The investigational drug, VRDN-001, is a monoclonal antibody that inhibits the activity of a cell surface receptor called insulin-like growth factor-1 receptor (IGF-1R). Inhibition of IGF-1R may help to reduce the inflammation and associated tissue swelling that occurs in participants with TED. The primary objective of this clinical trial is to evaluate the safety and tolerability of VRDN-001 in participants with TED.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
231
5 infusions of veligrotug
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Through Week 15
An adverse event (AE) was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all Serious Adverse Events (SAEs) and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Baseline through Week 15
Change From Baseline in Proptosis in the Study Eye as Measured by Exophthalmometer
Proptosis was defined as distance between the lateral orbital rim and the most anterior position of the cornea in millimeters (mm), measured using an exophthalmometer. Observed change from baseline in proptosis in study eye is reported. Missing data were not imputed.
Time frame: Baseline, Week 15
Number of Participants With TEAEs Through Week 52
An AE was defined as any untoward medical occurrence that developed or worsened in severity during the conduct of a clinical study and did not necessarily have a causal relationship to study drug. TEAE was defined as an AE occurring on or after the day of the first dose of study medication through the end of the study. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Baseline through Week 52
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United Medical Research Institute
Inglewood, California, United States
Advancing Research International, LLC
Los Angeles, California, United States
Stanford Byers Eye Institute
Palo Alto, California, United States
Cockerham Eye Consultants, PC
San Diego, California, United States
FOMAT Medical Research
Santa Maria, California, United States
University of Colorado - Dept of Ophthalmology
Aurora, Colorado, United States
Sina Medical Center LLC
Homestead, Florida, United States
Med-Care Research Inc.
Miami, Florida, United States
Edward Jenner Research Group Center LLC
Plantation, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
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