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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Graves' Disease

In brief

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.

Key facts

Study ID

NCT07018323

Run by

Immunovant Sciences GmbH

People needed

210

Starts

2025-06-19

Expected to finish

2027-05-01

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Site Number -1014 — Concord, California, United States (enrolling)
• Site Number - 1013 — Aurora, Colorado, United States (enrolling)
• Site Number - 1024 — Doral, Florida, United States (enrolling)
• Site Number - 1008 — Hialeah, Florida, United States (enrolling)
• Site Number - 1000 — Miami, Florida, United States (enrolling)
• Site Number - 1020 — Columbus, Georgia, United States (enrolling)
• Site Number - 1022 — Topeka, Kansas, United States (enrolling)
• Site Number - 1030 — Louisville, Kentucky, United States (enrolling)
• Site Number - 1033 — Jefferson City, Missouri, United States (enrolling)
• Site Number - 1004 — Kansas City, Missouri, United States (enrolling)
• Site Number - 1019 — St Louis, Missouri, United States (enrolling)
• Site Number - 1012 — Reno, Nevada, United States (enrolling)
• Site Number - 1032 — Long Island City, New York, United States (enrolling)
• Site Number - 1027 — New Hyde Park, New York, United States (enrolling)
• Site Number - 1009 — New York, New York, United States (enrolling)
• Site Number - 1018 — Williamsville, New York, United States (enrolling)
• Site Number - 1010 — Chapel Hill, North Carolina, United States (enrolling)
• Site Number - 1026 — Hickory, North Carolina, United States (enrolling)
• Site Number - 1001 — Morehead City, North Carolina, United States (enrolling)
• Site Number - 1034 — Raleigh, North Carolina, United States (enrolling)
• Site Number - 1007 — Oklahoma City, Oklahoma, United States (enrolling)
• Site Number - 1017 — Memphis, Tennessee, United States (enrolling)
• Site Number - 1029 — Dallas, Texas, United States (enrolling)
• Site Number - 1002 — El Paso, Texas, United States (enrolling)
• Site Number - 1015 — Tucson, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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