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    Summary
    EudraCT Number:2010-023437-30
    Sponsor's Protocol Code Number:A7281006
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-08
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-023437-30
    A.3Full title of the trial
    A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-00547659 IN SUBJECTS WITH CROHN’S DISEASE (OPERA)
    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 disease symptoms in patients with Crohn's disease that have not responded to other treatments
    A.3.2Name or abbreviated title of the trial where available
    OPERA
    A.4.1Sponsor's protocol code numberA7281006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01276509
    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, NY 10017
    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 Centre
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    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.3.1Product nameNot Applicable
    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.3.8INN - Proposed INNNot Applicable
    D.3.9.2Current sponsor codePF-00547659
    D.3.9.3Other descriptive nameNot applicable
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Yes
    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
    Crohn's Disease
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    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 PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the number of subjects that experience a decrease in CDAI (Crohn’s
    Disease Activity Index) of at least 70 points by the Week 8 or Week 12 assessment.
    E.2.2Secondary objectives of the trial
    • To evaluate safety and tolerability
    • To determine the number of subjects in whom the CDAI is reduced to less than
    150 points (ie achieve clinical remission) by Weeks 8 or 12.
    • To determine the number of subjects that experience remission or response at
    Weeks 2 through 12.
    • To evaluate the number of subjects developing anti-drug antibodies to PF-00547659.
    • To measure the concentration of PF-00547659 and to determine the concentration time curve.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An optional colonic substudy that will characterize the effect of PF-
    00547659 on mucosal healing and tissue biology.
    Exploratory Objectives:
    • To determine the effect of PF-00547659 on disease biology in lesional
    and non-lesional tissue obtained by colonoscopy.
    • To determine the effect of PF-00547659 on mucosal healing
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator’s study team before subjects are included in the study.
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study.
    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 comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    3. Male and/or female subjects between the ages of ≥18 and ≤75 years. The subject must meet the age criteria at the time of the baseline visit.
    4. Active moderate to severe ileal (terminal ileum), ileocolonic, or colonic CD (CDAI scores 220 450).
    5. Subjects must have a history of treatment failure or intolerance to either immunosuppressant therapy with azathioprine, 6-mercaptopurine or methotrexate AND/OR anti-TNF monoclonal antibodies:
    For Immunosuppressants:
    • Treatment failure means continued disease activity despite treatment with a therapeutic dose of azathioprine, 6-mercaptopurine and/or methotrexate.
    • Intolerance means that the subject has a history of having experienced an unacceptable or dose limiting toxicity associated with the use of the agent. Examples of intolerance include:
    o For azathioprine: severe leucopenia, thrombocytopenia, anemia, severe bone marrow suppression; serious infection; gastrointestinal hypersensitivity; hypersensitivity pancreatitis; or hepatotoxicity manifested by elevation of serum alkaline phosphatase, bilirubin, and/or serum transaminases.
    o For 6-mercaptopurine: bone marrow suppression including anemia, leucopenia, thrombocytopenia or hepatotoxicity.
    o For methotrexate: immunosuppression, bone marrow, liver (including fibrosis or cirrhosis), lung (including interstitial fibrosis), skin and kidney toxicities.
    For anti-TNF Monoclonal Antibodies
    • Treatment failure is characterized as either primary non-responsive or relapse.
    o Primary Non-Response: Subject experienced no clinical response to at least 1 treatment regimen with an anti TNF with an adequate dose and regimen.
    o Relapse: Subject experienced relapse after an initial clinical response or remission to at least 1 anti TNF with an adequate dose and regimen.

    • Intolerance is defined as: Clinically significant side effect(s) (including hypersensitivity and development of anti-drug antibodies) to at least 1 treatment regimen with an anti TNF.
    6. hsCRP >3.0 mg/L.
    7. Ulcerations on colonoscopy performed during screening as defined by the Simple Endoscopic Score – Crohn’s Disease (SES CD). Colonoscopy performed within 8 weeks of screening documenting ulceration and able to retrospectively complete the SES-CD is acceptable.
    Note: Colonoscopy to be completed after signing ICD and verification of eligible lab values if required.
    8. All women of childbearing potential (WOCBP) must have a negative
    serum pregnancy test result at screening and a negative urine pregnancy
    test result at baseline.
    Note: A negative urine pregnancy test will also be required for WOCBP
    prior to each dose.
    • 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) are defined as either
    postmenopausal (history of amenorrhea for ≥52 weeks and confirmation
    by FSH level) or who are surgically sterile, such as after hysterectomy,
    bilateral oophorectomy, or tubal ligation (procedure performed ≥52
    weeks before screening). This information must be documented in the
    subject's source documents.
    • WONCBP do not require a serum and urine pregnancy test.Please refer to the protocol for the full list of inclusion criteria
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Pregnant or breastfeeding women.
    2. Entero vesicular (ie, between the bowel and urinary bladder) fistulae are prohibited. Other fistulae are allowed (eg enterocutaneous fistulae). Documentation of active and inactive fistulae are required.
    3. Multiple small bowel resections resulting in clinically significant short bowel syndrome who require TPN.
    4. Previous bowel surgery resulting in an existing or current stoma Subjects who have a j-pouch are excluded as a j-pouch can result in a stoma.
    5. Surgical bowel resection within the past 3 months.
    6. History of diverticulitis or currently symptomatic diverticulosis.
    7. 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. Documentation of the official reading must be located and available in the source documentation).
    8. 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 an individual with active tuberculosis. Subjects who have a positive Mantoux (PPD) tuberculin skin test or a positive Interferon Gamma Release Assay performed locally (the following are acceptable assay: 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 randomization.
    • A positive Mantoux tuberculin skin test is defined as ≥5 mm of induration (or as defined by country specific or local standards) at 48 72 hours without consideration of prior Bacillus Calmette-Guérin (BCG) vaccination. Documentation of the dose and product used as well as the official test reading must be obtained and available in the subject's study file.
    • An IGRA is preferred for subjects with a prior Bacillus Calmette Guérin (BCG) vaccination (to be tested by the site’s local lab). Documentation of IGRA product used and the test result must be in the subject’s source documentation.
    9. Presence of active enteric infections (positive stool culture and sensitivity). The presence of Clostridium difficile or pseudomembranous colitis. Known active invasive fungal infections such as histoplasmosis. Subjects with a clinically significant underlying disease that could predispose the subject to infections. A history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the randomization visit or baseline visit. Pyoderma gangrenosum is allowed.
    10. Preexisting demyelinating disorder such as Multiple Sclerosis or new onset seizures, unexplained sensory, motor, or cognitive, behavioral, neurological deficits, or significant abnormalities noted during screening.
    11. 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).
    12. Significant concurrent medical conditions 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 (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic [eg, Felty syndrome], or local active infection/infectious illness) that, in the investigator’s judgment, 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 NPproBNP >124 pg/mL must have an echocardiogram and cardiology consult that exclude right or left heart failure.
    • Acute coronary syndrome (eg, myocardial infarction, unstable angina pectoris) and any history of significant cerebrovascular disease within 24 weeks before screening.
    13. Presence of a transplanted organ. Skin grafts to treat pyoderma gangrenosum are allowed.
    14. Any major elective surgery scheduled to occur during the study.
    15. Prior evidence of liver injury or toxicity due to methotrexate.
    Please refer to the protocol for the full list of exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    CDAI 70 response rate at Week 8 or Week 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8 and Week 12
    E.5.2Secondary end point(s)
    • Safety and tolerability of PF-00547659 dose levels versus placebo: the frequency of
    treatment adverse events, withdrawal due to adverse events, and serious adverse
    events (SAEs) will be reported. Any subject who receives at least 1 dose of
    investigational product will be included in the evaluation for safety.
    • Percent of subjects with a CDAI remission (CDAI <150), CDAI-70 and CDAI-100
    responses Weeks 2 through 12 (Day 14 to Day 84).
    E.5.2.1Timepoint(s) of evaluation of this end point
    All visits
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Dose Ranging
    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 trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Austria
    Belgium
    Bulgaria
    Canada
    France
    Germany
    Japan
    Korea, Republic of
    Netherlands
    Norway
    Poland
    Portugal
    Slovakia
    Slovenia
    South Africa
    Spain
    Sweden
    United States
    Croatia
    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
    As per protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 240
    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 the protocol
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-05-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-09
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