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This is a long-term extension study that will rollover participants completing feeder studies IMVT-1402-2502 (NCT06727604) or IMVT-1402-2503 (NCT07018323) to evaluate the efficacy and safety of IMVT-1402 in adult participants with GD. Eligible participants will be assigned to 1 of 3 study groups (Groups A, B and C) based on their GD status at the completion of their respective feeder study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | No Intervention | ||
| Group C | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMVT-1402 | Drug | Dose 1 for up to 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402 | At Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Group A Participants who are euthyroid and off ATD | At Week 26 | |
| Percentage of Group A Participants who are euthyroid and off ATD | Up to Week 52 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Number - 1561 | Phoenix | Arizona | 85006 | United States | ||
| Site Number - 1519 |
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| Percentage of Group A Participants who are euthyroid, off ATD, and off IMVT-1402 |
| Up to Week 52 |
| Time to earliest date of euthyroidism, off ATD, and off IMVT-1402 to the earliest date of confirmed relapse in Group A Participants | Up to Week 52 |
| Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402 | Up to Week 52 |
| Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402 | At Week 52 |
| Time from Week 0 to the earliest date of confirmed relapse in Group B Participants | Up to Week 52 |
| Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402 | Up to Week 52 |
| Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402 | At Week 52 |
| Time From Week 0 to the earliest date of confirmed relapse in Group C Participants | Up to Week 52 |
| Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb | At Week 26 |
| Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb | Up to Week 52 |
| Phoenix |
| Arizona |
| 85015 |
| United States |
| Site Number - 1530 | Tucson | Arizona | 85710 | United States |
| Site Number - 1510 | Concord | California | 94520 | United States |
| Site Number - 1587 | Huntington Beach | California | 92647 | United States |
| Site Number - 1554 | Los Angeles | California | 90033 | United States |
| Site Number - 1588 | Orange | California | 92868 | United States |
| Site Number - 1559 | San Francisco | California | 94143 | United States |
| Site Number - 1558 | Santa Clarita | California | 91321 | United States |
| Site Number - 1552 | Torrance | California | 90509 | United States |
| Site Number - 1533 | Aurora | Colorado | 80045 | United States |
| Site Number -1514 | Englewood | Colorado | 80113 | United States |
| Site Number - 1516 | Newark | Delaware | 19713 | United States |
| Site Number - 1567 | Washington D.C. | District of Columbia | 20010 | United States |
| Site Number - 1556 | Clearwater | Florida | 33756 | United States |
| Site Number - 1522 | Doral | Florida | 33166 | United States |
| Site Number - 1523 | Hialeah | Florida | 33016 | United States |
| Site Number - 1581 | Jacksonville | Florida | 32204-1177 | United States |
| Site Number - 1582 | Jacksonville | Florida | 48334 | United States |
| Site Number - 1505 | Miami | Florida | 33143 | United States |
| Site Number - 1564 | Miami | Florida | 39501 | United States |
| Site Number - 1591 | Miami | Florida | 78240 | United States |
| Site Number - 1590 | Ocoee | Florida | 34761 | United States |
| Site Number - 1508 | Orlando | Florida | 32819 | United States |
| Site Number - 1507 | Port Charlotte | Florida | 33952 | United States |
| Site Number - 1548 | West Palm Beach | Florida | 33401 | United States |
| Site Number - 1566 | Atlanta | Georgia | 30318 | United States |
| Site Number - 1526 | Columbus | Georgia | 31904 | United States |
| Site Number - 1579 | Macon | Georgia | 31210 | United States |
| Site Number - 1518 | Stockbridge | Georgia | 30281 | United States |
| Site Number - 1562 | Indianapolis | Indiana | 46202 | United States |
| Site Number - 1568 | Kansas City | Kansas | 66210 | United States |
| Site Number - 1534 | Topeka | Kansas | 66606 | United States |
| Site Number - 1571 | Bowling Green | Kentucky | 42101 | United States |
| Site Number - 1580 | Florence | Kentucky | 65613 | United States |
| Site Number - 1546 | Louisville | Kentucky | 40202 | United States |
| Site Number - 1589 | Metairie | Louisiana | 70006 | United States |
| Site Number - 1555 | New Orleans | Louisiana | 70112 | United States |
| Site Number - 1565 | Baltimore | Maryland | 21287 | United States |
| Site Number - 1557 | Boston | Massachusetts | 32216 | United States |
| Site Number - 1503 | Farmington Hills | Michigan | 33186 | United States |
| Site Number - 1595 | Flint | Michigan | 48532 | United States |
| Site Number - 1515 | Rochester | Minnesota | 55905 | United States |
| Site Number - 1594 | Gulfport | Mississippi | 33136 | United States |
| Site Number - 1511 | Jefferson City | Missouri | 65109-6023 | United States |
| Site Number - 1537 | Kansas City | Missouri | 64108 | United States |
| Site Number - 1521 | Omaha | Nebraska | 68105 | United States |
| Site Number - 1512 | Las Vegas | Nevada | 89148 | United States |
| Site Number - 1528 | Reno | Nevada | 89511 | United States |
| Site Number - 1576 | Monroe | New York | 10950 | United States |
| Site Number - 1544 | New Hyde Park | New York | 11042 | United States |
| Site Number - 1531 | New York | New York | 10022 | United States |
| Site Number - 1539 | New York | New York | 11106 | United States |
| Site Number - 1542 | Williamsville | New York | 14221 | United States |
| Site Number - 1577 | Asheville | North Carolina | 28803 | United States |
| Site Number - 1509 | Chapel Hill | North Carolina | 27514 | United States |
| Site Number - 1506 | Hickory | North Carolina | 28601 | United States |
| Site Number - 1500 | Morehead City | North Carolina | 28557 | United States |
| Site Number - 1540 | Raleigh | North Carolina | 27612 | United States |
| Site Number - 1586 | Wilmington | North Carolina | 28401 | United States |
| Site Number - 1583 | Canton | Ohio | 44718 | United States |
| Site Number - 1536 | Oklahoma City | Oklahoma | 73118 | United States |
| Site Number - 1549 | Portland | Oregon | 97035 | United States |
| Site Number - 1560 | Philadelphia | Pennsylvania | 19140 | United States |
| Site Number - 1570 | Pottstown | Pennsylvania | 19464 | United States |
| Site Number - 1550 | Summerville | South Carolina | 29485 | United States |
| Site Number - 1569 | Chattanooga | Tennessee | 37421 | United States |
| Site Number - 1524 | Memphis | Tennessee | 38119 | United States |
| Site Number - 1592 | Nashville | Tennessee | 37203 | United States |
| Site Number - 1575 | Nashville | Tennessee | 37212 | United States |
| Site Number - 1517 | Austin | Texas | 78731 | United States |
| Site Number - 1593 | Bellaire | Texas | 77401 | United States |
| Site Number - 1513 | Dallas | Texas | 75208 | United States |
| Site Number - 1551 | Dallas | Texas | 75231 | United States |
| Site Number - 1538 | Dallas | Texas | 75246 | United States |
| Site Number - 1502 | El Paso | Texas | 79935 | United States |
| Site Number - 1504 | Fort Worth | Texas | 76132 | United States |
| Site Number - 1597 | Houston | Texas | 77089 | United States |
| Site Number - 1525 | Irving | Texas | 75039 | United States |
| Site Number - 1529 | McKinney | Texas | 75069 | United States |
| Site Number - 1501 | Mesquite | Texas | 75149 | United States |
| Site Number - 1520 | Round Rock | Texas | 78681 | United States |
| Site Number - 1578 | San Antonio | Texas | 02114 | United States |
| Site Number - 1553 | San Antonio | Texas | 78215 | United States |
| Site Number - 1532 | San Antonio | Texas | 78229 | United States |
| Site Number - 1527 | San Antonio | Texas | 78231 | United States |
| Site Number - 1563 | Salt Lake City | Utah | 84108 | United States |
| Site Number - 1596 | Sandy City | Utah | 84093 | United States |
| Site Number - 1535 | Norfolk | Virginia | 23507 | United States |
| Site Number - 5150 | Southport | Queensland | 4222 | Australia |
| Site Number - 5651 | Varna | 9020 | Bulgaria |
| Site Number - 5654 | Varna | 9020 | Bulgaria |
| Site Number - 3252 | Prague | 190 14 | Czechia |
| 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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