Assessing IMVT-1402 for treating Graves' disease in adults
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
Run by Immunovant Sciences GmbH · NCT06727604 · Data updated 2026-11-12
This study is testing a new treatment called IMVT-1402 to see if it can help adults with Graves' disease who still have high thyroid levels despite taking other medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Immunovant Sciences GmbH Industry-sponsored |
| Locations | 134 sites (Phoenix, Arizona and 133 other locations) |
| Status | Recruiting |
| Started | December 17, 2024 |
| Main results expected | June 2028 |
| Study ends | June 2028 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT06727604 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults diagnosed with Graves' disease who have been on antithyroid drugs for at least three months and have a TSH level below 0.1 mIU/L.
✕Probably not a fit
Patients who have not been on antithyroid drugs or those with TSH levels above 0.1 mIU/L may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the efficacy, safety, and tolerability of IMVT-1402 in adult participants diagnosed with Graves' disease who remain hyperthyroid despite treatment with antithyroid drugs. Participants will be assessed for changes in thyroid hormone levels and ATD dosage over a 26-week period. The study compares the effects of IMVT-1402 against a placebo to determine its effectiveness in managing the condition.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with Graves' disease who do not respond adequately to current medications.
How similar studies have gone: Other studies have explored treatments for Graves' disease, but the specific approach of using IMVT-1402 is novel and has not been widely tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Site Number - 1036
Phoenix, Arizona, United States Recruiting -
Site Number - 1061
Huntington Beach, California, United States Recruiting -
Site Number - 1001
Los Angeles, California, United States Recruiting -
Site Number - 1047
Los Angeles, California, United States Recruiting -
Site Number - 1062
Orange, California, United States Recruiting -
Site Number - 1046
Sacramento, California, United States Recruiting
Show 44 more locations
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Site Number - 1034
San Francisco, California, United States Recruiting -
Site Number - 1005
Torrance, California, United States Recruiting -
Site Number - 1013
Englewood, Colorado, United States Recruiting -
Site Number - 1010
Newark, Delaware, United States Recruiting -
Site Number - 1040
Washington D.C., District of Columbia, United States Recruiting -
Site Number - 1029
Clearwater, Florida, United States Recruiting -
Site Number - 1055
Jacksonville, Florida, United States Recruiting -
Site Number - 1056
Jacksonville, Florida, United States Recruiting -
Site Number - 1028
Miami, Florida, United States Recruiting -
Site Number - 1065
Miami, Florida, United States Recruiting -
Site Number - 1064
Ocoee, Florida, United States Recruiting -
Site Number - 1016
Port Charlotte, Florida, United States Recruiting -
Site Number - 1038
Atlanta, Georgia, United States Recruiting -
Site Number - 1053
Macon, Georgia, United States Recruiting -
Site Number - 1027
Indianapolis, Indiana, United States Recruiting -
Site Number - 1041
Kansas City, Kansas, United States Recruiting -
Site Number - 1045
Bowling Green, Kentucky, United States Recruiting -
Site Number - 1054
Florence, Kentucky, United States Recruiting -
Site Number - 1063
Metairie, Louisiana, United States Recruiting -
Site Number - 1022
New Orleans, Louisiana, United States Recruiting -
Site Number - 1048
Shreveport, Louisiana, United States Recruiting -
Site Number - 1023
Baltimore, Maryland, United States Recruiting -
Site Number - 1026
Boston, Massachusetts, United States Recruiting -
Site Number - 1018
Farmington Hills, Michigan, United States Recruiting -
Site Number - 1069
Flint, Michigan, United States Recruiting -
Site Number - 1008
Rochester, Minnesota, United States Recruiting -
Site Number - 1068
Gulfport, Mississippi, United States Recruiting -
Site Number - 1017
Omaha, Nebraska, United States Recruiting -
Site Number - 1007
Las Vegas, Nevada, United States Recruiting -
Site Number - 1050
Monroe, New York, United States Recruiting -
Site Number - 1051
Asheville, North Carolina, United States Recruiting -
Site Number - 1060
Wilmington, North Carolina, United States Recruiting -
Site Number - 1057
Canton, Ohio, United States Recruiting -
Site Number - 1003
Portland, Oregon, United States Recruiting -
Site Number - 1043
Pottstown, Pennsylvania, United States Recruiting -
Site Number - 1015
Summerville, South Carolina, United States Recruiting -
Site Number - 1042
Chattanooga, Tennessee, United States Recruiting -
Site Number - 1066
Nashville, Tennessee, United States Recruiting -
Site Number - 1049
Nashville, Tennessee, United States Recruiting -
Site Number - 1002
Austin, Texas, United States Recruiting -
Site Number - 1067
Bellaire, Texas, United States Recruiting -
Site Number - 1019
Dallas, Texas, United States Recruiting -
Site Number - 1071
Houston, Texas, United States Recruiting -
Site Number - 1004
Mesquite, Texas, United States Recruiting
+84 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Central Study Contact
- Email: clinicaltrials@immunovant.com
- Phone: 18007970414
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Efgartigimod for Graves' Disease in adults
We are testing if efgartigimod given under the skin can help adults with Graves' disease by improving thyroid function and whether it is safe and tolerable.
-
ETHY-001 safety and activity in Thyroid Eye Disease (TED)
This study tests ETHY-001 versus placebo to see if it is safe, tolerable, and shows activity in people with thyroid eye disease.
-
Early risk stratification of thyroid eye disease in newly diagnosed Graves' disease
This study tests whether early eye-related signs, blood and tear biomarkers, or eye surface features can predict who with Graves’ disease will develop thyroid eye disease within a year.
-
Felzartamab for Graves’ Disease: See if it helps control thyroids and reduce need for ATDs
This study tests felzartamab vs placebo in adults with Graves’ disease to see if it can normalize thyroid hormones and let people stop anti-thyroid drugs.
-
AI-based MRI and ultrasound for thyroid-related eye disease
This study tests an AI model using orbital MRI and eye ultrasound to help diagnose activity and severity of thyroid-associated ophthalmopathy and predict its course in adults.
-
YB-101 for Graves' Disease: safety, dosing, and how it works
This study tests YB-101 versus placebo in adults with Graves' disease to see if it is safe, tolerated, and whether it can help thyroid symptoms over about 40 weeks.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.