source: U.S. National Library of Medicine
The purpose of the current study is to confirm safety/tolerability and key pharmacodynamic (PD) effects that are considered to drive clinical benefit in GO patients.
Primary Outcome Measure:
• Assessment of safety by analysis of adverse events (AEs) data [ Time Frame: 7 Weeks ] AE summaries of the number and percent of participants reporting each event at least once will be generated. Other safety data will be summarized descriptively.
• Percentage change from baseline in total IgG and IgG subclasses (1-4) [ Time Frame: 7 Weeks ]
• Percentage change in levels of anti-TSHR antibodies [ Time Frame: 7 Weeks ]
Secondary Outcome Measure:
• Percent change from baseline in proptosis [ Time Frame: 7 Weeks ]
• Total number of proptosis responders [ Time Frame: 7 Weeks ]
• Pharmacokinetics (PK) Parameters of AUC (0-168 h) after first and last dose [ Time Frame: 7 Weeks ]
• Pharmacokinetics (PK) maximum concentration (Cmax) after first and last dose [ Time Frame: 7 Weeks ]
• Concentration of RVT-1401 pre-dose (Ctrough) [ Time Frame: 7 Weeks ]
• Immunogenicity determined by number of participants with positive anti-RVT-1401 antibodies and characterization of any anti-RVT-1401 antibodies to confirm neutralization potential [ Time Frame: 7 Weeks ]