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
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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 Inve…
Interventions
- DrugIMVT-1402
Dose 1 for 26 weeks
- DrugIMVT-1402
Dose 2 for 26 weeks
- DrugPlacebo
For 26 weeks
Locations (126)
- Site Number - 1015Tucson, Arizona
- Site Number -1014Concord, California
- Site Number - 1013Aurora, Colorado
- Site Number - 1024Doral, Florida
- Site Number - 1008Hialeah, Florida
- Site Number - 1000Miami, Florida