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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516020-33-00 | EU Trial (CTIS) Number |
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This is a 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.
The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine [T3] or free triiodothyronine [FT3]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Period 1 and 2: IMVT-1402 | Experimental |
| |
| Group 2 Period 1 and 2: IMVT-1402 | Experimental |
| |
| Group 2 Period 1: IMVT-1402 and Period 2: Placebo | Experimental |
| |
| Group 3 Period 1 and 2: Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMVT-1402 | Drug | 600 mg SC QW for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who are euthyroid (local laboratory T3 [Total T3 or FT3], FT4, and TSH values within normal limits) and off ATD at Week 26 | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who are euthyroid and off ATD at Week 52 | Week 52 | |
| Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52 | Week 52 | |
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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| Site Number - 1032 | Withdrawn | Phoenix | Arizona | 85006 | United States | |
| Site Number - 1036 |
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| IMVT-1402 | Drug | 600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks |
|
| Placebo | Drug | SC QW for 52 weeks |
|
| Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78 |
| Week 78 |
| Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104 | Week 104 |
| Percentage of participants who have a TRAb value a specified amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52 | Week 52 |
| Percentage of participants who have a TRAb value a specific amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78 | Week 78 |
| 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 | 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 | Week 4 |
| Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26 | Week 26 |
| Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 26 | Week 26 |
| Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 52 | Week 52 |
| Recruiting |
| Phoenix |
| Arizona |
| 85015 |
| United States |
| Site Number - 1061 | Recruiting | Huntington Beach | California | 92647 | United States |
| Site Number - 1001 | Recruiting | Los Angeles | California | 90033 | United States |
| Site Number - 1047 | Recruiting | Los Angeles | California | 90095 | United States |
| Site Number - 1062 | Recruiting | Orange | California | 92868 | United States |
| Site Number - 1046 | Recruiting | Sacramento | California | 95816 | United States |
| Site Number - 1034 | Recruiting | San Francisco | California | 94143 | United States |
| Site Number - 1035 | Withdrawn | Santa Clarita | California | 91321 | United States |
| Site Number - 1005 | Recruiting | Torrance | California | 90502 | United States |
| Site Number - 1006 | Withdrawn | Walnut Creek | California | 94598 | United States |
| Site Number - 1013 | Recruiting | Englewood | Colorado | 80113 | United States |
| Site Number - 1010 | Recruiting | Newark | Delaware | 19713 | United States |
| Site Number - 1040 | Recruiting | Washington D.C. | District of Columbia | 20010 | United States |
| Site Number - 1029 | Recruiting | Clearwater | Florida | 33756 | United States |
| Site Number - 1055 | Recruiting | Jacksonville | Florida | 32204-1177 | United States |
| Site Number - 1056 | Recruiting | Jacksonville | Florida | 32216 | United States |
| Site Number - 1028 | Recruiting | Miami | Florida | 33136 | United States |
| Site Number - 1065 | Recruiting | Miami | Florida | 33186 | United States |
| Site Number - 1064 | Recruiting | Ocoee | Florida | 34761 | United States |
| Site Number - 1011 | Recruiting | Orlando | Florida | 32819 | United States |
| Site Number - 1016 | Recruiting | Port Charlotte | Florida | 33952 | United States |
| Site Number - 1012 | Recruiting | West Palm Beach | Florida | 33401 | United States |
| Site Number - 1038 | Recruiting | Atlanta | Georgia | 30318 | United States |
| Site Number - 1053 | Recruiting | Macon | Georgia | 31210 | United States |
| Site Number - 1020 | Recruiting | Stockbridge | Georgia | 30281 | United States |
| Site Number - 1027 | Recruiting | Indianapolis | Indiana | 46202 | United States |
| Site Number - 1041 | Recruiting | Kansas City | Kansas | 66210 | United States |
| Site Number - 1045 | Recruiting | Bowling Green | Kentucky | 42101 | United States |
| Site Number - 1054 | Recruiting | Florence | Kentucky | 41042 | United States |
| Site Number - 1063 | Recruiting | Metairie | Louisiana | 70006 | United States |
| Site Number - 1022 | Recruiting | New Orleans | Louisiana | 70112 | United States |
| Site Number - 1048 | Recruiting | Shreveport | Louisiana | 71103 | United States |
| Site Number - 1023 | Recruiting | Baltimore | Maryland | 21287 | United States |
| Site Number - 1026 | Recruiting | Boston | Massachusetts | 02114 | United States |
| Site Number - 1018 | Recruiting | Farmington Hills | Michigan | 48334 | United States |
| Site Number - 1069 | Recruiting | Flint | Michigan | 48532 | United States |
| Site Number - 1008 | Recruiting | Rochester | Minnesota | 55905 | United States |
| Site Number - 1068 | Recruiting | Gulfport | Mississippi | 39501 | United States |
| Site Number - 1017 | Recruiting | Omaha | Nebraska | 68105 | United States |
| Site Number - 1007 | Recruiting | Las Vegas | Nevada | 89148 | United States |
| Site Number - 1050 | Recruiting | Monroe | New York | 10950 | United States |
| Site Number - 1051 | Recruiting | Asheville | North Carolina | 28803 | United States |
| Site Number - 1060 | Recruiting | Wilmington | North Carolina | 28401 | United States |
| Site Number - 1057 | Recruiting | Canton | Ohio | 44718 | United States |
| Site Number - 1003 | Recruiting | Portland | Oregon | 97035 | United States |
| Site Number - 1033 | Withdrawn | Philadelphia | Pennsylvania | 19140 | United States |
| Site Number - 1043 | Recruiting | Pottstown | Pennsylvania | 19464 | United States |
| Site Number - 1015 | Recruiting | Summerville | South Carolina | 29485 | United States |
| Site Number - 1042 | Recruiting | Chattanooga | Tennessee | 37421 | United States |
| Site Number - 1066 | Recruiting | Nashville | Tennessee | 37203 | United States |
| Site Number - 1049 | Recruiting | Nashville | Tennessee | 37212 | United States |
| Site Number - 1002 | Recruiting | Austin | Texas | 78731 | United States |
| Site Number - 1067 | Recruiting | Bellaire | Texas | 77401 | United States |
| Site Number - 1019 | Recruiting | Dallas | Texas | 75208 | United States |
| Site Number - 1031 | Withdrawn | Dallas | Texas | 75231 | United States |
| Site Number - 1071 | Recruiting | Houston | Texas | 77089 | United States |
| Site Number - 1025 | Withdrawn | Houston | Texas | 77095 | United States |
| Site Number - 1004 | Recruiting | Mesquite | Texas | 75149 | United States |
| Site Number - 1009 | Recruiting | Round Rock | Texas | 78681 | United States |
| Site Number - 1014 | Recruiting | San Antonio | Texas | 78215 | United States |
| Site Number - 1052 | Recruiting | San Antonio | Texas | 78240 | United States |
| Site Number - 1030 | Recruiting | Salt Lake City | Utah | 84108 | United States |
| Site Number - 1070 | Recruiting | Sandy City | Utah | 84093 | United States |
| Site Number - 5303 | Recruiting | Antwerp | 2820 | Belgium |
| Site Number - 5301 | Recruiting | Bruges | 80000 | Belgium |
| Site Number - 5302 | Recruiting | Brussels | 1070 | Belgium |
| Site Number - 8002 | Recruiting | Batumi | 6000 | Georgia |
| Site Number - 8007 | Recruiting | Batumi | 6010 | Georgia |
| Site Number - 8006 | Recruiting | Kutaisi | 4600 | Georgia |
| Site Number - 8008 | Recruiting | Marneuli | 3000 | Georgia |
| Site Number - 8009 | Recruiting | Tbilisi | 0112 | Georgia |
| Site Number - 8004 | Recruiting | Tbilisi | 0144 | Georgia |
| Site Number - 8005 | Recruiting | Tbilisi | 0144 | Georgia |
| Site Number - 8001 | Recruiting | Tbilisi | 0159 | Georgia |
| Site Number - 8003 | Recruiting | Tbilisi | 0159 | Georgia |
| Site Number - 8011 | Recruiting | Tbilisi | 0159 | Georgia |
| Site Number - 8010 | Recruiting | Tbilisi | 0177 | Georgia |
| Site Number - 6505 | Recruiting | Dresden | Saxony | 01307 | Germany |
| Site Number - 6503 | Recruiting | Munich | 80336 | Germany |
| Site Number - 6508 | Recruiting | Munich | 81667 | Germany |
| Site Number - 6502 | Recruiting | Schwerin | 19049 | Germany |
| Site Number - 6507 | Recruiting | Würzburg | 97080 | Germany |
| Site Number - 7558 | Recruiting | Békéscsaba | 5600 | Hungary |
| Site Number - 7554 | Recruiting | Budapest | 1036 | Hungary |
| Site Number - 7556 | Recruiting | Budapest | 1083 | Hungary |
| Site Number - 7557 | Recruiting | Debrecen | 4032 | Hungary |
| Site Number - 7551 | Recruiting | Pécs | 7623 | Hungary |
| Site Number - 7552 | Recruiting | Szeged | 6725 | Hungary |
| Site Number - 6004 | Recruiting | Bologna | 40138 | Italy |
| Site Number - 6012 | Recruiting | Cagliari | 09124 | Italy |
| Site Number - 6011 | Recruiting | Genova | 16132 | Italy |
| Site Number - 6002 | Recruiting | Milan | 20122 | Italy |
| Site Number - 6009 | Recruiting | Milan | 20162 | Italy |
| Site Number - 6007 | Recruiting | Milan | 20149 | Italy |
| Site Number - 6010 | Recruiting | Naples | 80131 | Italy |
| Site Number - 6003 | Recruiting | Pisa | 56124 | Italy |
| Site Number - 6001 | Recruiting | Pisa | 56126 | Italy |
| Site Number - 6005 | Recruiting | Roma | 00189 | Italy |
| Site Number - 6013 | Recruiting | Siena | 53100 | Italy |
| Site Number - 6008 | Recruiting | Varese | 21100 | Italy |
| Site Number - 3006 | Recruiting | Gliwice | 44-102 | Poland |
| Site Number - 3002 | Recruiting | Krakow | 30-074 | Poland |
| Site Number -3003 | Recruiting | Krakow | 30-688 | Poland |
| Site Number - 3005 | Recruiting | Lublin | 20-400 | Poland |
| Site Number - 3008 | Recruiting | Lublin | 20-607 | Poland |
| Site Number - 3004 | Recruiting | Lublin | 91-495 | Poland |
| Site Number - 3007 | Recruiting | Poznan | 60-354 | Poland |
| Site Number - 3001 | Recruiting | Warsaw | 00-0189 | Poland |
| Site Number - 1058 | Recruiting | San Juan | 00907 | Puerto Rico |
| Site Number - 1037 | Withdrawn | San Juan | 00921-3313 | Puerto Rico |
| Site Number - 7104 | Recruiting | Badalona | Barcelona | 08916 | Spain |
| Site Number - 7109 | Recruiting | Barcelona | 08035 | Spain |
| Site Number - 7103 | Recruiting | Barcelona | 08036 | Spain |
| Site Number - 7102 | Recruiting | Córdoba | 14004 | Spain |
| Site Number - 7106 | Recruiting | Granada | 18014 | Spain |
| Site Number - 7105 | Recruiting | Madrid | 28006 | Spain |
| Site Number - 7107 | Recruiting | Pamplona | 31008 | Spain |
| Site Number - 7108 | Recruiting | Pamplona | 31008 | Spain |
| Site Number - 7101 | Recruiting | Seville | 41009 | Spain |
| Site Number - 7013 | Recruiting | Birmingham | England | B15 2TT | United Kingdom |
| Site Number - 7012 | Recruiting | Bristol | England | BS10 5NB | United Kingdom |
| Site Number - 7011 | Recruiting | Coventry | England | CV2 2DX | United Kingdom |
| Site Number - 7007 | Recruiting | London | England | NW1 2PG | United Kingdom |
| Site Number - 7014 | Recruiting | Cambridge | London | CB2 0QQ | United Kingdom |
| Site Number - 7002 | Recruiting | Cardiff | CF14 4XW | United Kingdom |
| Site Number - 7008 | Recruiting | Edinburgh | EH16 4SA | United Kingdom |
| Site Number - 7005 | Recruiting | Huddersfield | HD3 3EA | United Kingdom |
| Site Number - 7004 | Recruiting | Hull | HU6 7RX | United Kingdom |
| Site Number - 7003 | Recruiting | London | SE5 9RS | United Kingdom |
| Site Number - 7006 | Recruiting | Manchester | M20 4BX | United Kingdom |
| Site Number - 7001 | Recruiting | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| Site Number - 7009 | Recruiting | Norwich | NR4 7UY | United Kingdom |
| Site Number - 7010 | Recruiting | Nuneaton | CV10 7DJ | United Kingdom |
| ID | Term |
|---|---|
| D006111 | Graves Disease |
| D006980 | Hyperthyroidism |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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