Phase 1b Study of Cizutamig for Treating Moderate to Severe Thyroid Eye Disease in Adults

What this Trial Is About

Researchers are investigating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and early clinical effects of cizutamig in adults with thyroid eye disease TED. This is a Phase 1b, open-label, multicenter trial designed to better understand how this drug behaves in patients with active, moderate to severe TED, a condition associated with Graves Disease. Participants will receive cizutamig dosed according to the study protocol throughout the trial. No placebo or comparator groups are involved, as the study focuses on evaluating the investigational drugs effects and safety. The study will monitor patients from baseline through 12 months to collect data on how the drug works and is tolerated. During the study, participants will undergo regular assessments including vital signs heart rate, blood pressure, respiratory rate, body temperature, pulse oximetry, ECG measurements, and laboratory safety tests such as serum chemistry and blood counts. Researchers will also track any adverse events and analyze pharmacokinetic parameters like drug concentration and clearance. The total participation lasts up to one year, ensuring close monitoring of safety and clinical activity of cizutamig in TED patients.

A Clinical Study of Cizutamig in Thyroid Eye Disease