Phase 3 Trial Evaluating Safety and Effects of Efgartigimod PH20 SC Injection in Adults With Graves Disease Not Controlled by Antithyroid Drugs

What this Trial Is About

Researchers are evaluating how efgartigimod affects thyroid function in adults with Graves Disease GD. This study aims to assess the safety, tolerability, and immune response of efgartigimod, including its effects on antibody levels and how the body processes the drug. The trial is a Phase 3 study designed to understand the treatments impact on controlling GD symptoms and improving thyroid hormone levels. Participants are assigned to different groups in a randomized, parallel design. During the first part part A, participants receive either efgartigimod PH20 SC via prefilled syringe or a placebo in a double-blinded manner. The second part part B continues with either efgartigimod or placebo treatment and observation. In the third part part C, all participants receive open-label efgartigimod treatment. The total participation time ranges from 63 to 135 weeks, depending on individual responses. Throughout the study, participants undergo regular assessments including thyroid hormone levels fT3, fT4, TSH, antibody measurements, and safety monitoring. Researchers will track how many participants achieve normal thyroid function without antithyroid drugs by week 24 and over longer periods. The study also evaluates changes in quality of life and immune system markers. Participants receive ongoing monitoring to observe treatment effects and any adverse events during the extended study duration.

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease