Evaluating Intravenous Felzartamab for Thyroid Function and Safety in Adults with Graves Disease Compared to Placebo

What this Trial Is About

Researchers are evaluating felzartamab in adults with Graves Disease GD, an autoimmune condition where the immune system attacks the thyroid gland causing it to be overactive hyperthyroidism. This study aims to see if felzartamab can help normalize thyroid hormone levels and reduce the need for anti-thyroid drugs ATDs. The trial is a phase 2, randomized, double-blind study comparing felzartamab to placebo in participants aged 18 to 75 years. Participants will be randomly assigned to one of three groups two groups receive felzartamab and one group receives placebo. Treatment involves multiple intravenous IV infusions over 20 weeks. During this period, the study doctor may gradually lower ATD doses if thyroid levels normalize. After treatment, participants enter a 12-week follow-up phase. The total study duration is about 9 months with 22 visits in total. Participants will have regular assessments including thyroid hormone levels free thyroxine, free triiodothyronine, TSH, antibody levels, and safety monitoring. Researchers will evaluate how many participants maintain normal thyroid function without ATDs at Week 24. They will also study drug safety, how the body processes felzartamab, and track adverse events. The follow-up period allows for continued monitoring after treatment ends.

A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old