[Edaily Reporter SONG YOUNG-DOO ] Celltrion(068270)Celltrion will conduct a global Phase 3 clinical trial in South Korea for “Zimpentra” (CT-P13 SC), a subcutaneous infliximab, to expand its indication to rheumatoid arthritis. This move is part of the company’s efforts to broaden the treatment target to include rheumatoid arthritis patients, following its use for ulcerative colitis and Crohn’s disease.

Celltrion announced on the 14th that it had received approval from the Ministry of Food and Drug Safety for the Phase 3 clinical trial plan for CT-P13 SC in rheumatoid arthritis. The company had previously submitted the clinical trial plan on July 24.

This clinical trial will involve 296 patients with moderate to severe active rheumatoid arthritis. Patients will be randomly assigned to either the CT-P13 SC treatment group or the placebo group; the trial is designed as a double-blind study, meaning neither the patients nor the investigators will know which drug is being administered. The treatment period is 52 weeks.

The primary endpoint is to determine whether CT-P13 SC demonstrates superior efficacy compared to the placebo based on the “ACR50” response at Week 12. ACR50 is an indicator that assesses whether there has been an improvement of at least 50% in rheumatoid arthritis evaluation criteria—including the number of tender and swollen joints, pain, and physical function—according to specific standards.

CT-P13 SC is a medication developed as a subcutaneous (SC) formulation of “Remsima,” an infliximab biosimilar originally available as an intravenous (IV) injection. Celltrion explained that it was developed to enhance the convenience of administration and expand treatment options for patients.

According to the company, CT-P13 SC has completed Phase 3 clinical trials in adult patients with ulcerative colitis and Crohn’s disease and has obtained marketing authorization in several countries, including the United States and Europe. The company plans to pursue additional indications through this Phase 3 clinical trial for rheumatoid arthritis.

Celltrion stated, “We expect to be able to provide treatment opportunities to even more patients, in addition to the existing indications for ulcerative colitis and Crohn’s disease in adults.”