Horizon Pharma has completed patient enrolment for the Phase lll OPTIC trial of teprotumumab to treat patients with moderate-to-severe active thyroid eye disease (TED), ahead of schedule.
A total of 83 patients were enrolled at 13 sites across the US, Germany and Italy under the randomised, double-masked, placebo-controlled, parallel-group, multicentre trial.
During the course of the OPTIC trial, the enrolled patients will be randomised in a 1:1 ratio to receive eight infusions of teprotumumab or placebo every three weeks for 21 weeks.
The trial’s primary endpoint is the responder rate of more than 2mm reduction of proptosis, or bulging of the study eye at week 24.
Its secondary endpoints comprise 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, all of which will be measured at week 24.
The trial, which will also analyse the safety of teprotumumab, is expected to release topline results by the second quarter of next year.
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Horizon Pharma chairman, president and CEO Timothy Walbert said: “Our success in rapidly enrolling this trial speaks to the significant unmet need and the strong collaboration with Phase lll study investigators.
“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.”
Teprotumumab is a fully human monoclonal antibody (mAb) and is currently under investigation as an inhibitor of the insulin-like growth factor 1 receptor (IGF-1R).
It is yet to establish its safety and efficacy parameters.