A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
NCT ID: NCT06727604
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2024-12-17
2028-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1 Period 1 and 2: IMVT-1402
IMVT-1402
600 mg SC QW for 52 weeks
Group 2 Period 1 and 2: IMVT-1402
IMVT-1402
600 mg SC QW for 52 weeks
Group 2 Period 1: IMVT-1402 and Period 2: Placebo
IMVT-1402
600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
Group 3 Period 1 and 2: Placebo
Placebo
SC QW for 52 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Male or female participants aged ≥ 18 years.
* Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.
Exclusion Criteria
* Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.
* Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.
18 Years
75 Years
ALL
No
Sponsors
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Immunovant Sciences GmbH
INDUSTRY
Responsible Party
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Locations
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Site Number - 1032
Phoenix, Arizona, United States
Site Number - 1036
Phoenix, Arizona, United States
Site Number - 1001
Los Angeles, 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 - 1028
Miami, 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 - 1020
Stockbridge, Georgia, United States
Site Number - 1027
Indianapolis, Indiana, United States
Site Number - 1022
New Orleans, 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 - 1003
Portland, Oregon, United States
Site Number - 1033
Philadelphia, Pennsylvania, United States
Site Number - 1015
Summerville, South Carolina, United States
Site Number - 1042
Chattanooga, Tennessee, United States
Site Number - 1002
Austin, Texas, United States
Site Number - 1019
Dallas, Texas, United States
Site Number - 1031
Dallas, 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 - 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 - 7558
Békéscsaba, , Hungary
Site Number - 7554
Budapest, , Hungary
Site Number - 7556
Budapest, , 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
Napoli, , 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 - 1037
San Juan, , Puerto Rico
Site Number - 7104
Badalona, 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
Countries
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Central Contacts
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Other Identifiers
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2024-516020-33-00
Identifier Type: CTIS
Identifier Source: secondary_id
IMVT-1402-2502
Identifier Type: -
Identifier Source: org_study_id