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NCT03298867 · ClinicalTrials.gov registry record · Phase 3
Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 83
- Enrollment target
NCT03298867 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 83 participants.
The verdict
NCT03298867, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 83 participants
- Enrollment target
Study Summary
The overall objective is to investigate the efficacy, tolerability, and safety of teprotumumab (a fully human monoclonal antibody \[mAb\] inhibitor of the insulin-like growth factor-1 receptor \[IGF-1R\]) administered once every 3 weeks (q3W) for 21 weeks with a final assessment at Week 24, in comparison to placebo, in the treatment of participants with moderate-to-severe active thyroid eye disease (TED).
Interventions
- OTHER Placebo
- BIOLOGICAL Teprotumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2017-10-04 |
| Est. Completion | 2020-11-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03298867
The ClinicalTrials.gov registry entry for NCT03298867 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 83 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 Placebo is the first listed.
NCT03298867 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03298867 about?
NCT03298867 is a clinical study titled "Treatment of Graves' Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis With Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study". The overall objective is to investigate the efficacy, tolerability, and safety of teprotumumab (a fully human monoclonal antibody \[mAb\] inhibitor of the insulin-like growth factor-1 receptor \[IGF-1R\]) administered once every 3 weeks (q3W) for 21 weeks with a final assessment at Week 24, in compa...
What is the current status of trial NCT03298867?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2017-10-04. Estimated completion is 2020-11-30.
What interventions are being tested in trial NCT03298867?
The interventions under investigation include: Placebo (OTHER), Teprotumumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03298867?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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