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NCT05002998 · ClinicalTrials.gov registry record · Phase 4
TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study
A Phase 4 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 313
- Enrollment target
NCT05002998 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 313 participants.
The verdict
NCT05002998, a Phase 4 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 313 participants
- Enrollment target
Study Summary
This is a double-masked, randomized, parallel-assignment, multicenter trial examining the safety and tolerability of teprotumumab in the treatment of Thyroid Eye Disease (TED) in adult participants. This international, Phase 3b/4 trial is being conducted to fulfill an FDA post-marketing requirement for a descriptive trial to evaluate the safety, efficacy and need for re-treatment of 3 different teprotumumab treatment durations for TED. In addition, serum samples from participants with a Baseline Clinical Activity Score (CAS) ≥3 will be evaluated for biomarkers of disease.
Interventions
- DRUG Placebo
- DRUG Teprotumumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 313 participants |
| Start Date | 2021-09-16 |
| Est. Completion | 2025-12-19 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05002998
The ClinicalTrials.gov registry entry for NCT05002998 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 313 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.
NCT05002998 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05002998 about?
NCT05002998 is a clinical study titled "TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study". This is a double-masked, randomized, parallel-assignment, multicenter trial examining the safety and tolerability of teprotumumab in the treatment of Thyroid Eye Disease (TED) in adult participants. This international, Phase 3b/4 trial is being conducted to fulfill an FDA post-marketing requirement ...
What is the current status of trial NCT05002998?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 313 participants. The study started on 2021-09-16. Estimated completion is 2025-12-19.
What interventions are being tested in trial NCT05002998?
The interventions under investigation include: Placebo (DRUG), Teprotumumab (DRUG).
Who is sponsoring clinical trial NCT05002998?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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