Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

Summary

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

Keywords

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

Eligibility

You can join if…

Open to people ages 18-75

  • 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.

You CAN'T join if...

  • Have previously been successfully 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.

Locations

  • Site Number - 1047 accepting new patients
    Los Angeles California 90095 United States
  • Site Number - 1001 accepting new patients
    Los Angeles California 90033 United States
  • Site Number - 1005 accepting new patients
    Torrance California 90502 United States
  • Site Number - 1035 accepting new patients
    Santa Clarita California 91321 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Immunovant Sciences GmbH
Links
Sign up for this study
ID
NCT06727604
Phase
Phase 2 Graves' Disease Research Study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated