A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
Summary
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.
Timeline
- Start
- 2011-02
- Primary completion
- 2014-09
- Completion
- 2015-02
Outcome
Mixed primary results
registry analysis (superiority or other test); Placebo vs PF-04236921 50 mg; p = 0.0438; Mean Difference (Final Values) 18.7 (90% CI 0.7 to 36.7) NCT01287897 ↗
registry analysis (superiority or other test); Placebo vs PF-04236921 10 mg; p = 0.3406; Mean Difference (Final Values) 4.3 (90% CI -13.0 to 21.7) NCT01287897 ↗
paper Crohn's Disease Activity Index (CDAI)-70 response rates with PF-04236921 50mg were significantly greater than placebo at weeks 8 (49.3% vs 30.6%, P<0.05) and 12 (47.4% vs 28.6%, P<0.05) and met the primary end point. PMID 29247068 ↗
Publications
- Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.
- Danese S, Vermeire S, Hellstern P, Panaccione R, Rogler G, Fraser G, Kohn A, Desreumaux P, Leong RW, Comer GM, Cataldi F, Banerjee A, Maguire MK, Li C, Rath N, Beebe J, Schreiber S. Randomised trial and open-label extension study of an anti-interleukin-6 antibody in Crohn's disease (ANDANTE I and II). Gut. 2019 Jan;68(1):40-48. doi: 10.1136/gutjnl-2017-314562. Epub 2017 Dec 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PACIBEKITUG | Monoclonal antibody | 50 mg | Subcutaneous |
| Subject | PACIBEKITUG | Monoclonal antibody | 200 mg | Subcutaneous |