TEPEZZA® (Teprotumumab-trbw) Post-Marketing Requirement Study
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Phase
Phase 4
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
313actual
Sites
28
Countries
France, Germany, Italy +3
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-09-16 | actual | When the study began enrolling |
| Primary completion | 2025-12-19 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-12-19 | actual | The whole study's end, after follow-up |
| First posted | 2021-08-12 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Thyroid Eye Disease
Interventions
- Drug: Teprotumumab — also filed as TEPEZZA
- Drug: Placebo — also filed as Saline Solution
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants who experience at least 1 treatment-emergent adverse event (TEAE) and the percentage of participants who experience at least 1 treatment emergent AESI during treatment with teprotumumab
measured Screening to End of Study (last visit possible is Week 136)
Percentage of Participants who receive re-treatment
measured Week 27 to Week 136
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