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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Graves' Disease

In brief

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.

Key facts

Study ID

NCT06727604

Run by

Immunovant Sciences GmbH

People needed

240

Starts

2024-12-17

Expected to finish

2028-06-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• Site Number - 1027 — Indianapolis, Indiana, United States (enrolling)
• Site Number - 1061 — Huntington Beach, California, United States (enrolling)
• Site Number - 1036 — Phoenix, Arizona, United States (enrolling)
• Site Number - 1020 — Stockbridge, Georgia, United States (enrolling)
• Site Number - 1062 — Orange, California, United States (enrolling)
• Site Number - 1046 — Sacramento, California, United States (enrolling)
• Site Number - 1034 — San Francisco, California, United States (enrolling)
• Site Number - 1001 — Los Angeles, California, United States (enrolling)
• Site Number - 1005 — Torrance, California, United States (enrolling)
• Site Number - 1047 — Los Angeles, California, United States (enrolling)
• Site Number - 1013 — Englewood, Colorado, United States (enrolling)
• Site Number - 1010 — Newark, Delaware, United States (enrolling)
• Site Number - 1040 — Washington D.C., District of Columbia, United States (enrolling)
• Site Number - 1029 — Clearwater, Florida, United States (enrolling)
• Site Number - 1055 — Jacksonville, Florida, United States (enrolling)
• Site Number - 1056 — Jacksonville, Florida, United States (enrolling)
• Site Number - 1028 — Miami, Florida, United States (enrolling)
• Site Number - 1065 — Miami, Florida, United States (enrolling)
• Site Number - 1064 — Ocoee, Florida, United States (enrolling)
• Site Number - 1011 — Orlando, Florida, United States (enrolling)
• Site Number - 1016 — Port Charlotte, Florida, United States (enrolling)
• Site Number - 1012 — West Palm Beach, Florida, United States (enrolling)
• Site Number - 1038 — Atlanta, Georgia, United States (enrolling)
• Site Number - 1053 — Macon, Georgia, United States (enrolling)
• Site Number - 1041 — Kansas City, Kansas, United States (enrolling)

Full record on ClinicalTrials.gov

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