This is a clinical trial assessing the safety and tolerability of an investigational drug, VRDN-003, in participants with 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), controlled study that will include participants with TED of any duration. The key objectives of this study are to determine if VRDN-003 is safe and tolerable when administered as a series of subcutaneous (SC) injections every 4 weeks or every 8 weeks in participants with TED.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
321
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
Treatment Emergent Adverse Event (TEAE) incidence rate through Week 24
Time frame: Week 24
Change from baseline in proptosis in the study eye at Week 24 as measured by exophthalmometer
Change from baseline in proptosis in the study eye
Time frame: Week 24
TEAE incidence rate through Week 52
Treatment Emergent Adverse Event (TEAE) incidence rate measurement through Week 52
Time frame: Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Catalina Eye Care
Tuscon, Arizona, United States
United Medical Research Institute
Inglewood, California, United States
Orbital Plastics
Newport Beach, California, United States
California Eye Specialists Medical Group INC
Pasadena, California, United States
FOMAT Medical Research
Pismo Beach, California, United States
Pacific Neuroscience Institute
Santa Monica, California, United States
Pacific Neuroscience Institute at Saint John's Physician Partners
Torrance, California, United States
C A Clinical Trial Corp.
Cape Coral, Florida, United States
Herco Medical and Research Center
Coral Gables, Florida, United States
Alfa Medical Research
Davie, Florida, United States
...and 54 more locations