Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has submitted an application for Part 1 & Part 2 of a Phase 3 clinical trial plan to the European Medicines Agency (EMA) for Zymfentra (CT-P13 SC) in patients with rheumatoid arthritis. The study aims to secure additional clinical data, including racial diversity and varied prior treatment histories.
📊 [Summary of Key Disclosure Content & Major Figures]
- Regulatory Authority: European Medicines Agency (EMA)
- Application Date: July 24, 2026 (Local Time)
[Clinical Trial Details]
- Trial Title: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous CT-P13 (CT-P13 SC) in Patients with Moderate to Severely Active Rheumatoid Arthritis
- Development Phase: Global Phase 3 Clinical Trial
- Target Indication: Rheumatoid Arthritis (RA)
- Registration Number: EU CT number: 2026-526538-15
- Study Objective: To demonstrate the superiority of CT-P13 SC over placebo in terms of efficacy as determined by clinical response at ACR50 at Week 12
[Study Design & Purpose]
- Total Subjects: 296 patients
- Study Duration: 52-week treatment period
- Study Design: Randomized, placebo-controlled, double-blind, parallel-group Phase 3 clinical trial
- Purpose: Securing additional clinical data (racial diversity of patient population, diversification of prior treatment history, etc.) considering differentiation at the commercial stage and regulatory preferences for patient diversity
- Regulatory Note: Pursuant to revised EU clinical trial regulations, Part 1 (trial design and methodology evaluation) and Part 2 (clinical site and execution evaluation) were submitted simultaneously. Both Part 1 and Part 2 must receive approval for the trial to proceed.
[Related Prior Filings]
- None
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 European Medicines Agency (EMA) Approval Status of Phase 3 Trial Protocol (Part 1 & 2)
This disclosure pertains to the simultaneous submission of Part 1 and Part 2 of a Phase 3 clinical trial protocol to the EMA to collect additional data on rheumatoid arthritis patients. Verifying whether both Part 1 and Part 2 receive regulatory approval is essential for determining the formal initiation of the trial under the revised European trial regulations. Relevant updates can be verified in future regulatory disclosures, annual business reports, or quarterly and half-yearly reports.
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