Actively Recruiting
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
Led by Immunovant Sciences GmbH · Updated on 2026-05-22
240
Participants Needed
134
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating IMVT-1402 in adults with Graves' disease who remain hyperthyroid despite antithyroid drug treatment. This interventional, randomized, double-blind, placebo-controlled Phase 2b study aims to assess the efficacy, safety, and tolerability of IMVT-1402 compared to placebo. The study's main goal is to see how well IMVT-1402 controls thyroid hormone levels and reduces the need for antithyroid drugs by Week 26. Participants receive IMVT-1402 or placebo through subcutaneous injections once a week. Some groups receive IMVT-1402 for 52 weeks, others receive IMVT-1402 for 26 weeks followed by placebo for 26 weeks, and one group receives placebo for 52 weeks. The study tracks these treatments over a period of up to one year. During the study, participants will have regular blood tests to measure thyroid hormones including T3, FT3, FT4, and thyroid-stimulating hormone (TSH). Researchers will also monitor the dose of antithyroid drugs taken and assess various outcomes like the percentage of participants who achieve normal thyroid levels without antithyroid drugs at different time points. The study includes safety assessments and follows participants for up to 104 weeks to evaluate long-term results.
CONDITIONS
Brief Title
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the trial requirements and provide written informed consent
- Male or female aged 18 years or older
- Diagnosis of Graves' disease with hyperthyroidism despite antithyroid drug treatment
- Additional specific criteria as defined in the protocol
You will not qualify if you...
- Previous successful treatment with radioactive iodine therapy or total thyroidectomy
- Having an autoimmune disease other than Graves' disease that requires treatment and poses undue risk
- Moderate-to-severe active thyroid eye disease expected to require immediate surgical intervention or planned corrective surgery, irradiation, or medical therapy during the study
- Additional exclusion criteria as defined in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive weekly subcutaneous injections of IMVT-1402 or placebo for up to 52 weeks as part of the study treatment.
Weekly visits for up to 52 weeks
Duration - Up to 26 weeks after treatment
Participants are monitored for efficacy and safety outcomes after completing treatment.
Visits as scheduled for assessment up to Week 78 and Week 104
Trial Site Locations
Total: 134 locations
1
Site Number - 1032
Phoenix, Arizona, United States, 85006
Withdrawn
2
Site Number - 1036
Phoenix, Arizona, United States, 85015
Actively Recruiting
3
Site Number - 1061
Huntington Beach, California, United States, 92647
Actively Recruiting
4
Site Number - 1001
Los Angeles, California, United States, 90033
Actively Recruiting
5
Site Number - 1047
Los Angeles, California, United States, 90095
Actively Recruiting
6
Site Number - 1062
Orange, California, United States, 92868
Actively Recruiting
7
Site Number - 1046
Sacramento, California, United States, 95816
Actively Recruiting
8
Site Number - 1034
San Francisco, California, United States, 94143
Actively Recruiting
9
Site Number - 1035
Santa Clarita, California, United States, 91321
Withdrawn
10
Site Number - 1005
Torrance, California, United States, 90502
Actively Recruiting
11
Site Number - 1006
Walnut Creek, California, United States, 94598
Withdrawn
12
Site Number - 1013
Englewood, Colorado, United States, 80113
Actively Recruiting
13
Site Number - 1010
Newark, Delaware, United States, 19713
Actively Recruiting
14
Site Number - 1040
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
15
Site Number - 1029
Clearwater, Florida, United States, 33756
Actively Recruiting
16
Site Number - 1055
Jacksonville, Florida, United States, 32204-1177
Actively Recruiting
17
Site Number - 1056
Jacksonville, Florida, United States, 32216
Actively Recruiting
18
Site Number - 1028
Miami, Florida, United States, 33136
Actively Recruiting
19
Site Number - 1065
Miami, Florida, United States, 33186
Actively Recruiting
20
Site Number - 1064
Ocoee, Florida, United States, 34761
Actively Recruiting
21
Site Number - 1011
Orlando, Florida, United States, 32819
Actively Recruiting
22
Site Number - 1016
Port Charlotte, Florida, United States, 33952
Actively Recruiting
23
Site Number - 1012
West Palm Beach, Florida, United States, 33401
Actively Recruiting
24
Site Number - 1038
Atlanta, Georgia, United States, 30318
Actively Recruiting
25
Site Number - 1053
Macon, Georgia, United States, 31210
Actively Recruiting
26
Site Number - 1020
Stockbridge, Georgia, United States, 30281
Actively Recruiting
27
Site Number - 1027
Indianapolis, Indiana, United States, 46202
Actively Recruiting
28
Site Number - 1041
Kansas City, Kansas, United States, 66210
Actively Recruiting
29
Site Number - 1045
Bowling Green, Kentucky, United States, 42101
Actively Recruiting
30
Site Number - 1054
Florence, Kentucky, United States, 41042
Actively Recruiting
31
Site Number - 1063
Metairie, Louisiana, United States, 70006
Actively Recruiting
32
Site Number - 1022
New Orleans, Louisiana, United States, 70112
Actively Recruiting
33
Site Number - 1048
Shreveport, Louisiana, United States, 71103
Actively Recruiting
34
Site Number - 1023
Baltimore, Maryland, United States, 21287
Actively Recruiting
35
Site Number - 1026
Boston, Massachusetts, United States, 02114
Actively Recruiting
36
Site Number - 1018
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
37
Site Number - 1069
Flint, Michigan, United States, 48532
Actively Recruiting
38
Site Number - 1008
Rochester, Minnesota, United States, 55905
Actively Recruiting
39
Site Number - 1068
Gulfport, Mississippi, United States, 39501
Actively Recruiting
40
Site Number - 1017
Omaha, Nebraska, United States, 68105
Actively Recruiting
41
Site Number - 1007
Las Vegas, Nevada, United States, 89148
Actively Recruiting
42
Site Number - 1050
Monroe, New York, United States, 10950
Actively Recruiting
43
Site Number - 1051
Asheville, North Carolina, United States, 28803
Actively Recruiting
44
Site Number - 1060
Wilmington, North Carolina, United States, 28401
Actively Recruiting
45
Site Number - 1057
Canton, Ohio, United States, 44718
Actively Recruiting
46
Site Number - 1003
Portland, Oregon, United States, 97035
Actively Recruiting
47
Site Number - 1033
Philadelphia, Pennsylvania, United States, 19140
Withdrawn
48
Site Number - 1043
Pottstown, Pennsylvania, United States, 19464
Actively Recruiting
49
Site Number - 1015
Summerville, South Carolina, United States, 29485
Actively Recruiting
50
Site Number - 1042
Chattanooga, Tennessee, United States, 37421
Actively Recruiting
51
Site Number - 1066
Nashville, Tennessee, United States, 37203
Actively Recruiting
52
Site Number - 1049
Nashville, Tennessee, United States, 37212
Actively Recruiting
53
Site Number - 1002
Austin, Texas, United States, 78731
Actively Recruiting
54
Site Number - 1067
Bellaire, Texas, United States, 77401
Actively Recruiting
55
Site Number - 1019
Dallas, Texas, United States, 75208
Actively Recruiting
56
Site Number - 1031
Dallas, Texas, United States, 75231
Withdrawn
57
Site Number - 1071
Houston, Texas, United States, 77089
Actively Recruiting
58
Site Number - 1025
Houston, Texas, United States, 77095
Withdrawn
59
Site Number - 1004
Mesquite, Texas, United States, 75149
Actively Recruiting
60
Site Number - 1009
Round Rock, Texas, United States, 78681
Actively Recruiting
61
Site Number - 1014
San Antonio, Texas, United States, 78215
Actively Recruiting
62
Site Number - 1052
San Antonio, Texas, United States, 78240
Actively Recruiting
63
Site Number - 1030
Salt Lake City, Utah, United States, 84108
Actively Recruiting
64
Site Number - 1070
Sandy City, Utah, United States, 84093
Actively Recruiting
65
Site Number - 5303
Antwerp, Belgium, 2820
Actively Recruiting
66
Site Number - 5301
Bruges, Belgium, 80000
Actively Recruiting
67
Site Number - 5302
Brussels, Belgium, 1070
Actively Recruiting
68
Site Number - 8002
Batumi, Georgia, 6000
Actively Recruiting
69
Site Number - 8007
Batumi, Georgia, 6010
Actively Recruiting
70
Site Number - 8006
Kutaisi, Georgia, 4600
Actively Recruiting
71
Site Number - 8008
Marneuli, Georgia, 3000
Actively Recruiting
72
Site Number - 8009
Tbilisi, Georgia, 0112
Actively Recruiting
73
Site Number - 8004
Tbilisi, Georgia, 0144
Actively Recruiting
74
Site Number - 8005
Tbilisi, Georgia, 0144
Actively Recruiting
75
Site Number - 8001
Tbilisi, Georgia, 0159
Actively Recruiting
76
Site Number - 8003
Tbilisi, Georgia, 0159
Actively Recruiting
77
Site Number - 8011
Tbilisi, Georgia, 0159
Actively Recruiting
78
Site Number - 8010
Tbilisi, Georgia, 0177
Actively Recruiting
79
Site Number - 6505
Dresden, Saxony, Germany, 01307
Actively Recruiting
80
Site Number - 6503
Munich, Germany, 80336
Actively Recruiting
81
Site Number - 6508
Munich, Germany, 81667
Actively Recruiting
82
Site Number - 6502
Schwerin, Germany, 19049
Actively Recruiting
83
Site Number - 6507
Würzburg, Germany, 97080
Actively Recruiting
84
Site Number - 7558
Békéscsaba, Hungary, 5600
Actively Recruiting
85
Site Number - 7554
Budapest, Hungary, 1036
Actively Recruiting
86
Site Number - 7556
Budapest, Hungary, 1083
Actively Recruiting
87
Site Number - 7557
Debrecen, Hungary, 4032
Actively Recruiting
88
Site Number - 7551
Pécs, Hungary, 7623
Actively Recruiting
89
Site Number - 7552
Szeged, Hungary, 6725
Actively Recruiting
90
Site Number - 6004
Bologna, Italy, 40138
Actively Recruiting
91
Site Number - 6012
Cagliari, Italy, 09124
Actively Recruiting
92
Site Number - 6011
Genova, Italy, 16132
Actively Recruiting
93
Site Number - 6002
Milan, Italy, 20122
Actively Recruiting
94
Site Number - 6009
Milan, Italy, 20162
Actively Recruiting
95
Site Number - 6007
Milan, Italy, 20149
Actively Recruiting
96
Site Number - 6010
Naples, Italy, 80131
Actively Recruiting
97
Site Number - 6003
Pisa, Italy, 56124
Actively Recruiting
98
Site Number - 6001
Pisa, Italy, 56126
Actively Recruiting
99
Site Number - 6005
Roma, Italy, 00189
Actively Recruiting
100
Site Number - 6013
Siena, Italy, 53100
Actively Recruiting
101
Site Number - 6008
Varese, Italy, 21100
Actively Recruiting
102
Site Number - 3006
Gliwice, Poland, 44-102
Actively Recruiting
103
Site Number - 3002
Krakow, Poland, 30-074
Actively Recruiting
104
Site Number -3003
Krakow, Poland, 30-688
Actively Recruiting
105
Site Number - 3005
Lublin, Poland, 20-400
Actively Recruiting
106
Site Number - 3008
Lublin, Poland, 20-607
Actively Recruiting
107
Site Number - 3004
Lublin, Poland, 91-495
Actively Recruiting
108
Site Number - 3007
Poznan, Poland, 60-354
Actively Recruiting
109
Site Number - 3001
Warsaw, Poland, 00-0189
Actively Recruiting
110
Site Number - 1058
San Juan, Puerto Rico, 00907
Actively Recruiting
111
Site Number - 1037
San Juan, Puerto Rico, 00921-3313
Withdrawn
112
Site Number - 7104
Badalona, Barcelona, Spain, 08916
Actively Recruiting
113
Site Number - 7109
Barcelona, Spain, 08035
Actively Recruiting
114
Site Number - 7103
Barcelona, Spain, 08036
Actively Recruiting
115
Site Number - 7102
Córdoba, Spain, 14004
Actively Recruiting
116
Site Number - 7106
Granada, Spain, 18014
Actively Recruiting
117
Site Number - 7105
Madrid, Spain, 28006
Actively Recruiting
118
Site Number - 7107
Pamplona, Spain, 31008
Actively Recruiting
119
Site Number - 7108
Pamplona, Spain, 31008
Actively Recruiting
120
Site Number - 7101
Seville, Spain, 41009
Actively Recruiting
121
Site Number - 7013
Birmingham, England, United Kingdom, B15 2TT
Actively Recruiting
122
Site Number - 7012
Bristol, England, United Kingdom, BS10 5NB
Actively Recruiting
123
Site Number - 7011
Coventry, England, United Kingdom, CV2 2DX
Actively Recruiting
124
Site Number - 7007
London, England, United Kingdom, NW1 2PG
Actively Recruiting
125
Site Number - 7014
Cambridge, London, United Kingdom, CB2 0QQ
Actively Recruiting
126
Site Number - 7002
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
127
Site Number - 7008
Edinburgh, United Kingdom, EH16 4SA
Actively Recruiting
128
Site Number - 7005
Huddersfield, United Kingdom, HD3 3EA
Actively Recruiting
129
Site Number - 7004
Hull, United Kingdom, HU6 7RX
Actively Recruiting
130
Site Number - 7003
London, United Kingdom, SE5 9RS
Actively Recruiting
131
Site Number - 7006
Manchester, United Kingdom, M20 4BX
Actively Recruiting
132
Site Number - 7001
Newcastle upon Tyne, United Kingdom, NE1 4LP
Actively Recruiting
133
Site Number - 7009
Norwich, United Kingdom, NR4 7UY
Actively Recruiting
134
Site Number - 7010
Nuneaton, United Kingdom, CV10 7DJ
Actively Recruiting
Research Team
C
Central Study 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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