Phase
Condition
Thyroid Disease
Female Hormonal Deficiencies/abnormalities
Thyroid Disorders
Treatment
IMVT-1402
Placebo
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
Antwerp 2803138, 2820
BelgiumActive - Recruiting
Site Number - 5303
Antwerpen, 2820
BelgiumSite Not Available
Site Number - 5301
Bruges 2800931, 80000
BelgiumActive - Recruiting
Site Number - 8002
Batumi, 6000
GeorgiaSite Not Available
Site Number - 8002
Batumi 615532, 6000
GeorgiaActive - Recruiting
Site Number - 8007
Batumi 615532, 6010
GeorgiaActive - Recruiting
Site Number - 8006
Kutaisi, 4600
GeorgiaSite Not Available
Site Number - 8006
Kutaisi 613607, 4600
GeorgiaActive - Recruiting
Site Number - 8008
Marneuli 613074, 3000
GeorgiaActive - Recruiting
Site Number - 8009
Tbilisi, 0112
GeorgiaSite Not Available
Site Number - 8001
Tbilisi 611717, 0159
GeorgiaActive - Recruiting
Site Number - 8003
Tbilisi 611717, 0159
GeorgiaActive - Recruiting
Site Number - 8004
Tbilisi 611717, 0144
GeorgiaActive - Recruiting
Site Number - 8005
Tbilisi 611717, 0144
GeorgiaActive - Recruiting
Site Number - 8009
Tbilisi 611717, 0112
GeorgiaActive - Recruiting
Site Number - 8010
Tbilisi 611717, 0177
GeorgiaActive - Recruiting
Site Number - 8011
Tbilisi 611717, 0159
GeorgiaActive - Recruiting
Site Number - 6505
Dresden 2935022, Saxony 2842566 01307
GermanyActive - Recruiting
Site Number - 6502
Schwerin 2834282, 19049
GermanyActive - Recruiting
Site Number - 7554
Budapest, 1036
HungarySite Not Available
Site Number - 7554
Budapest 3054643, 1036
HungaryActive - Recruiting
Site Number - 7556
Budapest 3054643, 1083
HungaryActive - Recruiting
Site Number - 7551
Pécs, 7623
HungarySite Not Available
Site Number - 7551
Pécs 3046526, 7623
HungaryActive - Recruiting
Site Number - 7552
Szeged 715429, 6725
HungaryActive - Recruiting
Site Number - 6004
Bologna 3181928, 40138
ItalyActive - Recruiting
Site Number - 6012
Cagliari 2525473, 09124
ItalyActive - Recruiting
Site Number - 6007
Milan 6951411, 20149
ItalyActive - Recruiting
Site Number - 6010
Napoli 9031661, 80131
ItalyActive - Recruiting
Site Number - 3002
Krakow 3094802, 30-074
PolandActive - Recruiting
Site Number -3003
Krakow 3094802, 30-688
PolandActive - Recruiting
Site Number - 3004
Lublin, 91-495
PolandSite Not Available
Site Number - 3005
Lublin, 20-400
PolandActive - Recruiting
Site Number - 3004
Lublin 765876, 91-495
PolandActive - Recruiting
Site Number - 3005
Lublin 765876, 20-400
PolandActive - Recruiting
Site Number - 3001
Warsaw, 00-0189
PolandSite Not Available
Site Number - 3001
Warsaw 756135, 00-0189
PolandActive - Recruiting
Site Number - 1037
San Juan, 00921-3313
Puerto RicoSite Not Available
Site Number - 1037
San Juan 4568127, 00921-3313
Puerto RicoActive - Recruiting
Site Number - 7104
Badalona 3129028, Barcelona 08916
SpainActive - Recruiting
Site Number - 7103
Barcelona, 08036
SpainSite Not Available
Site Number - 7103
Barcelona 3128760, 08036
SpainActive - Recruiting
Site Number - 7102
Córdoba, 14004
SpainSite Not Available
Site Number - 7102
Córdoba 2519240, 14004
SpainActive - Recruiting
Site Number - 7105
Madrid 3117735, 28006
SpainActive - Recruiting
Site Number - 7101
Sevilla, 41009
SpainSite Not Available
Site Number - 7101
Seville 2510911, 41009
SpainActive - Recruiting
Site Number - 7007
London 2643743, England 6269131 NW1 2PG
United KingdomActive - Recruiting
Site Number - 7002
Cardiff, CF14 4XW
United KingdomSite Not Available
Site Number - 7002
Cardiff 2653822, CF14 4XW
United KingdomActive - Recruiting
Site Number - 7005
Huddersfield, HD3 3EA
United KingdomSite Not Available
Site Number - 7005
Huddersfield 2646458, HD3 3EA
United KingdomActive - Recruiting
Site Number - 7004
Hull 2645425, HU6 7RX
United KingdomActive - Recruiting
Site Number - 7003
London 2643743, SE5 9RS
United KingdomActive - Recruiting
Site Number - 7006
Manchester 2643123, M20 4BX
United KingdomActive - Recruiting
Site Number - 7001
Newcastle upon Tyne 2641673, NE1 4LP
United KingdomActive - Recruiting
Site Number - 1036
Phoenix, Arizona 85015
United StatesSite Not Available
Site Number - 1032
Phoenix 5308655, Arizona 5551752 85006
United StatesActive - Recruiting
Site Number - 1036
Phoenix 5308655, Arizona 5551752 85015
United StatesActive - Recruiting
Site Number - 1001
Los Angeles, California 90033
United StatesSite Not Available
Site Number - 1034
San Francisco, California 94143
United StatesSite Not Available
Site Number - 1035
Santa Clarita, California 91321
United StatesSite Not Available
Site Number - 1005
Torrance, California 90502
United StatesSite Not Available
Site Number - 1006
Walnut Creek, California 94598
United StatesSite Not Available
Site Number - 1001
Los Angeles 5368361, California 5332921 90033
United StatesActive - Recruiting
Site Number - 1034
San Francisco 5391959, California 5332921 94143
United StatesActive - Recruiting
Site Number - 1035
Santa Clarita 5393049, California 5332921 91321
United StatesActive - Recruiting
Site Number - 1005
Torrance 5403022, California 5332921 90502
United StatesActive - Recruiting
Site Number - 1006
Walnut Creek 5406990, California 5332921 94598
United StatesSite Not Available
Site Number - 1013
Englewood, Colorado 80113
United StatesSite Not Available
Site Number - 1013
Englewood 5421250, Colorado 5417618 80113
United StatesActive - Recruiting
Site Number - 1010
Newark, Delaware 19713
United StatesSite Not Available
Site Number - 1010
Newark 4143861, Delaware 4142224 19713
United StatesActive - Recruiting
Site Number - 1029
Clearwater, Florida 33756
United StatesSite Not Available
Site Number - 1011
Orlando, Florida 32819
United StatesSite Not Available
Site Number - 1016
Port Charlotte, Florida 33952
United StatesSite Not Available
Site Number - 1012
West Palm Beach, Florida 33401
United StatesSite Not Available
Site Number - 1029
Clearwater 4151316, Florida 4155751 33756
United StatesActive - Recruiting
Site Number - 1028
Miami 4164138, Florida 4155751 33136
United StatesActive - Recruiting
Site Number - 1011
Orlando 4167147, Florida 4155751 32819
United StatesActive - Recruiting
Site Number - 1016
Port Charlotte 4169130, Florida 4155751 33952
United StatesActive - Recruiting
Site Number - 1012
West Palm Beach 4177887, Florida 4155751 33401
United StatesActive - Recruiting
Site Number - 1020
Stockbridge, Georgia 30281
United StatesSite Not Available
Site Number - 1020
Stockbridge 4224681, Georgia 4197000 30281
United StatesActive - Recruiting
Site Number - 1027
Indianapolis 4259418, Indiana 4921868 46202
United StatesActive - Recruiting
Site Number - 1022
New Orleans, Louisiana 70112
United StatesSite Not Available
Site Number - 1022
New Orleans 4335045, Louisiana 4331987 70112
United StatesActive - Recruiting
Site Number - 1023
Baltimore 4347778, Maryland 4361885 21287
United StatesActive - Recruiting
Site Number - 1026
Boston, Massachusetts 02114
United StatesSite Not Available
Site Number - 1026
Boston 4930956, Massachusetts 6254926 02114
United StatesActive - Recruiting
Site Number - 1018
Farmington Hills, Michigan 48334
United StatesSite Not Available
Site Number - 1018
Farmington Hills 4992523, Michigan 5001836 48334
United StatesActive - Recruiting
Site Number - 1008
Rochester, Minnesota 55905
United StatesSite Not Available
Site Number - 1008
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
Site Number - 1017
Omaha, Nebraska 68105
United StatesSite Not Available
Site Number - 1017
Omaha 5074472, Nebraska 5073708 68105
United StatesActive - Recruiting
Site Number - 1007
Las Vegas, Nevada 89148
United StatesSite Not Available
Site Number - 1007
Las Vegas 5506956, Nevada 5509151 89148
United StatesActive - Recruiting
Site Number - 1003
Portland, Oregon 97035
United StatesSite Not Available
Site Number - 1003
Portland 5746545, Oregon 5744337 97035
United StatesActive - Recruiting
Site Number - 1033
Philadelphia 4560349, Pennsylvania 6254927 19140
United StatesActive - Recruiting
Site Number - 1015
Summerville, South Carolina 29485
United StatesSite Not Available
Site Number - 1015
Summerville 4597919, South Carolina 4597040 29485
United StatesActive - Recruiting
Site number - 1002
Austin, Texas 78731
United StatesSite Not Available
Site Number - 1019
Dallas, Texas 75208
United StatesSite Not Available
Site Number - 1031
Dallas, Texas 75231
United StatesActive - Recruiting
Site Number - 1025
Houston, Texas 77095
United StatesSite Not Available
Site Number - 1004
Mesquite, Texas 75149
United StatesSite Not Available
Site Number - 1009
Round Rock, Texas 78681
United StatesSite Not Available
Site Number - 1014
San Antonio, Texas 78215
United StatesSite Not Available
Site Number - 1002
Austin 4671654, Texas 4736286 78731
United StatesActive - Recruiting
Site Number - 1019
Dallas 4684888, Texas 4736286 75208
United StatesActive - Recruiting
Site Number - 1031
Dallas 4684888, Texas 4736286 75231
United StatesActive - Recruiting
Site Number - 1025
Houston 4699066, Texas 4736286 77095
United StatesSite Not Available
Site Number - 1004
Mesquite 4710826, Texas 4736286 75149
United StatesActive - Recruiting
Site Number - 1009
Round Rock 4724129, Texas 4736286 78681
United StatesActive - Recruiting
Site Number - 1014
San Antonio 4726206, Texas 4736286 78215
United StatesActive - Recruiting
Site Number - 1030
Salt Lake City 5780993, Utah 5549030 84108
United StatesActive - Recruiting
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