NCT06727604 · Immunovant Sciences GmbH
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
What this study is about
This is a study to assess the effectiveness, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.
View original scientific description
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.
Interventions
DRUG
IMVT-1402
600 mg SC QW for 52 weeks
DRUG
IMVT-1402
600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
DRUG
Placebo
SC QW for 52 weeks
Primary outcome measures
Percentage of participants who are euthyroid (local laboratory T3 [Total T3 or FT3], FT4, and TSH values within normal limits) and off ATD at Week 26
Time frame: Week 26
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Have documented diagnosis of GD.
- Have a TSH value \< 0.1 mIU/L as assessed by the local laboratory at the Screening Visit.
- Meet one of the following at the Screening Visit:
- Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and both of the following:
- Are on ATD at the Screening Visit with an ATD dose of ≥ 20 mg/day methimazole or equivalent for the 4-week period immediately preceding the Screening Visit.
- Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization.
- Have been on ATD for ≥ 6 months in the period immediately preceding the Screening Visit and all of the following:
- Have been treated with ≥ 15 mg/day methimazole or equivalent at any point during the participant's treatment history.
- Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening
Where
- Phoenix, Arizona
- Huntington Beach, California
- Los Angeles, California
- Orange, California
- Sacramento, California
- San Francisco, California
- Santa Clarita, California
- Torrance, California
- Walnut Creek, California
- Englewood, Colorado
- Newark, Delaware
- Washington D.C., District of Columbia
And 44 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2026 · Source of record for eligibility and locations