NCT04040894

Expanded Access Protocol of Teprotumumab (HZN-001) for Patients With Active Thyroid Eye Disease

Phase 3b, Multicenter, Open-label, Single-Arm Expanded Access Protocol of TEPROTUMUMAB (HZN-001)

• Status: Approved For Marketing
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This is an expanded access protocol intended to provide access to teprotumumab for the treatment of up to 60 patients in the United States with active moderate to severe thyroid eye disease where there is no comparable or satisfactory alternative therapy for treatment.

Detailed description

Requests for access to the Sponsor must be made by a licensed physician for a specific patient, based on a determination with the patient that the benefits of treatment with the investigational drug outweigh the risks. Licensed physician's with eligible patients must apply and meet requirements for participation in the expanded access program. Study acquired from Horizon in 2024.

Conditions

• Thyroid Eye Disease
• Graves' Orbitopathy

Interventions

Type	Name	Description
BIOLOGICAL	Teprotumumab	Treatment with 8 infusions of Teprotumumab q3W for a total of 21 weeks. Teprotumumab 10 mg/kg will be administered on Day 1 and Teprotumumab 20 mg/kg will be administered q3W for the remaining 7 infusions.

Timeline

• First posted: 2019-08-01
• Last updated: 2024-06-20

Locations

8 sites across 1 country: United States