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 of ≥ 20 mg/daymethimazole 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 - 5303
Antwerpen, 2820
BelgiumActive - Recruiting
Site Number - 8002
Batumi, 6000
GeorgiaActive - Recruiting
Site Number - 8006
Kutaisi, 4600
GeorgiaActive - Recruiting
Site Number - 8009
Tbilisi, 0112
GeorgiaActive - Recruiting
Site Number - 7554
Budapest, 1036
HungaryActive - Recruiting
Site Number - 7551
Pécs, 7623
HungaryActive - Recruiting
Site Number - 3004
Lublin, 91-495
PolandActive - Recruiting
Site Number - 3005
Lublin, 20-400
PolandActive - Recruiting
Site Number - 3001
Warsaw, 00-0189
PolandActive - Recruiting
Site Number - 1037
San Juan, 00921-3313
Puerto RicoActive - Recruiting
Site Number - 7103
Barcelona, 08036
SpainActive - Recruiting
Site Number - 7102
Córdoba, 14004
SpainActive - Recruiting
Site Number - 7101
Sevilla, 41009
SpainActive - Recruiting
Site Number - 7002
Cardiff, CF14 4XW
United KingdomActive - Recruiting
Site Number - 7005
Huddersfield, HD3 3EA
United KingdomActive - Recruiting
Site Number - 1036
Phoenix, Arizona 85015
United StatesActive - Recruiting
Site Number - 1001
Los Angeles, California 90033
United StatesActive - Recruiting
Site Number - 1034
San Francisco, California 94143
United StatesActive - Recruiting
Site Number - 1035
Santa Clarita, California 91321
United StatesActive - Recruiting
Site Number - 1005
Torrance, California 90502
United StatesActive - Recruiting
Site Number - 1006
Walnut Creek, California 94598
United StatesActive - Recruiting
Site Number - 1013
Englewood, Colorado 80113
United StatesActive - Recruiting
Site Number - 1010
Newark, Delaware 19713
United StatesActive - Recruiting
Site Number - 1029
Clearwater, Florida 33756
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 - 1020
Stockbridge, Georgia 30281
United StatesActive - Recruiting
Site Number - 1022
New Orleans, Louisiana 70112
United StatesActive - Recruiting
Site Number - 1026
Boston, Massachusetts 02114
United StatesActive - Recruiting
Site Number - 1018
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
Site Number - 1008
Rochester, Minnesota 55905
United StatesActive - Recruiting
Site Number - 1017
Omaha, Nebraska 68105
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 - 1025
Houston, Texas 77095
United StatesActive - Recruiting
Site Number - 1004
Mesquite, Texas 75149
United StatesActive - Recruiting
Site Number - 1009
Round Rock, Texas 78681
United StatesActive - Recruiting
Site Number - 1014
San Antonio, Texas 78215
United StatesActive - Recruiting
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