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

RecruitingPhase 2Ages 18 Years - 75 YearsAllImmunovant Sciences GmbH
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 18 years. * Participants with diagnosis of GD who are hyperthyroid despite ATD treatment. * Other, more specific inclusion criteria are defined in the protocol. Exclusion Criteria: * 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.
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What it tests

  • IMVT-1402
  • IMVT-1402
  • Placebo
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Where

134 sites
Site Number - 1032
Phoenix, United States
Site Number - 1036
Phoenix, United States
Site Number - 1061
Huntington Beach, United States
Site Number - 1001
Los Angeles, United States
Site Number - 1047
Los Angeles, United States
Site Number - 1062
Orange, United States
Site Number - 1046
Sacramento, United States
Site Number - 1034
San Francisco, United States

โ€ฆand 126 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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