RECRUITING

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

Description

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.

Conditions

Graves' Disease
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Related Conditions:

Graves' Disease

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Graves' Disease
Intervention / Treatment

-

Contacts and Locations

Hialeah

Site Number - 1008, Hialeah, Florida, United States, 33016

Miami

Site Number - 1000, Miami, Florida, United States, 33143

Morehead City

Site Number - 1001, Morehead City, North Carolina, United States, 27577

El Paso

Site Number - 1002, El Paso, Texas, United States, 79935

Fort Worth

Site Number - 1003, Fort Worth, Texas, United States, 76132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * Have previously been 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Immunovant Sciences GmbH,

Study Record Dates

2027-05