The investigational drug, veligrotug (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 patients with thyroid eye disease (TED). The primary objective of this clinical trial is to establish the safety, tolerability, and efficacy of veligrotug, and the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of veligrotug in active TED patients who received 10 mg/kg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
113
5 IV Infusions of veligrotug (VRDN-001) 10mg/kg
5 IV Infusions of veligrotug (VRDN-001) placebo
University of Colorado - Department of Ophthalmology
Aurora, California, United States
The Private Office of Raymond Douglas
Beverly Hills, California, United States
USC Roski Eye Institute
Los Angeles, California, United States
MACRO Trials, Inc.
Los Angeles, California, United States
Amy Patel Jain, MD
Newport Beach, California, United States
Proptosis Responder Rate
Proptosis Responder Rate in the study eye (i.e., reduction of proptosis of ≥ 2 mm from baseline \[without a corresponding increase of ≥ 2 mm in the fellow eye\] as measured by exophthalmometer)
Time frame: Week 15
Change from baseline in proptosis in the study eye
Change from baseline in proptosis in the study eye as measured by exophthalmometer
Time frame: Week 15
Proptosis Responder Rate in the most proptotic eye
Proptosis Responder Rate in the most proptotic eye as measured by MRI/CT
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 MRI/CT
Time frame: Week 15
Change from baseline in CAS
Change from baseline in Clinical Activity Score (CAS) in the study eye
Time frame: Week 15
Overall Responder Rate
Overall Responder Rate comprising Proptosis Responder Rate as measured by exophthalmometer and Clinical Activity Responder Rate in the study eye
Time frame: Week 15
Clinical Activity Responder Rate in the study eye
Clinical Activity Responder Rate in the study eye
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
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
Proportion of participants with a CAS score of zero or one in the study eye
Proportion of participants with a CAS of zero or one in the study eye
Time frame: Week 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Byers Eye Institute/Stanford University
Palo Alto, California, United States
Senta Clinic
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Sina Medical Center
Homestead, Florida, United States
...and 43 more locations