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

Last updated: September 26, 2025
Sponsor: Immunovant Sciences GmbH
Overall Status: Active - Recruiting

Phase

2

Condition

Thyroid Disease

Female Hormonal Deficiencies/abnormalities

Thyroid Disorders

Treatment

IMVT-1402

Placebo

Clinical Study ID

NCT06727604
IMVT-1402-2502
2024-516020-33-00
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have documented diagnosis of GD.

  • Have a TSH value < 0.1 mIU/L as assessed by the local laboratory at the ScreeningVisit.

  • Meet one of the following at the Screening Visit:

  • Have been on ATD for ≥ 3 months in the period immediately preceding theScreening Visit and both of the following:

  • Are on ATD at the Screening Visit with an ATD dose of ≥ 20 mg/daymethimazole or equivalent for the 4-week period immediately preceding theScreening Visit.

  • Are anticipated to be on a stable dose of ATD for the 4-week periodimmediately preceding Randomization.

  • Have been on ATD for ≥ 6 months in the period immediately preceding theScreening Visit and all of the following:

  • Have been treated with ≥ 15 mg/day methimazole or equivalent at any pointduring the participant's treatment history.

  • Are on ATD at the Screening Visit with an ATD dose a specified amount ofmethimazole or equivalent for the 4-week period immediately preceding theScreening Visit.

  • Are anticipated to be on a stable dose of ATD for the 4-week periodimmediately preceding Randomization.

Additional inclusion criteria are defined in the protocol.

Exclusion

Exclusion Criteria:

  • Have previously been treated with radioactive iodine (RAI) therapy or have undergonetotal thyroidectomy.

  • Have a T3 (Total T3 or FT3, as available and per standard of care at locallaboratory) or FT4 value < lower limit of normal (LLN) as assessed by the locallaboratory at the Screening Visit.

  • Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6weeks of the Screening Visit.

  • Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxicmultinodular goiter) and/or history of thyroid storm within 6 months of theScreening Visit.

  • Have an autoimmune disease other than GD requiring treatment that, in theInvestigator's judgment, puts the participant at undue risk.

  • Have moderate-to-severe active thyroid eye disease (TED) and are expected to requireimmediate surgical intervention and/or are planning corrective surgery/irradiationor medical therapy for TED during study participation.

Additional exclusion criteria are defined in the protocol.

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: IMVT-1402
Phase: 2
Study Start date:
December 17, 2024
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Site Number - 5303

    Antwerp 2803138, 2820
    Belgium

    Active - Recruiting

  • Site Number - 5303

    Antwerpen, 2820
    Belgium

    Site Not Available

  • Site Number - 5301

    Bruges 2800931, 80000
    Belgium

    Active - Recruiting

  • Site Number - 8002

    Batumi, 6000
    Georgia

    Site Not Available

  • Site Number - 8002

    Batumi 615532, 6000
    Georgia

    Active - Recruiting

  • Site Number - 8007

    Batumi 615532, 6010
    Georgia

    Active - Recruiting

  • Site Number - 8006

    Kutaisi, 4600
    Georgia

    Site Not Available

  • Site Number - 8006

    Kutaisi 613607, 4600
    Georgia

    Active - Recruiting

  • Site Number - 8008

    Marneuli 613074, 3000
    Georgia

    Active - Recruiting

  • Site Number - 8009

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Site Number - 8001

    Tbilisi 611717, 0159
    Georgia

    Active - Recruiting

  • Site Number - 8003

    Tbilisi 611717, 0159
    Georgia

    Active - Recruiting

  • Site Number - 8004

    Tbilisi 611717, 0144
    Georgia

    Active - Recruiting

  • Site Number - 8005

    Tbilisi 611717, 0144
    Georgia

    Active - Recruiting

  • Site Number - 8009

    Tbilisi 611717, 0112
    Georgia

    Active - Recruiting

  • Site Number - 8010

    Tbilisi 611717, 0177
    Georgia

    Active - Recruiting

  • Site Number - 8011

    Tbilisi 611717, 0159
    Georgia

    Active - Recruiting

  • Site Number - 6505

    Dresden 2935022, Saxony 2842566 01307
    Germany

    Active - Recruiting

  • Site Number - 6502

    Schwerin 2834282, 19049
    Germany

    Active - Recruiting

  • Site Number - 7554

    Budapest, 1036
    Hungary

    Site Not Available

  • Site Number - 7554

    Budapest 3054643, 1036
    Hungary

    Active - Recruiting

  • Site Number - 7556

    Budapest 3054643, 1083
    Hungary

    Active - Recruiting

  • Site Number - 7551

    Pécs, 7623
    Hungary

    Site Not Available

  • Site Number - 7551

    Pécs 3046526, 7623
    Hungary

    Active - Recruiting

  • Site Number - 7552

    Szeged 715429, 6725
    Hungary

    Active - Recruiting

  • Site Number - 6004

    Bologna 3181928, 40138
    Italy

    Active - Recruiting

  • Site Number - 6012

    Cagliari 2525473, 09124
    Italy

    Active - Recruiting

  • Site Number - 6007

    Milan 6951411, 20149
    Italy

    Active - Recruiting

  • Site Number - 6010

    Napoli 9031661, 80131
    Italy

    Active - Recruiting

  • Site Number - 3002

    Krakow 3094802, 30-074
    Poland

    Active - Recruiting

  • Site Number -3003

    Krakow 3094802, 30-688
    Poland

    Active - Recruiting

  • Site Number - 3004

    Lublin, 91-495
    Poland

    Site Not Available

  • Site Number - 3005

    Lublin, 20-400
    Poland

    Active - Recruiting

  • Site Number - 3004

    Lublin 765876, 91-495
    Poland

    Active - Recruiting

  • Site Number - 3005

    Lublin 765876, 20-400
    Poland

    Active - Recruiting

  • Site Number - 3001

    Warsaw, 00-0189
    Poland

    Site Not Available

  • Site Number - 3001

    Warsaw 756135, 00-0189
    Poland

    Active - Recruiting

  • Site Number - 1037

    San Juan, 00921-3313
    Puerto Rico

    Site Not Available

  • Site Number - 1037

    San Juan 4568127, 00921-3313
    Puerto Rico

    Active - Recruiting

  • Site Number - 7104

    Badalona 3129028, Barcelona 08916
    Spain

    Active - Recruiting

  • Site Number - 7103

    Barcelona, 08036
    Spain

    Site Not Available

  • Site Number - 7103

    Barcelona 3128760, 08036
    Spain

    Active - Recruiting

  • Site Number - 7102

    Córdoba, 14004
    Spain

    Site Not Available

  • Site Number - 7102

    Córdoba 2519240, 14004
    Spain

    Active - Recruiting

  • Site Number - 7105

    Madrid 3117735, 28006
    Spain

    Active - Recruiting

  • Site Number - 7101

    Sevilla, 41009
    Spain

    Site Not Available

  • Site Number - 7101

    Seville 2510911, 41009
    Spain

    Active - Recruiting

  • Site Number - 7007

    London 2643743, England 6269131 NW1 2PG
    United Kingdom

    Active - Recruiting

  • Site Number - 7002

    Cardiff, CF14 4XW
    United Kingdom

    Site Not Available

  • Site Number - 7002

    Cardiff 2653822, CF14 4XW
    United Kingdom

    Active - Recruiting

  • Site Number - 7005

    Huddersfield, HD3 3EA
    United Kingdom

    Site Not Available

  • Site Number - 7005

    Huddersfield 2646458, HD3 3EA
    United Kingdom

    Active - Recruiting

  • Site Number - 7004

    Hull 2645425, HU6 7RX
    United Kingdom

    Active - Recruiting

  • Site Number - 7003

    London 2643743, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Site Number - 7006

    Manchester 2643123, M20 4BX
    United Kingdom

    Active - Recruiting

  • Site Number - 7001

    Newcastle upon Tyne 2641673, NE1 4LP
    United Kingdom

    Active - Recruiting

  • Site Number - 1036

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • Site Number - 1032

    Phoenix 5308655, Arizona 5551752 85006
    United States

    Active - Recruiting

  • Site Number - 1036

    Phoenix 5308655, Arizona 5551752 85015
    United States

    Active - Recruiting

  • Site Number - 1001

    Los Angeles, California 90033
    United States

    Site Not Available

  • Site Number - 1034

    San Francisco, California 94143
    United States

    Site Not Available

  • Site Number - 1035

    Santa Clarita, California 91321
    United States

    Site Not Available

  • Site Number - 1005

    Torrance, California 90502
    United States

    Site Not Available

  • Site Number - 1006

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Site Number - 1001

    Los Angeles 5368361, California 5332921 90033
    United States

    Active - Recruiting

  • Site Number - 1034

    San Francisco 5391959, California 5332921 94143
    United States

    Active - Recruiting

  • Site Number - 1035

    Santa Clarita 5393049, California 5332921 91321
    United States

    Active - Recruiting

  • Site Number - 1005

    Torrance 5403022, California 5332921 90502
    United States

    Active - Recruiting

  • Site Number - 1006

    Walnut Creek 5406990, California 5332921 94598
    United States

    Site Not Available

  • Site Number - 1013

    Englewood, Colorado 80113
    United States

    Site Not Available

  • Site Number - 1013

    Englewood 5421250, Colorado 5417618 80113
    United States

    Active - Recruiting

  • Site Number - 1010

    Newark, Delaware 19713
    United States

    Site Not Available

  • Site Number - 1010

    Newark 4143861, Delaware 4142224 19713
    United States

    Active - Recruiting

  • Site Number - 1029

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Site Number - 1011

    Orlando, Florida 32819
    United States

    Site Not Available

  • Site Number - 1016

    Port Charlotte, Florida 33952
    United States

    Site Not Available

  • Site Number - 1012

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Site Number - 1029

    Clearwater 4151316, Florida 4155751 33756
    United States

    Active - Recruiting

  • Site Number - 1028

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • Site Number - 1011

    Orlando 4167147, Florida 4155751 32819
    United States

    Active - Recruiting

  • Site Number - 1016

    Port Charlotte 4169130, Florida 4155751 33952
    United States

    Active - Recruiting

  • Site Number - 1012

    West Palm Beach 4177887, Florida 4155751 33401
    United States

    Active - Recruiting

  • Site Number - 1020

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Site Number - 1020

    Stockbridge 4224681, Georgia 4197000 30281
    United States

    Active - Recruiting

  • Site Number - 1027

    Indianapolis 4259418, Indiana 4921868 46202
    United States

    Active - Recruiting

  • Site Number - 1022

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Site Number - 1022

    New Orleans 4335045, Louisiana 4331987 70112
    United States

    Active - Recruiting

  • Site Number - 1023

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Active - Recruiting

  • Site Number - 1026

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Site Number - 1026

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Active - Recruiting

  • Site Number - 1018

    Farmington Hills, Michigan 48334
    United States

    Site Not Available

  • Site Number - 1018

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Active - Recruiting

  • Site Number - 1008

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Site Number - 1008

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • Site Number - 1017

    Omaha, Nebraska 68105
    United States

    Site Not Available

  • Site Number - 1017

    Omaha 5074472, Nebraska 5073708 68105
    United States

    Active - Recruiting

  • Site Number - 1007

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Site Number - 1007

    Las Vegas 5506956, Nevada 5509151 89148
    United States

    Active - Recruiting

  • Site Number - 1003

    Portland, Oregon 97035
    United States

    Site Not Available

  • Site Number - 1003

    Portland 5746545, Oregon 5744337 97035
    United States

    Active - Recruiting

  • Site Number - 1033

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Active - Recruiting

  • Site Number - 1015

    Summerville, South Carolina 29485
    United States

    Site Not Available

  • Site Number - 1015

    Summerville 4597919, South Carolina 4597040 29485
    United States

    Active - Recruiting

  • Site number - 1002

    Austin, Texas 78731
    United States

    Site Not Available

  • Site Number - 1019

    Dallas, Texas 75208
    United States

    Site Not Available

  • Site Number - 1031

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Site Number - 1025

    Houston, Texas 77095
    United States

    Site Not Available

  • Site Number - 1004

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Site Number - 1009

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Site Number - 1014

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Site Number - 1002

    Austin 4671654, Texas 4736286 78731
    United States

    Active - Recruiting

  • Site Number - 1019

    Dallas 4684888, Texas 4736286 75208
    United States

    Active - Recruiting

  • Site Number - 1031

    Dallas 4684888, Texas 4736286 75231
    United States

    Active - Recruiting

  • Site Number - 1025

    Houston 4699066, Texas 4736286 77095
    United States

    Site Not Available

  • Site Number - 1004

    Mesquite 4710826, Texas 4736286 75149
    United States

    Active - Recruiting

  • Site Number - 1009

    Round Rock 4724129, Texas 4736286 78681
    United States

    Active - Recruiting

  • Site Number - 1014

    San Antonio 4726206, Texas 4736286 78215
    United States

    Active - Recruiting

  • Site Number - 1030

    Salt Lake City 5780993, Utah 5549030 84108
    United States

    Active - Recruiting

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