RECRUITING

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

Conditions

Graves' Disease IMVT-1402 Anti Thyroid Drug Hyperthyroidism Autoimmune thyroid disease

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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 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. The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine \[T3\] or free triiodothyronine \[FT3\]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.

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:2024-12-17

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06727604

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 Criteria	Exclusion Criteria
* Have documented diagnosis of GD. * Have a TSH value \< 0.1 mIU/L as assessed by the local laboratory at the Screening Visit. * Meet one of the following at the Screening Visit: * Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and both of the following: * Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening Visit. * Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization. * Have been on ATD for ≥ 6 months in the period immediately preceding the Screening Visit and all of the following: * Have been treated with ≥ 15 mg/day methimazole or equivalent at any point during the participant's treatment history. * Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening Visit. * Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.	* Have previously been treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy. * Have a T3 (Total T3 or FT3, as available and per standard of care at local laboratory) or FT4 value \< lower limit of normal (LLN) as assessed by the local laboratory at the Screening Visit. * Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks of the Screening Visit. * Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within 6 months of the Screening Visit. * 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.

Inclusion Criteria

Exclusion Criteria

* Have documented diagnosis of GD.
* Have a TSH value \< 0.1 mIU/L as assessed by the local laboratory at the Screening Visit.
* Meet one of the following at the Screening Visit:
* Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and both of the following:
* Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening Visit.
* Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.
* Have been on ATD for ≥ 6 months in the period immediately preceding the Screening Visit and all of the following:
* Have been treated with ≥ 15 mg/day methimazole or equivalent at any point during the participant's treatment history.
* Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening Visit.
* Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.

* Have previously been treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.
* Have a T3 (Total T3 or FT3, as available and per standard of care at local laboratory) or FT4 value \< lower limit of normal (LLN) as assessed by the local laboratory at the Screening Visit.
* Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks of the Screening Visit.
* Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within 6 months of the Screening Visit.
* 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.

Contacts and Locations

Study Contact

Central Study Contact

CONTACT

18007970414

clinicaltrials@immunovant.com

Study Locations (Sites)

Site number - 1002

Austin, Texas, 78731

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 Date2024-12-17

Study Completion Date2028-06

Study Record Updates

Study Start Date2024-12-17

Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

IMVT-1402
Anti Thyroid Drug
Hyperthyroidism
Autoimmune thyroid disease

Additional Relevant MeSH Terms

Graves' Disease