RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Immunovant Sciences GmbH • ClinicalTrials.gov ID: NCT06727604

Registry updated: 2026-08-25

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Description

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.

Interventions

IMVT-1402 (Drug)
600 mg SC QW for 52 weeks
IMVT-1402 (Drug)
600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
Placebo (Drug)
SC QW for 52 weeks

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy. * 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. * Additional exclusion criteria are defined in the protocol.

Conditions

Graves' Disease

Locations

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 - 1063 — Metairie, Louisiana, 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 - 1069 — Flint, Michigan, United States
Site Number - 1008 — Rochester, Minnesota, United States
Site Number - 1068 — Gulfport, Mississippi, 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 - 1060 — Wilmington, 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 - 1049 — 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 - 1070 — Sandy 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 - 6503 — Munich, 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 - 3008 — 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 - 7014 — Cambridge, London, 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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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