NCT07018323 · 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 multi-center, global, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment Phase 2b 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 multi-center, global, randomized, double-blind, placebo-controlled Phase 2b 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.
Interventions
DRUG
IMVT-1402
Dose 1 for 26 weeks
DRUG
IMVT-1402
Dose 2 for 26 weeks
DRUG
Placebo
For 26 weeks
Primary outcome measures
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)
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
- 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 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
- Tucson, Arizona
- Concord, California
- Aurora, Colorado
- Doral, Florida
- Hialeah, Florida
- Miami, Florida
- Columbus, Georgia
- Topeka, Kansas
- Louisville, Kentucky
- Jefferson City, Missouri
- Kansas City, Missouri
- St Louis, Missouri
And 19 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