
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Memphis, Tennessee, United States, 38119
- Recruiting
- Site Number - 1017
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Texas
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Dallas, Texas, United States, 75224
- Recruiting
- Site Number - 1029
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El Paso, Texas, United States, 79935
- Recruiting
- Site Number - 1002
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Fort Worth, Texas, United States, 76132
- Recruiting
- Site Number - 1003
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Houston, Texas, United States, 77030
- Recruiting
- Site Number - 1031
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Houston, Texas, United States, 77054
- Recruiting
- Site Number - 1028
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Irving, Texas, United States, 75031
- Recruiting
- Site Number -1023
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Irving, Texas, United States, 75039
- Recruiting
- Site Number - 1021
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McKinney, Texas, United States, 75069
- Recruiting
- Site Number - 1025
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San Antonio, Texas, United States, 78231
- Recruiting
- Site Number - 1011
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Virginia
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Norfolk, Virginia, United States, 23510
- Recruiting
- Site Number - 1016
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
- Male or female participants aged ≥ 18 years.
- Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.
- Other, more specific inclusion criteria are defined in the protocol.
Exclusion Criteria:
- Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
- Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.
- Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.
- Additional exclusion criteria are defined in the protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
For 26 weeks
|
|
Experimental: IMVT-1402 Dose 1
|
Dose 1 for 26 weeks
Dose 2 for 26 weeks
|
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Experimental: IMVT-1402 Dose 2
|
Dose 1 for 26 weeks
Dose 2 for 26 weeks
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)
Time Frame: Week 26
|
Week 26
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of participants who have triiodothyronine (T3) (Total of T3 or free triiodothyronine [FT3]) and free thyroxine (FT4) ≤ upper limit of normal (ULN) and are off ATD at Week 26 (Dose 1)
Time Frame: Week 26
|
Week 26
|
|
Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1)
Time Frame: Week 26
|
Week 26
|
|
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2)
Time Frame: Week 26
|
Week 26
|
|
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26 (Dose 2)
Time Frame: Week 26
|
Week 26
|
|
Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2)
Time Frame: Week 26
|
Week 26
|
|
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 1)
Time Frame: Baseline, Week 4
|
Baseline, Week 4
|
|
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 1)
Time Frame: Baseline, Week 2
|
Baseline, Week 2
|
|
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 2)
Time Frame: Baseline, Week 4
|
Baseline, Week 4
|
|
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 2)
Time Frame: Baseline, Week 2
|
Baseline, Week 2
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IMVT-1402-2503
- 2025-521920-31-00 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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