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
Immunovant Sciences GmbH
210 participants
Jun 19, 2025
INTERVENTIONAL
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
Inclusion Criteria3
- 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.
Exclusion Criteria3
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Dose 1 for 26 weeks
Dose 2 for 26 weeks
For 26 weeks
Locations(120)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07018323