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

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)

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo; Drug: PF-00547659 SC Injection; Drug: PF-00547659 SC Injection; Drug: PF-00547659 SC Injection; Drug: PF-00547659 SC Injection

• Study Type: Interventional
• Enrollment (Actual): 357
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Garran, Australia, 2605
    • The Canberra Hospital
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Royal Brisbane and Women'S Hospital
    • South Brisbane, Queensland, Australia, 4101
      • Mater Health Services
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital
• Austria
  • Wien, Austria, 1090
    • AKH Wien, Universitaetsklinik fuer Innere Medizin III
• Belgium
  • Herentals, Belgium, 2200
    • AZ St-Elisabeth Herentals
  • Leuven, Belgium, 3000
    • University Hospital Gasthuisberg
  • Mouscron, Belgium, 7700
    • Centre Hospitalier de Mouscron
• Bulgaria
  • Sofia, Bulgaria, 1431
    • MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
  • Sofia, Bulgaria, 1000
    • 4- MBAL
  • Sofia, Bulgaria, 1797
    • MBAL SofiaMed OOD
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 2K5
      • GI Research Institute (GIRI)
    • Victoria, British Columbia, Canada, V8R 6R3
      • Office of Dr. David C. Pearson
    • Victoria, British Columbia, Canada, V8V 3P9
      • PerCuro Clinical Research Limited
    • Victoria, British Columbia, Canada, V8V 3P9
      • Office of Drs. Ranjit Andrew Singh and Jamie D. Papp
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University Medical Center
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Hamilton Health Sciences Corporation, McMaster University Medical Centre
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre - University Hospital
    • Oshawa, Ontario, Canada, L1H 1B9
      • Oshawa Clinic
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Pavillion Rachel Tourigny, Hopital Maisonneuve-Rosemont
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0W8
      • Royal University Hospital
• Czechia
  • Hradec Kralove, Czechia, 50012
    • Hepato-Gastroenterology HK s.r.o.
  • Praha 7, Czechia, 170 04
    • Klinické Centrum ISCARE I.V.F
  • Usti nad Labem, Czechia, 401 13
    • Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem o.z.
• France
  • Amiens Cedex 01, France, 80054
    • CHU Amiens - Hopital Nord
  • Caen, France, 14033
    • Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
  • Lille, France, 59037 Cedex
    • Hopital Huriez CHRU de Lille
  • Nice Cedex 03, France, CS23079 06202
    • Hôpital l'Archet 2 CHU de Nice
  • Pessac, France, 33604
    • Hôpital Haut Lévêque
  • Saint Priest en Jarez, France, 42270
    • Hôpital Nord Service de Gastro-entérologie
  • Vandoeuvre les Nancy, France, 54511
    • CHU Nancy - Hôpital Brabois
• Germany
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Regensburg, Germany, 93053
    • Universitaetsklinik Regensburg
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus GmbH
• Hungary
  • Budapest, Hungary, 1136
    • Pannónia Magánorvosi Centrum Kft
  • Szentes, Hungary, 6600
    • Csongrad Megyei Dr. Bugyi Istvan Korhaz
• Israel
  • Jerusalem, Israel, 91031
    • Digestive Disease Institute
  • Jerusalem, Israel, 91120
    • Gastroenterology and Liver Diseases Unit - Hadassah Ein Kerem University Hospital
  • Kfar-Saba, Israel, 44281
    • Dept. of Gastroenterology & Hepatology, Meir Medical Center
  • Petah Tikva, Israel, 49100
    • Gastroenterology Division, Rabin Medical Center, Beilinson Campus
  • Tel Hashomer, Israel, 5262000
    • The Chaim Sheba Medical Center
• Italy
  • Catanzaro, Italy, 88100
    • Universita' degli Studi "Magna Graecia" di Catanzaro, UO di Fisiopatologia Digestiva
  • Milano, Italy, 20097
    • IRCCS Policlinico San Donato
  • Milano, Italy, 20089
    • IBD Center - Divisione Gastroenterologia - Istituto Clinico Humanitas IRCCS
  • Padova, Italy, 35128
    • Azienda Ospedaliera -Università di Padova
  • Roma, Italy, 00128
    • Policlinico Universitario Campus Bio-Medico
  • Roma, Italy, 00133
    • Azienda Ospedaliera Universitaria, Policlinico Tor Vergata
  • Roma, Italy, 00168
    • Universita Cattolica Sacro Cuore Policlinico "A. Gemelli"
  • Rome, Italy, 00152
    • AOS San Camillo Forlanini
  • San Giovanni Rotondo, Italy, 71013
    • Ospedale Casa Sollievo della Sofferenza
• Korea, Republic of
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Daegu, Korea, Republic of, 705717
    • Yeungnam University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 03181
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 03722
    • Yonsei University College of Medicine, Severance Hospital
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • University Medical Center Groningen (UMCG)
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
  • NH
    • Amsterdam, NH, Netherlands, 1105 AZ
      • Academic Medical Center - University of Amsterdam
• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Christchurch, New Zealand, 8014
    • Southern Endoscopy Centre
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
  • Hamilton, New Zealand, 3204
    • Midland Neurology & EMG Ltd.
  • Hamilton, New Zealand, 3204
    • The Hamilton Eye Clinic
  • Hamilton, New Zealand, 3216
    • Cardiac Services Ltd.
• Poland
  • Bydgoszcz, Poland, 85-168
    • Centrum endoskopii Zabiegowej, Poradnia Chorob Jelitowych,
  • Krakow, Poland, 31-009
    • Gabinet Endoskopii Przewodu Pokarmowego
  • Lodz, Poland, 90-302
    • Centrum Medyczne - Szpital Swietej Rodziny Sp. z o.o.
  • Poznan, Poland, 61-485
    • Centrum Medyczne HCP Lecznictwo Ambulatoryjne Pracownia Endoskopowa
  • Warszawa, Poland, 03-580
    • NZOZ Vivamed
  • Warszawa, Poland, 02-507
    • Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem
  • Wroclaw, Poland, 53-114
    • Lexmedica
  • Wroclaw, Poland, 50-981
    • Wojskowy Szpital Kliniczny z Poliklinika SPOZ
• Russian Federation
  • Saint-Petersburg, Russian Federation, 196247
    • SBEI of HPE North-West State Medical University n.a. I.I. Mechnikov of the MH of the RF St.P SBIH "
• Serbia
  • Belgrade, Serbia, 11000
    • Military Medical Academy
  • Belgrade, Serbia, 11000
    • Clinical Hospital Centre Bezanijska Kosa, Clinic for Internal medicine
  • Belgrade, Serbia, 11000
    • Clinical Hospital Centre Zvezdara Clinic for Gastroenterology and Hepatology
  • Belgrade, Serbia, 11080
    • Clinical Hospital Center Zemun, Gastroenterology and Hepatology Department
  • Nis, Serbia, 18000
    • Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology
• Slovakia
  • Bratislava, Slovakia, 83104
    • Gastroenterological Centre Thalion
  • Nitra, Slovakia, 949 01
    • KM Management spol. s.r.o. Gastroenterologicke a hepatologicke centrum Nitra
  • Ruzomberok, Slovakia, 034 26
    • Ustredna vojenska nemocnice SNP Ruzomberok
  • Slovak Republic
    • Presov, Slovak Republic, Slovakia, 08001
      • Gastro I., s.r.o.
• South Africa
  • Cape Town
    • Claremont, Cape Town, South Africa, 7708
      • Kingsbury Hospital
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clínic de Barcelona
  • Barcelona, Spain, 08022
    • Centro Medico Teknon
  • Barcelona, Spain, 08003
    • Parc de Salut Mar-Hospital del Mar
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda
• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85259
      • Mayo Clinic Arizona
  • California
    • La Jolla, California, United States, 92093
      • Clinical and Translational Research Institute
    • La Jolla, California, United States, 92037
      • UCSD Health System-Pharmacy only
    • La Jolla, California, United States, 92093
      • Perlman Medical Offices
    • La Jolla, California, United States, 92093
      • Thornton Hospital
    • Orange, California, United States, 92868
      • Community Clinical Trials
    • Orange, California, United States, 92868
      • GastroDiagnostics - Community Clinical Trials Drug
  • Colorado
    • Denver, Colorado, United States, 80222
      • Rocky Mountain Clinical Research, LLC.
    • Lafayette, Colorado, United States, 80026
      • Clinical Research of the Rockies
    • Thornton, Colorado, United States, 80229
      • Rocky Mountain Gastroenterology Associates
  • Connecticut
    • Guilford, Connecticut, United States, 06437
      • Endoscopy Center of Connecticut, LLC
    • Hamden, Connecticut, United States, 06518
      • Gastroenterology Center of Connecticut, PC
    • Hamden, Connecticut, United States, 06518
      • Endoscopy Center of Connecticut, LLC
    • Hamden, Connecticut, United States, 06518
      • Medical REsearch Center of CT Drug
    • Hamden, Connecticut, United States, 06518
      • Medical Research Network of Connecticut
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Florida Surgery Center
    • Crystal River, Florida, United States, 34429
      • Gastroenterology Associates
    • Hialeah, Florida, United States, 33013
      • Research Consultant Group
    • Hialeah, Florida, United States, 33016
      • Th Palmetto Surgery Center
    • Inverness, Florida, United States, 34452
      • Nature Coast Clinical Research
    • Inverness, Florida, United States, 34452
      • Citrus Memorial Hospital
    • Inverness, Florida, United States, 34453
      • Suncoast Endoscopy Center
    • Inverness, Florida, United States, 34452
      • Inverness Medical Imaging
    • Maitland, Florida, United States, 32751
      • Sand Lake Imaging
    • Miami, Florida, United States, 33136
      • Sylvester Comprehensive Cancer Center
    • Miami, Florida, United States, 33136
      • University of Miami Hospital
    • Miami, Florida, United States, 33136
      • University of Miami Hospital and Clinic
    • Miami, Florida, United States, 33136
      • University of Miami Hospital and Clinic - Local Lab
    • Miami, Florida, United States, 33144
      • Coral View Surgery Center
    • Miami Beach, Florida, United States, 33179
      • Center For Diagnostic Imaging
    • Miramar, Florida, United States, 33025
      • FQL Research, LLC
    • Miramar, Florida, United States, 33025
      • First Quality Laboratory
    • North Miami Beach, Florida, United States, 33162
      • Venutre Ambulatory Sugery Center
    • Orlando, Florida, United States, 32806
      • Internal Medicine Specialists
    • Orlando, Florida, United States, 32806
      • Citrus Ambulatory Surgery Center
    • Orlando, Florida, United States, 32806
      • Boston Diagnostic Imaging
    • Winter Park, Florida, United States, 32789
      • Shafran Gastroenterology Center
  • Georgia
    • Alpharetta, Georgia, United States, 30005
      • Georgia Endoscopy Center
    • Atlanta, Georgia, United States, 30342
      • GI Consultants
    • Suwanee, Georgia, United States, 30024
      • Atlanta Gastroenterology Specialist
  • Indiana
    • Indianapolis, Indiana, United States, 46214
      • Covance Central Laboratory Services Inc
    • Indianapolis, Indiana, United States, 46214
      • Covance Central Laboratory Services, Inc
    • Indianapolis, Indiana, United States, 46214
      • Covance Laboratory Services, Inc
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Medical Center
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky Chandler Medical Center
  • Maryland
    • Towson, Maryland, United States, 21204
      • Endoscopic Microsurgery Associates
  • Massachusetts
    • Brockton, Massachusetts, United States, 02302
      • Commonwealth Clinical Studies
    • Brockton, Massachusetts, United States, 02302
      • Signature Healthcare Brockton
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5000
      • University of Michigan Health Systems
    • Grand Rapids, Michigan, United States, 49546
      • East Valley Endoscopy
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan
    • Wyoming, Michigan, United States, 49519
      • Metro Health Endoscopy Unit
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Noran Neurology Clinic
    • Minneapolis, Minnesota, United States, 55404
      • Minneapolis Medical Eye Clinic
    • Plymouth, Minnesota, United States, 55446
      • Minnesota Gastroenterology, P.A.
    • Plymouth, Minnesota, United States, 55441
      • Minneapolis Heart Institute
    • Plymouth, Minnesota, United States, 55446
      • Consulting Radiology
  • Missouri
    • Columbia, Missouri, United States, 65265
      • Surgery Center of Columbia
    • Mexico, Missouri, United States, 65265
      • Center for Digestive and Liver Diseases
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Louis, Missouri, United States, 63110
      • Center for Advanced Medicine
    • Saint Louis, Missouri, United States, 63108
      • Barnes-Jewish Hospital Investigational Drug Service (IP Shipping Address)
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital Radiology (X-Ray Only)
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • University of Nevada School of Medicine (UNSOM)
    • Las Vegas, Nevada, United States, 89106
      • Las Vegas Surgery Center
    • Las Vegas, Nevada, United States, 89109
      • Steinberg Diagnostic Medical Imaging Centers
  • New Hampshire
    • Lebanon, New Hampshire, United States, 3756
      • Dartmouth-Hitchcock Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • New York, New York, United States, 10065
      • New York Presbyterian Hospital
    • New York, New York, United States, 10065
      • Weill Cornell Medical College - New York Presbyterian Hospital
    • New York, New York, United States, 10021
      • New York Presbyterian Hospital - Weill Cornell Medical College
    • New York, New York, United States, 10065
      • Weill Cornell Medical College of Cornell University
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group of the Hudson Valley, PC
    • Poughkeepsie, New York, United States, 12601
      • Premier Medical Group Research Department - Drug
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Memorial Hospital
    • Chapel Hill, North Carolina, United States, 27517
      • UNC Hospitals Endoscopy Center at Meadowmont
    • Chapel Hill, North Carolina, United States, 27599
      • Department of Pharmacy Investigational Drug Services
  • Oregon
    • Portland, Oregon, United States, 97225
      • The Oregon Clinic, PC - Gastroenterology West
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Gastro One
    • Memphis, Tennessee, United States, 38119
      • Diagnostic Imaging
    • Nashville, Tennessee, United States, 37212-1610
      • Vanderbilt University Medical Center: GI Clinical Research
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center: IBD Clinic
    • Nashville, Tennessee, United States, 37232-7610
      • Vanderbilt University Medical Center: Drug Shipment
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center: Endoscopy Lab
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center: Outpatient Radiology
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine - Baylor Medical Center
    • Houston, Texas, United States, 77004
      • Houston Hospital for Specialized Surgery
    • Houston, Texas, United States, 77030
      • Baylor Clinic (Drug Storage)
    • Humble, Texas, United States, 77338
      • Spring Gastroenterology and Associates
    • Humble, Texas, United States, 77338
      • Spring Gastroenterology Drug
    • Southlake, Texas, United States, 76092
      • Texas Digestive Disease Consultants
    • Sugar Land, Texas, United States, 77479
      • Pioneer Research Solutions, Inc
  • Virginia
    • Richmond, Virginia, United States, 23249
      • McGuire DVAMC
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53222
      • PI Radiology
    • Wauwatosa, Wisconsin, United States, 53226
      • Allegiance Research Specialists
    • Wauwatosa, Wisconsin, United States, 53226
      • Dynacare Laboratories
    • Wauwatosa, Wisconsin, United States, 53226
      • GI associates drug

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; 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; Drug: PF-00547659 SC Injection; Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug: PF-00547659 SC Injection; Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug: PF-00547659 SC Injection; Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks
Experimental: Drug Dose Level 2	Drug: PF-00547659 SC Injection; Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug: PF-00547659 SC Injection; Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug: PF-00547659 SC Injection; Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug: PF-00547659 SC Injection; Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks
Experimental: Drug Dose Level 3	Drug: PF-00547659 SC Injection; Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug: PF-00547659 SC Injection; Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug: PF-00547659 SC Injection; Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug: PF-00547659 SC Injection; Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks
Experimental: Drug Dose Level 4	Drug: PF-00547659 SC Injection; Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug: PF-00547659 SC Injection; Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug: PF-00547659 SC Injection; Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks; Drug: PF-00547659 SC Injection; Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants in Clinical Remission at Week 12	Clinical remission was defined as a Total Mayo Score of less than or equal (<=) 2 points with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1. The Mayo Score is a tool designed to measure disease activity for ulcerative colitis (UC). Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Clinical Response at Week 12	Clinical response was defined as a decrease from baseline of at least 3 points in Total Mayo Score with at least a 30 percent (%) change, accompanied by at least 1 point decrease or absolute score of 0 or 1 in rectal bleeding subscore. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.	Week 12
Percentage of Participants With Mucosal Healing at Week 12	Mucosal healing was defined as absolute Mayo subscore for endoscopy of 0 or 1. The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.	Week 12
Percentage of Participants With Absolute Partial Mayo Score of Less Than or Equal to (<=) 2 With no Individual Subscore More Than (>) 1 at Weeks 4, 8, and 12	An absolute Partial Mayo Score of <=2 corresponds to remission. However, this endpoint was incorrectly stated in the protocol and instead of "absolute Partial Mayo Score <=2", it was stated as "change from baseline in Partial Mayo Score <=2".	Weeks 4, 8, and 12
Change From Baseline in Total Mayo Score at Week 12	The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores, each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses.	Baseline, Week 12
Percentage of Participants With Change From Baseline in Individual Mayo Subscores - Stool Frequency, Rectal Bleeding, and Physician's Global Assessment (PGA) - at Weeks 4, 8, and 12	The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of less than (<) 0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.	Baseline; Weeks (W) 4, 8, and 12
Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12	The Mayo Score is a tool designed to measure disease activity for UC. Scoring ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, PGA, findings on flexible sigmoidoscopy), each graded 0 to 3 with higher score indicating more severe disease activity. Endoscopic readings from the local and the central reader were considered for analysis. The central reading was used as the primary analysis and the local readings were used for the sensitivity analyses. Changes from baseline in the subscore of <0, 0, and >0 corresponded to improvement (imp), no change (NC), and worsening (wors) in that specific subscore.	Baseline, Week 12
Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12	Fecal calprotectin was one of the pharmacodynamic (PD) biomarkers of the study.	Baseline, Weeks 4, 8, and 12
Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12	hsCRP was one of the PD biomarkers of the study.	Baseline; Weeks 4, 8, and 12
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12	IBDQ: Psychometrically validated patient reported outcome (PRO) instrument for measuring disease-specific quality of life (QOL) in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL.	Baseline, Week 12
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12	IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is the sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. There are 4 individual domains under the IBDQ: bowel function (fx)/symptoms (score range of 10-70), systemic symptoms (score range of 5-35), emotional status/fx (score range of 12-84), and social fx (score range of 5-35). As with total score, higher scores indicate better QOL in that domain.	Baseline (BL), Week 12
Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12	IBDQ: Psychometrically validated PRO instrument for measuring disease-specific QOL in participants with inflammatory bowel disease. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). Total score is sum of each item score, ranged from 32 to 224 with higher score indicating better QOL. Positive change in total score indicated improvement in QOL. A score of >=170 corresponds to clinical remission.	Week 12
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs During the Treatment Period (Weeks 0-12)	An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. TEAEs are defined as newly occurring AEs or those worsening after first dose. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.	Screening through to end of treatment period, up to 12 weeks
Maximum Serum PF-00547659 Concentration Achieved		Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal

Collaborators and Investigators

• Sponsor: Shire

Publications and helpful links

General 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. Erratum In: Lancet. 2019 Dec 22;392(10165):2696.

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Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2012
• Primary Completion (Actual): September 22, 2014
• Study Completion (Actual): February 4, 2016

Study Registration Dates

• First Submitted: June 13, 2012
• First Submitted That Met QC Criteria: June 13, 2012
• First Posted (Estimate): June 15, 2012

Study Record Updates

• Last Update Posted (Actual): June 11, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: A7281009; 2012-002030-37 (EudraCT Number); TURANDOT (Other Identifier: Alias Study Number)