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
Status: Recruiting
Location: See all (112) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b 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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
• Male or female participants aged ≥ 18 years.
• Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.
• Other, more specific inclusion criteria are defined in the protocol.
Locations
United States
Arizona
Site Number - 1015
RECRUITING
Tucson
California
Site Number -1014
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Concord
Colorado
Site Number - 1013
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Aurora
Florida
Site Number - 1024
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Doral
Site Number - 1008
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Hialeah
Site Number - 1000
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Miami
Georgia
Site Number - 1020
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Columbus
Kansas
Site Number - 1022
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Topeka
Kentucky
Site Number - 1030
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Louisville
Missouri
Site Number - 1033
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Jefferson City
Site Number - 1004
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Kansas City
Site Number - 1019
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St Louis
North Carolina
Site Number - 1010
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Chapel Hill
Site Number - 1026
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Hickory
Site Number - 1001
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Morehead City
Site Number - 1034
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Raleigh
Nevada
Site Number - 1012
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Reno
New York
Site Number - 1032
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Long Island City
Site Number - 1027
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New Hyde Park
Site Number - 1009
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New York
Site Number - 1018
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Williamsville
Oklahoma
Site Number - 1007
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Oklahoma City
Tennessee
Site Number - 1017
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Memphis
Texas
Site Number - 1029
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Dallas
Site Number - 1002
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El Paso
Site Number - 1003
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Fort Worth
Site Number - 1028
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Houston
Site Number - 1031
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Houston
Site Number - 1021
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Irving
Site Number -1023
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Irving
Site Number - 1025
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Mckinney
Site Number - 1011
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San Antonio
Virginia
Site Number - 1016
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Norfolk
Other Locations
Australia
Site Number - 5102
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Box Hill
Site Number - 5101
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Brisbane
Site Number - 5104
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Geelong
Site Number - 5108
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Perth
Site Number - 5109
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Saint Leonards
Site Number - 5100
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Southport
Site Number - 5105
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Sydney
Site Number - 5103
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Warrawong
Bulgaria
Site Number - 5613
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Dobrich
Site Number - 5606
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Plovdiv
Site Number - 5607
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Plovdiv
Site Number - 5601
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Sliven
Site Number - 5612
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Smolyan
Site Number - 5604
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Sofia
Site Number - 5608
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Sofia
Site Number - 5609
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Sofia
Site Number - 5610
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Sofia
Site Number- 5605
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Sofia
Site Number - 5602
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Varna
Site Number - 5603
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Varna
Site Number - 5611
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Varna
Site Number - 5600
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Yambol
Georgia
Site Number - 8004
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Imereti
Site Number - 8000
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Tbilisi
Site Number - 8001
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Tbilisi
Site Number - 8002
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Tbilisi
Site Number - 8003
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Tbilisi
Site Number - 8005
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Tbilisi
Greece
Site Number - 3900
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Athens
Site Number - 3901
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Athens
Site Number - 3902
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Athens
Israel
Site Number - 4211
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Beersheba
Site Number - 4203
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Haifa
Site Number - 4205
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Haifa
Site Number - 4201
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Jerusalem
Site Number - 4204
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Jerusalem
Site Number - 4210
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Kfar Saba
Site Number - 4209
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Nahariya
Site Number - 4200
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Petah Tikva
Site Number - 4202
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Ramat Gan
Site Number - 4208
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Rehovot
Site Number - 4207
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Tel Aviv
Site Number - 4206
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Tzfat
Italy
Site Number - 6003
RECRUITING
Milan
Site Number - 6001
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Rome
Site Number - 6002
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Udine
Latvia
Site Number - 4600
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Ogre
Site Number - 4602
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Riga
Site Number - 4603
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Riga
Site Number - 4604
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Sigulda
Site Number - 4601
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Ventspils
Netherlands
Site Number - 2003
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Rotterdam
Site Number - 2200
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Rotterdam
Site Number - 2201
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Rotterdam
Site Number - 2202
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Zwijndrecht
New Zealand
Site Number - 3301
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Auckland
Site Number - 3300
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Wellington
Poland
Site Number - 3004
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Bialystok
Site Number - 3002
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Bydgoszcz
Site Number - 3010
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Chorzów
Site Number - 3007
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Kielce
Site Number - 3000
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Lublin
Site Number - 3005
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Olsztyn
Site Number - 3009
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Opole
Site Number - 3006
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Poznan
Site Number - 3001
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Szczecin
Site Number - 3008
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Warsaw
Site Nnumber - 3003
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Wroclaw
Republic of Korea
Site Number - 4500
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Daegu
Site Number - 4503
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Goyang
Site Number - 4504
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Guri-si
Site Number - 4501
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Seoul
Site Number - 4505
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Seoul
Site Number - 4506
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Seoul
United Kingdom
Site Number - 7009
RECRUITING
Cornwell
Site Number - 7001
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London
Site Number - 7006
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London
Site Number - 7010
RECRUITING
Salford
Site Number - 7008
RECRUITING
Surrey
Contact Information
Primary
Central Study Contact
clinicaltrials@immunovant.com
18007970414
Time Frame
Start Date: 2025-06-19
Estimated Completion Date: 2027-05
Participants
Target number of participants: 210
Treatments
Experimental: IMVT-1402 Dose 1
Experimental: IMVT-1402 Dose 2
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Immunovant Sciences GmbH