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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants with the ability to understand the requirements of the trial, provide written willing to sign a consent form, 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 Should NOT Join This Trial: - Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy. - Have an autoimmune conditions (where your immune system attacks your own body) 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

IMVT-1402

Dose 1 for 26 weeks

DRUG

IMVT-1402

Dose 2 for 26 weeks

DRUG

Placebo

For 26 weeks

Locations (20)

Site Number - 1015
Tucson, Arizona, United States
Site Number -1014
Concord, California, United States
Site Number - 1013
Aurora, Colorado, United States
Site Number - 1024
Doral, Florida, United States
Site Number - 1008
Hialeah, Florida, United States
Site Number - 1000
Miami, Florida, United States
Site Number - 1020
Columbus, Georgia, United States
Site Number - 1022
Topeka, Kansas, United States
Site Number - 1033
Jefferson City, Missouri, United States
Site Number - 1004
Kansas City, Missouri, United States
Site Number - 1019
St Louis, Missouri, United States
Site Number - 1012
Reno, Nevada, United States
Site Number - 1032
Long Island City, New York, United States
Site Number - 1027
New Hyde Park, New York, United States
Site Number - 1009
New York, New York, United States
Site Number - 1018
Williamsville, New York, United States
Site Number - 1010
Chapel Hill, North Carolina, United States
Site Number - 1026
Hickory, North Carolina, United States
Site Number - 1001
Morehead City, North Carolina, United States
Site Number - 1034
Raleigh, North Carolina, United States