The purpose of the current study is to assess the efficacy and safety/tolerability of three dose regimens of RVT-1401 in the treatment of active, moderate to severe GO participants. In addition, the study is designed to characterize the effect of RVT-1401 exposure on reduction in anti-TSHR IgG
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
65
RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.
Percentage of Participants With Proptosis Response at Week 13
Proptosis was assessed using an exophthalmometer. A proptosis response was defined as having at least a 2 millimeter (mm) reduction in study eye proptosis without a deterioration (at least a 2 mm increase) in the fellow eye at the same visit. The study eye was defined as the most severely affected eye at the baseline visit.
Time frame: Baseline; Week 13
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (SAEs)
AEs - any untoward medical occurrences in a participant, temporally associated with use of a medicinal product, whether or not considered related to the product. Clinically significant changes determined by the Investigator such as vital signs, ECGs, and clinical laboratory values were also reported as AEs. TEAE is defined as an AE that starts on or after the first dose of the study drug and before 30 days after the last dose of the study drug. SAEs were defined as any untoward medical occurrences that: resulted in death; were life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in disability/incapacity; were congenital anomaly/birth defects; were important medical events that may have jeopardized the participant or may have required medical or surgical intervention; invasive or malignant cancers; and development of drug dependency or drug abuse.
Time frame: From Baseline up to Week 20
Least Square Mean Percent Change From Baseline in Binding Anti-thyroid-stimulating Hormone Receptor (TSHR) Antibody Levels to Week 13
Binding Anti-TSHR antibody serum levels are directly associated with GO clinical features. Baseline was the last available assessment prior to the time of the first dose unless it was specified otherwise and was identified as Day 1. A negative change from baseline in binding anti-TSHR antibody levels indicated therapeutic benefit.
Time frame: Baseline and Week 13
Least Square Mean Percent Change From Baseline in Total IgG Levels
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Multispecialty Aesthetic Clinical Research Organziation (MACRO)
Beverly Hills, California, United States
Doheny Eye Center UCLA
Pasadena, California, United States
University of Miami Miller School of Medicine Bascom Palmer Eye Institute
Miami, Florida, United States
University of Iowa Hospitals & Clinics - Eye Clinic
Iowa City, Iowa, United States
University of Michigan - Kellogg Eye Center
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University School of Medicine - Center for Advanced Medicine (CAM) - Eye Center
St Louis, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
Oregon Health & Science University (OHSU) - Casey Eye Institute (CEI)-Marquam Hill
Portland, Oregon, United States
Eye Wellness Center
Houston, Texas, United States
...and 15 more locations
Blood samples we collected to determine total IgG levels. Baseline was the last available assessment prior to the time of the first dose unless it was specified otherwise and was identified as Day 1. A negative change from baseline in the IgG levels indicated therapeutic benefit.
Time frame: Baseline and Week 13
Least Square Mean Percent Change From Baseline in IgG Subclasses 1, 2, 3 and 4
Blood samples were collected to determine IgG 1,2,3 and 4 levels. Baseline was the last available assessment prior to the time of the first dose unless it was specified otherwise and was identified as Day 1. A negative change from baseline in the IgG levels indicated therapeutic benefit.
Time frame: Baseline and Week 13