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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01620255




Registration number
NCT01620255
Ethics application status
Date submitted
13/06/2012
Date registered
15/06/2012
Date last updated
11/06/2021

Titles & IDs
Public title
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
Scientific 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)
Secondary ID [1] 0 0
2012-002030-37
Secondary ID [2] 0 0
A7281009
Universal Trial Number (UTN)
Trial acronym
TURANDOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Drugs - PF-00547659 SC Injection
Treatment: Drugs - PF-00547659 SC Injection
Treatment: Drugs - PF-00547659 SC Injection
Treatment: Drugs - PF-00547659 SC Injection

Placebo comparator: Placebo -

Experimental: Drug Dose Level 1 -

Experimental: Drug Dose Level 2 -

Experimental: Drug Dose Level 3 -

Experimental: Drug Dose Level 4 -


Treatment: Drugs: Placebo
Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks

Treatment: Drugs: PF-00547659 SC Injection
Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks

Treatment: Drugs: PF-00547659 SC Injection
Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks

Treatment: Drugs: PF-00547659 SC Injection
Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks

Treatment: Drugs: PF-00547659 SC Injection
Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants in Clinical Remission at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Percentage of Participants With Clinical Response at Week 12
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
Percentage of Participants With Mucosal Healing at Week 12
Timepoint [2] 0 0
Week 12
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Weeks 4, 8, and 12
Secondary outcome [4] 0 0
Change From Baseline in Total Mayo Score at Week 12
Timepoint [4] 0 0
Baseline, Week 12
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Baseline; Weeks (W) 4, 8, and 12
Secondary outcome [6] 0 0
Percentage of Participants With Change From Baseline in Individual Mayo Subscore - Findings on Flexible Sigmoidoscopy - at Week 12
Timepoint [6] 0 0
Baseline, Week 12
Secondary outcome [7] 0 0
Percent Change From Baseline in Fecal Calprotectin at Weeks 4, 8, and 12
Timepoint [7] 0 0
Baseline, Weeks 4, 8, and 12
Secondary outcome [8] 0 0
Percent Change From Baseline in High Sensitivity C-reactive Protein (hsCRP) at Weeks 4, 8, and 12
Timepoint [8] 0 0
Baseline; Weeks 4, 8, and 12
Secondary outcome [9] 0 0
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
Timepoint [9] 0 0
Baseline, Week 12
Secondary outcome [10] 0 0
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Scores at Week 12
Timepoint [10] 0 0
Baseline (BL), Week 12
Secondary outcome [11] 0 0
Percentage of Participants With an Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score of More Than or Equal to (>=) 170 at Week 12
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
Screening through to end of treatment period, up to 12 weeks
Secondary outcome [13] 0 0
Maximum Serum PF-00547659 Concentration Achieved
Timepoint [13] 0 0
Weeks 0 (baseline), 2, 4,8, 12, 16, 20, 24, 28, 32, and 36; Early Withdrawal

Eligibility
Key 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
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/02/2016
Sample size
Target
Accrual to date
Final
357
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Mater Health Services - South Brisbane
Recruitment hospital [4] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [5] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [6] 0 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
3004 - Melbourne
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
2605 - Garran
Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Indiana
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nevada
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New Hampshire
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New York
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North Carolina
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Oregon
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Tennessee
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Texas
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Virginia
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Washington
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Wisconsin
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Austria
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Wien
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Belgium
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Herentals
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Belgium
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Leuven
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Belgium
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Mouscron
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Sofia
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Ontario
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Quebec
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Saskatchewan
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Hradec Kralove
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Czechia
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Praha 7
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Czechia
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Usti nad Labem
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Amiens Cedex 01
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Caen
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France
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Lille
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France
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Nice Cedex 03
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France
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Pessac
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France
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Saint Priest en Jarez
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France
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Vandoeuvre les Nancy
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Germany
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Kiel
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Stuttgart
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Szentes
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Jerusalem
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Israel
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Kfar-Saba
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Israel
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Petah Tikva
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Israel
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Tel Hashomer
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Catanzaro
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Milano
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Padova
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Italy
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Roma
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Italy
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Rome
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Italy
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San Giovanni Rotondo
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Netherlands
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NH
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Groningen
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Maastricht
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New Zealand
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Christchurch
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New Zealand
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Hamilton
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Poland
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Bydgoszcz
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Krakow
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Lodz
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Poznan
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Warszawa
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Wroclaw
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Russian Federation
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Saint-Petersburg
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Serbia
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Belgrade
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Serbia
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Nis
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Slovakia
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Slovak Republic
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Slovakia
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Bratislava
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Slovakia
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Nitra
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Slovakia
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Ruzomberok
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South Africa
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Cape Town
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Spain
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Madrid
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Spain
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Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shire
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01620255
Trial related presentations / 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. doi: 10.1016/S0140-6736(18)33014-9.
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01620255