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

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.

Conditions

Graves' Disease

Study Overview

Study Details

Study overview

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.

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

Austin

Site number - 1002, Austin, Texas, United States, 78731

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

  • * 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.

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

2028-06