Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion announced that it has submitted an application for a global Phase 3 clinical trial plan to the U.S. Food and Drug Administration (FDA) to evaluate the efficacy and safety of CT-P13 SC (Zymfentra) in patients with rheumatoid arthritis.
📊 [Key Disclosure Details & Financial Highlights]
- Overview
- Title: Application for Phase 3 Clinical Trial Plan for CT-P13 SC (Zymfentra) in the U.S. (Patients with Rheumatoid Arthritis)
- Application Date: June 18, 2024 (Local Time)
- Regulatory Authority: U.S. Food and Drug Administration (FDA)
- Board Resolution or Fact Confirmation Date: June 18, 2024 (Date of submitting the clinical trial application to the U.S. FDA)
- Clinical Trial Details
- Trial Phase: Global Phase 3 Clinical Trial
- Indication: Rheumatoid Arthritis (RA)
- Clinical Trial Registration Number: EudraCT number 2024-510945-32
- Objective: To demonstrate the superiority of CT-P13 SC over placebo in terms of efficacy as determined by clinical response according to ACR20 at Week 12
- Number of Subjects: 189 patients
- Trial Duration: Treatment period of 52 weeks
- Study Design: Randomized, placebo-controlled, double-blind, parallel-group, Phase 3 clinical trial
- Future Plans & Important Notes
- CT-P13 SC (Zymfentra) previously completed Phase 3 trials for adult ulcerative colitis and Crohn’s disease, obtaining market authorizations in major markets including the U.S. and Europe. This Phase 3 trial aims to expand its indication to rheumatoid arthritis.
- Statistically, the probability of a clinical-stage drug candidate receiving final market authorization is known to be around 10%, and commercialization plans may be modified or abandoned depending on trial outcomes.
📝 Editor’s Comment (Key Follow-up Checkpoint)
📌 Verification of Approval Status of Clinical Trial Plan by the U.S. FDA
This disclosure reports the initial application stage for Phase 3 clinical trial approval in the U.S. for CT-P13 SC (Zymfentra) targeting rheumatoid arthritis. Tracking whether final approval of the clinical trial plan is granted by regulatory authorities after review is important for assessing the actual progress toward indication expansion. Detailed updates can be verified in subsequent disclosures and upcoming periodic reports (Quarterly, Half-Yearly, or Annual Reports).
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