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

May 21, 2026 updated by: Immunovant Sciences GmbH

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

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 Contact

Study Locations

  • Belgium
      • Antwerp, Belgium, 2820
        • Recruiting
        • Site Number - 5303
      • Bruges, Belgium, 80000
        • Recruiting
        • Site Number - 5301
      • Brussels, Belgium, 1070
        • Recruiting
        • Site Number - 5302
  • Georgia
      • Batumi, Georgia, 6000
        • Recruiting
        • Site Number - 8002
      • Batumi, Georgia, 6010
        • Recruiting
        • Site Number - 8007
      • Kutaisi, Georgia, 4600
        • Recruiting
        • Site Number - 8006
      • Marneuli, Georgia, 3000
        • Recruiting
        • Site Number - 8008
      • Tbilisi, Georgia, 0112
        • Recruiting
        • Site Number - 8009
      • Tbilisi, Georgia, 0144
        • Recruiting
        • Site Number - 8004
      • Tbilisi, Georgia, 0144
        • Recruiting
        • Site Number - 8005
      • Tbilisi, Georgia, 0159
        • Recruiting
        • Site Number - 8001
      • Tbilisi, Georgia, 0159
        • Recruiting
        • Site Number - 8003
      • Tbilisi, Georgia, 0159
        • Recruiting
        • Site Number - 8011
      • Tbilisi, Georgia, 0177
        • Recruiting
        • Site Number - 8010
  • Germany
      • Munich, Germany, 81667
        • Recruiting
        • Site Number - 6508
      • Munich, Germany, 80336
        • Recruiting
        • Site Number - 6503
      • Schwerin, Germany, 19049
        • Recruiting
        • Site Number - 6502
      • Würzburg, Germany, 97080
        • Recruiting
        • Site Number - 6507
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Site Number - 6505
  • Hungary
      • Budapest, Hungary, 1036
        • Recruiting
        • Site Number - 7554
      • Budapest, Hungary, 1083
        • Recruiting
        • Site Number - 7556
      • Békéscsaba, Hungary, 5600
        • Recruiting
        • Site Number - 7558
      • Debrecen, Hungary, 4032
        • Recruiting
        • Site Number - 7557
      • Pécs, Hungary, 7623
        • Recruiting
        • Site Number - 7551
      • Szeged, Hungary, 6725
        • Recruiting
        • Site Number - 7552
  • Italy
      • Bologna, Italy, 40138
        • Recruiting
        • Site Number - 6004
      • Cagliari, Italy, 09124
        • Recruiting
        • Site Number - 6012
      • Genova, Italy, 16132
        • Recruiting
        • Site Number - 6011
      • Milan, Italy, 20149
        • Recruiting
        • Site Number - 6007
      • Milan, Italy, 20122
        • Recruiting
        • Site Number - 6002
      • Milan, Italy, 20162
        • Recruiting
        • Site Number - 6009
      • Naples, Italy, 80131
        • Recruiting
        • Site Number - 6010
      • Pisa, Italy, 56124
        • Recruiting
        • Site Number - 6003
      • Pisa, Italy, 56126
        • Recruiting
        • Site Number - 6001
      • Roma, Italy, 00189
        • Recruiting
        • Site Number - 6005
      • Siena, Italy, 53100
        • Recruiting
        • Site Number - 6013
      • Varese, Italy, 21100
        • Recruiting
        • Site Number - 6008
  • Poland
      • Gliwice, Poland, 44-102
        • Recruiting
        • Site Number - 3006
      • Krakow, Poland, 30-074
        • Recruiting
        • Site Number - 3002
      • Krakow, Poland, 30-688
        • Recruiting
        • Site Number -3003
      • Lublin, Poland, 20-400
        • Recruiting
        • Site Number - 3005
      • Lublin, Poland, 91-495
        • Recruiting
        • Site Number - 3004
      • Lublin, Poland, 20-607
        • Recruiting
        • Site Number - 3008
      • Poznan, Poland, 60-354
        • Recruiting
        • Site Number - 3007
      • Warsaw, Poland, 00-0189
        • Recruiting
        • Site Number - 3001
  • Puerto Rico
      • San Juan, Puerto Rico, 00907
        • Recruiting
        • Site Number - 1058
      • San Juan, Puerto Rico, 00921-3313
        • Withdrawn
        • Site Number - 1037
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Site Number - 7103
      • Barcelona, Spain, 08035
        • Recruiting
        • Site Number - 7109
      • Córdoba, Spain, 14004
        • Recruiting
        • Site Number - 7102
      • Granada, Spain, 18014
        • Recruiting
        • Site Number - 7106
      • Madrid, Spain, 28006
        • Recruiting
        • Site Number - 7105
      • Pamplona, Spain, 31008
        • Recruiting
        • Site Number - 7107
      • Pamplona, Spain, 31008
        • Recruiting
        • Site Number - 7108
      • Seville, Spain, 41009
        • Recruiting
        • Site Number - 7101
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Site Number - 7104
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • Site Number - 7002
      • Edinburgh, United Kingdom, EH16 4SA
        • Recruiting
        • Site Number - 7008
      • Huddersfield, United Kingdom, HD3 3EA
        • Recruiting
        • Site Number - 7005
      • Hull, United Kingdom, HU6 7RX
        • Recruiting
        • Site Number - 7004
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • Site Number - 7003
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • Site Number - 7006
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Recruiting
        • Site Number - 7001
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • Site Number - 7009
      • Nuneaton, United Kingdom, CV10 7DJ
        • Recruiting
        • Site Number - 7010
    • England
      • Birmingham, England, United Kingdom, B15 2TT
        • Recruiting
        • Site Number - 7013
      • Bristol, England, United Kingdom, BS10 5NB
        • Recruiting
        • Site Number - 7012
      • Coventry, England, United Kingdom, CV2 2DX
        • Recruiting
        • Site Number - 7011
      • London, England, United Kingdom, NW1 2PG
        • Recruiting
        • Site Number - 7007
    • London
      • Cambridge, London, United Kingdom, CB2 0QQ
        • Recruiting
        • Site Number - 7014
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Recruiting
        • Site Number - 1036
      • Phoenix, Arizona, United States, 85006
        • Withdrawn
        • Site Number - 1032
    • California
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • Site Number - 1061
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Site Number - 1001
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Site Number - 1047
      • Orange, California, United States, 92868
        • Recruiting
        • Site Number - 1062
      • Sacramento, California, United States, 95816
        • Recruiting
        • Site Number - 1046
      • San Francisco, California, United States, 94143
        • Recruiting
        • Site Number - 1034
      • Santa Clarita, California, United States, 91321
        • Withdrawn
        • Site Number - 1035
      • Torrance, California, United States, 90502
        • Recruiting
        • Site Number - 1005
      • Walnut Creek, California, United States, 94598
        • Withdrawn
        • Site Number - 1006
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • Site Number - 1013
    • Delaware
      • Newark, Delaware, United States, 19713
        • Recruiting
        • Site Number - 1010
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Site Number - 1040
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Site Number - 1029
      • Jacksonville, Florida, United States, 32204-1177
        • Recruiting
        • Site Number - 1055
      • Jacksonville, Florida, United States, 32216
        • Recruiting
        • Site Number - 1056
      • Miami, Florida, United States, 33136
        • Recruiting
        • Site Number - 1028
      • Miami, Florida, United States, 33186
        • Recruiting
        • Site Number - 1065
      • Ocoee, Florida, United States, 34761
        • Recruiting
        • Site Number - 1064
      • Orlando, Florida, United States, 32819
        • Recruiting
        • Site Number - 1011
      • Port Charlotte, Florida, United States, 33952
        • Recruiting
        • Site Number - 1016
      • West Palm Beach, Florida, United States, 33401
        • Recruiting
        • Site Number - 1012
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Site Number - 1038
      • Macon, Georgia, United States, 31210
        • Recruiting
        • Site Number - 1053
      • Stockbridge, Georgia, United States, 30281
        • Recruiting
        • Site Number - 1020
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Site Number - 1027
    • Kansas
      • Kansas City, Kansas, United States, 66210
        • Recruiting
        • Site Number - 1041
    • Kentucky
      • Bowling Green, Kentucky, United States, 42101
        • Recruiting
        • Site Number - 1045
      • Florence, Kentucky, United States, 41042
        • Recruiting
        • Site Number - 1054
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Recruiting
        • Site Number - 1063
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Site Number - 1022
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Site Number - 1048
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Site Number - 1023
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Site Number - 1026
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Site Number - 1018
      • Flint, Michigan, United States, 48532
        • Recruiting
        • Site Number - 1069
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Site Number - 1008
    • Mississippi
      • Gulfport, Mississippi, United States, 39501
        • Recruiting
        • Site Number - 1068
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Recruiting
        • Site Number - 1017
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Site Number - 1007
    • New York
      • Monroe, New York, United States, 10950
        • Recruiting
        • Site Number - 1050
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Site Number - 1051
      • Wilmington, North Carolina, United States, 28401
        • Recruiting
        • Site Number - 1060
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Site Number - 1057
    • Oregon
      • Portland, Oregon, United States, 97035
        • Recruiting
        • Site Number - 1003
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Withdrawn
        • Site Number - 1033
      • Pottstown, Pennsylvania, United States, 19464
        • Recruiting
        • Site Number - 1043
    • South Carolina
      • Summerville, South Carolina, United States, 29485
        • Recruiting
        • Site Number - 1015
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Recruiting
        • Site Number - 1042
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Site Number - 1066
      • Nashville, Tennessee, United States, 37212
        • Recruiting
        • Site Number - 1049
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Site Number - 1002
      • Bellaire, Texas, United States, 77401
        • Recruiting
        • Site Number - 1067
      • Dallas, Texas, United States, 75208
        • Recruiting
        • Site Number - 1019
      • Dallas, Texas, United States, 75231
        • Withdrawn
        • Site Number - 1031
      • Houston, Texas, United States, 77095
        • Withdrawn
        • Site Number - 1025
      • Houston, Texas, United States, 77089
        • Recruiting
        • Site Number - 1071
      • Mesquite, Texas, United States, 75149
        • Recruiting
        • Site Number - 1004
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Site Number - 1009
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • Site Number - 1014
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Site Number - 1052
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • Site Number - 1030
      • Sandy City, Utah, United States, 84093
        • Recruiting
        • Site Number - 1070

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 with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
  • Male or female participants aged ≥ 18 years.
  • Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.
  • Other, more specific inclusion criteria are defined in the protocol.

Exclusion Criteria:

  • Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
  • Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.
  • Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.
  • Additional exclusion criteria are defined in the protocol.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 Period 1 and 2: IMVT-1402
Drug: IMVT-1402
600 mg SC QW for 52 weeks
Drug: IMVT-1402
600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
Experimental: Group 2 Period 1 and 2: IMVT-1402
Drug: IMVT-1402
600 mg SC QW for 52 weeks
Drug: IMVT-1402
600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
Experimental: Group 2 Period 1: IMVT-1402 and Period 2: Placebo
Drug: IMVT-1402
600 mg SC QW for 52 weeks
Drug: IMVT-1402
600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
Placebo Comparator: Group 3 Period 1 and 2: Placebo
Drug: Placebo
SC QW for 52 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants who are euthyroid (local laboratory T3 [Total T3 or FT3], FT4, and TSH values within normal limits) and off ATD at Week 26
Time Frame: Week 26
Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants who are euthyroid and off ATD at Week 52
Time Frame: Week 52
Week 52
Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52
Time Frame: Week 52
Week 52
Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78
Time Frame: Week 78
Week 78
Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104
Time Frame: Week 104
Week 104
Percentage of participants who have a TRAb value a specified amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52
Time Frame: Week 52
Week 52
Percentage of participants who have a TRAb value a specific amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78
Time Frame: Week 78
Week 78
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline
Time Frame: Week 2
Week 2
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline
Time Frame: Week 4
Week 4
Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26
Time Frame: Week 26
Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 26
Time Frame: Week 26
Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 52
Time Frame: Week 52
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)

December 17, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 9, 2024

First Posted (Actual)

December 11, 2024

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMVT-1402-2502
  • 2024-516020-33-00 (Ctis)

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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