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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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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Minnesota
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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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Bulgaria
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Sofia
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British Columbia
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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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Praha 7
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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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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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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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NH
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Groningen
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Maastricht
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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/ct2/show/NCT01620255
Trial related presentations / publications
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