Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04478994 · ClinicalTrials.gov registry record · Phase 1
A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)
A Phase 1 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT04478994 is a Phase 1 study that was terminated before completion, run by Amgen. The registered enrollment target is 3 participants.
The verdict
NCT04478994, a Phase 1 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
The overall objective is to investigate the safety, tolerability and effect on insulin-like growth factor-1 (IGF-1), inflammatory and fibrotic biomarkers of TEPEZZA (teprotumumab-trbw, HZN-001), a fully human monoclonal antibody (mAb) inhibitor of the IGF-1 receptor (IGF-1R), administered once every 3 weeks (q3W) for 24 weeks in the treatment of participants with diffuse cutaneous systemic sclerosis (dcSSc).
Interventions
- OTHER Placebo
- BIOLOGICAL TEPEZZA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2021-11-17 |
| Est. Completion | 2022-12-08 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04478994
The ClinicalTrials.gov registry entry for NCT04478994 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 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.
NCT04478994 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04478994 about?
NCT04478994 is a clinical study titled "A Study With TEPEZZA in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc)". The overall objective is to investigate the safety, tolerability and effect on insulin-like growth factor-1 (IGF-1), inflammatory and fibrotic biomarkers of TEPEZZA (teprotumumab-trbw, HZN-001), a fully human monoclonal antibody (mAb) inhibitor of the IGF-1 receptor (IGF-1R), administered once every...
What is the current status of trial NCT04478994?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2021-11-17. Estimated completion is 2022-12-08.
What interventions are being tested in trial NCT04478994?
The interventions under investigation include: Placebo (OTHER), TEPEZZA (BIOLOGICAL).
Who is sponsoring clinical trial NCT04478994?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.