Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

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.

Official Title

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

Details

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.

Keywords

Thyroid Eye Disease, Teprotumumab, Active Thyroid Eye Disease, Tepezza, Teprotumumab-trbw, Eye Diseases, Graves Ophthalmopathy, Thyroid Diseases

Eligibility

For people ages 18-80

Inclusion Criteria:

  1. Participant must provide written informed consent.
  2. Participant can be male or female and must be between the ages of 18 and 80 years, inclusive, at Screening.
  3. Participant must have a clinical diagnosis of Graves' disease associated with active TED with a CAS ≥ 3 (on the 7-item scale) for the most severely affected eye at Screening and Baseline.
  4. Participant must have moderate-to-severe active TED (not sight-threatening but has an appreciable impact on daily life), usually associated with 1 or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement and/or inconstant or constant diplopia. (Note: Participants with no diplopia at Baseline will be limited to approximately 25% of the total number enrolled.)
  5. Participant has proptosis ≥ 3 mm from Baseline (prior to diagnosis of TED), as estimated by treating physician, and/or proptosis ≥ 3 mm above normal for race and gender.
  6. Participant had onset of active TED symptoms (as determined by participan

Locations

  • Shiley Eye Center University of California at San Diego accepting new patients
    La Jolla California 92093-0001 United States
  • Cockerham Eye Consultants PC accepting new patients
    San Diego California 92108 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT06248619
Phase
Phase 3 Thyroid Eye Disease Research Study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated