Clinical trial NCT01620255: A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2012-06-15
Enrollment: 357
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Percentage of Participants in Clinical Remission at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants With Clinical Response at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Mucosal Healing at Week 12
timeFrame: Week 12
measure: 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
timeFrame: Weeks 4, 8, and 12
measure: Change From Baseline in Total Mayo Score at Week 12
timeFrame: Baseline, Week 12
measure: 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
timeFrame: Baseline; Weeks (W) 4, 8, and 12
measure: Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12
timeFrame: Baseline, Weeks 4, 8, and 12
measure: Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12
timeFrame: Baseline; Weeks 4, 8, and 12
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12
timeFrame: Baseline (BL), Week 12
measure: Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12
timeFrame: Week 12
measure: 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)
timeFrame: Screening through to end of treatment period, up to 12 weeks
measure: Maximum Serum PF-00547659 Concentration Achieved
timeFrame: Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: La Jolla
country: United States
facility: UCSD Health System-Pharmacy only
state: California
city: La Jolla
country: United States
facility: Clinical and Translational Research Institute
state: California
city: La Jolla
country: United States
facility: Perlman Medical Offices
state: California
city: La Jolla
country: United States
facility: Thornton Hospital
state: California
city: Orange
country: United States
facility: Community Clinical Trials
state: California
city: Orange
country: United States
facility: GastroDiagnostics - Community Clinical Trials Drug
state: California
city: Denver
country: United States
facility: Rocky Mountain Clinical Research, LLC.
state: Colorado
city: Lafayette
country: United States
facility: Clinical Research of the Rockies
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Gastroenterology Associates
state: Colorado
city: Guilford
country: United States
facility: Endoscopy Center of Connecticut, LLC
state: Connecticut
city: Hamden
country: United States
facility: Endoscopy Center of Connecticut, LLC
state: Connecticut
city: Hamden
country: United States
facility: Gastroenterology Center of Connecticut, PC
state: Connecticut
city: Hamden
country: United States
facility: Medical REsearch Center of CT Drug
state: Connecticut
city: Hamden
country: United States
facility: Medical Research Network of Connecticut
state: Connecticut
city: Altamonte Springs
country: United States
facility: Florida Surgery Center
state: Florida
city: Crystal River
country: United States
facility: Gastroenterology Associates
state: Florida
city: Hialeah
country: United States
facility: Research Consultant Group
state: Florida
city: Hialeah
country: United States
facility: Th Palmetto Surgery Center
state: Florida
city: Inverness
country: United States
facility: Citrus Memorial Hospital
state: Florida
city: Inverness
country: United States
facility: Inverness Medical Imaging
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Inverness
country: United States
facility: Suncoast Endoscopy Center
state: Florida
city: Maitland
country: United States
facility: Sand Lake Imaging
state: Florida
city: Miami Beach
country: United States
facility: Center for Diagnostic Imaging
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinic - Local Lab
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Miami
country: United States
facility: Coral View Surgery Center
state: Florida
city: Miramar
country: United States
facility: First Quality Laboratory
state: Florida
city: Miramar
country: United States
facility: FQL Research, LLC
state: Florida
city: North Miami Beach
country: United States
facility: Venutre Ambulatory Sugery Center
state: Florida
city: Orlando
country: United States
facility: Boston Diagnostic Imaging
state: Florida
city: Orlando
country: United States
facility: Citrus Ambulatory Surgery Center
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Alpharetta
country: United States
facility: Georgia Endoscopy Center
state: Georgia
city: Atlanta
country: United States
facility: GI Consultants
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialist
state: Georgia
city: Indianapolis
country: United States
facility: Covance Central Laboratory Services Inc
state: Indiana
city: Indianapolis
country: United States
facility: Covance Central Laboratory Services, Inc
state: Indiana
city: Indianapolis
country: United States
facility: Covance Laboratory Services, Inc
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Towson
country: United States
facility: Endoscopic Microsurgery Associates
state: Maryland
city: Brockton
country: United States
facility: Commonwealth Clinical Studies
state: Massachusetts
city: Brockton
country: United States
facility: Signature Healthcare Brockton
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health Systems
state: Michigan
city: Grand Rapids
country: United States
facility: East Valley Endoscopy
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan
state: Michigan
city: Wyoming
country: United States
facility: Metro Health Endoscopy Unit
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Medical Eye Clinic
state: Minnesota
city: Minneapolis
country: United States
facility: Noran Neurology Clinic
state: Minnesota
city: Plymouth
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Plymouth
country: United States
facility: Consulting Radiology
state: Minnesota
city: Plymouth
country: United States
facility: Minnesota Gastroenterology, P.A.
state: Minnesota
city: Columbia
country: United States
facility: Surgery Center of Columbia
state: Missouri
city: Mexico
country: United States
facility: Center for Digestive and Liver Diseases
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital Investigational Drug Service (IP Shipping Address)
state: Missouri
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital Radiology (X-Ray Only)
state: Missouri
city: Saint Louis
country: United States
facility: Center for Advanced Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Las Vegas
country: United States
facility: University of Nevada School of Medicine (UNSOM)
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Surgery Center
state: Nevada
city: Las Vegas
country: United States
facility: Steinberg Diagnostic Medical Imaging Centers
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital - Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College - New York Presbyterian Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College of Cornell University
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group of the Hudson Valley, PC
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group Research Department - Drug
state: New York
city: Chapel Hill
country: United States
facility: UNC Hospitals Endoscopy Center At Meadowmont
state: North Carolina
city: Chapel Hill
country: United States
facility: Department of Pharmacy Investigational Drug Services
state: North Carolina
city: Chapel Hill
country: United States
facility: UNC Memorial Hospital
state: North Carolina
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Portland
country: United States
facility: The Oregon Clinic, PC - Gastroenterology West
state: Oregon
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Memphis
country: United States
facility: Diagnostic Imaging
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center: GI Clinical Research
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center: IBD Clinic
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center: Drug Shipment
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center: Endoscopy Lab
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center: Outpatient Radiology
state: Tennessee
city: Houston
country: United States
facility: Houston Hospital for Specialized Surgery
state: Texas
city: Houston
country: United States
facility: Baylor Clinic (Drug Storage)
state: Texas
city: Houston
country: United States
facility: Baylor College Of Medicine - Baylor Medical Center
state: Texas
city: Humble
country: United States
facility: Spring Gastroenterology and Associates
state: Texas
city: Humble
country: United States
facility: Spring Gastroenterology Drug
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Sugar Land
country: United States
facility: Pioneer Research Solutions, Inc
state: Texas
city: Richmond
country: United States
facility: McGuire DVAMC
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Milwaukee
country: United States
facility: PI Radiology
state: Wisconsin
city: Wauwatosa
country: United States
facility: Allegiance Research Specialists
state: Wisconsin
city: Wauwatosa
country: United States
facility: Dynacare Laboratories
state: Wisconsin
city: Wauwatosa
country: United States
facility: GI associates drug
state: Wisconsin
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Health Services
state: Queensland
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Garran
country: Australia
facility: The Canberra Hospital
city: Wien
country: Austria
facility: AKH Wien, Universitaetsklinik fuer Innere Medizin III
city: Herentals
country: Belgium
facility: AZ St-Elisabeth Herentals
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Mouscron
country: Belgium
facility: Centre Hospitalier de Mouscron
city: Sofia
country: Bulgaria
facility: 4- MBAL
city: Sofia
country: Bulgaria
facility: MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia
city: Sofia
country: Bulgaria
facility: MBAL SofiaMed OOD
city: Vancouver
country: Canada
facility: GI Research Institute (GIRI)
state: British Columbia
city: Victoria
country: Canada
facility: Office of Dr. David C. Pearson
state: British Columbia
city: Victoria
country: Canada
facility: Office of Drs. Ranjit Andrew Singh and Jamie D. Papp
state: British Columbia
city: Victoria
country: Canada
facility: PerCuro Clinical Research Limited
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Center
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Oshawa
country: Canada
facility: Oshawa Clinic
state: Ontario
city: Montreal
country: Canada
facility: Pavillion Rachel Tourigny, Hopital Maisonneuve-Rosemont
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterology HK s.r.o.
city: Praha 7
country: Czechia
facility: Klinické Centrum ISCARE I.V.F
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni, a.s., Masarykova nemocnice v Usti nad Labem o.z.
city: Amiens Cedex 01
country: France
facility: CHU Amiens - Hôpital Nord
city: Caen
country: France
facility: Centre Hospitalier Universitaire (CHU) de Caen - Hopital Cote de Nacre
city: Lille
country: France
facility: Hopital Huriez CHRU de Lille
city: Nice Cedex 03
country: France
facility: Hôpital l'Archet 2 CHU de Nice
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Saint Priest en Jarez
country: France
facility: Hôpital Nord Service de Gastro-entérologie
city: Vandoeuvre les Nancy
country: France
facility: CHU Nancy - Hopital Brabois
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein, Campus Kiel
city: Regensburg
country: Germany
facility: Universitaetsklinik Regensburg
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus GmbH
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum Kft
city: Szentes
country: Hungary
facility: Csongrad Megyei Dr. Bugyi Istvan Korhaz
city: Jerusalem
country: Israel
facility: Digestive Disease Institute
city: Jerusalem
country: Israel
facility: Gastroenterology and Liver Diseases Unit - Hadassah Ein Kerem University Hospital
city: Kfar-Saba
country: Israel
facility: Dept. of Gastroenterology & Hepatology, Meir Medical Center
city: Petah Tikva
country: Israel
facility: Gastroenterology Division, Rabin Medical Center, Beilinson Campus
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Catanzaro
country: Italy
facility: Universita' degli Studi "Magna Graecia" di Catanzaro, UO di Fisiopatologia Digestiva
city: Milano
country: Italy
facility: IBD Center - Divisione Gastroenterologia - Istituto Clinico Humanitas IRCCS
city: Milano
country: Italy
facility: IRCCS Policlinico San Donato
city: Padova
country: Italy
facility: Azienda Ospedaliera -Università di Padova
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria, Policlinico Tor Vergata
city: Roma
country: Italy
facility: Universita Cattolica Sacro Cuore Policlinico "A. Gemelli"
city: Rome
country: Italy
facility: AOS San Camillo Forlanini
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Amsterdam
country: Netherlands
facility: Academic Medical Center - University of Amsterdam
state: NH
city: Groningen
country: Netherlands
facility: University Medical Center Groningen (UMCG)
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Christchurch
country: New Zealand
facility: Southern Endoscopy Centre
city: Hamilton
country: New Zealand
facility: Midland Neurology & EMG Ltd.
city: Hamilton
country: New Zealand
facility: The Hamilton Eye Clinic
city: Hamilton
country: New Zealand
facility: Cardiac Services Ltd.
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Bydgoszcz
country: Poland
facility: Centrum endoskopii Zabiegowej, Poradnia Chorob Jelitowych,
city: Krakow
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
city: Lodz
country: Poland
facility: Centrum Medyczne - Szpital Swietej Rodziny Sp. z o.o.
city: Poznan
country: Poland
facility: Centrum Medyczne HCP Lecznictwo Ambulatoryjne Pracownia Endoskopowa
city: Warszawa
country: Poland
facility: Klinika Chorob Wewnetrznych i Gastroenterologii z Pododdzialem
city: Warszawa
country: Poland
facility: NZOZ Vivamed
city: Wroclaw
country: Poland
facility: Wojskowy Szpital Kliniczny z Poliklinika SPOZ
city: Wroclaw
country: Poland
facility: Lexmedica
city: Saint-Petersburg
country: Russian Federation
facility: SBEI of HPE North-West State Medical University n.a. I.I. Mechnikov of the MH of the RF St.P SBIH "
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Bezanijska Kosa, Clinic for Internal medicine
city: Belgrade
country: Serbia
facility: Clinical Hospital Centre Zvezdara Clinic for Gastroenterology and Hepatology
city: Belgrade
country: Serbia
facility: Military medical Academy
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zemun, Gastroenterology and Hepatology Department
city: Nis
country: Serbia
facility: Clinical Centre of Nis, Clinic for Gastroenterology and Hepatology
city: Presov
country: Slovakia
facility: Gastro I., s.r.o.
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Gastroenterological Centre Thalion
city: Nitra
country: Slovakia
facility: KM Management spol. s.r.o. Gastroenterologicke a hepatologicke centrum Nitra
city: Ruzomberok
country: Slovakia
facility: Ustredna vojenska nemocnice SNP Ruzomberok
city: Claremont
country: South Africa
facility: Kingsbury Hospital
state: Cape Town
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: Barcelona
country: Spain
facility: Parc de Salut Mar-Hospital del Mar
city: Barcelona
country: Spain
facility: Centro Medico Teknon
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.