RECRUITING

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

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Conditions

Graves' DiseaseIMVT-1402Thyroid-Stimulating Hormone ReceptorImmunoglobulin GAntithyroid drug

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-06-19
Study Completion:2027-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07018323

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.
  2. * Male or female participants aged ≥ 18 years.
  3. * Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.
  4. * Other, more specific inclusion criteria are defined in the protocol.
  1. * Have previously been treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
  2. * Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.
  3. * 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.
  4. * Additional exclusion criteria are defined in the protocol.

Contacts and Locations

Study Contact

Central Study Contact
CONTACT
18007970414
clinicaltrials@immunovant.com

Study Locations (Sites)

Site Number - 1008
Hialeah, Florida, 33016
United States
Site Number - 1000
Miami, Florida, 33143
United States
Site Number - 1001
Morehead City, North Carolina, 27577
United States
Site Number - 1002
El Paso, Texas, 79935
United States
Site Number - 1003
Fort Worth, Texas, 76132
United States

Collaborators and Investigators

Sponsor: Immunovant Sciences GmbH

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-19
Study Completion Date2027-05

Study Record Updates

Study Start Date2025-06-19
Study Completion Date2027-05

Terms related to this study

Keywords Provided by Researchers

  • IMVT-1402
  • Graves' disease
  • Thyroid-Stimulating Hormone Receptor
  • Immunoglobulin G
  • Antithyroid drug

Additional Relevant MeSH Terms

  • Graves' Disease