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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
89
SC injection
SC injection
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).
Time frame: Week 24
Mean change from Baseline in proptosis measurement in the study eye
Time frame: 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)
Time frame: Week 24
Percentage of participants with a CAS value of 0 or 1
Time frame: Week 24
Change from Baseline in diplopia as ordinal response categories
Time frame: Week 24
Diplopia responder rate, defined as the percentage of participants with Baseline binocular diplopia > 0 who have a reduction of ≥ 1 grade
Time frame: Week 24
Complete diplopia responder rate, defined as the percentage of participants with a Baseline binocular diplopia score > 0 and a score of 0
Time frame: Week 24
Mean change from Baseline in the GO-QoL questionnaire overall score
Time frame: Week 24
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