Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves' Ophthalmopathy | oneGRAVESvoice

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Reference Materials

Study of RVT-1401 for the Treatment of Patients With Moderate to Severe Active Graves’ Ophthalmopathy

key information

source: U.S. National Library of Medicine

year: 2021

summary/abstract:

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 ]