NCT06727604 A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
| NCT ID | NCT06727604 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Immunovant Sciences GmbH |
| Condition | Graves' Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-12-17 |
| Primary Completion | 2028-06 |
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 240 participants in total. It began in 2024-12-17 with a primary completion date of 2028-06.
⚠ 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 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.
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 NCT06727604 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 NCT06727604 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 NCT06727604 currently recruiting?
Yes, NCT06727604 is actively recruiting participants. Contact the research team at clinicaltrials@immunovant.com for enrollment information.
Where is the NCT06727604 trial being conducted?
This trial is being conducted at Phoenix, United States, Phoenix, United States, Huntington Beach, United States, Los Angeles, United States and 11 additional locations.
Who is sponsoring the NCT06727604 clinical trial?
NCT06727604 is sponsored by Immunovant Sciences GmbH. The trial plans to enroll 240 participants.