MedDataX Logo

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

NCT ID: NCT07018323

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-19

Study Completion Date

2027-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Graves' Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IMVT-1402 Dose 1

Group Type EXPERIMENTAL

IMVT-1402

Intervention Type DRUG

Dose 1 for 26 weeks

IMVT-1402 Dose 2

Group Type EXPERIMENTAL

IMVT-1402

Intervention Type DRUG

Dose 2 for 26 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

For 26 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

IMVT-1402

Dose 1 for 26 weeks

Intervention Type DRUG

IMVT-1402

Dose 2 for 26 weeks

Intervention Type DRUG

Placebo

For 26 weeks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Immunovant Sciences GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site Number - 1015

Tucson, Arizona, United States

Site Status RECRUITING

Site Number -1014

Concord, California, United States

Site Status RECRUITING

Site Number - 1013

Aurora, Colorado, United States

Site Status RECRUITING

Site Number - 1024

Doral, Florida, United States

Site Status RECRUITING

Site Number - 1008

Hialeah, Florida, United States

Site Status RECRUITING

Site Number - 1000

Miami, Florida, United States

Site Status RECRUITING

Site Number - 1020

Columbus, Georgia, United States

Site Status RECRUITING

Site Number - 1022

Topeka, Kansas, United States

Site Status RECRUITING

Site Number - 1033

Jefferson City, Missouri, United States

Site Status RECRUITING

Site Number - 1004

Kansas City, Missouri, United States

Site Status RECRUITING

Site Number - 1012

Reno, Nevada, United States

Site Status RECRUITING

Site Number - 1032

Long Island City, New York, United States

Site Status RECRUITING

Site Number - 1009

New York, New York, United States

Site Status RECRUITING

Site Number - 1026

Hickory, North Carolina, United States

Site Status RECRUITING

Site Number - 1001

Morehead City, North Carolina, United States

Site Status RECRUITING

Site Number - 1034

Raleigh, North Carolina, United States

Site Status RECRUITING

Site Number - 1007

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Site Number - 1017

Memphis, Tennessee, United States

Site Status RECRUITING

Site Number - 1029

Dallas, Texas, United States

Site Status RECRUITING

Site Number - 1002

El Paso, Texas, United States

Site Status RECRUITING

Site Number - 1003

Fort Worth, Texas, United States

Site Status RECRUITING

Site Number -1023

Irving, Texas, United States

Site Status RECRUITING

Site Number - 1021

Irving, Texas, United States

Site Status RECRUITING

Site Number - 1025

McKinney, Texas, United States

Site Status RECRUITING

Site Number - 1011

San Antonio, Texas, United States

Site Status RECRUITING

Site Number - 1016

Norfolk, Virginia, United States

Site Status RECRUITING

Site Number - 5100

Southport, Queensland, Australia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Central Study Contact

Role: CONTACT

Phone: 18007970414

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-521920-31-00

Identifier Type: CTIS

Identifier Source: secondary_id

IMVT-1402-2503

Identifier Type: -

Identifier Source: org_study_id