NCT01868997

Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease

A Multicenter, Double-Masked, Placebo-Controlled, Efficacy And Safety Study Of RV 001, An Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody (Fully Human), Administered Every 3 Weeks (q3W) By Intravenous (IV) Infusion In Patients Suffering From Active Thyroid Eye Disease (TED)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thyroid Associated Ophthalmopathies
• Thyroid-Associated Ophthalmopathy

Interventions

Type	Name	Description
DRUG	teprotumumab
DRUG	normal saline

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-03-01
• Completion: 2017-02-22
• First posted: 2013-06-05
• Last updated: 2024-12-17
• Results posted: 2017-08-30

Locations

15 sites across 4 countries: United States, Germany, Italy, United Kingdom