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A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Sponsor: Immunovant Sciences GmbH
Summary
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.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-12-17
Completion Date
2028-06
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
IMVT-1402
600 mg SC QW for 52 weeks
IMVT-1402
600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
Placebo
SC QW for 52 weeks
Locations (125)
Site Number - 1032
Phoenix, Arizona, United States
Site Number - 1036
Phoenix, Arizona, United States
Site Number - 1061
Huntington Beach, California, United States
Site Number - 1001
Los Angeles, California, United States
Site Number - 1047
Los Angeles, California, United States
Site Number - 1062
Orange, California, United States
Site Number - 1046
Sacramento, California, United States
Site Number - 1034
San Francisco, California, United States
Site Number - 1035
Santa Clarita, California, United States
Site Number - 1005
Torrance, California, United States
Site Number - 1006
Walnut Creek, California, United States
Site Number - 1013
Englewood, Colorado, United States
Site Number - 1010
Newark, Delaware, United States
Site Number - 1040
Washington D.C., District of Columbia, United States
Site Number - 1029
Clearwater, Florida, United States
Site Number - 1055
Jacksonville, Florida, United States
Site Number - 1056
Jacksonville, Florida, United States
Site Number - 1028
Miami, Florida, United States
Site Number - 1065
Miami, Florida, United States
Site Number - 1064
Ocoee, Florida, United States
Site Number - 1011
Orlando, Florida, United States
Site Number - 1016
Port Charlotte, Florida, United States
Site Number - 1012
West Palm Beach, Florida, United States
Site Number - 1038
Atlanta, Georgia, United States
Site Number - 1053
Macon, Georgia, United States
Site Number - 1020
Stockbridge, Georgia, United States
Site Number - 1027
Indianapolis, Indiana, United States
Site Number - 1041
Kansas City, Kansas, United States
Site Number - 1045
Bowling Green, Kentucky, United States
Site Number - 1054
Florence, Kentucky, United States
Site Number - 1022
New Orleans, Louisiana, United States
Site Number - 1048
Shreveport, Louisiana, United States
Site Number - 1023
Baltimore, Maryland, United States
Site Number - 1026
Boston, Massachusetts, United States
Site Number - 1018
Farmington Hills, Michigan, United States
Site Number - 1008
Rochester, Minnesota, United States
Site Number - 1017
Omaha, Nebraska, United States
Site Number - 1007
Las Vegas, Nevada, United States
Site Number - 1050
Monroe, New York, United States
Site Number - 1051
Asheville, North Carolina, United States
Site Number - 1057
Canton, Ohio, United States
Site Number - 1003
Portland, Oregon, United States
Site Number - 1033
Philadelphia, Pennsylvania, United States
Site Number - 1043
Pottstown, Pennsylvania, United States
Site Number - 1015
Summerville, South Carolina, United States
Site Number - 1042
Chattanooga, Tennessee, United States
Site Number - 1066
Nashville, Tennessee, United States
Site Number - 1002
Austin, Texas, United States
Site Number - 1067
Bellaire, Texas, United States
Site Number - 1019
Dallas, Texas, United States
Site Number - 1031
Dallas, Texas, United States
Site Number - 1071
Houston, Texas, United States
Site Number - 1025
Houston, Texas, United States
Site Number - 1004
Mesquite, Texas, United States
Site Number - 1009
Round Rock, Texas, United States
Site Number - 1014
San Antonio, Texas, United States
Site Number - 1052
San Antonio, Texas, United States
Site Number - 1030
Salt Lake City, Utah, United States
Site Number - 5303
Antwerp, Belgium
Site Number - 5301
Bruges, Belgium
Site Number - 5302
Brussels, Belgium
Site Number - 8002
Batumi, Georgia
Site Number - 8007
Batumi, Georgia
Site Number - 8006
Kutaisi, Georgia
Site Number - 8008
Marneuli, Georgia
Site Number - 8009
Tbilisi, Georgia
Site Number - 8004
Tbilisi, Georgia
Site Number - 8005
Tbilisi, Georgia
Site Number - 8001
Tbilisi, Georgia
Site Number - 8003
Tbilisi, Georgia
Site Number - 8011
Tbilisi, Georgia
Site Number - 8010
Tbilisi, Georgia
Site Number - 6505
Dresden, Saxony, Germany
Site Number - 6508
Munich, Germany
Site Number - 6502
Schwerin, Germany
Site Number - 6507
Würzburg, Germany
Site Number - 7558
Békéscsaba, Hungary
Site Number - 7554
Budapest, Hungary
Site Number - 7556
Budapest, Hungary
Site Number - 7557
Debrecen, Hungary
Site Number - 7551
Pécs, Hungary
Site Number - 7552
Szeged, Hungary
Site Number - 6004
Bologna, Italy
Site Number - 6012
Cagliari, Italy
Site Number - 6011
Genova, Italy
Site Number - 6002
Milan, Italy
Site Number - 6009
Milan, Italy
Site Number - 6007
Milan, Italy
Site Number - 6010
Naples, Italy
Site Number - 6003
Pisa, Italy
Site Number - 6001
Pisa, Italy
Site Number - 6005
Roma, Italy
Site Number - 6013
Siena, Italy
Site Number - 6008
Varese, Italy
Site Number - 3006
Gliwice, Poland
Site Number - 3002
Krakow, Poland
Site Number -3003
Krakow, Poland
Site Number - 3005
Lublin, Poland
Site Number - 3004
Lublin, Poland
Site Number - 3007
Poznan, Poland
Site Number - 3001
Warsaw, Poland
Site Number - 1058
San Juan, Puerto Rico
Site Number - 1037
San Juan, Puerto Rico
Site Number - 7104
Badalona, Barcelona, Spain
Site Number - 7109
Barcelona, Spain
Site Number - 7103
Barcelona, Spain
Site Number - 7102
Córdoba, Spain
Site Number - 7106
Granada, Spain
Site Number - 7105
Madrid, Spain
Site Number - 7107
Pamplona, Spain
Site Number - 7108
Pamplona, Spain
Site Number - 7101
Seville, Spain
Site Number - 7013
Birmingham, England, United Kingdom
Site Number - 7012
Bristol, England, United Kingdom
Site Number - 7011
Coventry, England, United Kingdom
Site Number - 7007
London, England, United Kingdom
Site Number - 7002
Cardiff, United Kingdom
Site Number - 7008
Edinburgh, United Kingdom
Site Number - 7005
Huddersfield, United Kingdom
Site Number - 7004
Hull, United Kingdom
Site Number - 7003
London, United Kingdom
Site Number - 7006
Manchester, United Kingdom
Site Number - 7001
Newcastle upon Tyne, United Kingdom
Site Number - 7009
Norwich, United Kingdom
Site Number - 7010
Nuneaton, United Kingdom