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 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
- 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
600 mg SC QW for 52 weeks
- DrugIMVT-1402
600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
- DrugPlacebo
SC QW for 52 weeks
Locations (133)
- Site Number - 1032Phoenix, Arizona
- Site Number - 1036Phoenix, Arizona
- Site Number - 1061Huntington Beach, California
- Site Number - 1001Los Angeles, California
- Site Number - 1047Los Angeles, California
- Site Number - 1062Orange, California