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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
240
600 mg SC QW for 52 weeks
600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
SC QW for 52 weeks
Site Number - 1032
Phoenix, Arizona, United States
WITHDRAWNSite Number - 1036
Phoenix, Arizona, United States
RECRUITINGSite Number - 1061
Huntington Beach, California, United States
RECRUITINGSite Number - 1001
Los Angeles, California, United States
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
Time frame: Week 26
Percentage of participants who are euthyroid and off ATD at Week 52
Time frame: Week 52
Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52
Time frame: Week 52
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 4
Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26
Time frame: Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 26
Time frame: Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 52
Time frame: Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site Number - 1047
Los Angeles, California, United States
RECRUITINGSite Number - 1062
Orange, California, United States
RECRUITINGSite Number - 1046
Sacramento, California, United States
RECRUITINGSite Number - 1034
San Francisco, California, United States
RECRUITINGSite Number - 1035
Santa Clarita, California, United States
WITHDRAWNSite Number - 1005
Torrance, California, United States
RECRUITING...and 124 more locations