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

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).

Timeline

Start

2016-09-29

Primary completion

2019-02-04

Completion

2019-10-02

Publications

• Schreiber S, D'Haens G, Cummings F, Irving PM, Ye BD, Ben-Horin S, Kim DH, Jeong AL, Reinisch W. Switching from intravenous to subcutaneous infliximab maintenance therapy in inflammatory bowel disease: Post hoc longitudinal analysis of a randomized trial. Dig Liver Dis. 2024 Jul;56(7):1204-1212. doi: 10.1016/j.dld.2023.12.013. Epub 2024 Feb 15.
• D'Haens G, Reinisch W, Schreiber S, Cummings F, Irving PM, Ye BD, Kim DH, Yoon S, Ben-Horin S. Subcutaneous Infliximab Monotherapy Versus Combination Therapy with Immunosuppressants in Inflammatory Bowel Disease: A Post Hoc Analysis of a Randomised Clinical Trial. Clin Drug Investig. 2023 Apr;43(4):277-288. doi: 10.1007/s40261-023-01252-z. Epub 2023 Apr 1.
• Schreiber S, Ben-Horin S, Leszczyszyn J, Dudkowiak R, Lahat A, Gawdis-Wojnarska B, Pukitis A, Horynski M, Farkas K, Kierkus J, Kowalski M, Lee SJ, Kim SH, Suh JH, Kim MR, Lee SG, Ye BD, Reinisch W. Randomized Controlled Trial: Subcutaneous vs Intravenous Infliximab CT-P13 Maintenance in Inflammatory Bowel Disease. Gastroenterology. 2021 Jun;160(7):2340-2353. doi: 10.1053/j.gastro.2021.02.068. Epub 2021 Mar 5.

Drugs

Indications