Assessing IMVT-1402 for treating Graves' disease in adults
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
PHASE2 · Immunovant Sciences GmbH · NCT06727604
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Immunovant Sciences GmbH (industry) |
| Locations | 133 sites (Phoenix, Arizona and 132 other locations) |
| Trial ID | NCT06727604 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have explored treatments for Graves' disease, but the specific approach of using IMVT-1402 is novel and has not been widely tested.
Eligibility criteria
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 this trial is running
Phoenix, Arizona and 132 other locations
- Site Number - 1032 — Phoenix, Arizona, United States (RECRUITING)
- 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)
- Site Number - 1034 — San Francisco, California, United States (RECRUITING)
- Site Number - 1035 — Santa Clarita, California, United States (RECRUITING)
- Site Number - 1005 — Torrance, California, United States (RECRUITING)
- Site Number - 1006 — Walnut Creek, California, United States (WITHDRAWN)
- 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 - 1011 — Orlando, Florida, United States (RECRUITING)
- Site Number - 1016 — Port Charlotte, Florida, United States (RECRUITING)
- Site Number - 1012 — West Palm Beach, Florida, United States (RECRUITING)
- Site Number - 1038 — Atlanta, Georgia, United States (RECRUITING)
- Site Number - 1053 — Macon, Georgia, United States (RECRUITING)
- Site Number - 1020 — Stockbridge, 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 - 1033 — Philadelphia, Pennsylvania, 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)
+83 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Central Study Contact
- Email: clinicaltrials@immunovant.com
- Phone: 18007970414
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Graves' Disease, IMVT-1402, Anti Thyroid Drug, Hyperthyroidism, Autoimmune thyroid disease, Imeroprubart