ClinicalTrials.gg
RecruitingNCT07018323Updated Oct 30, 2026

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

A Phase 2 interventional study of IMVT-1402 and IMVT-1402 in Graves' Disease, sponsored by Immunovant Sciences GmbH. Recruiting at 163 sites in 18 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Immunovant Sciences GmbH · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Updated Oct 30, 2026Site recruiting status changed1 site added+1 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Graves' Disease

Browse trials for

Keywords

  • IMVT-1402
  • Graves' disease
  • Thyroid-Stimulating Hormone Receptor
  • Immunoglobulin G
  • Antithyroid drug
  • Imeroprubart
03

In context

Graves Disease

162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.

This study's planned enrollment of 210 is above the median of 60 across 104 interventional studies indexed under Graves Disease.

Browse Graves Disease studies →

Lead sponsor

Immunovant Sciences GmbH is the lead sponsor of 19 studies on the registry; 5 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants with the ability to understand the requirements of the trial, provide written , 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

Exclusion Criteria:

  • Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
  • Have an 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    IMVT-1402 Dose 1

    Drug: IMVT-1402

  • Experimental
    IMVT-1402 Dose 2

    Drug: IMVT-1402

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)

    Time frame: Week 26

Secondary outcomes

  1. 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

  2. Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1)

    Time frame: Week 26

  3. Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2)

    Time frame: Week 26

  4. 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

  5. Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2)

    Time frame: Week 26

  6. 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

  7. 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

  8. 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

  9. 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

07

Study locations

157 of 163 sites recruiting
  • Site Number - 1015
    Tucson, Arizona 85710, United States
    Recruiting
  • Site Number -1014
    Concord, California 94520, United States
    Recruiting
  • Site Number - 1013
    Aurora, Colorado 80045, United States
    Recruiting
  • Site Number - 1024
    Doral, Florida 33166, United States
    Recruiting
  • Site Number - 1008
    Hialeah, Florida 33016, United States
    Recruiting
  • Site Number - 1000
    Miami, Florida 33143, United States
    Recruiting
  • Site Number - 1020
    Columbus, Georgia 31904, United States
    Recruiting
  • Site Number - 1022
    Topeka, Kansas 66606, United States
    Recruiting
  • Site Number - 1030
    Louisville, Kentucky 40202, United States
    Recruiting
  • Site Number - 1033
    Jefferson City, Missouri 65109, United States
    Recruiting
  • Site Number - 1004
    Kansas City, Missouri 64110, United States
    Recruiting
  • Site Number - 1019
    St Louis, Missouri 63110, United States
    Recruiting
  • Site Number - 1012
    Reno, Nevada 89511, United States
    Recruiting
  • Site Number - 1032
    Long Island City, New York 11106, United States
    Recruiting
  • Site Number - 1027
    New Hyde Park, New York 11434, United States
    Recruiting
  • Site Number - 1009
    New York, New York 10022, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • Site Number - 1018
    Williamsville, New York 14221, United States
    Recruiting
  • Site Number - 1010
    Chapel Hill, North Carolina 27514, United States
    Recruiting
  • Site Number - 1026
    Hickory, North Carolina 28601, United States
    Recruiting
  • Site Number - 1001
    Morehead City, North Carolina 27577, United States
    Recruiting
  • Site Number - 1034
    Raleigh, North Carolina 27612, United States
    Recruiting
  • Site Number - 1007
    Oklahoma City, Oklahoma 73134, United States
    Recruiting
  • Site Number - 1017
    Memphis, Tennessee 38119, United States
    Recruiting
  • Site Number - 1029
    Dallas, Texas 75224, United States
    Recruiting
  • Site Number - 1002
    El Paso, Texas 79935, United States
    Recruiting
  • Site Number - 1003
    Fort Worth, Texas 76132, United States
    Recruiting
  • Site Number - 1031
    Houston, Texas 77030, United States
    Recruiting
  • Site Number - 1028
    Houston, Texas 77054, United States
    Recruiting
  • Site Number -1023
    Irving, Texas 75031, United States
    Completed

    Not enrolling at this site — choose another above.

  • Site Number - 1021
    Irving, Texas 75039, United States
    Recruiting
  • Site Number - 1025
    McKinney, Texas 75069, United States
    Recruiting
  • Site Number - 1011
    San Antonio, Texas 78231, United States
    Recruiting
  • Site Number - 1016
    Norfolk, Virginia 23510, United States
    Recruiting
  • Site Number - 5105
    Sydney, New South Wales 2050, Australia
    Recruiting
  • Site Number - 5103
    Warrawong, New South Wales 2502, Australia
    Recruiting
  • Site Number - 5101
    Brisbane, Queensland 4101, Australia
    Recruiting
  • Site Number - 5107
    Douglas, Queensland 4814, Australia
    Recruiting
  • Site Number - 5100
    Southport, Queensland 4222, Australia
    Recruiting
  • Site Number - 5102
    Box Hill, Victoria 3128, Australia
    Recruiting
  • Site Number - 5104
    Geelong, Victoria 3220, Australia
    Recruiting
  • Site Number - 5110
    Parkville, Victoria 3050, Australia
    Recruiting
  • Site Number - 5108
    Perth, 6009, Australia
    Recruiting
  • Site Number - 5109
    Saint Leonards, 2065, Australia
    Recruiting
  • Site Number - 5511
    Fortaleza, Ceará 21941-913, Brazil
    Recruiting
  • Site Number - 5513
    Belo Horizonte, Minas Gerais 30150-320, Brazil
    Recruiting
  • Site Number - 5500
    Campinas, São Paulo 09060-870, Brazil
    Recruiting
  • Site Number - 5505
    Santo André, São Paulo 09060-870, Brazil
    Recruiting
  • Site Number - 5502
    Brasília, 70200-730, Brazil
    Recruiting
  • Site Number - 5503
    Curitiba, 80060-240, Brazil
    Recruiting
  • Site Number - 5504
    Curitiba, 80810040, Brazil
    Recruiting
  • Site Number - 5501
    Porto Alegre, 90035903, Brazil
    Recruiting
  • Site Number - 5512
    Rio de Janeiro, 21941-913, Brazil
    Recruiting
  • Site Number - 5506
    São Paulo, 01221-020, Brazil
    Recruiting
  • Site Number - 5508
    São Paulo, 01228-000, Brazil
    Recruiting
  • Site Number - 5510
    São Paulo, 05403-000, Brazil
    Recruiting
  • Site Number - 5507
    São Paulo, 15500-003, Brazil
    Recruiting
  • Site Number - 5509
    São Paulo, 17504-072, Brazil
    Recruiting
  • Site Number - 5610
    Sofia, Sofia-Grad 1431, Bulgaria
    Recruiting
  • Site Number - 5613
    Dobrich, 7002, Bulgaria
    Recruiting
  • Site Number - 5606
    Plovdiv, 4001, Bulgaria
    Recruiting
  • Site Number - 5607
    Plovdiv, 4002, Bulgaria
    Recruiting
  • Site Number - 5601
    Sliven, 8800, Bulgaria
    Recruiting
  • Site Number - 5612
    Smolyan, 4700, Bulgaria
    Recruiting
  • Site Number - 5604
    Sofia, 1233, Bulgaria
    Recruiting
  • Site Number - 5609
    Sofia, 1431, Bulgaria
    Recruiting
  • Site Number - 5608
    Sofia, 1680, Bulgaria
    Recruiting
  • Site Number- 5605
    Sofia, 1750, Bulgaria
    Recruiting
  • Site Number - 5602
    Varna, 9002, Bulgaria
    Recruiting
  • Site Number - 5603
    Varna, 9020, Bulgaria
    Recruiting
  • Site Number - 5611
    Varna, 9020, Bulgaria
    Recruiting
  • Site Number - 5600
    Yambol, 8600, Bulgaria
    Recruiting
  • Site Number - 5700
    Santiago, 7690000, Chile
    Recruiting
  • Site Number - 5701
    Santiago, 8380456, Chile
    Recruiting
  • Site Number - 3203
    Náchod, 547 01, Czechia
    Recruiting
  • Site Number - 3201
    Prague, 149 00, Czechia
    Recruiting
  • Site Number - 3200
    Prague, 181 00, Czechia
    Recruiting
  • Site Number - 3202
    Prague, 190 14, Czechia
    Recruiting
  • Site Number - 8004
    Imereti, 4600, Georgia
    Withdrawn

    Not enrolling at this site — choose another above.

  • Site Number - 8003
    Tbilisi, 0114, Georgia
    Recruiting
  • Site Number - 8000
    Tbilisi, 0145, Georgia
    Recruiting
  • Site Number - 8002
    Tbilisi, 0159, Georgia
    Recruiting
  • Site Number - 8001
    Tbilisi, 0160, Georgia
    Recruiting
  • Site Number - 8005
    Tbilisi, 0186, Georgia
    Recruiting
  • Site Number - 3902
    Athens, 106 76, Greece
    Recruiting
  • Site Number - 3900
    Athens, 115 27, Greece
    Recruiting
  • Site Number - 3901
    Athens, 115 28, Greece
    Recruiting
  • Site Number - 3903
    Thessaloniki, 546 42, Greece
    Recruiting
  • Site Number - 4202
    Ramat Gan, Central District 5265601, Israel
    Recruiting
  • Site Number - 4205
    Haifa, Haifa District 3104802, Israel
    Recruiting
  • Site Number - 4203
    Haifa, Haifa District 3109601, Israel
    Recruiting
  • Site Number - 4209
    Nahariya, Northern District 2210001, Israel
    Recruiting
  • Site Number - 4206
    Tzfat, Northern District 1311001, Israel
    Recruiting
  • Site Number - 4211
    Beersheba, Southern District 8410101, Israel
    Recruiting
  • Site Number - 4201
    Jerusalem, 9103102, Israel
    Recruiting
  • Site Number - 4204
    Jerusalem, 9112001, Israel
    Recruiting
  • Site Number - 4210
    Kfar Saba, 4428164, Israel
    Recruiting
  • Site Number - 4200
    Petah Tikva, 4941492, Israel
    Recruiting
  • Site Number - 4208
    Rehovot, 7661041, Israel
    Recruiting
  • Site Number - 4207
    Tel Aviv, 6423906, Israel
    Recruiting
  • Site Number - 6005
    Rozzano, Milan 20089, Italy
    Recruiting

Showing the first 100 of 163 sites across 18 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2025 (actual). Primary completion is estimated for May 2027, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 14, 2025
First posted
Jun 12, 2025
StartActual
Jun 19, 2025
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added, 1 site removed. 5 sites changed recruiting status (4 now withdrawn, 1 now completed)
Show 5 sites
  • Site Number - 1009 · New York, United StatesRecruiting→Withdrawn
  • Site Number -1023 · Irving, United StatesRecruiting→Completed
  • Site Number - 8004 · Imereti, GeorgiaRecruiting→Withdrawn
  • Site Number - 4601 · Ventspils, LatviaRecruiting→Withdrawn
  • Site Number - 3301 · Auckland, New ZealandRecruiting→Withdrawn
Show site
  • Site Number - 2203 · Rotterdam, Netherlands
Show 1 removed
  • Site Number - 2003 · Rotterdam, Netherlands
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    1 site added, 1 site removed. 5 sites changed recruiting status (4 now withdrawn, 1 now completed)
    Show 5 sites
    • Site Number - 1009 · New York, United StatesRecruiting→Withdrawn
    • Site Number -1023 · Irving, United StatesRecruiting→Completed
    • Site Number - 8004 · Imereti, GeorgiaRecruiting→Withdrawn
    • Site Number - 4601 · Ventspils, LatviaRecruiting→Withdrawn
    • Site Number - 3301 · Auckland, New ZealandRecruiting→Withdrawn
    Show site
    • Site Number - 2203 · Rotterdam, Netherlands
    Show 1 removed
    • Site Number - 2003 · Rotterdam, Netherlands
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07018323
Lead sponsor
Immunovant Sciences GmbH
Responsible party
Sponsor
First posted
Jun 12, 2025
Start date
Jun 19, 2025
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Oct 30, 2026

Study contacts

Central Study Contact
Contact
clinicaltrials@immunovant.com
18007970414

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Imeroprubart

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