drugset / Trial / NCT01276509
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
Timeline
- Start
- 2011-04-06
- Primary completion
- 2014-02-07
- Completion
- 2015-10-09
Outcome
Missed primary endpoint
paper Although CDAI-70 response was not significantly different with placebo versus PF-00547659 treatment at weeks 8 or 12 PMID 28982740 ↗
paper Clinical endpoint differences between PF-00547659 and placebo did not reach statistical significance in patients with moderate-to-severe CD. PMID 28982740 ↗
Publications
- Saruta M, Park DI, Kim YH, Yang SK, Jang BI, Cheon JH, Im JP, Kanai T, Katsuno T, Ishiguro Y, Nagaoka M, Isogawa N, Li Y, Banerjee A, Ahmad A, Hassan-Zahraee M, Clare R, Gorelick KJ, Cataldi F, Watanabe M, Hibi T. Anti-MAdCAM-1 antibody (PF-00547659) for active refractory Crohn's disease in Japanese and Korean patients: the OPERA study. Intest Res. 2020 Jan;18(1):45-55. doi: 10.5217/ir.2019.00039. Epub 2020 Jan 30.
- Sandborn WJ, Lee SD, Tarabar D, Louis E, Klopocka M, Klaus J, Reinisch W, Hebuterne X, Park DI, Schreiber S, Nayak S, Ahmad A, Banerjee A, Brown LS, Cataldi F, Gorelick KJ, Cheng JB, Hassan-Zahraee M, Clare R, D'Haens GR. Phase II evaluation of anti-MAdCAM antibody PF-00547659 in the treatment of Crohn's disease: report of the OPERA study. Gut. 2018 Oct;67(10):1824-1835. doi: 10.1136/gutjnl-2016-313457. Epub 2017 Oct 5.
- Hassan-Zahraee M, Banerjee A, Cheng JB, Zhang W, Ahmad A, Page K, von Schack D, Zhang B, Martin SW, Nayak S, Reddy P, Xi L, Neubert H, Fernandez Ocana M, Gorelick K, Clare R, Vincent M, Cataldi F, Hung K. Anti-MAdCAM Antibody Increases ss7+ T Cells and CCR9 Gene Expression in the Peripheral Blood of Patients With Crohn's Disease. J Crohns Colitis. 2018 Jan 5;12(1):77-86. doi: 10.1093/ecco-jcc/jjx121.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ontamalimab | Monoclonal antibody | 22.5 mg | Subcutaneous |
| Subject | Ontamalimab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Ontamalimab | Monoclonal antibody | 225 mg | Subcutaneous |