drugset / Trial / NCT01620255
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
RandomizedParallel-groupTriple-blindTreatment
Summary
To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.
Timeline
- Start
- 2012-11-02
- Primary completion
- 2014-09-22
- Completion
- 2016-02-04
Outcome
Met primary endpoint
paper Remission rates at week 12 were significantly greater in three of four active-treatment groups than in the placebo group (2·7% [two of 73]): PMID 28527704 ↗
paper These rates corresponded to a stratum-adjusted (anti-TNFα-naive and anti-TNFα-experienced) risk difference versus placebo of 8·0% for 7·5 mg (90% CI 1·9 to 14, p=0·0425) PMID 28527704 ↗
release “In this Phase 2 study, called TURANDOT, SHP647, the first anti-MAdCAM antibody in clinical development, met its primary endpoint” takeda.com ↗
Publications
- Zhou H, Xi L, Ziemek D, O'Neil S, Lee J, Stewart Z, Zhan Y, Zhao S, Zhang Y, Page K, Huang A, Maciejewski M, Zhang B, Gorelick KJ, Fitz L, Pradhan V, Cataldi F, Vincent M, Von Schack D, Hung K, Hassan-Zahraee M. Molecular Profiling of Ulcerative Colitis Subjects from the TURANDOT Trial Reveals Novel Pharmacodynamic/Efficacy Biomarkers. J Crohns Colitis. 2019 May 27;13(6):702-713. doi: 10.1093/ecco-jcc/jjy217.
- Vermeire S, Sandborn WJ, Danese S, Hebuterne X, Salzberg BA, Klopocka M, Tarabar D, Vanasek T, Gregus M, Hellstern PA, Kim JS, Sparrow MP, Gorelick KJ, Hinz M, Ahmad A, Pradhan V, Hassan-Zahraee M, Clare R, Cataldi F, Reinisch W. Anti-MAdCAM antibody (PF-00547659) for ulcerative colitis (TURANDOT): a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2017 Jul 8;390(10090):135-144. doi: 10.1016/S0140-6736(17)30930-3. Epub 2017 May 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ontamalimab | Monoclonal antibody | 7.5 mg | Subcutaneous |
| Subject | Ontamalimab | Monoclonal antibody | 22.5 mg | Subcutaneous |
| Subject | Ontamalimab | Monoclonal antibody | 75 mg | Subcutaneous |
| Subject | Ontamalimab | Monoclonal antibody | 225 mg | Subcutaneous |