A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD)

NCT07286006 — Phase 2, Enrolling by invitation, 372 participants, Immunovant Sciences GmbH
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A Long-Term Extension Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Patients With Graves' Disease

RegistryNCT07286006
StatusEnrolling by invitation
PhasePhase 2
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment372 (Estimated)
SponsorImmunovant Sciences GmbH (Industry)
ConditionsGraves' Disease
InterventionsIMVT-1402 (Drug)
Datesstart 2026-01-26, primary completion 2030-03-01 (estimated), completion 2030-03-01 (estimated), first posted 2025-12-16, last updated 2026-09-29
Locations131 sites in United States, Australia, Bulgaria, Czechia, Georgia, Hungary, Israel, Latvia and 3 more countries

Related Papers Related Patents Related Grants Related Experts
All trials for Graves' Disease All trials of IMVT-1402

-Summary

This is a long-term extension study that will rollover participants completing feeder studies IMVT-1402-2502 (NCT06727604) or IMVT-1402-2503 (NCT07018323) to evaluate the efficacy and safety of IMVT-1402 in adult participants with GD. Eligible participants will be assigned to 1 of 3 study groups (Groups A, B and C) based on their GD status at the completion of their respective feeder study.

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+Arms and interventions

ArmTypeInterventionsDescription
Group AExperimentalDrug: IMVT-1402
Group BNo intervention
Group CNo intervention
  • IMVT-1402 (Drug): Dose 1 for up to 52 weeks

+Outcome measures

Primary outcomes

  • Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402 [At Week 52]

Secondary outcomes

  • Percentage of Group A Participants who are euthyroid and off ATD [At Week 26]
  • Percentage of Group A Participants who are euthyroid and off ATD [Up to Week 52]
  • Percentage of Group A Participants who are euthyroid, off ATD, and off IMVT-1402 [Up to Week 52]
  • Time to earliest date of euthyroidism, off ATD, and off IMVT-1402 to the earliest date of confirmed relapse in Group A Participants [Up to Week 52]
  • Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402 [Up to Week 52]
  • Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402 [At Week 52]
  • Time from Week 0 to the earliest date of confirmed relapse in Group B Participants [Up to Week 52]
  • Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402 [Up to Week 52]
  • Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402 [At Week 52]
  • Time From Week 0 to the earliest date of confirmed relapse in Group C Participants [Up to Week 52]
  • Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb [At Week 26]
  • Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb [Up to Week 52]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Participants who completed Study IMVT-1402-2502 or Study IMVT-1402-2503.
* Other, more specific inclusion criteria are defined in the protocol.

Exclusion Criteria:

* Have permanently discontinued IMP during the treatment period in the feeder study or have met study stopping criteria at any point up until the end of participation in the feeder study.

+Locations (131)

FacilityCityCountryStatus
Site Number - 1561Phoenix, ArizonaUnited States
Site Number - 1519Phoenix, ArizonaUnited States
Site Number - 1530Tucson, ArizonaUnited States
Site Number - 1510Concord, CaliforniaUnited States
Site Number - 1587Huntington Beach, CaliforniaUnited States
Site Number - 1554Los Angeles, CaliforniaUnited States
Site Number - 1588Orange, CaliforniaUnited States
Site Number - 1559San Francisco, CaliforniaUnited States
Site Number - 1558Santa Clarita, CaliforniaUnited States
Site Number - 1552Torrance, CaliforniaUnited States
Site Number - 1533Aurora, ColoradoUnited States
Site Number -1514Englewood, ColoradoUnited States
Site Number - 1516Newark, DelawareUnited States
Site Number - 1567Washington D.C., District of ColumbiaUnited States
Site Number - 1556Clearwater, FloridaUnited States
Site Number - 1522Doral, FloridaUnited States
Site Number - 1523Hialeah, FloridaUnited States
Site Number - 1581Jacksonville, FloridaUnited States
Site Number - 1582Jacksonville, FloridaUnited States
Site Number - 1505Miami, FloridaUnited States
Site Number - 1564Miami, FloridaUnited States
Site Number - 1591Miami, FloridaUnited States
Site Number - 1590Ocoee, FloridaUnited States
Site Number - 1508Orlando, FloridaUnited States
Site Number - 1507Port Charlotte, FloridaUnited States
Site Number - 1548West Palm Beach, FloridaUnited States
Site Number - 1566Atlanta, GeorgiaUnited States
Site Number - 1526Columbus, GeorgiaUnited States
Site Number - 1579Macon, GeorgiaUnited States
Site Number - 1518Stockbridge, GeorgiaUnited States
Site Number - 1562Indianapolis, IndianaUnited States
Site Number - 1568Kansas City, KansasUnited States
Site Number - 1534Topeka, KansasUnited States
Site Number - 1571Bowling Green, KentuckyUnited States
Site Number - 1580Florence, KentuckyUnited States
Site Number - 1546Louisville, KentuckyUnited States
Site Number - 1589Metairie, LouisianaUnited States
Site Number - 1555New Orleans, LouisianaUnited States
Site Number - 1565Baltimore, MarylandUnited States
Site Number - 1557Boston, MassachusettsUnited States
Site Number - 1503Farmington Hills, MichiganUnited States
Site Number - 1595Flint, MichiganUnited States
Site Number - 1515Rochester, MinnesotaUnited States
Site Number - 1594Gulfport, MississippiUnited States
Site Number - 1511Jefferson City, MissouriUnited States
Site Number - 1537Kansas City, MissouriUnited States
Site Number - 1521Omaha, NebraskaUnited States
Site Number - 1512Las Vegas, NevadaUnited States
Site Number - 1528Reno, NevadaUnited States
Site Number - 1576Monroe, New YorkUnited States
Site Number - 1544New Hyde Park, New YorkUnited States
Site Number - 1531New York, New YorkUnited States
Site Number - 1539New York, New YorkUnited States
Site Number - 1542Williamsville, New YorkUnited States
Site Number - 1577Asheville, North CarolinaUnited States
Site Number - 1509Chapel Hill, North CarolinaUnited States
Site Number - 1506Hickory, North CarolinaUnited States
Site Number - 1500Morehead City, North CarolinaUnited States
Site Number - 1540Raleigh, North CarolinaUnited States
Site Number - 1586Wilmington, North CarolinaUnited States
Site Number - 1583Canton, OhioUnited States
Site Number - 1536Oklahoma City, OklahomaUnited States
Site Number - 1549Portland, OregonUnited States
Site Number - 1560Philadelphia, PennsylvaniaUnited States
Site Number - 1570Pottstown, PennsylvaniaUnited States
Site Number - 1550Summerville, South CarolinaUnited States
Site Number - 1569Chattanooga, TennesseeUnited States
Site Number - 1524Memphis, TennesseeUnited States
Site Number - 1592Nashville, TennesseeUnited States
Site Number - 1575Nashville, TennesseeUnited States
Site Number - 1517Austin, TexasUnited States
Site Number - 1593Bellaire, TexasUnited States
Site Number - 1513Dallas, TexasUnited States
Site Number - 1551Dallas, TexasUnited States
Site Number - 1538Dallas, TexasUnited States
Site Number - 1502El Paso, TexasUnited States
Site Number - 1504Fort Worth, TexasUnited States
Site Number - 1597Houston, TexasUnited States
Site Number - 1525Irving, TexasUnited States
Site Number - 1529McKinney, TexasUnited States
Site Number - 1501Mesquite, TexasUnited States
Site Number - 1520Round Rock, TexasUnited States
Site Number - 1578San Antonio, TexasUnited States
Site Number - 1553San Antonio, TexasUnited States
Site Number - 1532San Antonio, TexasUnited States
Site Number - 1527San Antonio, TexasUnited States
Site Number - 1563Salt Lake City, UtahUnited States
Site Number - 1596Sandy City, UtahUnited States
Site Number - 1535Norfolk, VirginiaUnited States
Site Number - 5152South Brisbane, QueenslandAustralia
Site Number - 5150Southport, QueenslandAustralia
Site Number - 5154PerthAustralia
Site Number - 5151St LeonardsAustralia
Site Number - 5158SydneyAustralia
Site Number - 5660PlovdivBulgaria
Site Number - 5653SlivenBulgaria
Site Number - 5655SmolyanBulgaria
Site Number - 5656SofiaBulgaria
Site Number - 5650VarnaBulgaria
Site Number - 5651VarnaBulgaria

31 more sites not listed.