NCT02883452

A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis

An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 randomized, open-label, multicenter, parallel-group study designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 subcutaneous (SC) and CT-P13 intravenous (IV) in patients with active Crohn's Disease (CD) and active Ulcerative Colitis (UC).

Detailed description

A new subcutaneous infliximab formulation is developed by Celltrion, Inc. as an alternative to the intravenous regimen where subcutaneous infliximab injection typically takes less than 2 minutes. The availability of a subcutaneous formulation of infliximab would increase the treatment options available to patients, particularly those wishing to self-administer their therapy. This Phase 1 randomized, open-label, multicenter, parallel-group study is designed to evaluate efficacy, pharmacokinetics and safety between CT-P13 SC and CT-P13 IV in patients with active CD and active UC.

Conditions

• Crohn's Disease
• Ulcerative Colitis (Part 2 Only)

Interventions

Type	Name	Description
BIOLOGICAL	CT-P13	CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks (Part 1)
BIOLOGICAL	CT-P13	CT-P13 (120 mg) by single SC injection every 2 weeks (Part 1)
BIOLOGICAL	CT-P13	CT-P13 (180 mg) by double SC 90 mg injections every 2 weeks (Part 1)
BIOLOGICAL	CT-P13	CT-P13 (240 mg) by double SC 120 mg injections every 2 weeks (Part 1)
BIOLOGICAL	CT-P13	CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 6 (Part 2)
BIOLOGICAL	CT-P13	CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks up to Week 22. From Week 30, CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 30 (Part 2)

Timeline

• Start date: 2016-09-29
• Primary completion: 2019-02-04
• Completion: 2019-10-02
• First posted: 2016-08-30
• Last updated: 2020-06-09
• Results posted: 2020-06-09

Locations

1 site across 1 country: South Korea