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

June 5, 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 multi-center, global, randomized, double-blind, placebo-controlled Phase 2b 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

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

  • Australia
      • Perth, Australia, 6009
        • Recruiting
        • Site Number - 5108
      • Saint Leonards, Australia, 2065
        • Recruiting
        • Site Number - 5109
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Recruiting
        • Site Number - 5105
      • Warrawong, New South Wales, Australia, 2502
        • Recruiting
        • Site Number - 5103
    • Queensland
      • Brisbane, Queensland, Australia, 4101
        • Recruiting
        • Site Number - 5101
      • Douglas, Queensland, Australia, 4814
        • Recruiting
        • Site Number - 5107
      • Southport, Queensland, Australia, 4222
        • Recruiting
        • Site Number - 5100
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Recruiting
        • Site Number - 5102
      • Geelong, Victoria, Australia, 3220
        • Recruiting
        • Site Number - 5104
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • Site Number - 5110
  • Brazil
      • Brasília, Brazil, 70200-730
        • Recruiting
        • Site Number - 5502
      • Curitiba, Brazil, 80060-240
        • Recruiting
        • Site Number - 5503
      • Curitiba, Brazil, 80810040
        • Recruiting
        • Site Number - 5504
      • Porto Alegre, Brazil, 90035903
        • Recruiting
        • Site Number - 5501
      • Rio de Janeiro, Brazil, 21941-913
        • Recruiting
        • Site Number - 5512
      • São Paulo, Brazil, 01228-000
        • Recruiting
        • Site Number - 5508
      • São Paulo, Brazil, 01221-020
        • Recruiting
        • Site Number - 5506
      • São Paulo, Brazil, 05403-000
        • Recruiting
        • Site Number - 5510
      • São Paulo, Brazil, 15500-003
        • Recruiting
        • Site Number - 5507
      • São Paulo, Brazil, 17504-072
        • Recruiting
        • Site Number - 5509
    • Ceará
      • Fortaleza, Ceará, Brazil, 21941-913
        • Recruiting
        • Site Number - 5511
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-320
        • Recruiting
        • Site Number - 5513
    • São Paulo
      • Campinas, São Paulo, Brazil, 09060-870
        • Recruiting
        • Site Number - 5500
      • Santo André, São Paulo, Brazil, 09060-870
        • Recruiting
        • Site Number - 5505
  • Bulgaria
      • Dobrich, Bulgaria, 7002
        • Recruiting
        • Site Number - 5613
      • Plovdiv, Bulgaria, 4001
        • Recruiting
        • Site Number - 5606
      • Plovdiv, Bulgaria, 4002
        • Recruiting
        • Site Number - 5607
      • Sliven, Bulgaria, 8800
        • Recruiting
        • Site Number - 5601
      • Smolyan, Bulgaria, 4700
        • Recruiting
        • Site Number - 5612
      • Sofia, Bulgaria, 1233
        • Recruiting
        • Site Number - 5604
      • Sofia, Bulgaria, 1431
        • Recruiting
        • Site Number - 5609
      • Sofia, Bulgaria, 1680
        • Recruiting
        • Site Number - 5608
      • Sofia, Bulgaria, 1750
        • Recruiting
        • Site Number- 5605
      • Varna, Bulgaria, 9002
        • Recruiting
        • Site Number - 5602
      • Varna, Bulgaria, 9020
        • Recruiting
        • Site Number - 5603
      • Varna, Bulgaria, 9020
        • Recruiting
        • Site Number - 5611
      • Yambol, Bulgaria, 8600
        • Recruiting
        • Site Number - 5600
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1431
        • Recruiting
        • Site Number - 5610
  • Czechia
      • Náchod, Czechia, 547 01
        • Recruiting
        • Site Number - 3203
      • Prague, Czechia, 149 00
        • Recruiting
        • Site Number - 3201
      • Prague, Czechia, 181 00
        • Recruiting
        • Site Number - 3200
      • Prague, Czechia, 190 14
        • Recruiting
        • Site Number - 3202
  • Georgia
      • Imereti, Georgia, 4600
        • Recruiting
        • Site Number - 8004
      • Tbilisi, Georgia, 0160
        • Recruiting
        • Site Number - 8001
      • Tbilisi, Georgia, 0114
        • Recruiting
        • Site Number - 8003
      • Tbilisi, Georgia, 0145
        • Recruiting
        • Site Number - 8000
      • Tbilisi, Georgia, 0159
        • Recruiting
        • Site Number - 8002
      • Tbilisi, Georgia, 0186
        • Recruiting
        • Site Number - 8005
  • Greece
      • Athens, Greece, 106 76
        • Recruiting
        • Site Number - 3902
      • Athens, Greece, 115 27
        • Recruiting
        • Site Number - 3900
      • Athens, Greece, 115 28
        • Recruiting
        • Site Number - 3901
  • Israel
      • Jerusalem, Israel, 9103102
        • Recruiting
        • Site Number - 4201
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Site Number - 4204
      • Kfar Saba, Israel, 4428164
        • Recruiting
        • Site Number - 4210
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Site Number - 4200
      • Rehovot, Israel, 7661041
        • Recruiting
        • Site Number - 4208
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Site Number - 4207
    • Central District
      • Ramat Gan, Central District, Israel, 5265601
        • Recruiting
        • Site Number - 4202
    • Haifa District
      • Haifa, Haifa District, Israel, 3104802
        • Recruiting
        • Site Number - 4205
      • Haifa, Haifa District, Israel, 3109601
        • Recruiting
        • Site Number - 4203
    • Northern District
      • Nahariya, Northern District, Israel, 2210001
        • Recruiting
        • Site Number - 4209
      • Tzfat, Northern District, Israel, 1311001
        • Recruiting
        • Site Number - 4206
    • Southern District
      • Beersheba, Southern District, Israel, 8410101
        • Recruiting
        • Site Number - 4211
  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • Site Number - 6004
      • Milan, Italy, 20132
        • Recruiting
        • Site Number - 6003
      • Pavia, Italy, 27100
        • Recruiting
        • Site Number - 6006
      • Rome, Italy, 135
        • Recruiting
        • Site Number - 6001
      • Udine, Italy, 33100
        • Recruiting
        • Site Number - 6002
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Recruiting
        • Site Number - 6005
  • Japan
      • Kumamoto, Japan, 860-8556
        • Recruiting
        • Site Number - 4007
      • Kyoto, Japan, 612-8555
        • Recruiting
        • Site Number - 4006
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8555
        • Recruiting
        • Site Number - 4011
      • Kurume, Fukuoka, Japan, 830-0011
        • Recruiting
        • Site Number - 4004
    • Gifu
      • Minokamo, Gifu, Japan, 505-8510
        • Recruiting
        • Site Number - 4005
    • Gunma
      • Maebashi, Gunma, Japan, 371-8512
        • Recruiting
        • Site Number - 4008
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 230-8765
        • Recruiting
        • Site Number - 4009
    • Kochi
      • Nankoku, Kochi, Japan, 791-0295
        • Recruiting
        • Site Number - 4003
  • Latvia
      • Ogre, Latvia, LV-5001
        • Recruiting
        • Site Number - 4600
      • Riga, Latvia, LV-1006
        • Recruiting
        • Site Number - 4602
      • Riga, Latvia, LV-1050
        • Recruiting
        • Site Number - 4603
      • Sigulda, Latvia, LV-2150
        • Recruiting
        • Site Number - 4604
      • Ventspils, Latvia, LV-3601
        • Recruiting
        • Site Number - 4601
  • Netherlands
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3079 DZ
        • Recruiting
        • Site Number - 2200
      • Rotterdam, South Holland, Netherlands, 3083 AN
        • Recruiting
        • Site Number - 2201
      • Rotterdam, South Holland, Netherlands, 3045 PM
        • Recruiting
        • Site Number - 2003
      • Zwijndrecht, South Holland, Netherlands, 3318 AT
        • Recruiting
        • Site Number - 2202
  • New Zealand
      • Auckland, New Zealand, 2025
        • Recruiting
        • Site Number - 3301
      • Wellington, New Zealand, 6242
        • Recruiting
        • Site Number - 3300
  • Poland
      • Bydgoszcz, Poland, 85-605
        • Recruiting
        • Site Number - 3002
      • Chorzów, Poland, 41-516
        • Recruiting
        • Site Number - 3010
      • Kielce, Poland, 25-734
        • Recruiting
        • Site Number - 3007
      • Lublin, Poland, 20-607
        • Recruiting
        • Site Number - 3000
      • Olsztyn, Poland, 10-117
        • Recruiting
        • Site Number - 3005
      • Opole, Poland, 45-301
        • Recruiting
        • Site Number - 3009
      • Poznan, Poland, 60-693
        • Recruiting
        • Site Number - 3006
      • Warsaw, Poland, 02-482
        • Recruiting
        • Site Number - 3008
      • Warsaw, Poland, 02-507
        • Recruiting
        • Site Number - 3011
      • Wroclaw, Poland, 50-367
        • Recruiting
        • Site Nnumber - 3003
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-276
        • Recruiting
        • Site Number - 3004
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-252
        • Recruiting
        • Site Number - 3001
  • South Korea
      • Daegu, South Korea, 42415
        • Recruiting
        • Site Number - 4500
      • Goyang, South Korea, 410-77
        • Recruiting
        • Site Number - 4503
      • Guri-si, South Korea, 11923
        • Recruiting
        • Site Number - 4504
      • Seoul, South Korea, 02841
        • Recruiting
        • Site Number - 4501
      • Seoul, South Korea, 03181
        • Recruiting
        • Site Number - 4506
      • Seoul, South Korea, 05278
        • Recruiting
        • Site Number - 4505
  • United Kingdom
      • Cornwell, United Kingdom, TR1 3LJ
        • Recruiting
        • Site Number - 7009
      • London, United Kingdom, W2 1NY
        • Recruiting
        • Site Number - 7001
      • London, United Kingdom, SE1 9RT
        • Recruiting
        • Site Number - 7006
      • Merthyr Tydfil, United Kingdom, CF72 8XR
        • Recruiting
        • Site Number - 7003
      • Salford, United Kingdom, M6 8HD
        • Recruiting
        • Site Number - 7010
      • Surrey, United Kingdom, GU2 7XX
        • Recruiting
        • Site Number - 7008
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Recruiting
        • Site Number - 1015
    • California
      • Concord, California, United States, 94520
        • Recruiting
        • Site Number -1014
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Site Number - 1013
    • Florida
      • Doral, Florida, United States, 33166
        • Recruiting
        • Site Number - 1024
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Site Number - 1008
      • Miami, Florida, United States, 33143
        • Recruiting
        • Site Number - 1000
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • Site Number - 1020
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • Site Number - 1022
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Site Number - 1030
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Recruiting
        • Site Number - 1033
      • Kansas City, Missouri, United States, 64110
        • Recruiting
        • Site Number - 1004
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Site Number - 1019
    • Nevada
      • Reno, Nevada, United States, 89511
        • Recruiting
        • Site Number - 1012
    • New York
      • Long Island City, New York, United States, 11106
        • Recruiting
        • Site Number - 1032
      • New Hyde Park, New York, United States, 11434
        • Recruiting
        • Site Number - 1027
      • New York, New York, United States, 10022
        • Recruiting
        • Site Number - 1009
      • Williamsville, New York, United States, 14221
        • Recruiting
        • Site Number - 1018
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • Site Number - 1010
      • Hickory, North Carolina, United States, 28601
        • Recruiting
        • Site Number - 1026
      • Morehead City, North Carolina, United States, 27577
        • Recruiting
        • Site Number - 1001
      • Raleigh, North Carolina, United States, 27612
        • Recruiting
        • Site Number - 1034
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73134
        • Recruiting
        • Site Number - 1007
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Site Number - 1017
    • Texas
      • Dallas, Texas, United States, 75224
        • Recruiting
        • Site Number - 1029
      • El Paso, Texas, United States, 79935
        • Recruiting
        • Site Number - 1002
      • Fort Worth, Texas, United States, 76132
        • Recruiting
        • Site Number - 1003
      • Houston, Texas, United States, 77030
        • Recruiting
        • Site Number - 1031
      • Houston, Texas, United States, 77054
        • Recruiting
        • Site Number - 1028
      • Irving, Texas, United States, 75031
        • Recruiting
        • Site Number -1023
      • Irving, Texas, United States, 75039
        • Recruiting
        • Site Number - 1021
      • McKinney, Texas, United States, 75069
        • Recruiting
        • Site Number - 1025
      • San Antonio, Texas, United States, 78231
        • Recruiting
        • Site Number - 1011
    • Virginia
      • Norfolk, Virginia, United States, 23510
        • Recruiting
        • Site Number - 1016

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
Placebo Comparator: Placebo
Drug: Placebo
For 26 weeks
Experimental: IMVT-1402 Dose 1
Drug: IMVT-1402
Dose 1 for 26 weeks
Drug: IMVT-1402
Dose 2 for 26 weeks
Experimental: IMVT-1402 Dose 2
Drug: IMVT-1402
Dose 1 for 26 weeks
Drug: IMVT-1402
Dose 2 for 26 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)
Time Frame: Week 26
Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants who have triiodothyronine (T3) (Total of T3 or free triiodothyronine [FT3]) and free thyroxine (FT4) ≤ upper limit of normal (ULN) and are off ATD at Week 26 (Dose 1)
Time Frame: Week 26
Week 26
Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1)
Time Frame: Week 26
Week 26
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2)
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 (Dose 2)
Time Frame: Week 26
Week 26
Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2)
Time Frame: Week 26
Week 26
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 (Dose 1)
Time Frame: Baseline, Week 4
Baseline, Week 4
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 (Dose 1)
Time Frame: Baseline, Week 2
Baseline, 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 (Dose 2)
Time Frame: Baseline, Week 4
Baseline, Week 4
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 (Dose 2)
Time Frame: Baseline, Week 2
Baseline, Week 2

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)

June 19, 2025

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

May 14, 2025

First Submitted That Met QC Criteria

June 4, 2025

First Posted (Actual)

June 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMVT-1402-2503
  • 2025-521920-31-00 (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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