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

NCT07286006 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 1 other identifier: IMVT-1402-2505
• Study Type: interventional
• Target: 372
• Locations: 11 countries
• Sites: 131

Brief 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.

Conditions

Graves' Disease

Keywords

IMVT-1402; Graves' disease; Immunoglobulin G; Thyroid-Stimulating Hormone Receptor; Antithyroid drug; FcRn; Imeroprubart

Outcome Measures

Primary Outcomes (1)

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

  At Week 52

Secondary Outcomes (12)

• 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

Study Arms (3)

Group A

EXPERIMENTAL

Drug: IMVT-1402

Group B

NO INTERVENTION

Group C

NO INTERVENTION

Interventions

IMVT-1402 DRUG

Dose 1 for up to 52 weeks

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who completed Study IMVT-1402-2502 or Study IMVT-1402-2503.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunovant Sciences GmbH: lead

Study Sites (131)

Site Number - 1561

Phoenix, Arizona, 85006, United States

Location

Site Number - 1519

Phoenix, Arizona, 85015, United States

Location

Site Number - 1530

Tucson, Arizona, 85710, United States

Location

Site Number - 1510

Concord, California, 94520, United States

Location

Site Number - 1587

Huntington Beach, California, 92647, United States

Location

Site Number - 1554

Los Angeles, California, 90033, United States

Location

Site Number - 1588

Orange, California, 92868, United States

Location

Site Number - 1559

San Francisco, California, 94143, United States

Location

Site Number - 1558

Santa Clarita, California, 91321, United States

Location

Site Number - 1552

Torrance, California, 90509, United States

Location

Site Number - 1533

Aurora, Colorado, 80045, United States

Location

Site Number -1514

Englewood, Colorado, 80113, United States

Location

Site Number - 1516

Newark, Delaware, 19713, United States

Location

Site Number - 1567

Washington D.C., District of Columbia, 20010, United States

Location

Site Number - 1556

Clearwater, Florida, 33756, United States

Location

Site Number - 1522

Doral, Florida, 33166, United States

Location

Site Number - 1523

Hialeah, Florida, 33016, United States

Location

Site Number - 1581

Jacksonville, Florida, 32204-1177, United States

Location

Site Number - 1582

Jacksonville, Florida, 48334, United States

Location

Site Number - 1505

Miami, Florida, 33143, United States

Location

Site Number - 1564

Miami, Florida, 39501, United States

Location

Site Number - 1591

Miami, Florida, 78240, United States

Location

Site Number - 1590

Ocoee, Florida, 34761, United States

Location

Site Number - 1508

Orlando, Florida, 32819, United States

Location

Site Number - 1507

Port Charlotte, Florida, 33952, United States

Location

Site Number - 1548

West Palm Beach, Florida, 33401, United States

Location

Site Number - 1566

Atlanta, Georgia, 30318, United States

Location

Site Number - 1526

Columbus, Georgia, 31904, United States

Location

Site Number - 1579

Macon, Georgia, 31210, United States

Location

Site Number - 1518

Stockbridge, Georgia, 30281, United States

Location

Site Number - 1562

Indianapolis, Indiana, 46202, United States

Location

Site Number - 1568

Kansas City, Kansas, 66210, United States

Location

Site Number - 1534

Topeka, Kansas, 66606, United States

Location

Site Number - 1571

Bowling Green, Kentucky, 42101, United States

Location

Site Number - 1580

Florence, Kentucky, 65613, United States

Location

Site Number - 1546

Louisville, Kentucky, 40202, United States

Location

Site Number - 1589

Metairie, Louisiana, 70006, United States

Location

Site Number - 1555

New Orleans, Louisiana, 70112, United States

Location

Site Number - 1565

Baltimore, Maryland, 21287, United States

Location

Site Number - 1557

Boston, Massachusetts, 32216, United States

Location

Site Number - 1503

Farmington Hills, Michigan, 33186, United States

Location

Site Number - 1595

Flint, Michigan, 48532, United States

Location

Site Number - 1515

Rochester, Minnesota, 55905, United States

Location

Site Number - 1594

Gulfport, Mississippi, 33136, United States

Location

Site Number - 1511

Jefferson City, Missouri, 65109-6023, United States

Location

Site Number - 1537

Kansas City, Missouri, 64108, United States

Location

Site Number - 1521

Omaha, Nebraska, 68105, United States

Location

Site Number - 1512

Las Vegas, Nevada, 89148, United States

Location

Site Number - 1528

Reno, Nevada, 89511, United States

Location

Site Number - 1576

Monroe, New York, 10950, United States

Location

Site Number - 1544

New Hyde Park, New York, 11042, United States

Location

Site Number - 1531

New York, New York, 10022, United States

Location

Site Number - 1539

New York, New York, 11106, United States

Location

Site Number - 1542

Williamsville, New York, 14221, United States

Location

Site Number - 1577

Asheville, North Carolina, 28803, United States

Location

Site Number - 1509

Chapel Hill, North Carolina, 27514, United States

Location

Site Number - 1506

Hickory, North Carolina, 28601, United States

Location

Site Number - 1500

Morehead City, North Carolina, 28557, United States

Location

Site Number - 1540

Raleigh, North Carolina, 27612, United States

Location

Site Number - 1586

Wilmington, North Carolina, 28401, United States

Location

Site Number - 1583

Canton, Ohio, 44718, United States

Location

Site Number - 1536

Oklahoma City, Oklahoma, 73118, United States

Location

Site Number - 1549

Portland, Oregon, 97035, United States

Location

Site Number - 1560

Philadelphia, Pennsylvania, 19140, United States

Location

Site Number - 1570

Pottstown, Pennsylvania, 19464, United States

Location

Site Number - 1550

Summerville, South Carolina, 29485, United States

Location

Site Number - 1569

Chattanooga, Tennessee, 37421, United States

Location

Site Number - 1524

Memphis, Tennessee, 38119, United States

Location

Site Number - 1592

Nashville, Tennessee, 37203, United States

Location

Site Number - 1575

Nashville, Tennessee, 37212, United States

Location

Site Number - 1517

Austin, Texas, 78731, United States

Location

Site Number - 1593

Bellaire, Texas, 77401, United States

Location

Site Number - 1513

Dallas, Texas, 75208, United States

Location

Site Number - 1551

Dallas, Texas, 75231, United States

Location

Site Number - 1538

Dallas, Texas, 75246, United States

Location

Site Number - 1502

El Paso, Texas, 79935, United States

Location

Site Number - 1504

Fort Worth, Texas, 76132, United States

Location

Site Number - 1597

Houston, Texas, 77089, United States

Location

Site Number - 1525

Irving, Texas, 75039, United States

Location

Site Number - 1529

McKinney, Texas, 75069, United States

Location

Site Number - 1501

Mesquite, Texas, 75149, United States

Location

Site Number - 1520

Round Rock, Texas, 78681, United States

Location

Site Number - 1578

San Antonio, Texas, 02114, United States

Location

Site Number - 1553

San Antonio, Texas, 78215, United States

Location

Site Number - 1532

San Antonio, Texas, 78229, United States

Location

Site Number - 1527

San Antonio, Texas, 78231, United States

Location

Site Number - 1563

Salt Lake City, Utah, 84108, United States

Location

Site Number - 1596

Sandy City, Utah, 84093, United States

Location

Site Number - 1535

Norfolk, Virginia, 23507, United States

Location

Site Number - 5152

South Brisbane, Queensland, 4101, Australia

Location

Site Number - 5150

Southport, Queensland, 4222, Australia

Location

Site Number - 5154

Perth, 6009, Australia

Location

Site Number - 5151

St Leonards, 2065, Australia

Location

Site Number - 5158

Sydney, 2050, Australia

Location

Site Number - 5660

Plovdiv, 4001, Bulgaria

Location

Site Number - 5653

Sliven, 8800, Bulgaria

Location

Site Number - 5655

Smolyan, 4700, Bulgaria

Location

Site Number - 5656

Sofia, 1431, Bulgaria

Location

Site Number - 5650

Varna, 9000, Bulgaria

Location

Site Number - 5651

Varna, 9020, Bulgaria

Location

Site Number - 5654

Varna, 9020, Bulgaria

Location

Site Number - 5652

Yambol, 8600, Bulgaria

Location

Site Number - 3251

Prague, Czech Republic, 149 00, Czechia

Location

Site Number - 3254

Náchod, 547 01, Czechia

Location

Site Number - 3252

Prague, 190 14, Czechia

Location

Site Numner - 8051

Batumi, Adjara, 6010, Georgia

Location

Site Number - 8050

Kutaisi, Imereti, 4600, Georgia

Location

Site Number - 8052

Marneuli, Kvemo Kartli, 3000, Georgia

Location

Site Number - 7576

Budapest, 1083, Georgia

Location

Site Number - 8053

Tbilisi, 0177, Georgia

Location

Site Number - 8063

Tbilisi, 159, Georgia

Location

Site Number - 7575

Pécs, Baranya, 7624, Hungary

Location

Site Number - 4236

Beersheba, 84101, Israel

Location

Site Number - 4230

Jerusalem, 91100001, Israel

Location

Site Number - 4226

Petah Tikva, 4941492, Israel

Location

Site Number - 4233

Ramat Gan, 5265601, Israel

Location

Site Number - 4227

Tel Aviv, 6423906, Israel

Location

Site Number - 4650

Ogre, LV5001, Latvia

Location

Site Number - 4653

Riga, LV-1050, Latvia

Location

Site Number - 4654

Sigulda, LV-2150, Latvia

Location

Site Number - 3103

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605, Poland

Location

Site Number - 3102

Lublin, Lubusz Voivodeship, 20-011, Poland

Location

Site Number - 3104

Lublin, Lubusz Voivodeship, 20-607, Poland

Location

Site Number - 3100

Lublin, Lubusz Voivodeship, 20-701, Poland

Location

Site Number - 3108

Warsaw, Masovian Voivodeship, 02-482, Poland

Location

Site Number - 3112

Kielce, Silesian Voivodeship, 25-734, Poland

Location

Site Number - 3101

Warsaw, 00-189, Poland

Location

Site Number - 4552

Daegu, 42415, South Korea

Location

Site Number - 4553

Gyeonggi-do, 10326, South Korea

Location

Site Number - 4556

Gyeonggi-do, 11923, South Korea

Location

Site Number - 7051

Truro, Cornwall, TR1 3LJ, United Kingdom

Location

MeSH Terms

Conditions

Graves Disease

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 16, 2025
• Study Start: January 26, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2030
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

LA (3); PL (7); KR (3); US (89); CZ (3); BU (8); AU (5); IL (5); HU (1); GB (1); GE (6)