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

NCT06727604

RecruitingPhase 2

Sponsor: Immunovant Sciences GmbH

Conditions: Graves' Disease

Interventions: IMVT-1402, IMVT-1402, Placebo

Countries: United States, Belgium, Georgia, Germany, Hungary, Italy, Poland, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 ≥ 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.
Locations (134)
  • Phoenix, Arizona, United States
  • Phoenix, Arizona, United States
  • Huntington Beach, California, United States
  • Los Angeles, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Sacramento, California, United States
  • San Francisco, California, United States
  • Santa Clarita, California, United States
  • Torrance, California, United States
  • Walnut Creek, California, United States
  • Englewood, Colorado, United States
  • Newark, Delaware, United States
  • Washington D.C., District of Columbia, United States
  • Clearwater, Florida, United States
  • Jacksonville, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Ocoee, Florida, United States
  • Orlando, Florida, United States
  • Port Charlotte, Florida, United States
  • West Palm Beach, Florida, United States
  • Atlanta, Georgia, United States
  • Macon, Georgia, United States
  • Stockbridge, Georgia, United States
  • Indianapolis, Indiana, United States
  • Kansas City, Kansas, United States
  • Bowling Green, Kentucky, United States
  • Florence, Kentucky, United States
  • + 104 more on CT.gov