At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 88 enrolled
Drug / intervention
teprotumumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 2 clinical trial evaluating teprotumumab and normal saline for Thyroid Associated Ophthalmopathies and Thyroid-Associated Ophthalmopathy. Completed, enrolled 88 participants across 15 sites in 4 countries.
Detailed 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"
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Italy, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 2013
Enrollment StartJul 2013
Primary CompletionMar 2016
Study CompletionFeb 2017
TodayJul 2026
First PostedJun 5, 2013
Enrollment StartJul 1, 2013
Primary CompletionMar 1, 2016
Study CompletionFeb 22, 2017
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 13.1 years ago
Interventions
teprotumumabdrug
normal salinedrug