Horizon Therapeutics plc announced that the first patient has been enrolled in a Phase 3 clinical trial in Japan evaluating TEPEZZA for the treatment of adults with chronic Thyroid Eye Disease (TED) and low clinical activity score (CAS), which is a measure of disease activity. The trial includes patients with an initial diagnosis of TED between two to 10 years prior to the study and low levels of disease activity. Findings from this study will build on a separate Phase 3 clinical trial (OPTIC-J) that is currently underway in Japan and is evaluating TEPEZZA for the treatment of TED patients with disease duration of nine months or less and higher levels of disease activity.
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. TEPEZZA was approved by the U.S. Food and Drug Administration (FDA) in January 2020 and is the first and only medicine for TED, regardless of TED activity or duration. TEPEZZA has not been approved for commercial use in Japan. There are no medicines approved for the treatment of TED in Japan.
This randomized, double-masked, placebo-controlled, parallel-group, multicenter trial will be evaluating the efficacy, safety and tolerability of TEPEZZA compared to placebo in adults with chronic TED and low CAS. All study participants will be required to have a CAS of ≤2 at the screening and baseline visits, two to 10 years since initial diagnosis of TED, and no worsening in proptosis, diplopia or inflammatory symptoms of TED for at least one year.
“We know that patients who have lived with Thyroid Eye Disease for quite some time may continue to experience debilitating symptoms that impact their day to day lives and activities,” said Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. “Therefore, it’s important that we explore the efficacy of TEPEZZA in those with more chronic disease. We are grateful to have the opportunity to work with local researchers, regulators and patients on this trial to accomplish that goal.”
SOURCE: Businesswire