Long-Term Safety Of PF-00547659 In Ulcerative Colitis (TURANDOT II)

May 11, 2021 updated by: Shire

A Multicenter Open-Label Extension Study To Assess Long-Term Safety Of PF-00547659 In Subjects With Ulcerative Colitis (TURANDOT II)

Subjects with Ulcerative Colitis who have completed an induction study with PF-00547659 will receive an additional 144 weeks of open-label treatment to evaluate the long-term safety of the drug.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, 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, 3052
        • 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
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • (G.I.R.I.) GI Research Institute
      • Victoria, British Columbia, Canada, V8V 3P9
        • Percuro Clinical Research, Ltd
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Hamilton Health Sciences Corp, McMaster Univ Medical Centre
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre - University Hospital
      • Oshawa, Ontario, Canada, L1H 7K4
        • Taunton Surgical Centre
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
  • Czechia
      • Hradec Kralove, Czechia, 50012
        • Hepato-Gastroenterologie HK s.r.o. Poliklinika III
      • Prague, Czechia, 170 04
        • IBD Clinical and Research centre
      • Usti nad Labem, Czechia, 401 13
        • Krajská zdravotní, a.s., Masarykova nemocnice v Ústí nad Labem
  • France
      • Amiens, France, 80054
        • CHU Amiens-Picardie - Hopital Sud
      • 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, 06200
        • CHU De Nice Hopital De L'Archet II
      • Saint Priest En Jarez, France, 42270
        • Chu de Saint-Etienne Hopital Nord
      • Vandoeuvre les Nancy, France, 54511
        • CHU de Nancy - Hôpital Brabois
  • Germany
      • Regensburg, Germany, 93053
        • Universitaetsklinikum Regensburg, Klinik und Poliklinik fuer Innere Medizin 1
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein, Campus Kiel
  • Hungary
    • Csongrad
      • Szentes, Csongrad, Hungary, 6600
        • Csongrád Megyei Dr. Bugyi István Kórház
  • Israel
      • Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Ein Kerem University Hospital - Gastroenterology and Liver Diseases Unit
      • Kfar-Saba, Israel, 44281
        • Meir Medical Center
      • Tel Hashomer, Israel, 5262000
        • The Chaim Sheba Medical Center
  • Italy
      • Catanzaro, Italy, 88100
        • Universita' degli Studi "Magna Graecia" di Catanzaro
      • Milano, Italy, 20089
        • Milan University, Humanitas Clinical Institute
      • Roma, Italy, 00168
        • Universita Cattolica del Sacro Cuore
      • Roma, Italy, 00128
        • Policlinico Universitario Campus Bio-Medico
      • Roma, Italy, 00133
        • Azienda Ospedaliera Universitaria, Policlinico Tor Vergata
      • Roma, Italy, 00152
        • Azienda Ospedaliera San Camillo Forlanini
      • San Giovanni Rotondo, Italy, 71013
        • Ospedale Casa Sollievo della Sofferenza
  • Korea, Republic of
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Medical Center
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen (UMCG)
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Center
  • New Zealand
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
    • Canterbury
      • Christchurch, Canterbury, New Zealand, 8140
        • Christchurch Hospital
  • Poland
      • Krakow, Poland, 31-009
        • Gabinet Endoskopii Przewodu Pokarmowego
      • Poznan, Poland, 61-485
        • NZOZ Centrum Medyczne HCP sp. z o.o
      • Warszawa, Poland, 02-507
        • Klinika Chorob Wewnetrznych I Gastroenterologii
      • Warszawa, Poland, 03-580
        • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED
      • Wroclaw, Poland, 53-114
        • LexMedica
    • Kujawsko-Pomorskie
      • Bydgoszcz, Kujawsko-Pomorskie, Poland, 85-168
        • Centrum Endoskopii Zabiegowej
    • Wojlodzkie
      • Lodz, Wojlodzkie, Poland, 90-302
        • Centrum Medyczne-Szpital Swietej Rodziny Sp.z.o.o.
  • Russian Federation
      • Saint-Petersburg, Russian Federation, 191015
        • St. Petersburg State Medical Academy for Postgraduate Education
  • Serbia
      • Belgrade, Serbia, 11000
        • Military Medical Academy
      • Belgrade, Serbia, 11080
        • Clinical Hospital Center Zemun
      • Belgrade, Serbia, 11080
        • Clinical Hospital Centre Bezanijska Kosa
  • Slovakia
      • Nitra, Slovakia, 949 01
        • Ustredna vojenska nemocnica SNP Ruzomberok - Fakultna nemocnica
      • Presov, Slovakia, 080 01
        • Gastro L., s.r.o.
      • Ruzomberok, Slovakia, 034 26
        • Ustredna vojenska nemocnice SNP Ruzomberok - Fakultna nemocnica
  • South Africa
    • Cape Town
      • Claremont, Cape Town, South Africa, 7708
        • Kingsbury Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona
      • Barcelona, Spain, 08022
        • Centro Medico Teknon-Institut de la Macula i de la Retina
      • Barcelona, Spain, 8003
        • Parc de Salut Mar-Hospital del Mar
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona - Scottsdale
    • California
      • La Jolla, California, United States, 92093
        • UCSD Altman Clinical and Translational Research Institute
      • Orange, California, United States, 92868
        • Community Clinical Trials
    • Colorado
      • Thornton, Colorado, United States, 80229
        • Rocky Mountain Gastroenterology
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Center of Connecticut, LLC
    • Florida
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Miramar, Florida, United States, 33025
        • Bassan and Bloom M.D.s
      • Orlando, Florida, United States, 32806
        • Internal Medicine Specialists
      • Winter Park, Florida, United States, 32789
        • Shafran Gastroenterology Center
    • Georgia
      • Suwanee, Georgia, United States, 30024
        • Atlanta Gastroenterology Specialists, PC
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Medical Center
    • Massachusetts
      • Brockton, Massachusetts, United States, 02302
        • Commonwealth Clinical Studies
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Gastroenterology, PA
    • Missouri
      • Mexico, Missouri, United States, 65265
        • Center for Digestive and Liver Diseases
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University of Nevada School of Medicine
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • New York, New York, United States, 10021
        • Weill Cornell Medical College of Cornell University
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley, PC
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Memorial Hospital
    • Oregon
      • Portland, Oregon, United States, 97225
        • The Oregon Clinic-West Hills Gastroenterology Associates, P.C.
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine - Baylor Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire DVAMC
    • Washington
      • Seattle, Washington, United States, 98195
        • Univeristy of Washington
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Allegiance Research Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects between 18 and 66 years of age.
  • Subjects previously enrolled in study A7281009 (NCT01620255) who have completed the 84 day (12 week) induction period.

Exclusion Criteria:

  • Subjects that have completed Day 84 (Week 12) of study A7281009 but have experienced serious event(s) related to the investigational product, an unstable medical condition, or any other reason, in the opinion of the investigator, would preclude entry or participation in this study.
  • Subjects who are taking any dose of Azathioprine (AZA), 6-mercaptopurine(6 MP) or Methotrexate (MTX).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SHP647 75 mg
Participants will receive 75 milligrams (mg) of SHP647 subcutaneous (SC) injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks is allowed after 8 weeks of the study for participants who experience clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate will be guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants will receive 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Drug: 75mg SHP647 (PF-00547659)
75 mg sterile liquid injected subcutaneously every 4 weeks.
Experimental: SHP647 225 mg
Participants will receive 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen.
Drug: 225mg SHP647 (PF-00547659)
225 mg sterile liquid injected subcutaneously every 4 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From start of study drug administration up to 168 weeks
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant who was administered a product or medical device; the event did not need to necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) was any untoward medical occurrence at any dose that resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in congenital anomaly/birth defect. Number of participants with TEAEs, STEAEs, and those withdrew from treatment due to TEAEs were reported.
From start of study drug administration up to 168 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Mucosal Healing at Week 16
Time Frame: Week 16
Mucosal healing was defined as an absolute Mayo subscore for endoscopy of 0 or 1 (based on centrally read score) as assessed by flexible sigmoidoscopy or colonoscopy. The Mayo score is a tool designed to measure disease activity for ulcerative colitis (UC). The Mayo scoring system ranges from 0 to 12 points and consists of 4 subscores (stool frequency, rectal bleeding, findings on flexible sigmoidoscopy, and physician's global assessment [PGA]) each graded 0 to 3 with the higher score indicating more severe disease activity. The percentage of participants with mucosal healing at week 16 was reported.
Week 16
Serum Trough Concentrations of SHP647 Versus Time
Time Frame: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156
Serum trough concentrations of SHP647 versus time was reported.
Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156
Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)
Time Frame: Baseline, Week 8, 16, 24, 40, 48, 64 and 156
The anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64. The number of participants with positive ADA was reported.
Baseline, Week 8, 16, 24, 40, 48, 64 and 156
Number of Participants With Positive Neutralizing Antibodies (NAb)
Time Frame: Baseline, Week 8, 16, 24, 40, 48, 64 and 156
The positive Neutralizing Antibodies (NAb) was defined as NAb titer greater than or equal to (>=) 0.903. The number of participants with NAb was reported. Here "inconclusive" refers to participants who were neither reported as positive nor negative for NAb and anti-drug antibodies (ADA) positive was defined as ADA log base 2 titer greater than or equal to (>=) 4.64.
Baseline, Week 8, 16, 24, 40, 48, 64 and 156

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shire

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Shire Director, Takeda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 13, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A7281010
  • 2012-002031-28 (EudraCT Number)
  • TURANDOT II (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD Sharing Access Criteria

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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