This is a clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab treatment but subsequently had a disease recurrence.
This is a Phase 4, single-arm, open-label (meaning study doctor, participant and the sponsor will know which study arm participant is assigned to) clinical trial to evaluate the safety and efficacy of veligrotug (LUMVOA™) in participants with moderate to severe TED who previously received and responded to an initial course of teprotumumab but subsequently had disease recurrence. The primary objective of this trial is to evaluate the safety and tolerability of veligrotug when given as 5 intravenous (IV) infusions of 10 mg/kg administered every 3 weeks. To evaluate safety, the incidence rate of treatment-emergent adverse events (TEAEs) 3 weeks after the fifth infusion (ie, Week 15) will be determined.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
intravenous infusions
Office of Dr. Amy Patel Jain, MD
Newport Beach, California, United States
Sarasota Retina Institute
Sarasota, Florida, United States
Ophthalmic Consultants of Boston
East Weymouth, Massachusetts, United States
Kahana Oculoplastic & Orbital Surgery
Safety and tolerability of veligrotrug (LUMVOA™)
Treatment Emergent Adverse Event (TEAE) incidence rate
Time frame: Through Week 15
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