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

RecruitingPhase 2

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

Who can join

Ages 18 to 75 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Immunovant Sciences GmbH · Participants: 210 · Started: Jun 19, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07018323

Locations in the U.S.

ArizonaSite Number - 1015, Tucson
CaliforniaSite Number -1014, Concord
ColoradoSite Number - 1013, Aurora
FloridaSite Number - 1024, Doral
Site Number - 1008, Hialeah
Site Number - 1000, Miami
GeorgiaSite Number - 1020, Columbus
KansasSite Number - 1022, Topeka
KentuckySite Number - 1030, Louisville
MissouriSite Number - 1033, Jefferson City
Site Number - 1004, Kansas City
Site Number - 1019, St Louis
NevadaSite Number - 1012, Reno
New YorkSite Number - 1032, Long Island City
Site Number - 1027, New Hyde Park
Site Number - 1009, New York
Site Number - 1018, Williamsville
North CarolinaSite Number - 1010, Chapel Hill
Site Number - 1026, Hickory
Site Number - 1001, Morehead City
Site Number - 1034, Raleigh
OklahomaSite Number - 1007, Oklahoma City
TennesseeSite Number - 1017, Memphis
TexasSite Number - 1029, Dallas
Site Number - 1002, El Paso
Site Number - 1003, Fort Worth
Site Number - 1028, Houston
Site Number - 1031, Houston
Site Number - 1021, Irving
Site Number -1023, Irving
Site Number - 1025, McKinney
Site Number - 1011, San Antonio
VirginiaSite Number - 1016, Norfolk

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.