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Graves' DiseasePhase 2NCT07286006

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

A Phase 2 study testing IMVT-1402 in people with Graves' Disease, run by Immunovant Sciences GmbH at 131 sites in 11 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Graves' Disease
What is being tested?
IMVT-1402
Could I receive a placebo?
No, everyone receives an active treatment
How many people
372 participants
Where
131 sitesin 11 countries
Study dates
26 Jan 2026to Mar 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

131 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

131 sites in 11 countries

United States89 sites

  • Site Number - 1577

    Asheville, North Carolina, 28803

  • Site Number - 1566

    Atlanta, Georgia, 30318

  • Site Number - 1533

    Aurora, Colorado, 80045

  • Site Number - 1517

    Austin, Texas, 78731

  • Site Number - 1565

    Baltimore, Maryland, 21287

  • Site Number - 1593

    Bellaire, Texas, 77401

  • Site Number - 1557

    Boston, Massachusetts, 32216

  • Site Number - 1571

    Bowling Green, Kentucky, 42101

  • Site Number - 1583

    Canton, Ohio, 44718

  • Site Number - 1509

    Chapel Hill, North Carolina, 27514

  • Site Number - 1569

    Chattanooga, Tennessee, 37421

  • Site Number - 1556

    Clearwater, Florida, 33756

  • Site Number - 1526

    Columbus, Georgia, 31904

  • Site Number - 1510

    Concord, California, 94520

  • Site Number - 1513

    Dallas, Texas, 75208

  • Site Number - 1551

    Dallas, Texas, 75231

  • Site Number - 1538

    Dallas, Texas, 75246

  • Site Number - 1522

    Doral, Florida, 33166

  • Site Number - 1502

    El Paso, Texas, 79935

  • Site Number -1514

    Englewood, Colorado, 80113

  • Site Number - 1503

    Farmington Hills, Michigan, 33186

  • Site Number - 1595

    Flint, Michigan, 48532

  • Site Number - 1580

    Florence, Kentucky, 65613

  • Site Number - 1504

    Fort Worth, Texas, 76132

  • Site Number - 1594

    Gulfport, Mississippi, 33136

  • Site Number - 1523

    Hialeah, Florida, 33016

  • Site Number - 1506

    Hickory, North Carolina, 28601

  • Site Number - 1597

    Houston, Texas, 77089

  • Site Number - 1587

    Huntington Beach, California, 92647

  • Site Number - 1562

    Indianapolis, Indiana, 46202

  • Site Number - 1525

    Irving, Texas, 75039

  • Site Number - 1581

    Jacksonville, Florida, 32204-1177

  • Site Number - 1582

    Jacksonville, Florida, 48334

  • Site Number - 1511

    Jefferson City, Missouri, 65109-6023

  • Site Number - 1568

    Kansas City, Kansas, 66210

  • Site Number - 1537

    Kansas City, Missouri, 64108

  • Site Number - 1512

    Las Vegas, Nevada, 89148

  • Site Number - 1554

    Los Angeles, California, 90033

  • Site Number - 1546

    Louisville, Kentucky, 40202

  • Site Number - 1579

    Macon, Georgia, 31210

  • Site Number - 1529

    McKinney, Texas, 75069

  • Site Number - 1524

    Memphis, Tennessee, 38119

  • Site Number - 1501

    Mesquite, Texas, 75149

  • Site Number - 1589

    Metairie, Louisiana, 70006

  • Site Number - 1505

    Miami, Florida, 33143

  • Site Number - 1564

    Miami, Florida, 39501

  • Site Number - 1591

    Miami, Florida, 78240

  • Site Number - 1576

    Monroe, New York, 10950

  • Site Number - 1500

    Morehead City, North Carolina, 28557

  • Site Number - 1592

    Nashville, Tennessee, 37203

  • Site Number - 1575

    Nashville, Tennessee, 37212

  • Site Number - 1544

    New Hyde Park, New York, 11042

  • Site Number - 1555

    New Orleans, Louisiana, 70112

  • Site Number - 1531

    New York, New York, 10022

  • Site Number - 1539

    New York, New York, 11106

  • Site Number - 1516

    Newark, Delaware, 19713

  • Site Number - 1535

    Norfolk, Virginia, 23507

  • Site Number - 1590

    Ocoee, Florida, 34761

  • Site Number - 1536

    Oklahoma City, Oklahoma, 73118

  • Site Number - 1521

    Omaha, Nebraska, 68105

  • Site Number - 1588

    Orange, California, 92868

  • Site Number - 1508

    Orlando, Florida, 32819

  • Site Number - 1560

    Philadelphia, Pennsylvania, 19140

  • Site Number - 1561

    Phoenix, Arizona, 85006

  • Site Number - 1519

    Phoenix, Arizona, 85015

  • Site Number - 1507

    Port Charlotte, Florida, 33952

  • Site Number - 1549

    Portland, Oregon, 97035

  • Site Number - 1570

    Pottstown, Pennsylvania, 19464

  • Site Number - 1540

    Raleigh, North Carolina, 27612

  • Site Number - 1528

    Reno, Nevada, 89511

  • Site Number - 1515

    Rochester, Minnesota, 55905

  • Site Number - 1520

    Round Rock, Texas, 78681

  • Site Number - 1563

    Salt Lake City, Utah, 84108

  • Site Number - 1578

    San Antonio, Texas, 02114

  • Site Number - 1553

    San Antonio, Texas, 78215

  • Site Number - 1532

    San Antonio, Texas, 78229

  • Site Number - 1527

    San Antonio, Texas, 78231

  • Site Number - 1559

    San Francisco, California, 94143

  • Site Number - 1596

    Sandy City, Utah, 84093

  • Site Number - 1558

    Santa Clarita, California, 91321

  • Site Number - 1518

    Stockbridge, Georgia, 30281

  • Site Number - 1550

    Summerville, South Carolina, 29485

  • Site Number - 1534

    Topeka, Kansas, 66606

  • Site Number - 1552

    Torrance, California, 90509

  • Site Number - 1530

    Tucson, Arizona, 85710

  • Site Number - 1567

    Washington D.C., District of Columbia, 20010

  • Site Number - 1548

    West Palm Beach, Florida, 33401

  • Site Number - 1542

    Williamsville, New York, 14221

  • Site Number - 1586

    Wilmington, North Carolina, 28401

Other trials in United States

Bulgaria8 sites

  • Site Number - 5660

    Plovdiv, 4001

  • Site Number - 5653

    Sliven, 8800

  • Site Number - 5655

    Smolyan, 4700

  • Site Number - 5656

    Sofia, 1431

  • Site Number - 5650

    Varna, 9000

  • Site Number - 5651

    Varna, 9020

  • Site Number - 5654

    Varna, 9020

  • Site Number - 5652

    Yambol, 8600

Other trials in Bulgaria

Poland7 sites

  • Site Number - 3103

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605

  • Site Number - 3112

    Kielce, Silesian Voivodeship, 25-734

  • Site Number - 3102

    Lublin, Lubusz Voivodeship, 20-011

  • Site Number - 3104

    Lublin, Lubusz Voivodeship, 20-607

  • Site Number - 3100

    Lublin, Lubusz Voivodeship, 20-701

  • Site Number - 3108

    Warsaw, Masovian Voivodeship, 02-482

  • Site Number - 3101

    Warsaw, 00-189

Other trials in Poland

Georgia6 sites

  • Site Numner - 8051

    Batumi, Adjara, 6010

  • Site Number - 7576

    Budapest, 1083

  • Site Number - 8050

    Kutaisi, Imereti, 4600

  • Site Number - 8052

    Marneuli, Kvemo Kartli, 3000

  • Site Number - 8053

    Tbilisi, 0177

  • Site Number - 8063

    Tbilisi, 159

Other trials in Georgia

Australia5 sites

  • Site Number - 5154

    Perth, 6009

  • Site Number - 5152

    South Brisbane, Queensland, 4101

  • Site Number - 5150

    Southport, Queensland, 4222

  • Site Number - 5151

    St Leonards, 2065

  • Site Number - 5158

    Sydney, 2050

Other trials in Australia

Israel5 sites

  • Site Number - 4236

    Beersheba, 84101

  • Site Number - 4230

    Jerusalem, 91100001

  • Site Number - 4226

    Petah Tikva, 4941492

  • Site Number - 4233

    Ramat Gan, 5265601

  • Site Number - 4227

    Tel Aviv, 6423906

Other trials in Israel

Czechia3 sites

  • Site Number - 3254

    Náchod, 547 01

  • Site Number - 3251

    Prague, Czech Republic, 149 00

  • Site Number - 3252

    Prague, 190 14

Other trials in Czechia

Latvia3 sites

  • Site Number - 4650

    Ogre, LV5001

  • Site Number - 4653

    Riga, LV-1050

  • Site Number - 4654

    Sigulda, LV-2150

Other trials in Latvia

South Korea3 sites

  • Site Number - 4552

    Daegu, 42415

  • Site Number - 4553

    Gyeonggi-do, 10326

  • Site Number - 4556

    Gyeonggi-do, 11923

Other trials in South Korea

Hungary1 site

  • Site Number - 7575

    Pécs, Baranya, 7624

Other trials in Hungary

United Kingdom1 site

  • Site Number - 7051

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

About this study

Official title: 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.

Conditions
Graves' Disease
Being tested
IMVT-1402
Keywords
IMVT-1402, Graves' disease, Immunoglobulin G, Thyroid-Stimulating Hormone Receptor, Antithyroid drug, FcRn, Imeroprubart
Medical subject headings
Graves Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMVT-1402Drug

    Dose 1 for up to 52 weeks

Study groups in NCT07286006
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Drug: IMVT-1402
Group BNo interventionNot described
Group CNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402

    Measured: At Week 52

Secondary outcomes (12)

  1. Percentage of Group A Participants who are euthyroid and off ATD

    Measured: At Week 26

  2. Percentage of Group A Participants who are euthyroid and off ATD

    Measured: Up to Week 52

  3. Percentage of Group A Participants who are euthyroid, off ATD, and off IMVT-1402

    Measured: Up to Week 52

  4. Time to earliest date of euthyroidism, off ATD, and off IMVT-1402 to the earliest date of confirmed relapse in Group A Participants

    Measured: Up to Week 52

  5. Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402

    Measured: Up to Week 52

  6. Percentage of Group B Participants who remain euthyroid, off ATD, and off IMVT-1402

    Measured: At Week 52

  7. Time from Week 0 to the earliest date of confirmed relapse in Group B Participants

    Measured: Up to Week 52

  8. Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402

    Measured: Up to Week 52

  9. Percentage of Group C Participants who remain euthyroid, off ATD, and off IMVT-1402

    Measured: At Week 52

  10. Time From Week 0 to the earliest date of confirmed relapse in Group C Participants

    Measured: Up to Week 52

  11. Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb

    Measured: At Week 26

  12. Percentage of Group A Participants who are euthyroid, off ATD, and seronegative for TRAb

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start26 Jan 2026
  3. Primary completionMar 2030 (estimated)
  4. Study completionMar 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
372 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07286006
Sponsor's protocol ID
IMVT-1402-2505
Status last verified
Sep 2026
First submitted
10 Dec 2025
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMVT-1402 in people with Graves' Disease, run by Immunovant Sciences GmbH at 131 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States, Bulgaria, Poland, Georgia, Australia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Group A Participants who remain euthyroid, Off ATD, and Off IMVT-1402 (time frame: At Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07286006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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