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

NCT01620255 | Completed Phase 2 Results DMC

• 3 other identifiers: A72810092012-002030-37TURANDOT
• Study Type: interventional
• Target: 357
• Locations: 20 countries
• Sites: 189

Brief 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.

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Percentage of Participants With Clinical Response at Week 12

  Week 12

• Percentage of Participants With Mucosal Healing at Week 12

  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

  Weeks 4, 8, and 12

• Change From Baseline in Total Mayo Score at Week 12

  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

  Baseline; Weeks (W) 4, 8, and 12

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Drug Dose Level 1

EXPERIMENTAL

Drug: PF-00547659 SC Injection

Drug Dose Level 2

EXPERIMENTAL

Drug: PF-00547659 SC Injection

Drug Dose Level 3

EXPERIMENTAL

Drug: PF-00547659 SC Injection

Drug Dose Level 4

EXPERIMENTAL

Drug: PF-00547659 SC Injection

Interventions

Placebo DRUG

Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks

Placebo

PF-00547659 SC Injection DRUG

Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks

Drug Dose Level 1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breast feeding.
• Diagnosis of indeterminate colitis or Crohn's Disease
• Subjects with history of colonic or small bowel obstruction or resection.

Sponsors & Collaborators

• Shire: lead

Study Sites (190)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

UCSD Health System-Pharmacy only

La Jolla, California, 92037, United States

Location

Clinical and Translational Research Institute

La Jolla, California, 92093, United States

Location

Perlman Medical Offices

La Jolla, California, 92093, United States

Location

Thornton Hospital

La Jolla, California, 92093, United States

Location

Community Clinical Trials

Orange, California, 92868, United States

Location

GastroDiagnostics - Community Clinical Trials Drug

Orange, California, 92868, United States

Location

Rocky Mountain Clinical Research, LLC.

Denver, Colorado, 80222, United States

Location

Clinical Research of the Rockies

Lafayette, Colorado, 80026, United States

Location

Rocky Mountain Gastroenterology Associates

Thornton, Colorado, 80229, United States

Location

Endoscopy Center of Connecticut, LLC

Guilford, Connecticut, 06437, United States

Location

Endoscopy Center of Connecticut, LLC

Hamden, Connecticut, 06518, United States

Location

Gastroenterology Center of Connecticut, PC

Hamden, Connecticut, 06518, United States

Location

Medical REsearch Center of CT Drug

Hamden, Connecticut, 06518, United States

Location

Medical Research Network of Connecticut

Hamden, Connecticut, 06518, United States

Location

Florida Surgery Center

Altamonte Springs, Florida, 32701, United States

Location

Gastroenterology Associates

Crystal River, Florida, 34429, United States

Location

Research Consultant Group

Hialeah, Florida, 33013, United States

Location

Th Palmetto Surgery Center

Hialeah, Florida, 33016, United States

Location

Citrus Memorial Hospital

Inverness, Florida, 34452, United States

Location

Inverness Medical Imaging

Inverness, Florida, 34452, United States

Location

Nature Coast Clinical Research

Inverness, Florida, 34452, United States

Location

Suncoast Endoscopy Center

Inverness, Florida, 34453, United States

Location

Sand Lake Imaging

Maitland, Florida, 32751, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

University of Miami Hospital and Clinic - Local Lab

Miami, Florida, 33136, United States

Location

University of Miami Hospital and Clinic

Miami, Florida, 33136, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Coral View Surgery Center

Miami, Florida, 33144, United States

Location

Center for Diagnostic Imaging

Miami Beach, Florida, 33179, United States

Location

First Quality Laboratory

Miramar, Florida, 33025, United States

Location

FQL Research, LLC

Miramar, Florida, 33025, United States

Location

Venutre Ambulatory Sugery Center

North Miami Beach, Florida, 33162, United States

Location

Boston Diagnostic Imaging

Orlando, Florida, 32806, United States

Location

Citrus Ambulatory Surgery Center

Orlando, Florida, 32806, United States

Location

Internal Medicine Specialists

Orlando, Florida, 32806, United States

Location

Shafran Gastroenterology Center

Winter Park, Florida, 32789, United States

Location

Georgia Endoscopy Center

Alpharetta, Georgia, 30005, United States

Location

GI Consultants

Atlanta, Georgia, 30342, United States

Location

Atlanta Gastroenterology Specialist

Suwanee, Georgia, 30024, United States

Location

Covance Central Laboratory Services Inc

Indianapolis, Indiana, 46214, United States

Location

Covance Central Laboratory Services, Inc

Indianapolis, Indiana, 46214, United States

Location

Covance Laboratory Services, Inc

Indianapolis, Indiana, 46214, United States

Location

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Endoscopic Microsurgery Associates

Towson, Maryland, 21204, United States

Location

Commonwealth Clinical Studies

Brockton, Massachusetts, 02302, United States

Location

Signature Healthcare Brockton

Brockton, Massachusetts, 02302, United States

Location

University of Michigan Health Systems

Ann Arbor, Michigan, 48109-5000, United States

Location

East Valley Endoscopy

Grand Rapids, Michigan, 49546, United States

Location

Gastroenterology Associates of Western Michigan

Wyoming, Michigan, 49519, United States

Location

Metro Health Endoscopy Unit

Wyoming, Michigan, 49519, United States

Location

Minneapolis Medical Eye Clinic

Minneapolis, Minnesota, 55404, United States

Location

Noran Neurology Clinic

Minneapolis, Minnesota, 55407, United States

Location

Minneapolis Heart Institute

Plymouth, Minnesota, 55441, United States

Location

Consulting Radiology

Plymouth, Minnesota, 55446, United States

Location

Minnesota Gastroenterology, P.A.

Plymouth, Minnesota, 55446, United States

Location

Surgery Center of Columbia

Columbia, Missouri, 65265, United States

Location

Center for Digestive and Liver Diseases

Mexico, Missouri, 65265, United States

Location

Barnes-Jewish Hospital Investigational Drug Service (IP Shipping Address)

St Louis, Missouri, 63108, United States

Location

Barnes-Jewish Hospital Radiology (X-Ray Only)

St Louis, Missouri, 63110, United States

Location

Center for Advanced Medicine

St Louis, Missouri, 63110, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nevada School of Medicine (UNSOM)

Las Vegas, Nevada, 89102, United States

Location

Las Vegas Surgery Center

Las Vegas, Nevada, 89106, United States

Location

Steinberg Diagnostic Medical Imaging Centers

Las Vegas, Nevada, 89109, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 3756, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

New York Presbyterian Hospital - Weill Cornell Medical College

New York, New York, 10021, United States

Location

New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Weill Cornell Medical College - New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Weill Cornell Medical College of Cornell University

New York, New York, 10065, United States

Location

Premier Medical Group of the Hudson Valley, PC

Poughkeepsie, New York, 12601, United States

Location

Premier Medical Group Research Department - Drug

Poughkeepsie, New York, 12601, United States

Location

UNC Hospitals Endoscopy Center At Meadowmont

Chapel Hill, North Carolina, 27517, United States

Location

Department of Pharmacy Investigational Drug Services

Chapel Hill, North Carolina, 27599, United States

Location

UNC Memorial Hospital

Chapel Hill, North Carolina, 27599, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

The Oregon Clinic, PC - Gastroenterology West

Portland, Oregon, 97225, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Diagnostic Imaging

Memphis, Tennessee, 38119, United States

Location

Vanderbilt University Medical Center: GI Clinical Research

Nashville, Tennessee, 37212-1610, United States

Location

Vanderbilt University Medical Center: IBD Clinic

Nashville, Tennessee, 37212, United States

Location

Vanderbilt University Medical Center: Drug Shipment

Nashville, Tennessee, 37232-7610, United States

Location

Vanderbilt University Medical Center: Endoscopy Lab

Nashville, Tennessee, 37232, United States

Location

Vanderbilt University Medical Center: Outpatient Radiology

Nashville, Tennessee, 37232, United States

Location

Houston Hospital for Specialized Surgery

Houston, Texas, 77004, United States

Location

Baylor Clinic (Drug Storage)

Houston, Texas, 77030, United States

Location

Baylor College Of Medicine - Baylor Medical Center

Houston, Texas, 77030, United States

Location

Spring Gastroenterology and Associates

Humble, Texas, 77338, United States

Location

Spring Gastroenterology Drug

Humble, Texas, 77338, United States

Location

Texas Digestive Disease Consultants

Southlake, Texas, 76092, United States

Location

Pioneer Research Solutions, Inc

Sugar Land, Texas, 77479, United States

Location

McGuire DVAMC

Richmond, Virginia, 23249, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

PI Radiology

Milwaukee, Wisconsin, 53222, United States

Location

Allegiance Research Specialists

Wauwatosa, Wisconsin, 53226, United States

Location

Dynacare Laboratories

Wauwatosa, Wisconsin, 53226, United States

Location

GI associates drug

Wauwatosa, Wisconsin, 53226, United States

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Mater Health Services

South Brisbane, Queensland, 4101, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

The Canberra Hospital

Garran, 2605, Australia

Location

AKH Wien, Universitaetsklinik fuer Innere Medizin III

Vienna, 1090, Austria

Location

AZ St-Elisabeth Herentals

Herentals, 2200, Belgium

Location

University Hospital Gasthuisberg

Leuven, 3000, Belgium

Location

Centre Hospitalier de Mouscron

Mouscron, 7700, Belgium

Location

4- MBAL

Sofia, 1000, Bulgaria

Location

MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia

Sofia, 1431, Bulgaria

Location

MBAL SofiaMed OOD

Sofia, 1797, Bulgaria

Location

GI Research Institute (GIRI)

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Office of Dr. David C. Pearson

Victoria, British Columbia, V8R 6R3, Canada

Location

Office of Drs. Ranjit Andrew Singh and Jamie D. Papp

Victoria, British Columbia, V8V 3P9, Canada

Location

PerCuro Clinical Research Limited

Victoria, British Columbia, V8V 3P9, Canada

Location

Hamilton Health Sciences Corporation, McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

McMaster University Medical Center

Hamilton, Ontario, L8N 3Z5, Canada

Location

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location

Oshawa Clinic

Oshawa, Ontario, L1H 1B9, Canada

Location

Pavillion Rachel Tourigny, Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Hepato-Gastroenterology HK s.r.o.

Hradec Králové, 50012, Czechia

Location

Klinické Centrum ISCARE I.V.F

Prague, 170 04, Czechia

Location

Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem o.z.

Ústí nad Labem, 401 13, Czechia

Location

CHU Amiens - Hôpital Nord

Amiens, 80054, France

Location

Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre

Caen, 14033, France

Location

Hopital Huriez CHRU de Lille

Lille, 59037 Cedex, France

Location

Hôpital l'Archet 2 CHU de Nice

Nice, CS23079 06202, France

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

Hôpital Nord Service de Gastro-entérologie

Saint-Priest-en-Jarez, 42270, France

Location

CHU Nancy - Hopital Brabois

Vandœuvre-lès-Nancy, 54511, France

Location

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

Kiel, 24105, Germany

Location

Universitaetsklinik Regensburg

Regensburg, 93053, Germany

Location

Robert-Bosch-Krankenhaus GmbH

Stuttgart, 70376, Germany

Location

Pannonia Maganorvosi Centrum Kft

Budapest, 1136, Hungary

Location

Csongrad Megyei Dr. Bugyi Istvan Korhaz

Szentes, 6600, Hungary

Location

Digestive Disease Institute

Jerusalem, 91031, Israel

Location

Gastroenterology and Liver Diseases Unit - Hadassah Ein Kerem University Hospital

Jerusalem, 91120, Israel

Location

Dept. of Gastroenterology & Hepatology, Meir Medical Center

Kfar Saba, 44281, Israel

Location

Gastroenterology Division, Rabin Medical Center, Beilinson Campus

Petah Tikva, 49100, Israel

Location

The Chaim Sheba Medical Center

Tel Litwinsky, 5262000, Israel

Location

Universita' degli Studi "Magna Graecia" di Catanzaro, UO di Fisiopatologia Digestiva

Catanzaro, 88100, Italy

Location

IBD Center - Divisione Gastroenterologia - Istituto Clinico Humanitas IRCCS

Milan, 20089, Italy

Location

IRCCS Policlinico San Donato

Milan, 20097, Italy

Location

Azienda Ospedaliera -Università di Padova

Padua, 35128, Italy

Location

Policlinico Universitario Campus Bio-Medico

Roma, 00128, Italy

Location

Azienda Ospedaliera Universitaria, Policlinico Tor Vergata

Roma, 00133, Italy

Location

Universita Cattolica Sacro Cuore Policlinico "A. Gemelli"

Roma, 00168, Italy

Location

AOS San Camillo Forlanini

Rome, 00152, Italy

Location

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, 71013, Italy

Location

Academic Medical Center - University of Amsterdam

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

University Medical Center Groningen (UMCG)

Groningen, 9713 GZ, Netherlands

Location

Maastricht University Medical Center

Maastricht, 6229 HX, Netherlands

Location

Christchurch Hospital

Christchurch, 8011, New Zealand

Location

Southern Endoscopy Centre

Christchurch, 8014, New Zealand

Location

Midland Neurology & EMG Ltd.

Hamilton, 3204, New Zealand

Location

The Hamilton Eye Clinic

Hamilton, 3204, New Zealand

Location

Cardiac Services Ltd.

Hamilton, 3216, New Zealand

Location

Waikato Hospital

Hamilton, 3240, New Zealand

Location

Centrum endoskopii Zabiegowej, Poradnia Chorob Jelitowych,

Bydgoszcz, 85-168, Poland

Location

Gabinet Endoskopii Przewodu Pokarmowego

Krakow, 31-009, Poland

Location

Centrum Medyczne - Szpital Swietej Rodziny Sp. z o.o.

Lodz, 90-302, Poland

Location

Centrum Medyczne HCP Lecznictwo Ambulatoryjne Pracownia Endoskopowa

Poznan, 61-485, Poland

Location

Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem

Warsaw, 02-507, Poland

Location

NZOZ Vivamed

Warsaw, 03-580, Poland

Location

Wojskowy Szpital Kliniczny z Poliklinika SPOZ

Wroclaw, 50-981, Poland

Location

Lexmedica

Wroclaw, 53-114, Poland

Location

SBEI of HPE North-West State Medical University n.a. I.I. Mechnikov of the MH of the RF St.P SBIH "

Saint Petersburg, 196247, Russia

Location

Clinical Hospital Centre Bezanijska Kosa, Clinic for Internal medicine

Belgrade, 11000, Serbia

Location

Clinical Hospital Centre Zvezdara Clinic for Gastroenterology and Hepatology

Belgrade, 11000, Serbia

Location

Military medical Academy

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Zemun, Gastroenterology and Hepatology Department

Belgrade, 11080, Serbia

Location

Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology

Niš, 18000, Serbia

Location

Gastro I., s.r.o.

Prešov, Slovak Republic, 08001, Slovakia

Location

Gastroenterological Centre Thalion

Bratislava, 83104, Slovakia

Location

KM Management spol. s.r.o. Gastroenterologicke a hepatologicke centrum Nitra

Nitra, 949 01, Slovakia

Location

Ustredna vojenska nemocnice SNP Ruzomberok

Ružomberok, 034 26, Slovakia

Location

Kingsbury Hospital

Claremont, CAPE TOWN, 7708, South Africa

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Yeungnam University Hospital

Daegu, 705717, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Yonsei University College of Medicine, Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Parc de Salut Mar-Hospital del Mar

Barcelona, 08003, Spain

Location

Centro Medico Teknon

Barcelona, 08022, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Related Publications (2)

• 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.

  PMID: 30901380 DERIVED

• 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.

  PMID: 28527704 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2012
• First Posted: June 15, 2012
• Study Start: November 2, 2012
• Primary Completion: September 22, 2014
• Study Completion: February 4, 2016
• Last Updated: June 11, 2021
• Results First Posted: March 27, 2017

Record last verified: 2021-06

Locations

ZA (1); BE (3); NZ (6); US (99); AU (6); HU (2); NL (3); FR (7); RU (1); ES (4); IL (5); DE (3); KR (7); CA (10); PL (8); CZ (3); IT (9); BU (3); SE (5); SL (4)