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Graves' DiseasePhase 2NCT06727604

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

A Phase 2 study testing IMVT-1402 in people with Graves' Disease, run by Immunovant Sciences GmbH at 134 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Graves' Disease
What is being tested?
IMVT-1402
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
240 participants
Where
134 sitesin 10 countries
Study dates
17 Dec 2024to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

134 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Central Study Contact contact

18007970414

clinicaltrials@immunovant.com

134 sites in 10 countries

United States64 sites, 55 recruiting
  • Site Number - 1051

    Asheville, North Carolina, 28803

    Recruiting
  • Site Number - 1038

    Atlanta, Georgia, 30318

    Recruiting
  • Site Number - 1002

    Austin, Texas, 78731

    Recruiting
  • Site Number - 1023

    Baltimore, Maryland, 21287

    Recruiting
  • Site Number - 1067

    Bellaire, Texas, 77401

    Recruiting
  • Site Number - 1026

    Boston, Massachusetts, 02114

    Recruiting
  • Site Number - 1045

    Bowling Green, Kentucky, 42101

    Recruiting
  • Site Number - 1057

    Canton, Ohio, 44718

    Recruiting
  • Site Number - 1042

    Chattanooga, Tennessee, 37421

    Recruiting
  • Site Number - 1029

    Clearwater, Florida, 33756

    Recruiting
  • Site Number - 1019

    Dallas, Texas, 75208

    Recruiting
  • Site Number - 1031

    Dallas, Texas, 75231

    Withdrawn
  • Site Number - 1013

    Englewood, Colorado, 80113

    Recruiting
  • Site Number - 1018

    Farmington Hills, Michigan, 48334

    Recruiting
  • Site Number - 1069

    Flint, Michigan, 48532

    Recruiting
  • Site Number - 1054

    Florence, Kentucky, 41042

    Recruiting
  • Site Number - 1068

    Gulfport, Mississippi, 39501

    Recruiting
  • Site Number - 1071

    Houston, Texas, 77089

    Recruiting
  • Site Number - 1025

    Houston, Texas, 77095

    Withdrawn
  • Site Number - 1061

    Huntington Beach, California, 92647

    Recruiting
  • Site Number - 1027

    Indianapolis, Indiana, 46202

    Recruiting
  • Site Number - 1055

    Jacksonville, Florida, 32204-1177

    Recruiting
  • Site Number - 1056

    Jacksonville, Florida, 32216

    Recruiting
  • Site Number - 1041

    Kansas City, Kansas, 66210

    Recruiting
  • Site Number - 1007

    Las Vegas, Nevada, 89148

    Recruiting
  • Site Number - 1001

    Los Angeles, California, 90033

    Recruiting
  • Site Number - 1047

    Los Angeles, California, 90095

    Recruiting
  • Site Number - 1053

    Macon, Georgia, 31210

    Recruiting
  • Site Number - 1004

    Mesquite, Texas, 75149

    Recruiting
  • Site Number - 1063

    Metairie, Louisiana, 70006

    Recruiting
  • Site Number - 1028

    Miami, Florida, 33136

    Recruiting
  • Site Number - 1065

    Miami, Florida, 33186

    Recruiting
  • Site Number - 1050

    Monroe, New York, 10950

    Recruiting
  • Site Number - 1066

    Nashville, Tennessee, 37203

    Recruiting
  • Site Number - 1049

    Nashville, Tennessee, 37212

    Recruiting
  • Site Number - 1022

    New Orleans, Louisiana, 70112

    Recruiting
  • Site Number - 1010

    Newark, Delaware, 19713

    Recruiting
  • Site Number - 1064

    Ocoee, Florida, 34761

    Recruiting
  • Site Number - 1017

    Omaha, Nebraska, 68105

    Recruiting
  • Site Number - 1062

    Orange, California, 92868

    Recruiting
  • Site Number - 1011

    Orlando, Florida, 32819

    Withdrawn
  • Site Number - 1033

    Philadelphia, Pennsylvania, 19140

    Withdrawn
  • Site Number - 1032

    Phoenix, Arizona, 85006

    Withdrawn
  • Site Number - 1036

    Phoenix, Arizona, 85015

    Recruiting
  • Site Number - 1016

    Port Charlotte, Florida, 33952

    Recruiting
  • Site Number - 1003

    Portland, Oregon, 97035

    Recruiting
  • Site Number - 1043

    Pottstown, Pennsylvania, 19464

    Recruiting
  • Site Number - 1008

    Rochester, Minnesota, 55905

    Recruiting
  • Site Number - 1009

    Round Rock, Texas, 78681

    Recruiting
  • Site Number - 1046

    Sacramento, California, 95816

    Recruiting
  • Site Number - 1030

    Salt Lake City, Utah, 84108

    Recruiting
  • Site Number - 1014

    San Antonio, Texas, 78215

    Recruiting
  • Site Number - 1052

    San Antonio, Texas, 78240

    Recruiting
  • Site Number - 1034

    San Francisco, California, 94143

    Recruiting
  • Site Number - 1070

    Sandy City, Utah, 84093

    Recruiting
  • Site Number - 1035

    Santa Clarita, California, 91321

    Withdrawn
  • Site Number - 1048

    Shreveport, Louisiana, 71103

    Recruiting
  • Site Number - 1020

    Stockbridge, Georgia, 30281

    Withdrawn
  • Site Number - 1015

    Summerville, South Carolina, 29485

    Recruiting
  • Site Number - 1005

    Torrance, California, 90502

    Recruiting
  • Site Number - 1006

    Walnut Creek, California, 94598

    Withdrawn
  • Site Number - 1040

    Washington D.C., District of Columbia, 20010

    Recruiting
  • Site Number - 1012

    West Palm Beach, Florida, 33401

    Withdrawn
  • Site Number - 1060

    Wilmington, North Carolina, 28401

    Recruiting

Other trials in United States

United Kingdom14 sites, 14 recruiting
  • Site Number - 7013

    Birmingham, England, B15 2TT

    Recruiting
  • Site Number - 7012

    Bristol, England, BS10 5NB

    Recruiting
  • Site Number - 7014

    Cambridge, London, CB2 0QQ

    Recruiting
  • Site Number - 7002

    Cardiff, CF14 4XW

    Recruiting
  • Site Number - 7011

    Coventry, England, CV2 2DX

    Recruiting
  • Site Number - 7008

    Edinburgh, EH16 4SA

    Recruiting
  • Site Number - 7005

    Huddersfield, HD3 3EA

    Recruiting
  • Site Number - 7004

    Hull, HU6 7RX

    Recruiting
  • Site Number - 7007

    London, England, NW1 2PG

    Recruiting
  • Site Number - 7003

    London, SE5 9RS

    Recruiting
  • Site Number - 7006

    Manchester, M20 4BX

    Recruiting
  • Site Number - 7001

    Newcastle upon Tyne, NE1 4LP

    Recruiting
  • Site Number - 7009

    Norwich, NR4 7UY

    Recruiting
  • Site Number - 7010

    Nuneaton, CV10 7DJ

    Recruiting

Other trials in United Kingdom

Italy12 sites, 12 recruiting
  • Site Number - 6004

    Bologna, 40138

    Recruiting
  • Site Number - 6012

    Cagliari, 09124

    Recruiting
  • Site Number - 6011

    Genova, 16132

    Recruiting
  • Site Number - 6002

    Milan, 20122

    Recruiting
  • Site Number - 6009

    Milan, 20162

    Recruiting
  • Site Number - 6007

    Milan, 20149

    Recruiting
  • Site Number - 6010

    Naples, 80131

    Recruiting
  • Site Number - 6003

    Pisa, 56124

    Recruiting
  • Site Number - 6001

    Pisa, 56126

    Recruiting
  • Site Number - 6005

    Roma, 00189

    Recruiting
  • Site Number - 6013

    Siena, 53100

    Recruiting
  • Site Number - 6008

    Varese, 21100

    Recruiting

Other trials in Italy

Georgia11 sites, 11 recruiting
  • Site Number - 8002

    Batumi, 6000

    Recruiting
  • Site Number - 8007

    Batumi, 6010

    Recruiting
  • Site Number - 8006

    Kutaisi, 4600

    Recruiting
  • Site Number - 8008

    Marneuli, 3000

    Recruiting
  • Site Number - 8009

    Tbilisi, 0112

    Recruiting
  • Site Number - 8004

    Tbilisi, 0144

    Recruiting
  • Site Number - 8005

    Tbilisi, 0144

    Recruiting
  • Site Number - 8001

    Tbilisi, 0159

    Recruiting
  • Site Number - 8003

    Tbilisi, 0159

    Recruiting
  • Site Number - 8011

    Tbilisi, 0159

    Recruiting
  • Site Number - 8010

    Tbilisi, 0177

    Recruiting

Other trials in Georgia

Spain9 sites, 9 recruiting
  • Site Number - 7104

    Badalona, Barcelona, 08916

    Recruiting
  • Site Number - 7109

    Barcelona, 08035

    Recruiting
  • Site Number - 7103

    Barcelona, 08036

    Recruiting
  • Site Number - 7102

    Córdoba, 14004

    Recruiting
  • Site Number - 7106

    Granada, 18014

    Recruiting
  • Site Number - 7105

    Madrid, 28006

    Recruiting
  • Site Number - 7107

    Pamplona, 31008

    Recruiting
  • Site Number - 7108

    Pamplona, 31008

    Recruiting
  • Site Number - 7101

    Seville, 41009

    Recruiting

Other trials in Spain

Poland8 sites, 8 recruiting
  • Site Number - 3006

    Gliwice, 44-102

    Recruiting
  • Site Number - 3002

    Krakow, 30-074

    Recruiting
  • Site Number -3003

    Krakow, 30-688

    Recruiting
  • Site Number - 3005

    Lublin, 20-400

    Recruiting
  • Site Number - 3008

    Lublin, 20-607

    Recruiting
  • Site Number - 3004

    Lublin, 91-495

    Recruiting
  • Site Number - 3007

    Poznan, 60-354

    Recruiting
  • Site Number - 3001

    Warsaw, 00-0189

    Recruiting

Other trials in Poland

Hungary6 sites, 6 recruiting
  • Site Number - 7558

    Békéscsaba, 5600

    Recruiting
  • Site Number - 7554

    Budapest, 1036

    Recruiting
  • Site Number - 7556

    Budapest, 1083

    Recruiting
  • Site Number - 7557

    Debrecen, 4032

    Recruiting
  • Site Number - 7551

    Pécs, 7623

    Recruiting
  • Site Number - 7552

    Szeged, 6725

    Recruiting

Other trials in Hungary

Germany5 sites, 5 recruiting
  • Site Number - 6505

    Dresden, Saxony, 01307

    Recruiting
  • Site Number - 6503

    Munich, 80336

    Recruiting
  • Site Number - 6508

    Munich, 81667

    Recruiting
  • Site Number - 6502

    Schwerin, 19049

    Recruiting
  • Site Number - 6507

    Würzburg, 97080

    Recruiting

Other trials in Germany

Belgium3 sites, 3 recruiting
  • Site Number - 5303

    Antwerp, 2820

    Recruiting
  • Site Number - 5301

    Bruges, 80000

    Recruiting
  • Site Number - 5302

    Brussels, 1070

    Recruiting

Other trials in Belgium

Puerto Rico2 sites, 1 recruiting
  • Site Number - 1058

    San Juan, 00907

    Recruiting
  • Site Number - 1037

    San Juan, 00921-3313

    Withdrawn

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions
Graves' Disease
Being tested
IMVT-1402, Placebo
Keywords
IMVT-1402, Anti Thyroid Drug, Hyperthyroidism, Autoimmune thyroid disease, Imeroprubart
Medical subject headings
Graves Disease, Hyperthyroidism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IMVT-1402Drug

    600 mg SC QW for 52 weeks

  • IMVT-1402Drug

    600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks

  • PlaceboDrug

    SC QW for 52 weeks

Study groups in NCT06727604
Study groupRoleWhat they receive
Group 1 Period 1 and 2: IMVT-1402ExperimentalNot described
Receives: Drug: IMVT-1402
Group 2 Period 1 and 2: IMVT-1402ExperimentalNot described
Receives: Drug: IMVT-1402
Group 2 Period 1: IMVT-1402 and Period 2: PlaceboExperimentalNot described
Receives: Drug: IMVT-1402
Group 3 Period 1 and 2: PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 26

Secondary outcomes (11)
  1. Percentage of participants who are euthyroid and off ATD at Week 52

    Measured: Week 52

  2. Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52

    Measured: Week 52

  3. 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

    Measured: Week 78

  4. 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

    Measured: Week 104

  5. 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

    Measured: Week 52

  6. 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

    Measured: Week 78

  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

    Measured: 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

    Measured: Week 4

  9. Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26

    Measured: Week 26

  10. Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 26

    Measured: Week 26

  11. Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 52

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2024
  2. Study start17 Dec 2024
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06727604
Sponsor's protocol ID
IMVT-1402-2502
Other IDs
2024-516020-33-00
Status last verified
Aug 2026
First submitted
9 Dec 2024
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMVT-1402 in people with Graves' Disease, run by Immunovant Sciences GmbH at 134 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 134 sites in United States, United Kingdom, Italy, Georgia, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Central Study Contact (18007970414, clinicaltrials@immunovant.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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