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    Summary
    EudraCT Number:2010-023034-23
    Sponsor's Protocol Code Number:B0151003
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-05
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-023034-23
    A.3Full title of the trial
    A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04236921 IN SUBJECTS WITH CROHN’S DISEASE WHO ARE ANTI-TNF INADEQUATE RESPONDERS (ANDANTE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of PF-04236921 in Subjects with Crohn's Disease Who are Anti-TNF Inadequate Responsers
    A.3.2Name or abbreviated title of the trial where available
    ANDANTE
    A.4.1Sponsor's protocol code numberB0151003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01345318
    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 Address235E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017, USA
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailClinicalTrials.govCallCenter@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-04236921
    D.3.4Pharmaceutical form Powder 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-04236921
    D.3.9.3Other descriptive nameThe investigational medicinal product (IMP) may be labelled as either “PF-04236921 106 mg/vial, Clonal SC lyophilized form” or “PF-04236921 Powder for Injection, 106 mg/vial”. Supplies labelled with either nomenclature are equivalent.
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number106
    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 placeboPowder 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 (active moderate to severe)
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease (active moderate to severe)
    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 16.1
    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
    The primary objectives of this study are to demonstrate clinical activity of PF 04236921 that will induce a clinical response and remission in subjects with Crohn’s Disease (CD) via the Crohn’s Disease Activity Index (CDAI) and to select dose(s) for future clinical studies.
    E.2.2Secondary objectives of the trial
    The secondary objectives include:
    • Evaluate safety, tolerability, and immunogenicity of PF-04236921.
    • Characterize PK of PF-04236921 in subjects with CD.

    Exploratory Objectives
    • Explore the relationship between PK/PD and CDAI score and biomarkers.
    • Characterize PD and other biomarkers
    • Assess health outcome measures in IBDQ and EQ 5D™.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of personally signed & dated informed consent document indicating.
    2. Subjects willing & able to comply with scheduled visits, & other study procedures.
    3. Subjects between ages of ≥18 &≤75 years.
    4. Subjects must have failed or are intolerant to anti TNFs; Relapsed after at least 1 anti TNF; Primary non-responder to at least 1 anti TNF ; Intolerant to at least 1 anti TNF; Other – Discontinued at least 1 anti TNF regimen for other reasons.
    5. Active moderate to severe ileal (terminal ileum), ileocolic or colonic CD (CDAI scores ≥220 to ≤450), despite previous or current use of conventional therapies including mesalamine (5 ASAs), oral steroids and/or immunosupressants (AZA, 6 MP, & MTX) (May continue use of 5 ASAs, AZA, MTX, 6 MP and oral steroids in this trial; dose should be stable 2 weeks prior to randomization). (Note: current use of immunosuppressant therapy type (AZA, 6MP, MTX or none) is another stratification factor in this study.)
    6. hsCRP ≥5.0 mg/L.
    7. Ulcerations demonstrated by colonoscopy as defined by the Simple Endoscopic Score– Crohn’s Disease (SES-CD). Colonoscopy performed within 8 weeks of study entry (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 negative urine pregnancy test result at baseline and throughout study duration. WOCBP are defined as women biologically capable of becoming pregnant, including women using contraceptives or whose sexual partners are either sterile or using contraceptives; WONCBP are defined as either postmenopausal (history of amenorrhea for ≥52 weeks and confirmation by FSH level) or who are surgically sterile as after hysterectomy, bilateral oophorectomy or tubal ligation (procedure performed ≥52 weeks before screening). This information must be documented in subject's source documents; WONCBP do not require a serum and urine pregnancy test.
    9. WOCBP who have sexual intercourse with a non-surgically sterilized male must agree and commit to the use of following highly effective methods of contraception for the duration of the study (defined as the time of the signing of the ICD through the conclusion of subject participation or for approximately 36 weeks from the last dose of investigational product for any subject who discontinues early from the study). Female subjects who meet criteria will be advised to continue a highly effective method of birth control for additional 40 weeks at conclusion of study participation due to possible presence of low levels of investigational product. Contraceptive methods considered acceptable for use in this study include:
    (a) Established use [≥2 months prior to the screening visit] of oral, injected, transdermal or implanted hormonal methods of contraception. Subjects who have used such methods for less than 2 months at the screening visit are required to use one of the methods under c) or d) until the establishment of hormonal contraception methods.
    (b)Hormonal contraception must be accompanied by use of a physical barrier method such as use of a spermicidal condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ suppository. In countries where spermicidal condoms are not allowed ordinary condoms could be used in combination with spermicidal cream.
    (c) Double barrier contraception: condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/ film/cream/suppository. A female condom & a male condom should not be used together as friction between the two can result in either, or both, product(s) failing.
    (d) An intrauterine device or system. An additional barrier method (condom or spermicide) are encouraged.
    10. All men (unless surgically sterile, as defined below) who have sexual intercourse with a WOCBP must agree and commit to use a highly effective method of contraception as described under WOCBP for the duration of the study (defined as the time of signing of the ICD through the conclusion of subject participation or for approximately 36 weeks from last dose of investigational product for any subject who discontinues early from the study). Male subjects who meet criteria will be advised to continue a highly effective method of birth control for additional 40 weeks at conclusion of study participation due to possible presence of low levels of investigational product. Highly effective methods of contraception include properly used spermicidal condom; To be considered surgically sterilized, a male partner must have had a vasectomy at least 24 weeks or bi lateral orchiectomy >30 days before screening.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study: Medical History:
    1. Pregnant or breastfeeding women.
    2. CD with active fistulae or abscess. CT or MR enterography is required within 6 months prior to study entry (screening) to exclude active fistulae (one that drains spontaneously or with gentle pressure) or abdominal or perineal/perianal abscess. Small bowel series could be performed if CT/MR enterography is not accessible or cannot be performed within the screening period.
    3. Subjects who had a total colectomy with ileorectal anastomosis. Multiple small bowel resections resulting in clinically significant short bowel syndrome with malabsorption or need for TPN.
    4. Presence of a bowel stoma. Surgical bowel resection within the past 3 months.
    5. History of diverticulitis or symptomatic diverticulosis.
    6. Pre existing demyelinating disorder such as multiple sclerosis, new onset seizures, unexplained sensory, motor, or cognitive, behavioral or neurological deficits.
    7. 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 12 months of screening is acceptable and does not need to be repeated).
    8. 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, GI, 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).
    • Class III or IV congestive heart failure as defined by the New York Heart Association.
    • Acute coronary syndrome (eg, myocardial infarction, unstable angina pectoris) and any history of significant cerebrovascular disease within 24 weeks before screening.
    9. Any major elective surgery scheduled to occur during the study.
    10. Presence of a transplanted organ.
    11. Methotrexate use with evidence of current or prior liver injury or toxicity (increase in ALT/AST or fibrosis).
    Physical and Laboratory Findings
    12. Abnormal findings on the a 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).
    13. 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 performed locally or central lab where applicable (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 study entry (screening).
    • 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 or central lab where applicable). Documentation of IGRA product used and the test result must be in the subject’s source documentation.
    14. Presence of active enteric infection (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 of randomization (baseline). Pyoderma gangrenosum is allowed.

    For further exclusion criteria see Additional Exclusion criteria from Protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The CDAI 70 response rate at Week 8 or Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8 or Week 12
    E.5.2Secondary end point(s)
    • Percent of subjects with a CDAI remission (CDAI <150), CDAI 70 and CDAI 100 responses Weeks 2 through 12 (Day 14 to Day 84).
    • Mean change from baseline for CDAI score Weeks 2 through 12 (Day 14 to Day 84).
    • Safety and tolerability of PF-04236921 dose levels versus placebo: the frequency of on treatment adverse events, withdrawals due to adverse events, and 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 that develop ADAs and NAbs, if observed, measured at baseline, and Weeks 4, 8, 12, 16, 24, 32 and 40 will be reported.
    • Serum concentrations of PF-04236921 measured at baseline and every two weeks up to Week 12 and monthly through Week 40 will be reported.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoints are defined with the secondary endpoints
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability & Immunogenicity
    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 trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA84
    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
    Belgium
    Canada
    Denmark
    France
    Greece
    Ireland
    Italy
    Austria
    New Zealand
    Sweden
    Australia
    Brazil
    Czech Republic
    Germany
    Hungary
    Israel
    Switzerland
    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
    As per protocol. Please refer to Sections 13.1 and 13.2 of the 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 months0
    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 months0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 220
    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)
    Please refer to 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 Decision2011-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-12
    P. End of Trial
    P.End of Trial StatusCompleted
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