NCT06064864

Efficacy and Safety of Formulation Switching Between SC Infliximab and IV Infliximab in Patients With CD

Efficacy and Safety of Formulation Switching Between Subcutaneous Infliximab and Intravenous Infliximab in Patients With Crohn's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this prospective, multicenter, open-label, randomized controlled, non-inferiority trial is to test efficacy and safety of formulation switching between subcutaneous (SC) infliximab and intravenous (IV) infliximab in patients with moderately to severely active Crohn's disease (CD). The primary endpoint of this study is deep remission at week 54. The main questions this study aims to answer are: Question-1) Is maintenance therapy with SC infliximab (120mg every 2 weeks) non-inferior to IV infliximab (5mg/kg every 8 weeks) in terms of deep remission at week 54? Question-2) Is maintenance therapy with SC infliximab (120mg every 2 weeks) non-inferior to IV infliximab (10mg/kg every 8 weeks) in terms of deep remission at week 54?

Detailed description

Remsima (CT-P13) is the first biosimilar of infliximab and its intravenous (IV) formulation has been used for patients with active Crohn's disease (CD). Recently, subcutaneous (SC) formulation of Remsima (Remsima SC) was developed and approved by the Korean FDA (Food and Drug Administration). However, until now, besides a registration trial, real-life experiences of Remsima SC is still limited and the efficacy and safety of switching from SC to IV Remsima is still unknown. In this study, patients with moderately to severely active CD who achieve clinical response to SC Remsima at week 30 (IV Remsima 5mg/kg at week 0 and 2, followed by SC Remsima 120mg every 2 weeks from week 6) will be randomly (1:1) assigned to IV Remsima group (Arm 2) or to continued SC Remsima group (Arm 3). Non-responders at week 30 will be allocated to Arm 1 (IV Remsima 10 mg/kg). The primary endpoint is the non-inferiority of Arm 3 compared with Arm 2 in terms of deep remission rate at week 54. The secondary endpoint is the non-inferiority of Arm 3 compared with Arm 1 in terms of deep remission rate at week 54. The non-inferiority margin is set as -20% and a total of 100 patients will be enrolled. Through this study, the investigators aim to provide the clinical evidence for selecting the most optimal formulation of infliximab according to therapeutic response among Korean patients with CD.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DRUG	Infliximab-Dyyb	Continued infliximab SC 120 mg every other week, if response to SC infliximab at week 30

Timeline

• Start date: 2023-10-09
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-10-03
• Last updated: 2024-05-14

Locations

1 site across 1 country: South Korea