Enrollment completed in Phase III trial of teprotumumab in patients living with moderate-to-severe active thyroid eye disease.- Horizon Pharma.
Horizon Pharma plc announced the early completion of enrollment for the confirmatory Phase III trial of teprotumumab in patients living with moderate-to-severe active thyroid eye disease (TED). The study (NCT03298867 and EudraCT 2017-002763-18) enrolled 83 patients at 13 sites across the United States, Germany and Italy. Topline results are expected in the second quarter of 2019.
Completing enrollment in the confirmatory Phase III trial marks a key milestone for people living with TED and Horizon Pharma. The Treatment of Graves� Orbitopathy (Thyroid Eye Disease) to Reduce Proptosis with Teprotumumab Infusions in a Randomized, Placebo-Controlled, Clinical Study (OPTIC) is a randomized, double-masked, placebo-controlled, parallel-group, multicenter study. OPTIC reached its target enrollment of 76 patients on 3 August 2018 those remaining in screening were allowed to randomize for a final total of 83 patients.
Patients will be randomized in a 1:1 ratio to receive eight infusions of teprotumumab or placebo every three weeks for 21 weeks. The primary endpoint is the responder rate of ? 2 mm reduction of proptosis, or bulging of the eye, in the study eye (without deterioration in the fellow eye) at week 24, in teprotumumab treated versus placebo treated patients. In addition, the secondary endpoints at week 24, include overall responder rate, percentage of participants with a Clinical Activity Score value of 0 or 1, mean change from baseline in proptosis measurement and the Graves� Ophthalmopathy Quality of Life questionnaire overall score. Safety is evaluated throughout the duration of the study.
Comment: There is no FDA-approved therapy for TED, which can result in bulging of the eyes, known as proptosis, and cause additional challenges for those living with the disease.
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