Fact Source: Financial Supervisory Service DART
💡 3-Second Summary
Celltrion announced that the European Medicines Agency (EMA) has approved Part 1 (trial design and methodology) of its global Phase 3 clinical trial plan for CT-P13 SC (Remsima SC) in pediatric patients with ulcerative colitis.
📊 [Key Disclosure Details & Financial Highlights]
- Overview
- Title: Approval of Phase 3 Clinical Trial Plan (Part 1) in Europe for CT-P13 SC (Remsima SC) (Pediatric Patients with Ulcerative Colitis)
- Application Date: February 27, 2024 (Local Time)
- Approval Date: June 17, 2024 (Local Time)
- Regulatory Authority: European Medicines Agency (EMA)
- Board Resolution or Fact Confirmation Date: June 18, 2024 (Date of confirmation via CTIS)
- Clinical Trial Details
- Trial Phase: Global Phase 3 Clinical Trial
- Indication: Pediatric patients (ages 6-17) with moderately to severely active ulcerative colitis
- Clinical Trial Registration Number: EU CT number 2024-511605-31
- Objective: To compare and evaluate the efficacy of low-dose vs. high-dose CT-P13 SC maintenance therapy (every 2 weeks) in achieving clinical remission at Week 54
- Number of Subjects: 243 patients
- Trial Duration: Treatment period of 106 weeks
- Study Design: Randomized, double-blind, Phase 3 clinical trial
- Regulatory Information & Future Plans
- Under revised EU Clinical Trials Regulations, procedures are split into Part 1 (assessment of trial design and methodology) and Part 2 (assessment of trial sites and execution). This disclosure corresponds to Part 1 approval; final approval through Part 2 is required to initiate actual trial execution.
- Aims to expand the indication to pediatric ulcerative colitis in addition to existing adult ulcerative colitis and Crohn’s disease indications.
- 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 Part 2 Approval Status and Subsequent Disclosures
This disclosure reports the Part 1 approval (trial design and methodology) from the EMA for the Phase 3 clinical trial plan of CT-P13 SC targeting pediatric ulcerative colitis. Under revised EU regulations, tracking whether Part 2 approval (site and operational evaluation) is subsequently granted to enable trial execution is important for monitoring the 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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