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    Summary
    EudraCT Number:2012-002030-37
    Sponsor's Protocol Code Number:A7281009
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-05-27
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2012-002030-37
    A.3Full title of the trial
    A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS (TURANDOT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test whether PF-00547659 is safe and improves symptoms in patients with UC
    A.3.2Name or abbreviated title of the trial where available
    TURANDOT
    A.4.1Sponsor's protocol code numberA7281009
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc, 235 East 42nd Street, New York, NY10017, United States
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailclinicaltrials.gov_inquiries@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code PF-00547659
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePF-00547659
    D.3.9.3Other descriptive nameAnti-MAdCAM antibody
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5, 22.5,75,225
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis (UC)
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis (UC)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To characterize the dose-response and efficacy of PF-00547659 in inducing clinical remission based upon Mayo Score in subjects with moderate to severe ulcerative colitis.
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    • To evaluate the induction of clinical response based upon Mayo Score in subjects with moderate to severe ulcerative colitis.
    • To evaluate the safety and tolerability of PF-00547659 in subjects with moderate to severe ulcerative colitis.
    • To assess the PF-00547659 concentration time course.
    • To evaluate the effect of induction treatment of PF-00547659 on quality-of-life in subjects with moderately to severely active ulcerative colitis.

    Exploratory Objective
    To explore the relationship between PK, PD, and clinical endpoints.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    2. Subjects are willing and able to participate in the study, complete subject assessments, attend scheduled clinic visits, and comply with all protocol requirements as evidenced by written informed consent.
    3. Male and/or female subjects between the ages of ≥18 and ≤65 years at the time of informed consent.
    4. A diagnosis of UC for ≥3 months. A biopsy report must be available to confirm the histological diagnosis in the subject’s source documentation. In addition, a report documenting disease duration and extent of disease (e.g., proctosigmoiditis, left-sided colitis and pancolitis) based upon prior colonoscopy must also be available in source documentation. NOTE: A colonoscopy with biopsy will need to be performed, if this documentation is not available.
    5. Must have a flexible sigmoidoscopy (or colonoscopy, if preferred) indicative of active UC (Mayo endoscopic subscore of at least 2) during screening after all other inclusion criteria have been met.
    6. Must have active disease beyond the rectum (>15 cm of active disease at the Screening endoscopy).
    7. Must have active UC with a Total Mayo Score of 6 to 12 points and moderate to severe disease on endoscopy (Mayo endoscopic subscore of at least 2).
    8. Must have failed or been intolerant of at least one conventional therapy such as mesalamine, steroids and immunosuppressants (AZA, 6-MP or MTX) or anti-TNF. Subjects will be stratified based upon prior experience with anti-TNFs (naïve or experienced). Documentation of the current and prior UC treatment (ie, steroids and immunosuppressants) will be captured for additional analyses and must be provided in the source documentation.
    9. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception (defined at the time of signing the informed consent) throughout the study and through the conclusion of subject participation. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
    • Women of childbearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at baseline. WOCBP are defined as women who are biologically capable of becoming pregnant, including women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
    • Women of non-childbearing potential (WONCBP) do not require a serum and urine pregnancy test and must meet at least one of the following criteria:
    • Have undergone hysterectomy or bilateral oophorectomy;
    • Have medically confirmed ovarian failure or
    • Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; laboratory confirmation of FSH level may be indicated if subject has history of amenorrhea for ≥ 52 weeks).
    E.4Principal exclusion criteria
    1. Subjects with a diagnosis of indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or Crohn’s disease. Subjects with clinical findings suggestive of Crohn’s disease, e.g., fistulae or granulomas on biopsy are also excluded.
    2. Subjects with an imminent need for or planned surgery.
    3. Subjects with colonic dysplasia or neoplasia.
    4. Subjects with toxic megacolon.
    5. Subjects with primary sclerosing cholangitis.
    6. Subjects with known colonic stricture.
    7. Subjects with a history of colonic or small bowel obstruction or resection.
    8. Abnormal findings on the chest x-ray film performed routinely before initiating a new biologic therapy, such as presence of tuberculosis (TB), general infections, heart failure, or malignancy. (Chest x-ray examination may be performed up to 12 weeks prior to study entry (screening). Documentation of the official reading must be located and available in the source documentation).
    9. Any history or current evidence of latent or active tuberculosis infection, evidence of prior or currently active tuberculosis by chest radiography, residing with or frequent close contact with individual(s) with active tuberculosis. Subjects who have a positive Mantoux (PPD) tuberculin skin test or a positive Interferon Gamma Release Assay (IGRA to be tested at the site’s local lab) during screening or within 12 weeks prior to randomization. The following are acceptable assays: QuantiFERON® - TB Gold test (QFT-G), QuantiFERON® - TB Gold In-Tube test (QFT-GIT) and T-SPOT®-TB test) during screening or within 12 weeks prior to screening.
    10. Presence of active enteric infections (positive stool culture and sensitivity). Please refer to the Protocol Amendment 2 for full exclusion criteria 10.
    11. Pre-existing demyelinating disorder such as Multiple Sclerosis or new onset seizures, unexplained sensory motor, or cognitive behavioral, neurological deficits, or significant abnormalities noted during screening.
    12. Known history of HIV based on documented history with positive serological test, or positive HIV serologic test at screening, tested at the site’s local lab. (Note: a documented negative HIV test within one year of screening is acceptable and does not need to be repeated).
    13. Presence of transplanted organ. Skin grafts to treat pyoderma gangrenosum are allowed.
    14. Significant concurrent medical condition at the time of screening or baseline visit, including, but not limited to, the following:
    • Any major illness/condition or evidence of an unstable clinical condition that, in the investigator’s judgement will substantially increase the risk to the subject if he or she participates in the study.
    • Cancer or history of cancer or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence).
    • Right or left heart failure including symptomatic diastolic dysfunction or unexplained elevation of troponin I (>0.05 ng/mL). Subjects with screening or baseline value of NTproBNP >124 pg/mL must have an echocardiogram and cardiology consult that excludes right or left heart failure.
    • Acute coronary syndrome and any history of significant cerebrovascular disease within 24 weeks before screening.
    15. Any major elective surgery scheduled to occur during the study.
    16. Prior evidence of liver injury or toxicity due to methotrexate.
    17. Abnormality in hematology and/or chemistry profiles during screening:
    18. IV or IM (parenteral) steroids are excluded. If receiving corticosteroid treatment orally, subjects must have been on a stable dose for at least 1 week prior to baseline and must be willing to maintain the stable dose regimen through Week 12.
    19. If receiving 6-MP or AZA (≤2.5 mg/kg) or MTX subjects must have been on a stable dose for at least 8 weeks prior to screening.
    20. If receiving 5-aminosalicylic acid (5-ASA) treatment orally, subjects must be on a stable dose for at least 2 weeks prior to Mayo Score screening procedures.
    21. Other biologics including any anti-TNFs within 6 weeks from baseline/randomization.
    22. Known use of prior therapy of natalizumab, vedolizumab, AMG-181 or rhuMAb b7.
    23. Treatment with another investigational procedure, product (s) such as immunosuppressants used in transplantation or live (attenuated) vaccine within 30 days before the baseline visit.
    24. Inability to complete any of the neurological assessments without a clear explanation.
    25. Current or history within 2 years of serious psychiatric disease or alcohol or drug abuse.
    26. Pregnant or breastfeeding women.
    27. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of subjects in Clinical Remission at Week 12 as defined by a Total Mayo Score of 2 points or lower with no individual subscore exceeding 1 point and rectal bleed subscore of 0 or 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    Secondary Endpoints
    • Proportion of subjects with a Clinical Response at Week 12 with a decrease from baseline in Total Mayo Score by at least 3 points and at least 30% decrease in subscore for rectal bleeding of at least 1 point or absolute subscore of 0 or 1.
    • Proportion of subjects with mucosal healing at Week 12 (defined as absolute Mayo subscore for endoscopy of 0 or 1).
    • Proportion of subjects with change from baseline in partial Mayo Score of ≤ 2 with no individual subscore >1 at Weeks 4, 8, 12.
    • Change from baseline in Mayo Score and in individual Mayo subscores at Weeks 4, 8, and 12.
    • Change from baseline in fecal calprotectin at Weeks 4, 8, 12.
    • Change from baseline in hsCRP at Weeks 4, 8, 12.
    • Change over time in the mean IBDQ domain and total scores from baseline to Week 12.
    • Proportion of subjects with an IBDQ total score of ≥170 at Week 12.
    • Safety and tolerability evaluated by the frequency of AEs, SAEs, AEs leading to discontinuation of study treatment.
    • PF-00547659 concentration-time profile.

    Exploratory Endpoints
    • Change from baseline in Simple Clinical Colitis Activity Index (SCCAI) at Weeks 4, 8, 12.
    • Percentage of subjects with a decrease in the SCCAI scores of ≥3 points at Weeks 4 and 12.

    • Percentage of subjects with clinical remission at Weeks 4, 8, and 12 defined as a total SCCAI score of < 2 points.
    • Laboratory tests, electrocardiograms (ECGs) and vital signs will be summarized.

    Health Outcomes
    • Proportion of subjects with a clinically meaningful change in the IBDQ total score (>/= 16 points) at Week 12.
    • Changes over time in the European Quality of Life 5 Dimensions questionnaire (EQ 5D)(TM) and EQ 5D visual analog scale (VAS) scores from baseline to Week 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 4, 8, and 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Croatia
    Czech Republic
    Denmark
    France
    Germany
    Hungary
    Israel
    Italy
    Korea, Republic of
    Netherlands
    New Zealand
    Norway
    Poland
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Sweden
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 300
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    As per protocol
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-02-04
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