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A Trial to Investigate Teprotumumab Subcutaneous Administration Compared With Placebo in Male and Female Adult Participants With Moderate-to-severe Active Thyroid Eye Disease
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.
Study 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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-07-05
Primary completion: 2025-10-15
Study completion finish: 2026-05-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT06248619
Intervention or treatment
BIOLOGICAL: Teprotumumab
OTHER: Placebo
Conditions
- • Thyroid Eye Disease
Find a site
Closest Location:
Centre For Eye Research Australia Ltd
Research sites nearby
Select from list below to view details:
Centre For Eye Research Australia Ltd
East Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Teprotumumab
| BIOLOGICAL: Teprotumumab
|
PLACEBO_COMPARATOR: Placebo
| OTHER: Placebo
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Proptosis responder rate (percentage of participants with a ≥ 2-mm reduction from baseline in proptosis in the study eye without deterioration [≥ 2-mm increase] of proptosis in the fellow eye). | Not Specified | Week 24 |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Mean change from Baseline in proptosis measurement in the study eye | Not Specified | Week 24 |
Overall responder rate (percentage of participants with ≥ 2-point reduction in CAS AND ≥ 2-mm reduction in proptosis from Baseline, provided there is no corresponding deterioration [≥ 2-point/mm increase] in CAS or proptosis in the fellow eye) | Not Specified | Week 24 |
Percentage of participants with a CAS value of 0 or 1 | Not Specified | Week 24 |
Change from Baseline in diplopia as ordinal response categories | Not Specified | Week 24 |
Diplopia responder rate, defined as the percentage of participants with Baseline binocular diplopia > 0 who have a reduction of ≥ 1 grade | Not Specified | Week 24 |
Complete diplopia responder rate, defined as the percentage of participants with a Baseline binocular diplopia score > 0 and a score of 0 | Not Specified | Week 24 |
Mean change from Baseline in the GO-QoL questionnaire overall score | Not Specified | Week 24 |
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