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

May 6, 2026 updated by: Immunovant Sciences GmbH

A Long-Term Extension Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Patients With Graves' Disease

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

372

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Site Number - 1561
      • Phoenix, Arizona, United States, 85015
        • Site Number - 1519
      • Tucson, Arizona, United States, 85710
        • Site Number - 1530
    • California
      • Concord, California, United States, 94520
        • Site Number - 1510
      • Huntington Beach, California, United States, 92647
        • Site Number - 1587
      • Los Angeles, California, United States, 90033
        • Site Number - 1554
      • Orange, California, United States, 92868
        • Site Number - 1588
      • San Francisco, California, United States, 94143
        • Site Number - 1559
      • Santa Clarita, California, United States, 91321
        • Site Number - 1558
      • Torrance, California, United States, 90509
        • Site Number - 1552
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Site Number - 1533
      • Englewood, Colorado, United States, 80113
        • Site Number -1514
    • Delaware
      • Newark, Delaware, United States, 19713
        • Site Number - 1516
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Site Number - 1567
    • Florida
      • Clearwater, Florida, United States, 33756
        • Site Number - 1556
      • Doral, Florida, United States, 33166
        • Site Number - 1522
      • Hialeah, Florida, United States, 33016
        • Site Number - 1523
      • Jacksonville, Florida, United States, 32204-1177
        • Site Number - 1581
      • Jacksonville, Florida, United States, 48334
        • Site Number - 1582
      • Miami, Florida, United States, 33143
        • Site Number - 1505
      • Miami, Florida, United States, 39501
        • Site Number - 1564
      • Miami, Florida, United States, 78240
        • Site Number - 1591
      • Ocoee, Florida, United States, 34761
        • Site Number - 1590
      • Orlando, Florida, United States, 32819
        • Site Number - 1508
      • Port Charlotte, Florida, United States, 33952
        • Site Number - 1507
      • West Palm Beach, Florida, United States, 33401
        • Site Number - 1548
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Site Number - 1566
      • Columbus, Georgia, United States, 31904
        • Site Number - 1526
      • Macon, Georgia, United States, 31210
        • Site Number - 1579
      • Stockbridge, Georgia, United States, 30281
        • Site Number - 1518
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Site Number - 1562
    • Kansas
      • Kansas City, Kansas, United States, 66210
        • Site Number - 1568
      • Topeka, Kansas, United States, 66606
        • Site Number - 1534
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Site Number - 1571
      • Florence, Kentucky, United States, 65613
        • Site Number - 1580
      • Louisville, Kentucky, United States, 40202
        • Site Number - 1546
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Site Number - 1589
      • New Orleans, Louisiana, United States, 70112
        • Site Number - 1555
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Site Number - 1565
    • Massachusetts
      • Boston, Massachusetts, United States, 32216
        • Site Number - 1557
    • Michigan
      • Farmington Hills, Michigan, United States, 33186
        • Site Number - 1503
      • Flint, Michigan, United States, 48532
        • Site Number - 1595
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Site Number - 1515
    • Mississippi
      • Gulfport, Mississippi, United States, 33136
        • Site Number - 1594
    • Missouri
      • Jefferson City, Missouri, United States, 65109-6023
        • Site Number - 1511
      • Kansas City, Missouri, United States, 64108
        • Site Number - 1537
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Site Number - 1521
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Site Number - 1512
      • Reno, Nevada, United States, 89511
        • Site Number - 1528
    • New York
      • Monroe, New York, United States, 10950
        • Site Number - 1576
      • New Hyde Park, New York, United States, 11042
        • Site Number - 1544
      • New York, New York, United States, 10022
        • Site Number - 1531
      • New York, New York, United States, 11106
        • Site Number - 1539
      • Williamsville, New York, United States, 14221
        • Site Number - 1542
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Site Number - 1577
      • Chapel Hill, North Carolina, United States, 27514
        • Site Number - 1509
      • Hickory, North Carolina, United States, 28601
        • Site Number - 1506
      • Morehead City, North Carolina, United States, 28557
        • Site Number - 1500
      • Raleigh, North Carolina, United States, 27612
        • Site Number - 1540
      • Wilmington, North Carolina, United States, 28401
        • Site Number - 1586
    • Ohio
      • Canton, Ohio, United States, 44718
        • Site Number - 1583
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Site Number - 1536
    • Oregon
      • Portland, Oregon, United States, 97035
        • Site Number - 1549
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Site Number - 1560
      • Pottstown, Pennsylvania, United States, 19464
        • Site Number - 1570
    • South Carolina
      • Summerville, South Carolina, United States, 29485
        • Site Number - 1550
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Site Number - 1569
      • Memphis, Tennessee, United States, 38119
        • Site Number - 1524
      • Nashville, Tennessee, United States, 37203
        • Site Number - 1592
      • Nashville, Tennessee, United States, 37212
        • Site Number - 1575
    • Texas
      • Austin, Texas, United States, 78731
        • Site Number - 1517
      • Bellaire, Texas, United States, 77401
        • Site Number - 1593
      • Dallas, Texas, United States, 75231
        • Site Number - 1551
      • Dallas, Texas, United States, 75208
        • Site Number - 1513
      • Dallas, Texas, United States, 75246
        • Site Number - 1538
      • El Paso, Texas, United States, 79935
        • Site Number - 1502
      • Fort Worth, Texas, United States, 76132
        • Site Number - 1504
      • Houston, Texas, United States, 77089
        • Site Number - 1597
      • Irving, Texas, United States, 75039
        • Site Number - 1525
      • McKinney, Texas, United States, 75069
        • Site Number - 1529
      • Mesquite, Texas, United States, 75149
        • Site Number - 1501
      • Round Rock, Texas, United States, 78681
        • Site Number - 1520
      • San Antonio, Texas, United States, 02114
        • Site Number - 1578
      • San Antonio, Texas, United States, 78215
        • Site Number - 1553
      • San Antonio, Texas, United States, 78229
        • Site Number - 1532
      • San Antonio, Texas, United States, 78231
        • Site Number - 1527
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Site Number - 1563
      • Sandy City, Utah, United States, 84093
        • Site Number - 1596
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Site Number - 1535

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Drug: IMVT-1402
Dose 1 for up to 52 weeks
No Intervention: Group C
No Intervention: Group B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402
Time Frame: At Week 52
At Week 52

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunovant Sciences GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2030

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

December 10, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMVT-1402-2505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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