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Ulcerative ColitisPhase 2TURANDOT IINCT01771809

Long-Term Safety Of PF-00547659 In Ulcerative Colitis

A Phase 2 study testing 75mg SHP647 (PF-00547659) and 225mg SHP647 (PF-00547659) in people with Ulcerative Colitis, run by Shire at 99 sites in 21 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 66 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
75mg SHP647 (PF-00547659) and 225mg SHP647 (PF-00547659)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
99 sitesin 21 countries
Study dates
18 Mar 2013to 13 Dec 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 66 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

99 sites in 21 countries.

99 sites in 21 countries

United States29 sites

  • Albany Medical College

    Albany, New York, 12208

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Commonwealth Clinical Studies

    Brockton, Massachusetts, 02302

  • UNC Memorial Hospital

    Chapel Hill, North Carolina, 27599

  • Gastro One

    Germantown, Tennessee, 38138

  • Medical Research Center of Connecticut, LLC

    Hamden, Connecticut, 06518

  • Baylor College Of Medicine - Baylor Medical Center

    Houston, Texas, 77030

  • Nature Coast Clinical Research

    Inverness, Florida, 34452

  • UCSD Altman Clinical and Translational Research Institute

    La Jolla, California, 92093

  • University of Nevada School of Medicine

    Las Vegas, Nevada, 89102

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536

  • Center for Digestive and Liver Diseases

    Mexico, Missouri, 65265

  • Bassan and Bloom M.D.s

    Miramar, Florida, 33025

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212

  • Weill Cornell Medical College of Cornell University

    New York, New York, 10021

  • Community Clinical Trials

    Orange, California, 92868

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Minnesota Gastroenterology, PA

    Plymouth, Minnesota, 55446

  • The Oregon Clinic-West Hills Gastroenterology Associates, P.C.

    Portland, Oregon, 97225

  • Premier Medical Group of the Hudson Valley, PC

    Poughkeepsie, New York, 12601

  • McGuire DVAMC

    Richmond, Virginia, 23249

  • Mayo Clinic Arizona - Scottsdale

    Scottsdale, Arizona, 85259

  • Univeristy of Washington

    Seattle, Washington, 98195

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Atlanta Gastroenterology Specialists, PC

    Suwanee, Georgia, 30024

  • Rocky Mountain Gastroenterology

    Thornton, Colorado, 80229

  • Allegiance Research Specialists

    Wauwatosa, Wisconsin, 53226

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

Other trials in United States

Canada7 sites

  • Hamilton Health Sciences Corp, McMaster Univ Medical Centre

    Hamilton, Ontario, L8S 4K1

  • London Health Sciences Centre - University Hospital

    London, Ontario, N6A 5A5

  • Universite de Montreal - Hopital Maisonneuve-Rosemont (HMR)

    Montreal, Quebec, H1T 2M4

  • Taunton Surgical Centre

    Oshawa, Ontario, L1H 7K4

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • (G.I.R.I.) GI Research Institute

    Vancouver, British Columbia, V6Z 2K5

  • Percuro Clinical Research, Ltd

    Victoria, British Columbia, V8V 3P9

Other trials in Canada

Italy7 sites

  • Universita' degli Studi "Magna Graecia" di Catanzaro

    Catanzaro, 88100

  • Milan University, Humanitas Clinical Institute

    Milan, 20089

  • Policlinico Universitario Campus Bio-Medico

    Roma, 00128

  • Azienda Ospedaliera Universitaria, Policlinico Tor Vergata

    Roma, 00133

  • Azienda Ospedaliera San Camillo Forlanini

    Roma, 00152

  • Universita Cattolica del Sacro Cuore

    Roma, 00168

  • Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, 71013

Other trials in Italy

Poland7 sites

  • Centrum Endoskopii Zabiegowej

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Gabinet Endoskopii Przewodu Pokarmowego

    Krakow, 31-009

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

    Lodz, Wojlodzkie, 90-302

  • NZOZ Centrum Medyczne HCP sp. z o.o

    Poznan, 61-485

  • Klinika Chorob Wewnetrznych I Gastroenterologii

    Warsaw, 02-507

  • Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED

    Warsaw, 03-580

  • Lexmedica

    Wroclaw, 53-114

Other trials in Poland

Australia6 sites

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • The Royal Melbourne Hospital

    Parkville, Victoria, 3052

  • Mater Health Services

    South Brisbane, Queensland, 4101

Other trials in Australia

France6 sites

  • CHU Amiens-Picardie - Hopital Sud

    Amiens, 80054

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

    Caen, 14033

  • Hopital Huriez CHRU de Lille

    Lille, 59037 Cedex

  • CHU De Nice Hopital De L'Archet II

    Nice, 06200

  • CHU de Saint-Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42270

  • CHU de Nancy - Hopital Brabois

    Vandœuvre-lès-Nancy, 54511

Other trials in France

South Korea5 sites

  • Yeungnam University Medical Center

    Daegu, 42415

  • Seoul National University Hospital

    Seoul, 03080

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 135-710

Other trials in South Korea

Israel4 sites

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Hadassah Ein Kerem University Hospital - Gastroenterology and Liver Diseases Unit

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 44281

  • The Chaim Sheba Medical Center

    Tel HaShomer, 5262000

Other trials in Israel

Spain4 sites

  • Centro Medico Teknon-Institut de la Macula i de la Retina

    Barcelona, 08022

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Parc de Salut Mar-Hospital del Mar

    Barcelona, 8003

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

Other trials in Spain

Belgium3 sites

  • AZ St. Elisabeth Herentals

    Herentals, 2200

  • University Hospital Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier de Mouscron

    Mouscron, 7700

Other trials in Belgium

Czechia3 sites

  • Hepato-Gastroenterologie HK s.r.o. Poliklinika III

    Hradec Králové, 50012

  • IBD Clinical and Research Centre

    Prague, 170 04

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

    Ústí nad Labem, 401 13

Other trials in Czechia

Netherlands3 sites

  • Academic Medical Center

    Amsterdam, 1105 AZ

  • University Medical Center Groningen (UMCG)

    Groningen, 9713 GZ

  • Maastricht University Medical Center

    Maastricht, 6229 HX

Other trials in Netherlands

Serbia3 sites

  • Military Medical Academy

    Belgrade, 11000

  • Clinical Hospital Center Zemun

    Belgrade, 11080

  • Clinical Hospital Centre Bezanijska Kosa

    Belgrade, 11080

Other trials in Serbia

Slovakia3 sites

  • Ustredna vojenska nemocnica SNP Ruzomberok - Fakultna nemocnica

    Nitra, 949 01

  • Gastro L., s.r.o.

    Prešov, 080 01

  • Ustredna vojenska nemocnice SNP Ruzomberok - Fakultna nemocnica

    Ružomberok, 034 26

Other trials in Slovakia

Germany2 sites

  • Universitaetsklinikum Schleswig-Holstein, Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • Universitaetsklinikum Regensburg, Klinik und Poliklinik fuer Innere Medizin 1

    Regensburg, 93053

Other trials in Germany

New Zealand2 sites

  • Christchurch Hospital

    Christchurch, Canterbury, 8140

  • Waikato Hospital

    Hamilton, 3240

Other trials in New Zealand

Austria1 site

  • AKH Wien, Universitaetsklinik fuer Innere Medizin III

    Vienna, 1090

Other trials in Austria

Bulgaria1 site

  • MBAL Sveti Ivan Rilski, Klinika po Gastroenterologia

    Sofia, 1431

Other trials in Bulgaria

Hungary1 site

  • Csongrad Megyei Dr. Bugyi Istvan Korhaz

    Szentes, Csongrád megye, 6600

Other trials in Hungary

Russia1 site

  • St. Petersburg State Medical Academy for Postgraduate Education

    Saint Petersburg, 191015

Other trials in Russia

South Africa1 site

  • Kingsbury Hospital

    Claremont, Cape Town, 7708

Other trials in South Africa

About this study

Official title: 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.

Being tested
75mg SHP647 (PF-00547659), 225mg SHP647 (PF-00547659)
Keywords
Anti-TNF Refractory, Active Ulcerative Colitis, Immunosuppressant Refractory
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 75mg SHP647 (PF-00547659)Drug

    75 mg sterile liquid injected subcutaneously every 4 weeks.

  • 225mg SHP647 (PF-00547659)Drug

    225 mg sterile liquid injected subcutaneously every 4 weeks.

Study groups in NCT01771809
Study groupRoleWhat they receive
SHP647 75 mgExperimentalParticipants 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.
Receives: Drug: 75mg SHP647 (PF-00547659)
SHP647 225 mgExperimentalParticipants 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.
Receives: Drug: 225mg SHP647 (PF-00547659)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    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.

    Measured: From start of study drug administration up to 168 weeks

Secondary outcomes (4)

  1. Percentage of Participants With Mucosal Healing at 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.

    Measured: Week 16

  2. Serum Trough Concentrations of SHP647 Versus Time

    Serum trough concentrations of SHP647 versus time was reported.

    Measured: Baseline, Week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72 and 156

  3. Number of Participants With Positive Anti-drug (SHP647) Antibodies (ADA)

    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.

    Measured: Baseline, Week 8, 16, 24, 40, 48, 64 and 156

  4. Number of Participants With Positive Neutralizing Antibodies (NAb)

    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.

    Measured: Baseline, Week 8, 16, 24, 40, 48, 64 and 156

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2013 (estimated)
  2. Study start18 Mar 2013
  3. Primary completion13 Dec 2017
  4. Study completion13 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01771809
Sponsor's protocol ID
A7281010
Other IDs
2012-002031-28, TURANDOT II
Acronym
TURANDOT II
Status last verified
May 2021
First submitted
8 Jan 2013
Last updated
3 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 75mg SHP647 (PF-00547659) and 225mg SHP647 (PF-00547659) in people with Ulcerative Colitis, run by Shire at 99 sites in 21 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, Canada, Italy, Poland, Australia and 16 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01771809.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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