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NCT04583735 · ClinicalTrials.gov registry record · Phase 4
A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease
A Phase 4 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 62
- Enrollment target
NCT04583735: Completed Phase 4 study, sponsored by Amgen.
NCT04583735 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 62 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04583735, a Phase 4 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 62 participants
- Enrollment target
Study Summary
The overall objective is to investigate the efficacy, safety and tolerability of TEPEZZA® in participants with chronic (inactive) TED (thyroid eye disease). Approximately 57 participants will be enrolled. There will be a treatment period (through Week 24) and a follow up period (where TEPEZZA will not be infused).
Primary Outcome
Proptosis assessments were performed using a Hertel exophthalmometer. It measures the anterior projection of the eye from the lateral orbital rim to the cornea (proptosis).
Interventions
- DRUG Placebo
- BIOLOGICAL TEPEZZA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2021-09-02 |
| Est. Completion | 2023-10-12 |
| Phase | Phase 4 |
What the finished NCT04583735 record still lists
NCT04583735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04583735 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04583735 about?
NCT04583735 is a clinical study titled "A Study Evaluating TEPEZZA® Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease". The overall objective is to investigate the efficacy, safety and tolerability of TEPEZZA® in participants with chronic (inactive) TED (thyroid eye disease). Approximately 57 participants will be enrolled. There will be a treatment period (through Week 24) and a follow up period (where TEPEZZA will n...
What is the current status of trial NCT04583735?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2021-09-02. Estimated completion is 2023-10-12.
What interventions are being tested in trial NCT04583735?
The interventions under investigation include: Placebo (DRUG), TEPEZZA (BIOLOGICAL).
Who is sponsoring clinical trial NCT04583735?
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 NCT04583735's enrollment target sits among peer trials
62 1110th of 2000 higher than 882 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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