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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: Completed Phase 4 study, sponsored by Amgen.
NCT05002998 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 313 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment emergent adverse events and treatment emergent adverse events of special interest will be evaluated from the beginning of the study until follow up.
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 |
What the finished NCT05002998 record still lists
NCT05002998 is an interventional study that assigns participants to a tested intervention. The registered 313 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05002998 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05002998's enrollment target sits among peer trials
313 262nd of 2000 higher than 1,739 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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