This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, veligrotug (VRDN-001), in participants with chronic thyroid eye disease (TED).
This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with chronic TED. The key objectives of this study are to determine if veligrotug (VRDN-001) is efficacious, safe, and tolerable when administered as 5 IV infusions given every 3 weeks for a total of 12 weeks in participants with chronic TED
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
188
Veligrotug (VRDN-001) is a humanized monoclonal antibody directed against the IGF-1 receptor
5 IV infusions of placebo
Proptosis Responder Rate in the most proptotic eye
Proptosis Responder Rate in the most proptotic eye (i.e., reduction of proptosis of ≥2 mm from baseline \[without a corresponding increase of ≥2 mm in the other eye\]) as measured by exophthalmometer.
Time frame: Week 15
Change from baseline in proptosis in the most proptotic eye
Change from baseline in proptosis in the most proptotic eye as measured by exophthalmometer
Time frame: Week 15
Proptosis Responder Rate in the most proptotic eye
Change from baseline in proptosis in the most proptotic eye
Time frame: Week 15
Clinical Activity Responder Rate in the most proptotic eye
Clinical Activity Responder Rate in the most proptotic eye (i.e., no worsening in CAS from baseline \[without a corresponding increase of ≥2 points in the other eye\]) as measured by exophthalmometer
Time frame: Week 15
Overall Responder Rate in the most proptotic eye
Overall Responder Rate comprised of Proptosis Responder Rate in the most proptotic eye as measured by exophthalmometer and Clinical Activity Responder rate in the most proptotic eye as measured by exophthalmometer
Time frame: Week 15
Diplopia Responder Rate
Diplopia Responder Rate (i.e., reduction in Gorman Subjective Diplopia Score of ≥1 from baseline for participants with baseline Gorman Subjective Diplopia Score \>0)
Time frame: Week 15
Diplopia Resolution Rate
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Advancing Research International, LLC
Los Angeles, California, United States
USC Roski Eye Institute
Los Angeles, California, United States
Amy Patel Jain, MD
Newport Beach, California, United States
Stanford Byers Eye Institute
Palo Alto, California, United States
Cockerham Eye Consultants, PC
San Diego, California, United States
Bascom Palmer Eye Institute - Ophthalmology - Miami
Miami, Florida, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Northwestern University
Chicago, Illinois, United States
Family Eye Physicians, Ltd
Oak Lawn, Illinois, United States
Massachusetts Eye and Ear
Boston, Massachusetts, United States
...and 47 more locations
Diplopia Resolution Rate (i.e., reduction in Gorman Subjective Diplopia Score to 0 from baseline for participants with baseline Gorman Subjective Diplopia Score \> 0)
Time frame: Week 15