First patient enrolled in phase 4 trial of Tepezza for chronic thyroid eye disease
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The first patient has been enrolled in a phase 4 clinical trial to evaluate the safety and efficacy of Tepezza in patients with chronic thyroid eye disease, according to a press release from Horizon Therapeutics.
“It is common for patients who are in the chronic phase of the disease to continue having debilitating symptoms, like eye pain and bulging, that interfere with daily living and require treatment,” trial investigator Raymond Douglas, MD, PhD, said in the release. “In a number of published case reports and analyses, Tepezza improved thyroid eye disease symptoms, including eye bulging, when administered in the chronic phase. This trial will help us understand these observations in a controlled clinical setting.”
The double-masked, placebo-controlled, parallel-group, multicenter trial will comprise about 60 patients aged 18 years or older randomly assigned 2:1 to receive Tepezza (teprotumumab) or placebo, 10 mg/kg for the first infusion and then 20 mg/kg for seven infusions.
The primary efficacy endpoint of the study is change in proptosis in the study eye from baseline to week 24. Investigators will also explore proptosis responder rate, diplopia responder rate, change in orbital pain, change in muscle volume, and change in the Graves’ Ophthalmopathy Quality of Life questionnaire appearance and visual functioning subscales, according to the release.
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