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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
372
Dose 1 for up to 52 weeks
Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402
Time frame: At Week 52
Percentage of Group A Participants who are euthyroid and off ATD
Time frame: At Week 26
Percentage of Group A Participants who are euthyroid and off ATD
Time frame: Up to Week 52
Percentage of Group A Participants who are euthyroid, off ATD, and off IMVT-1402
Time frame: 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
Time frame: Up to Week 52
Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402
Time frame: Up to Week 52
Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402
Time frame: At Week 52
Time from Week 0 to the earliest date of confirmed relapse in Group B Participants
Time frame: Up to Week 52
Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402
Time frame: Up to Week 52
Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402
Time frame: At Week 52
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Site Number - 1561
Phoenix, Arizona, United States
Site Number - 1519
Phoenix, Arizona, United States
Site Number - 1530
Tucson, Arizona, United States
Site Number - 1510
Concord, California, United States
Site Number - 1587
Huntington Beach, California, United States
Site Number - 1554
Los Angeles, California, United States
Site Number - 1588
Orange, California, United States
Site Number - 1559
San Francisco, California, United States
Site Number - 1558
Santa Clarita, California, United States
Site Number - 1552
Torrance, California, United States
...and 79 more locations
Time From Week 0 to the earliest date of confirmed relapse in Group C Participants
Time frame: Up to Week 52
Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb
Time frame: At Week 26
Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb
Time frame: Up to Week 52