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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01868997

Public ClinicalTrials.gov record NCT01868997. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 10:32 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01868997
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Amgen
Industry
Enrollment
88 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2013 (Actual)
Primary completion
Mar 2016 (Actual)
Completion
Feb 22, 2017 (Actual)
Last update posted
Dec 17, 2024

2013 – 2017

United States locations

U.S. sites
11
U.S. states
11
U.S. cities
11
Facility City State ZIP Site status
Jules Stein Eye Institute at UCLA Los Angeles California 90095 —
University of Denver Aurora Colorado 80045 —
Emory University Department of Ophthalmology Atlanta Georgia 30322 —
University of Iowa Hospitals and Clinics, Department of Ophthalmology Iowa City Iowa 52242 —
Kellogg Eye Center at University of Michigan Ann Arbor Michigan 48105 —
Washington University Department of Ophthalmology St Louis Missouri 63110 —
University of Nebraska Medical Center Department of Ophthalmology Omaha Nebraska 68198 —
Casey Eye Institute at Oregon Health and Science University Portland Oregon 97239 —
Hamilton Eye Institute at University of Tennessee Memphis Tennessee 38163 —
Eye Wellness Center Houston Texas 77005 —
Medical College of Wisconsin, The Eye Institute Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01868997, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 17, 2024 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01868997 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →