NCT06248619

A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease

A Phase 3, Randomized, Double-masked, Placebo-controlled, Parallel-group, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Teprotumumab in Participants With Moderate-to-Severe Active Thyroid Eye Disease

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study consists of a randomized double-masked, placebo-controlled, parallel-group, multicenter trial with an optional open-label treatment period for proptosis non-responders who complete the Double-masked Treatment Period.

Detailed description

The main objective of the study is to evaluate the effect of teprotumumab subcutaneous administration versus placebo on the proptosis responder rate (ie, the percentage of participants with a ≥ 2-mm reduction from Baseline in the study eye without deterioration \[≥ 2-mm increase\] of proptosis in the fellow eye) at Week 24. Acquired from Horizon in 2024.

Conditions

• Thyroid Eye Disease

Interventions

Type	Name	Description
BIOLOGICAL	Teprotumumab	SC injection
OTHER	Placebo	SC injection

Timeline

• Start date: 2024-07-05
• Primary completion: 2026-01-14
• Completion: 2026-09-02
• First posted: 2024-02-08
• Last updated: 2026-01-28

Locations

38 sites across 11 countries: United States, Argentina, Australia, Canada, France, Germany, Italy, Japan, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study