Overview

This trial is active, not recruiting.

Condition ulcerative colitis
Treatments pf-00547659 sc injection
Phase phase 2
Sponsor Pfizer
Start date November 2012
End date September 2014
Trial size 300 participants
Trial identifier NCT01620255, 2012-002030-37, A7281009, TURANDOT

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.

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)
Primary purpose treatment
Arm
(Placebo Comparator)
pf-00547659 sc injection
Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks
(Experimental)
pf-00547659 sc injection
Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks
(Experimental)
pf-00547659 sc injection
Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks
(Experimental)
pf-00547659 sc injection
Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks
(Experimental)
pf-00547659 sc injection
Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks

Primary Outcomes

Measure
The proportion of subjects in Clinical Remission as defined by a Total Mayo Score of 2 points or lower with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1.
time frame: Week 12

Secondary Outcomes

Measure
Proportion of subjects with a Clinical Response with a decrease in Total Mayo Score by at least 3 points and at least 30% decrease in subscore for rectal bleeding of at least 1 point or absolute subscore of 0 or 1.
time frame: Week 0, 12
Proportion of subjects with mucosal healing (defined as absolute Mayo subscore of endoscopy of 0 or 1).
time frame: Week 12
Proporation of subjects with change in partial Mayo Score of less than or equal to 2 with no individual subscore greater than 1.
time frame: Weeks 0, 4, 8, 12
Change in Mayo Score and in individual Mayo subscores.
time frame: Weeks 0, 4, 8, 12
Change in fecal calprotectin.
time frame: Weeks 0, 4, 8, 12
Change in high sensitivity C-reactive protein.
time frame: Weeks 0, 4, 8, 12
Change over time in the mean Inflammatory Bowel Disease Questionnaire domain and total scores.
time frame: Baseline, Week 12
Proportion of subjects with an Inflammatory Bowel Disease Questionnaire total score of greater than or equal to 170.
time frame: Week 12
PF-00547659 concentration-time profile
time frame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Subjects with diagnosis of Ulcerative Colitis for 3 or more months. - Ulcerative colitis must be active beyond the rectum. - Must active Ulcerative Colitis with a Total Mayo Score of 6 to 12 points Exclusion Criteria: - Pregnant or breast feeding. - Diagnosis of indeterminate colitis or Crohn's Disease - Subjects with history of colonic or small bowel obstruction or resection.

Additional Information

Official title A Double-blind, Randomized, Placebo-controlled, Parallel, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Moderate To Severe Ulcerative Colitis (Turandot)
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Pfizer.