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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521920-31-00 | EU Trial (CTIS) Number |
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This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMVT-1402 Dose 1 | Experimental |
| |
| IMVT-1402 Dose 2 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMVT-1402 | Drug | Dose 1 for 26 weeks |
| |
| IMVT-1402 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1) | Week 26 |
| Measure | Description | 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) | Week 26 | |
| Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Central Study Contact | Contact | 18007970414 | clinicaltrials@immunovant.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Number - 1015 | Recruiting | Tucson | Arizona | 85710 | United States | |
| Site Number -1014 |
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| Drug |
Dose 2 for 26 weeks |
|
| Placebo | Drug | For 26 weeks |
|
| Week 26 |
| Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2) | Week 26 |
| Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26 (Dose 2) | Week 26 |
| Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2) | 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) | 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) | 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) | 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) | Baseline, Week 2 |
| Recruiting |
| Concord |
| California |
| 94520 |
| United States |
| Site Number - 1013 | Recruiting | Aurora | Colorado | 80045 | United States |
| Site Number - 1024 | Recruiting | Doral | Florida | 33166 | United States |
| Site Number - 1008 | Recruiting | Hialeah | Florida | 33016 | United States |
| Site Number - 1000 | Recruiting | Miami | Florida | 33143 | United States |
| Site Number - 1020 | Recruiting | Columbus | Georgia | 31904 | United States |
| Site Number - 1022 | Recruiting | Topeka | Kansas | 66606 | United States |
| Site Number - 1030 | Recruiting | Louisville | Kentucky | 40202 | United States |
| Site Number - 1033 | Recruiting | Jefferson City | Missouri | 65109 | United States |
| Site Number - 1004 | Recruiting | Kansas City | Missouri | 64110 | United States |
| Site Number - 1019 | Recruiting | St Louis | Missouri | 63110 | United States |
| Site Number - 1012 | Recruiting | Reno | Nevada | 89511 | United States |
| Site Number - 1032 | Recruiting | Long Island City | New York | 11106 | United States |
| Site Number - 1027 | Recruiting | New Hyde Park | New York | 11434 | United States |
| Site Number - 1009 | Recruiting | New York | New York | 10022 | United States |
| Site Number - 1018 | Recruiting | Williamsville | New York | 14221 | United States |
| Site Number - 1010 | Recruiting | Chapel Hill | North Carolina | 27514 | United States |
| Site Number - 1026 | Recruiting | Hickory | North Carolina | 28601 | United States |
| Site Number - 1001 | Recruiting | Morehead City | North Carolina | 27577 | United States |
| Site Number - 1034 | Recruiting | Raleigh | North Carolina | 27612 | United States |
| Site Number - 1007 | Recruiting | Oklahoma City | Oklahoma | 73134 | United States |
| Site Number - 1017 | Recruiting | Memphis | Tennessee | 38119 | United States |
| Site Number - 1029 | Recruiting | Dallas | Texas | 75224 | United States |
| Site Number - 1002 | Recruiting | El Paso | Texas | 79935 | United States |
| Site Number - 1003 | Recruiting | Fort Worth | Texas | 76132 | United States |
| Site Number - 1031 | Recruiting | Houston | Texas | 77030 | United States |
| Site Number - 1028 | Recruiting | Houston | Texas | 77054 | United States |
| Site Number -1023 | Recruiting | Irving | Texas | 75031 | United States |
| Site Number - 1021 | Recruiting | Irving | Texas | 75039 | United States |
| Site Number - 1025 | Recruiting | McKinney | Texas | 75069 | United States |
| Site Number - 1011 | Recruiting | San Antonio | Texas | 78231 | United States |
| Site Number - 1016 | Recruiting | Norfolk | Virginia | 23510 | United States |
| Site Number - 5105 | Recruiting | Sydney | New South Wales | 2050 | Australia |
| Site Number - 5103 | Recruiting | Warrawong | New South Wales | 2502 | Australia |
| Site Number - 5101 | Recruiting | Brisbane | Queensland | 4101 | Australia |
| Site Number - 5107 | Recruiting | Douglas | Queensland | 4814 | Australia |
| Site Number - 5100 | Recruiting | Southport | Queensland | 4222 | Australia |
| Site Number - 5102 | Recruiting | Box Hill | Victoria | 3128 | Australia |
| Site Number - 5104 | Recruiting | Geelong | Victoria | 3220 | Australia |
| Site Number - 5110 | Recruiting | Parkville | Victoria | 3050 | Australia |
| Site Number - 5108 | Recruiting | Perth | 6009 | Australia |
| Site Number - 5109 | Recruiting | Saint Leonards | 2065 | Australia |
| Site Number - 5511 | Recruiting | Fortaleza | Ceará | 21941-913 | Brazil |
| Site Number - 5513 | Recruiting | Belo Horizonte | Minas Gerais | 30150-320 | Brazil |
| Site Number - 5500 | Recruiting | Campinas | São Paulo | 09060-870 | Brazil |
| Site Number - 5505 | Recruiting | Santo André | São Paulo | 09060-870 | Brazil |
| Site Number - 5502 | Recruiting | Brasília | 70200-730 | Brazil |
| Site Number - 5503 | Recruiting | Curitiba | 80060-240 | Brazil |
| Site Number - 5504 | Recruiting | Curitiba | 80810040 | Brazil |
| Site Number - 5501 | Recruiting | Porto Alegre | 90035903 | Brazil |
| Site Number - 5512 | Recruiting | Rio de Janeiro | 21941-913 | Brazil |
| Site Number - 5506 | Recruiting | São Paulo | 01221-020 | Brazil |
| Site Number - 5508 | Recruiting | São Paulo | 01228-000 | Brazil |
| Site Number - 5510 | Recruiting | São Paulo | 05403-000 | Brazil |
| Site Number - 5507 | Recruiting | São Paulo | 15500-003 | Brazil |
| Site Number - 5509 | Recruiting | São Paulo | 17504-072 | Brazil |
| Site Number - 5610 | Recruiting | Sofia | Sofia-Grad | 1431 | Bulgaria |
| Site Number - 5613 | Recruiting | Dobrich | 7002 | Bulgaria |
| Site Number - 5606 | Recruiting | Plovdiv | 4001 | Bulgaria |
| Site Number - 5607 | Recruiting | Plovdiv | 4002 | Bulgaria |
| Site Number - 5601 | Recruiting | Sliven | 8800 | Bulgaria |
| Site Number - 5612 | Recruiting | Smolyan | 4700 | Bulgaria |
| Site Number - 5604 | Recruiting | Sofia | 1233 | Bulgaria |
| Site Number - 5609 | Recruiting | Sofia | 1431 | Bulgaria |
| Site Number - 5608 | Recruiting | Sofia | 1680 | Bulgaria |
| Site Number- 5605 | Recruiting | Sofia | 1750 | Bulgaria |
| Site Number - 5602 | Recruiting | Varna | 9002 | Bulgaria |
| Site Number - 5603 | Recruiting | Varna | 9020 | Bulgaria |
| Site Number - 5611 | Recruiting | Varna | 9020 | Bulgaria |
| Site Number - 5600 | Recruiting | Yambol | 8600 | Bulgaria |
| Site Number - 5700 | Recruiting | Santiago | 7690000 | Chile |
| Site Number - 3203 | Recruiting | Náchod | 547 01 | Czechia |
| Site Number - 3201 | Recruiting | Prague | 149 00 | Czechia |
| Site Number - 3200 | Recruiting | Prague | 181 00 | Czechia |
| Site Number - 3202 | Recruiting | Prague | 190 14 | Czechia |
| Site Number - 8004 | Recruiting | Imereti | 4600 | Georgia |
| Site Number - 8003 | Recruiting | Tbilisi | 0114 | Georgia |
| Site Number - 8000 | Recruiting | Tbilisi | 0145 | Georgia |
| Site Number - 8002 | Recruiting | Tbilisi | 0159 | Georgia |
| Site Number - 8001 | Recruiting | Tbilisi | 0160 | Georgia |
| Site Number - 8005 | Recruiting | Tbilisi | 0186 | Georgia |
| Site Number - 3902 | Recruiting | Athens | 106 76 | Greece |
| Site Number - 3900 | Recruiting | Athens | 115 27 | Greece |
| Site Number - 3901 | Recruiting | Athens | 115 28 | Greece |
| Site Number - 4202 | Recruiting | Ramat Gan | Central District | 5265601 | Israel |
| Site Number - 4205 | Recruiting | Haifa | Haifa District | 3104802 | Israel |
| Site Number - 4203 | Recruiting | Haifa | Haifa District | 3109601 | Israel |
| Site Number - 4209 | Recruiting | Nahariya | Northern District | 2210001 | Israel |
| Site Number - 4206 | Recruiting | Tzfat | Northern District | 1311001 | Israel |
| Site Number - 4211 | Recruiting | Beersheba | Southern District | 8410101 | Israel |
| Site Number - 4201 | Recruiting | Jerusalem | 9103102 | Israel |
| Site Number - 4204 | Recruiting | Jerusalem | 9112001 | Israel |
| Site Number - 4210 | Recruiting | Kfar Saba | 4428164 | Israel |
| Site Number - 4200 | Recruiting | Petah Tikva | 4941492 | Israel |
| Site Number - 4208 | Recruiting | Rehovot | 7661041 | Israel |
| Site Number - 4207 | Recruiting | Tel Aviv | 6423906 | Israel |
| Site Number - 6005 | Recruiting | Rozzano | Milan | 20089 | Italy |
| Site Number - 6004 | Recruiting | Bergamo | 24127 | Italy |
| Site Number - 6015 | Recruiting | Cuneo | 12100 | Italy |
| Site Number - 6003 | Recruiting | Milan | 20132 | Italy |
| Site Number - 6006 | Recruiting | Pavia | 27100 | Italy |
| Site Number - 6001 | Recruiting | Rome | 135 | Italy |
| Site Number - 6002 | Recruiting | Udine | 33100 | Italy |
| Site Number - 4010 | Recruiting | Nagoya | Aichi-ken | 467-8602 | Japan |
| Site Number - 4001 | Recruiting | Kamogawa | Chiba | 296-0041 | Japan |
| Site Number - 4011 | Recruiting | Kitakyushu | Fukuoka | 807-8555 | Japan |
| Site Number - 4004 | Recruiting | Kurume | Fukuoka | 830-0011 | Japan |
| Site Number - 4005 | Recruiting | Minokamo | Gifu | 505-8510 | Japan |
| Site Number - 4008 | Recruiting | Maebashi | Gunma | 371-8512 | Japan |
| Site Number - 4009 | Recruiting | Yokohama | Kanagawa | 230-8765 | Japan |
| Site Number - 4003 | Recruiting | Nankoku | Kochi | 791-0295 | Japan |
| Site Number - 4012 | Recruiting | Shibuya City | Tokyo | 150-8308 | Japan |
| Site Number - 4007 | Recruiting | Kumamoto | 860-8556 | Japan |
| Site Number - 4006 | Recruiting | Kyoto | 612-8555 | Japan |
| Site Number - 4002 | Recruiting | Nagasaki | 852-8501 | Japan |
| Site Number - 4600 | Recruiting | Ogre | LV-5001 | Latvia |
| Site Number - 4605 | Recruiting | Riga | LV-1002 | Latvia |
| Site Number - 4602 | Recruiting | Riga | LV-1006 | Latvia |
| Site Number - 4603 | Recruiting | Riga | LV-1050 | Latvia |
| Site Number - 4604 | Recruiting | Sigulda | LV-2150 | Latvia |
| Site Number - 4601 | Recruiting | Ventspils | LV-3601 | Latvia |
| Site Number - 2003 | Recruiting | Rotterdam | South Holland | 3045 PM | Netherlands |
| Site Number - 2200 | Recruiting | Rotterdam | South Holland | 3079 DZ | Netherlands |
| Site Number - 2201 | Recruiting | Rotterdam | South Holland | 3083 AN | Netherlands |
| Site Number - 2202 | Recruiting | Zwijndrecht | South Holland | 3318 AT | Netherlands |
| Site Number - 3301 | Recruiting | Auckland | 2025 | New Zealand |
| Site Number - 3300 | Recruiting | Wellington | 6242 | New Zealand |
| Site Number - 3004 | Recruiting | Bialystok | Podlaskie Voivodeship | 15-276 | Poland |
| Site Number - 3001 | Recruiting | Szczecin | West Pomeranian Voivodeship | 71-252 | Poland |
| Site Number - 3002 | Recruiting | Bydgoszcz | 85-605 | Poland |
| Site Number - 3010 | Recruiting | Chorzów | 41-516 | Poland |
| Site Number - 3007 | Recruiting | Kielce | 25-734 | Poland |
| Site Number - 3000 | Recruiting | Lublin | 20-607 | Poland |
| Site Number - 3005 | Recruiting | Olsztyn | 10-117 | Poland |
| Site Number - 3009 | Recruiting | Opole | 45-301 | Poland |
| Site Number - 3006 | Recruiting | Poznan | 60-693 | Poland |
| Site Number - 3008 | Recruiting | Warsaw | 02-482 | Poland |
| Site Number - 3011 | Recruiting | Warsaw | 02-507 | Poland |
| Site Nnumber - 3003 | Recruiting | Wroclaw | 50-367 | Poland |
| Site Number - 4500 | Recruiting | Daegu | 42415 | South Korea |
| Site Number - 4503 | Recruiting | Goyang | 410-77 | South Korea |
| Site Number - 4504 | Recruiting | Guri-si | 11923 | South Korea |
| Site Number - 4501 | Recruiting | Seoul | 02841 | South Korea |
| Site Number - 4508 | Recruiting | Seoul | 03080 | South Korea |
| Site Number - 4506 | Recruiting | Seoul | 03181 | South Korea |
| Site Number - 4505 | Recruiting | Seoul | 05278 | South Korea |
| Site Number - 4507 | Recruiting | Seoul | 6591 | South Korea |
| Site Number - 7009 | Recruiting | Cornwell | TR1 3LJ | United Kingdom |
| Site Number - 7006 | Recruiting | London | SE1 9RT | United Kingdom |
| Site Number - 7001 | Recruiting | London | W2 1NY | United Kingdom |
| Site Number - 7003 | Recruiting | Merthyr Tydfil | CF72 8XR | United Kingdom |
| Site Number - 7010 | Recruiting | Salford | M6 8HD | United Kingdom |
| Site Number - 7008 | Recruiting | Surrey | GU2 7XX | United Kingdom |
| ID | Term |
|---|---|
| D006111 | Graves Disease |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D006980 | Hyperthyroidism |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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