Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01868997 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by Amgen.

Completed
Registry status
Phase 2
Development phase
88
Enrollment target

NCT01868997 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 88 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01868997, a Phase 2 study, has completed, sponsored by Amgen.

COMPLETED
Registry status
Phase 2
Development phase
88 participants
Enrollment target

Study 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"

Interventions

  • DRUG normal saline
  • DRUG teprotumumab

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2013-07
Est. Completion 2017-02-22
Phase Phase 2

Sponsor

Amgen

558 total trials

What the Registry Record Tells You About NCT01868997

The ClinicalTrials.gov registry entry for NCT01868997 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which normal saline is the first listed.

NCT01868997 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01868997 about?

NCT01868997 is a clinical study titled "Teprotumumab (RV 001) Treatment in Patients With Active Thyroid Eye Disease". 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"

What is the current status of trial NCT01868997?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 88 participants. The study started on 2013-07. Estimated completion is 2017-02-22.

What interventions are being tested in trial NCT01868997?

The interventions under investigation include: normal saline (DRUG), teprotumumab (DRUG).

Who is sponsoring clinical trial NCT01868997?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.