Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at San Francisco, 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 - 1034 accepting new patients
    San Francisco California 94143 United States
  • Site Number - 1006 withdrawn
    Walnut Creek California 94598 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
ID
NCT06727604
Phase
Phase 2 Graves' Disease Research Study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated