Horizon Therapeutics plc Announces Completion Of Enrollment Of Phase 3 Clinical Trial In Japan Evaluating TEPEZZA For The Treatment Of Active Thyroid Eye Disease
Horizon Therapeutics plc (NASDAQ:HZNP) today announced that it has completed enrollment of its Phase 3 clinical trial (OPTIC-J) in Japan evaluating TEPEZZA for the treatment of active Thyroid Eye Disease (TED).
TED is a serious, progressive and potentially vision-threatening rare autoimmune disease that can cause proptosis (eye bulging), diplopia (double vision), eye pain, redness and swelling.1 TEPEZZA was approved by the U.S. Food and Drug Administration (FDA) in January 2020 as the first and only medicine for TED. TEPEZZA has not been approved for commercial use in Japan. There are no other medicines approved for the treatment of active TED in Japan.
“Completing enrollment of this trial is an important step in our efforts to address the unmet need of people living with Thyroid Eye Disease in Japan,” said Yuji Hiromatsu, M.D., emeritus professor, Kurume University Medical Center and co-coordinating trial investigator. “The burden of Thyroid Eye Disease is heavy – daily tasks and activities can be impacted for many, and some withdraw from family and friends due to not looking or feeling like themselves. With this trial, we hope to explore the role that TEPEZZA could have for Japanese patients struggling with active Thyroid Eye Disease.”
The OPTIC-J trial is a randomized, double-masked, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, tolerability and safety of TEPEZZA in the treatment of patients with moderate-to-severe active TED in Japan. The trial methodology is based on the OPTIC Phase 3 trial conducted in the United States and Europe. Adult participants who met the eligibility criteria were randomized in a 1:1 ratio to receive TEPEZZA or placebo once every three weeks for a total of eight infusions (10 mg/kg for the first infusion and 20 mg/kg for the remaining seven infusions).
The primary efficacy endpoint is proptosis response rate at Week 24, measured by the percentage of participants with at least a 2 mm reduction in proptosis from baseline in the study eye, without deterioration in the fellow eye (≥ 2 mm increase). Study participants who complete the treatment period and are proptosis non-responders at Week 24 may choose to enter an open-label extension period to receive an additional eight infusions of TEPEZZA.
“We are so grateful for the participation and partnership of those living with Thyroid Eye Disease in Japan and our principal investigators,” said Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. “The need for a non-surgical, non-steroidal treatment option for Thyroid Eye Disease in Japan is significant. We look forward to continuing to work with local researchers and regulators to possibly bring relief and hope to Thyroid Eye Disease patients in the region.”
The trial was designed in consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). More information about the trial, including eligibility criteria, is available on the Japan Registry of Clinical Trials website (trial ID number jRCT2031210453).