Phase
Condition
Thyroid Disease
Thyroid Disorders
Treatment
Placebo
IMVT-1402
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have documented diagnosis of GD.
Have a TSH value < 0.1 mIU/L as assessed by the local laboratory at the ScreeningVisit.
Meet one of the following at the Screening Visit:
Have been on ATD for ≥ 3 months in the period immediately preceding theScreening Visit and both of the following:
Are on ATD at the Screening Visit with an ATD dose a specified amount ofmethimazole or equivalent for the 4-week period immediately preceding theScreening Visit.
Are anticipated to be on a stable dose of ATD for the 4-week periodimmediately preceding Randomization.
Have been on ATD for ≥ 6 months in the period immediately preceding theScreening Visit and all of the following:
Have been treated with ≥ 15 mg/day methimazole or equivalent at any pointduring the participant's treatment history.
Are on ATD at the Screening Visit with an ATD dose a specified amount ofmethimazole or equivalent for the 4-week period immediately preceding theScreening Visit.
Are anticipated to be on a stable dose of ATD for the 4-week periodimmediately preceding Randomization.
Additional inclusion criteria are defined in the protocol.
Exclusion
Exclusion Criteria:
Have previously been treated with radioactive iodine (RAI) therapy or have undergonetotal thyroidectomy.
Have a T3 (Total T3 or FT3, as available and per standard of care at locallaboratory) or FT4 value < lower limit of normal (LLN) as assessed by the locallaboratory at the Screening Visit.
Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6weeks of the Screening Visit.
Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxicmultinodular goiter) and/or history of thyroid storm within 6 months of theScreening Visit.
Have an autoimmune disease other than GD requiring treatment that, in theInvestigator's judgment, puts the participant at undue risk.
Have moderate-to-severe active thyroid eye disease (TED) and are expected to requireimmediate surgical intervention and/or are planning corrective surgery/irradiationor medical therapy for TED during study participation.
Additional exclusion criteria are defined in the protocol.
Study Design
Connect with a study center
Site Number - 1006
Walnut Creek, California 94598
United StatesActive - Recruiting
Site Number - 1013
Englewood, Colorado 80113
United StatesActive - Recruiting
Site Number - 1011
Orlando, Florida 32819
United StatesActive - Recruiting
Site Number - 1016
Port Charlotte, Florida 33952
United StatesActive - Recruiting
Site Number - 1012
West Palm Beach, Florida 33401
United StatesActive - Recruiting
Site Number - 1018
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
Site Number - 1007
Las Vegas, Nevada 89148
United StatesActive - Recruiting
Site Number - 1003
Portland, Oregon 97035
United StatesActive - Recruiting
Site Number - 1015
Summerville, South Carolina 29485
United StatesActive - Recruiting
Site Number - 1002
Austin, Texas 78731
United StatesActive - Recruiting
Site Number - 1019
Dallas, Texas 75208
United StatesActive - Recruiting
Site Number - 1031
Dallas, Texas 75231
United StatesActive - Recruiting
Site Number - 1004
Mesquite, Texas 75149
United StatesActive - Recruiting
Site Number - 1009
Round Rock, Texas 78681
United StatesActive - Recruiting
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