Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06727604

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease

Led by Immunovant Sciences GmbH · Updated on 2026-05-08

240

Participants Needed

133

Research Sites

180 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand trial requirements, provide written informed consent, and comply with study procedures
  • Male or female participants aged 18 years or older
  • Diagnosis of Graves' disease with hyperthyroidism despite antithyroid drug treatment
  • Additional specific inclusion criteria defined in the protocol
Not Eligible

You will not qualify if you...

  • Prior successful treatment with radioactive iodine therapy or total thyroidectomy
  • Presence of autoimmune disease other than Graves' disease requiring treatment and posing undue risk
  • Moderate-to-severe active thyroid eye disease needing or planning immediate surgery, irradiation, or medical therapy
  • Additional exclusion criteria defined in the protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 133 locations

1

Site Number - 1032

Phoenix, Arizona, United States, 85006

Actively Recruiting

2

Site Number - 1036

Phoenix, Arizona, United States, 85015

Actively Recruiting

3

Site Number - 1061

Huntington Beach, California, United States, 92647

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4

Site Number - 1001

Los Angeles, California, United States, 90033

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5

Site Number - 1047

Los Angeles, California, United States, 90095

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6

Site Number - 1062

Orange, California, United States, 92868

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7

Site Number - 1046

Sacramento, California, United States, 95816

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8

Site Number - 1034

San Francisco, California, United States, 94143

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9

Site Number - 1035

Santa Clarita, California, United States, 91321

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10

Site Number - 1005

Torrance, California, United States, 90502

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11

Site Number - 1006

Walnut Creek, California, United States, 94598

Withdrawn

12

Site Number - 1013

Englewood, Colorado, United States, 80113

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13

Site Number - 1010

Newark, Delaware, United States, 19713

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14

Site Number - 1040

Washington D.C., District of Columbia, United States, 20010

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15

Site Number - 1029

Clearwater, Florida, United States, 33756

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16

Site Number - 1055

Jacksonville, Florida, United States, 32204-1177

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17

Site Number - 1056

Jacksonville, Florida, United States, 32216

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18

Site Number - 1028

Miami, Florida, United States, 33136

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19

Site Number - 1065

Miami, Florida, United States, 33186

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20

Site Number - 1064

Ocoee, Florida, United States, 34761

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21

Site Number - 1011

Orlando, Florida, United States, 32819

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22

Site Number - 1016

Port Charlotte, Florida, United States, 33952

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23

Site Number - 1012

West Palm Beach, Florida, United States, 33401

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24

Site Number - 1038

Atlanta, Georgia, United States, 30318

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25

Site Number - 1053

Macon, Georgia, United States, 31210

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26

Site Number - 1020

Stockbridge, Georgia, United States, 30281

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27

Site Number - 1027

Indianapolis, Indiana, United States, 46202

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28

Site Number - 1041

Kansas City, Kansas, United States, 66210

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29

Site Number - 1045

Bowling Green, Kentucky, United States, 42101

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30

Site Number - 1054

Florence, Kentucky, United States, 41042

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31

Site Number - 1063

Metairie, Louisiana, United States, 70006

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32

Site Number - 1022

New Orleans, Louisiana, United States, 70112

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33

Site Number - 1048

Shreveport, Louisiana, United States, 71103

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34

Site Number - 1023

Baltimore, Maryland, United States, 21287

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35

Site Number - 1026

Boston, Massachusetts, United States, 02114

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36

Site Number - 1018

Farmington Hills, Michigan, United States, 48334

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37

Site Number - 1069

Flint, Michigan, United States, 48532

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38

Site Number - 1008

Rochester, Minnesota, United States, 55905

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39

Site Number - 1068

Gulfport, Mississippi, United States, 39501

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40

Site Number - 1017

Omaha, Nebraska, United States, 68105

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41

Site Number - 1007

Las Vegas, Nevada, United States, 89148

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42

Site Number - 1050

Monroe, New York, United States, 10950

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43

Site Number - 1051

Asheville, North Carolina, United States, 28803

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44

Site Number - 1060

Wilmington, North Carolina, United States, 28401

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45

Site Number - 1057

Canton, Ohio, United States, 44718

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46

Site Number - 1003

Portland, Oregon, United States, 97035

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47

Site Number - 1033

Philadelphia, Pennsylvania, United States, 19140

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48

Site Number - 1043

Pottstown, Pennsylvania, United States, 19464

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49

Site Number - 1015

Summerville, South Carolina, United States, 29485

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50

Site Number - 1042

Chattanooga, Tennessee, United States, 37421

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51

Site Number - 1066

Nashville, Tennessee, United States, 37203

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52

Site Number - 1049

Nashville, Tennessee, United States, 37212

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53

Site Number - 1002

Austin, Texas, United States, 78731

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54

Site Number - 1067

Bellaire, Texas, United States, 77401

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55

Site Number - 1019

Dallas, Texas, United States, 75208

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56

Site Number - 1031

Dallas, Texas, United States, 75231

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57

Site Number - 1071

Houston, Texas, United States, 77089

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58

Site Number - 1025

Houston, Texas, United States, 77095

Withdrawn

59

Site Number - 1004

Mesquite, Texas, United States, 75149

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60

Site Number - 1009

Round Rock, Texas, United States, 78681

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61

Site Number - 1014

San Antonio, Texas, United States, 78215

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62

Site Number - 1052

San Antonio, Texas, United States, 78240

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63

Site Number - 1030

Salt Lake City, Utah, United States, 84108

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64

Site Number - 1070

Sandy City, Utah, United States, 84093

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65

Site Number - 5303

Antwerp, Belgium, 2820

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66

Site Number - 5301

Bruges, Belgium, 80000

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67

Site Number - 5302

Brussels, Belgium, 1070

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68

Site Number - 8002

Batumi, Georgia, 6000

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69

Site Number - 8007

Batumi, Georgia, 6010

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70

Site Number - 8006

Kutaisi, Georgia, 4600

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71

Site Number - 8008

Marneuli, Georgia, 3000

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72

Site Number - 8009

Tbilisi, Georgia, 0112

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73

Site Number - 8004

Tbilisi, Georgia, 0144

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74

Site Number - 8005

Tbilisi, Georgia, 0144

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75

Site Number - 8001

Tbilisi, Georgia, 0159

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76

Site Number - 8003

Tbilisi, Georgia, 0159

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77

Site Number - 8011

Tbilisi, Georgia, 0159

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78

Site Number - 8010

Tbilisi, Georgia, 0177

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79

Site Number - 6505

Dresden, Saxony, Germany, 01307

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80

Site Number - 6503

Munich, Germany, 80336

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81

Site Number - 6508

Munich, Germany, 81667

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82

Site Number - 6502

Schwerin, Germany, 19049

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83

Site Number - 6507

Würzburg, Germany, 97080

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84

Site Number - 7558

Békéscsaba, Hungary, 5600

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85

Site Number - 7554

Budapest, Hungary, 1036

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86

Site Number - 7556

Budapest, Hungary, 1083

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87

Site Number - 7557

Debrecen, Hungary, 4032

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88

Site Number - 7551

Pécs, Hungary, 7623

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89

Site Number - 7552

Szeged, Hungary, 6725

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90

Site Number - 6004

Bologna, Italy, 40138

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91

Site Number - 6012

Cagliari, Italy, 09124

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92

Site Number - 6011

Genova, Italy, 16132

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93

Site Number - 6002

Milan, Italy, 20122

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94

Site Number - 6009

Milan, Italy, 20162

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95

Site Number - 6007

Milan, Italy, 20149

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96

Site Number - 6010

Naples, Italy, 80131

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97

Site Number - 6003

Pisa, Italy, 56124

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98

Site Number - 6001

Pisa, Italy, 56126

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99

Site Number - 6005

Roma, Italy, 00189

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100

Site Number - 6013

Siena, Italy, 53100

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101

Site Number - 6008

Varese, Italy, 21100

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102

Site Number - 3006

Gliwice, Poland, 44-102

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103

Site Number - 3002

Krakow, Poland, 30-074

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104

Site Number -3003

Krakow, Poland, 30-688

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105

Site Number - 3005

Lublin, Poland, 20-400

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106

Site Number - 3008

Lublin, Poland, 20-607

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107

Site Number - 3004

Lublin, Poland, 91-495

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108

Site Number - 3007

Poznan, Poland, 60-354

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109

Site Number - 3001

Warsaw, Poland, 00-0189

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110

Site Number - 1058

San Juan, Puerto Rico, 00907

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111

Site Number - 1037

San Juan, Puerto Rico, 00921-3313

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112

Site Number - 7104

Badalona, Barcelona, Spain, 08916

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113

Site Number - 7109

Barcelona, Spain, 08035

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114

Site Number - 7103

Barcelona, Spain, 08036

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115

Site Number - 7102

Córdoba, Spain, 14004

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116

Site Number - 7106

Granada, Spain, 18014

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117

Site Number - 7105

Madrid, Spain, 28006

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118

Site Number - 7107

Pamplona, Spain, 31008

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119

Site Number - 7108

Pamplona, Spain, 31008

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120

Site Number - 7101

Seville, Spain, 41009

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121

Site Number - 7013

Birmingham, England, United Kingdom, B15 2TT

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122

Site Number - 7012

Bristol, England, United Kingdom, BS10 5NB

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123

Site Number - 7011

Coventry, England, United Kingdom, CV2 2DX

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124

Site Number - 7007

London, England, United Kingdom, NW1 2PG

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125

Site Number - 7002

Cardiff, United Kingdom, CF14 4XW

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126

Site Number - 7008

Edinburgh, United Kingdom, EH16 4SA

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127

Site Number - 7005

Huddersfield, United Kingdom, HD3 3EA

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128

Site Number - 7004

Hull, United Kingdom, HU6 7RX

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129

Site Number - 7003

London, United Kingdom, SE5 9RS

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130

Site Number - 7006

Manchester, United Kingdom, M20 4BX

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131

Site Number - 7001

Newcastle upon Tyne, United Kingdom, NE1 4LP

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132

Site Number - 7009

Norwich, United Kingdom, NR4 7UY

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133

Site Number - 7010

Nuneaton, United Kingdom, CV10 7DJ

Actively Recruiting

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Research Team

C

Central Study Contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease | DecenTrialz