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

NCT07018323

RecruitingPhase 2

Sponsor: Immunovant Sciences GmbH

Conditions: Graves' Disease

Interventions: IMVT-1402, IMVT-1402, Placebo

Countries: United States, Australia, Brazil, Bulgaria, Chile, Czechia, Georgia, Greece

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (158)

Tucson, Arizona, United States
Concord, California, United States
Aurora, Colorado, United States
Doral, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Columbus, Georgia, United States
Topeka, Kansas, United States
Louisville, Kentucky, United States
Jefferson City, Missouri, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Reno, Nevada, United States
Long Island City, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Williamsville, New York, United States
Chapel Hill, North Carolina, United States
Hickory, North Carolina, United States
Morehead City, North Carolina, United States
Raleigh, North Carolina, United States
Oklahoma City, Oklahoma, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Irving, Texas, United States
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