NCT07018323 A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
| NCT ID | NCT07018323 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Immunovant Sciences GmbH |
| Condition | Graves' Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2025-06-19 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 210 participants in total. It began in 2025-06-19 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07018323 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Graves' Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07018323 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07018323 currently recruiting?
Yes, NCT07018323 is actively recruiting participants. Contact the research team at clinicaltrials@immunovant.com for enrollment information.
Where is the NCT07018323 trial being conducted?
This trial is being conducted at Tucson, United States, Concord, United States, Aurora, United States, Doral, United States and 11 additional locations.
Who is sponsoring the NCT07018323 clinical trial?
NCT07018323 is sponsored by Immunovant Sciences GmbH. The trial plans to enroll 210 participants.