CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 62 enrolled
Drug / intervention
TEPEZZA +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04583735
NCT04583735Phase 4Completed

A Phase 4, Randomized, Double-masked, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of TEPEZZA® in Treating Patients With Chronic (Inactive) Thyroid Eye Disease

Amgen·interventional·Posted Oct 12, 2020·Updated Jul 1, 2024

In Brief

A Phase 4 clinical trial evaluating TEPEZZA and Placebo for Thyroid Eye Disease and Chronic (Inactive) Thyroid Eye Disease. Completed, enrolled 62 participants across 12 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
202120222023202420252026
First PostedOct 12, 2020
Enrollment StartSep 2, 2021
Primary CompletionMar 17, 2023
Study CompletionOct 12, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.7 years ago

Interventions

TEPEZZAbiological

Intravenous infusion

Placebodrug

Intravenous infusion