Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion has submitted an application to the U.S. Food and Drug Administration (FDA) for a Phase 3 clinical trial plan for Zymfentra (CT-P13 SC) in patients with rheumatoid arthritis. The trial aims to secure additional clinical data, including patient racial diversity and varied treatment histories.
📊 [Summary of Key Disclosure Content & Major Figures]
- Regulatory Authority: U.S. Food and Drug Administration (FDA)
- 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
[Related Prior Filings]
- None
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 U.S. FDA Approval Status of the Phase 3 Clinical Trial Protocol
This disclosure pertains to an application submitted to the U.S. FDA for a Phase 3 clinical trial protocol to gather additional data on rheumatoid arthritis patients. Verifying whether the regulatory authority grants approval and tracking the finalized trial conditions and timeline is essential for understanding the formal initiation of the trial. Relevant updates can be verified in future regulatory disclosures, annual business reports, or quarterly and half-yearly reports.
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