A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis (TURANDOT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01620255
First received: June 13, 2012
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Ulcerative Colitis
Drug: PF-00547659 SC Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, Parallel, Dose-Ranging Study To Evaluate The Efficacy And Safety Of PF-00547659 In Subjects With Moderate To Severe Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of subjects with mucosal healing (defined as absolute Mayo subscore of endoscopy of 0 or 1). [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in Mayo Score and in individual Mayo subscores. [ Time Frame: Weeks 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Change in fecal calprotectin. [ Time Frame: Weeks 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Change in high sensitivity C-reactive protein. [ Time Frame: Weeks 0, 4, 8, 12 ] [ Designated as safety issue: No ]
  • Change over time in the mean Inflammatory Bowel Disease Questionnaire domain and total scores. [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Proportion of subjects with an Inflammatory Bowel Disease Questionnaire total score of greater than or equal to 170. [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • PF-00547659 concentration-time profile [ Time Frame: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36 ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: November 2012
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: PF-00547659 SC Injection
Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks
Experimental: Drug Dose Level 1 Drug: PF-00547659 SC Injection
Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks
Experimental: Drug Dose Level 2 Drug: PF-00547659 SC Injection
Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks
Experimental: Drug Dose Level 3 Drug: PF-00547659 SC Injection
Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks
Experimental: Drug Dose Level 4 Drug: PF-00547659 SC Injection
Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620255

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 166 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01620255     History of Changes
Other Study ID Numbers: A7281009
Study First Received: June 13, 2012
Last Updated: September 10, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Ulcer
Colitis, Ulcerative
Colitis
Pathologic Processes
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Inflammatory Bowel Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 18, 2014