Conditions: Thyroid Associated Ophthalmopathies Thyroid-Associated Ophthalmopathy
Keywords: Thyroid Eye Disease, Graves Orbitopathy, Thyroid Associated Ophthalmopathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 88
Healthy volunteers: no

Brief summary:
The primary objective of this study is to investigate the efficacy, safety, and tolerability of RV 001 (teprotumumab), a fully human anti-IGF1R antibody, administered q3W for 6 months, in comparison to placebo, in the treatment of participants suffering from active TED.

"Funding Source - FDA OOPD"

Detailed description:
Study with completed results acquired from Horizon in 2024.

Arms:
arm 1: A placebo infusion (normal saline) administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. arm 2: Teprotumumab administered q3W by IV infusion over a period of 24 weeks for a total of 8 infusions. All participants start treatment at a dose of 10 mg/kg. At Week 3, the dose is escalated to 20 mg/kg and kept constant for the remainder of the study.

Interventions: intervention 1: teprotumumab intervention 2: normal saline
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: