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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease

A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease (NCT06727604) is a Phase 2 interventional studying Graves' Disease, sponsored by Immunovant Sciences GmbH. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Graves' Disease and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 240 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Graves' Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants with the ability to understand the requirements of the trial, provide written willing to sign a consent form, 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. Who Should NOT Join This Trial: - Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy. - Have an autoimmune conditions (where your immune system attacks your own body) 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Site Number - 1032
Phoenix, Arizona, United States
Site Number - 1036
Phoenix, Arizona, United States
Site Number - 1061
Huntington Beach, California, United States
Site Number - 1001
Los Angeles, California, United States
Site Number - 1047
Los Angeles, California, United States
Site Number - 1062
Orange, California, United States
Site Number - 1046
Sacramento, California, United States
Site Number - 1034
San Francisco, California, United States
Site Number - 1035
Santa Clarita, California, United States
Site Number - 1005
Torrance, California, United States
Site Number - 1006
Walnut Creek, California, United States
Site Number - 1013
Englewood, Colorado, United States
Site Number - 1010
Newark, Delaware, United States
Site Number - 1040
Washington D.C., District of Columbia, United States
Site Number - 1029
Clearwater, Florida, United States
Site Number - 1055
Jacksonville, Florida, United States
Site Number - 1056
Jacksonville, Florida, United States
Site Number - 1028
Miami, Florida, United States
Site Number - 1065
Miami, Florida, United States
Site Number - 1064
Ocoee, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06727604), the sponsor (Immunovant Sciences GmbH), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06727604 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06727604?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06727604?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06727604. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06727604. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.