Overview

This trial is active, not recruiting.

Condition crohn's disease
Treatments pf-00547659 sc injection
Phase phase 2
Sponsor Pfizer
Start date April 2011
End date February 2014
Trial size 240 participants
Trial identifier NCT01276509, 2010-023437-30, A7281006, OPERA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
pf-00547659 sc injection
Placebo delivered SC, 3 doses separated by 4 weeks
(Experimental)
pf-00547659 sc injection
Drug dose level 1 delivered SC, 3 doses separated by 4 weeks
(Experimental)
pf-00547659 sc injection
Drug dose level 2 delivered SC, 3 doses separated by 4 weeks
(Experimental)
pf-00547659 sc injection
Drug dose level 3 delivered SC, 3 doses separated by 4 weeks

Primary Outcomes

Measure
Crohn's Disease Activity Index (CDAI) 70 response rate at week 8 or week 12 (between the investigational product group and the placebo group).
time frame: 16 months

Secondary Outcomes

Measure
Safety and tolerability of PF-00547659 dose levels versus placebo: the frequency of treatment adverse events, withdrawal due to adverse events, and serious adverse events (SAEs) will be reported.
time frame: 40 months
Percent of subjects with a CDAI remission (CDAI <150), CDAI 70 and CDAI 100 responses Weeks 2 through 12.
time frame: 16 months
Immunogenicity assessments of antidrug antibodies (ADAs).
time frame: 40 months
The PK of total PF-00547659 will be characterized using a population PK approach. PK parameters including but not limited to AUC, CL and half life will be estimated using data pooled from both typical and additional PK groups.
time frame: 40 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Subjects must have failed or are intolerant to anti-TNFs and/or immunosuppressants (AZA, 6-MP, and/or MTX). - hsCRP greater than 3mg/L - Ulcerations demonstrated by colonoscopy performed during screening or 8 weeks prior to screening Exclusion Criteria: - Pregnant or breast feeding - Short bowel syndrome due to multiple small bowel resections - Presence of a stoma

Additional Information

Official title A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Pfizer.