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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
210
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)
Time frame: Week 26
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
Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1)
Time frame: Week 26
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2)
Time frame: 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
Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2)
Time frame: 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
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
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
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Site Number - 1015
Tucson, Arizona, United States
RECRUITINGSite Number -1014
Concord, California, United States
RECRUITINGSite Number - 1013
Aurora, Colorado, United States
RECRUITINGSite Number - 1024
Doral, Florida, United States
RECRUITINGSite Number - 1008
Hialeah, Florida, United States
RECRUITINGSite Number - 1000
Miami, Florida, United States
RECRUITINGSite Number - 1020
Columbus, Georgia, United States
RECRUITINGSite Number - 1022
Topeka, Kansas, United States
RECRUITINGSite Number - 1030
Louisville, Kentucky, United States
RECRUITINGSite Number - 1033
Jefferson City, Missouri, United States
RECRUITING...and 135 more locations
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