Phase 3 Study to Evaluate Safety and Effectiveness of Efgartigimod PH20 SC Prefilled Syringe in Adults with Graves Disease Not Controlled by Antithyroid Drugs

What this Trial Is About

Researchers are evaluating the effects of efgartigimod on thyroid function in adults with Graves Disease, focusing on its safety, how it is processed in the body, and its impact on antibody levels and the immune system. This Phase 3 study involves a randomized, double-masked, placebo-controlled design to better understand treatment outcomes for participants whose disease is not well controlled with antithyroid drugs. Participants may receive efgartigimod PH20 SC or a placebo via subcutaneous injection using a prefilled syringe during the first two parts of the study, which include a double-blinded treatment period and a treatmentobservation period. In the third part, participants receive open-label efgartigimod treatment. The study spans between 63 and 135 weeks depending on each participants response to treatment. Throughout the study, participants undergo regular assessments of thyroid hormone levels, antibody levels, and immune response markers. Safety is monitored continuously, including tracking adverse events. The primary outcome measures focus on the percentage of participants achieving normal thyroid hormone levels without antithyroid drugs at 24 weeks. Additional evaluations include quality of life questionnaires and long-term monitoring of treatment effects and tolerability.

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