NCT06389578

A Study of TEPEZZA® Treatment in Participants With Thyroid Eye Disease

A Phase 1b, Open-label, Multicenter Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Two Formulations of a Single Subcutaneous Dose of Teprotumumab Followed by Multiple Intravenous Doses of TEPEZZA in Participants With Thyroid Eye Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this study is to learn how teprotumumab will be processed in the body (Pharmacokinetics) subcutaneously and whether it is safe and tolerable after administration into adult patients with thyroid eye disease.

Detailed description

This is a Phase 1b, open-label, multicenter trial to assess the PK, safety, and tolerability of a single SC dose of lyophilized teprotumumab and high concentration formulation teprotumumab in participants with thyroid eye disease. Approximately 6 participants (in Cohort 1) and approximately 10 participants (in Cohort 2) who meet the trial eligibility criteria will be enrolled in a 1:1 ratio. Study acquired from Horizon in 2024.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
DRUG	Teprotumumab	SC administration and IV infusion

Timeline

• Start date: 2022-07-14
• Primary completion: 2023-02-28
• Completion: 2023-09-12
• First posted: 2024-04-29
• Last updated: 2024-06-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study