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    Summary
    EudraCT Number:2011-000722-30
    Sponsor's Protocol Code Number:B0151005
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-17
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2011-000722-30
    A.3Full title of the trial
    A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003 (ANDANTE II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A MULTICENTER OPEN-LABEL EXTENSION STUDY FOR SUBJECTS WHO PARTICIPATED IN STUDY B0151003
    A.3.2Name or abbreviated title of the trial where available
    ANDANTE II
    A.4.1Sponsor's protocol code numberB0151005
    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
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailClinicalTrials.govCallCentre@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) will be labeled as “PF-04236921 106 mg/vial, Clonal SC lyophilized form", which is equivalent to "PF-04236921 Powder for Injection, 106 mg/vial" as described in the enclosed CTA.
    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
    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 (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 18.0
    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
    The primary objective of this study is to evaluate the long term safety, tolerability, and immunogenicity of PF-04236921.
    E.2.2Secondary objectives of the trial
    The exploratory objectives include assessment of the proportion of subjects in remission, relapse rates, response rates, and the need for dose escalation. Additionally, population PK and biomarkers will be assessed.
    E.2.3Trial contains a sub-study No
    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 this study.
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into this study:
    1. Subjects previously enrolled in study B0151003 and completed the blinded 84 day (12 week) induction period.
    2. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    3. All women of childbearing potential (WOCBP) as determined during study B0151003 (data must be available as source documents for this study) must have a negative urine pregnancy test result at the baseline (Week 12 [Day 84] visit of B0151003) visit and at specified visits during this study (defined as the time of the signing of the ICD through the end of this study). 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 nonchildbearing potential as determined during the previous study do not require urine pregnancy tests in this study.
    4. WOCBP who have sexual intercourse with a non surgically sterilized male partner must agree and commit to the use of two highly effective methods of birth control from signing the ICD through the Final Study Evaluation.
    Note: The subject is strongly advised to continue a highly effective birth control for an additional 26 weeks after the Final Study Evaluation due to the possible presence of measurable investigational product. If the subject withdrawals early from the study and refuses to return for the recommended follow up visit schedule, they will be strongly advised to continue a highly effective birth control for 62 weeks from their last dose of investigational product.
    Contraceptive methods considered acceptable for use in this study include:
    • Established use of oral, injected, transdermal, or implanted hormonal methods of contraception (data must be available as source documents for this study).
    • Hormonal contraception must be accompanied by the 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 chould be used in combination with spermicidal creams.
    • Double barrier contraception: Condom and Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository. A female condom and a male condom should not be used together as friction between the two can result in either, or both, product(s) failing.
    • An intrauterine device or system. An additional barrier method (condom or spermicide) are engouraged.
    5. 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 this study (defined as the time of signing the ICD through the Final Study Evaluation). Highly effective methods of contraception include properly used spermicidal condom.
    Note: The subject is strongly advised to continue a highly effective birth control for an additional 26 weeks after the Final Study Evaluation due to the possible presence of measurable investigational product. If the subject withdrawals early from the study and refuses to return for the recommended follow up visit schedule, they will be strongly advised to continue a highly effective birth control for 62 weeks from their last dose of investigational product.
    6. To be considered surgically sterilized, a male partner must have had a vasectomy at least 24 weeks or bi lateral orchiectomy >30 days before the baseline visit of this study.
    7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in this study:
    1. Subjects who are investigational site staff members and their family members or subjects who are Pfizer employees and their familiy members directly involved with the conduct of the trial.
    2. Subjects that have completed Day 84 (Week 12) visit of study B0151003, and 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 inclusion in this study.
    3. Pregnant or breastfeeding women.
    4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or ability to comply with study procedures, investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    5. Received any prohibited treatment during study B0151003 that, in the opinion of the investigator, compromised the safety or efficacy of this study.
    6. Planned live (attenuated) vaccination during the course of this study.
    7. Planned major elective medical or surgical procedure during the course of this study.
    8. Participation in other studies during participation in this study.
    E.5 End points
    E.5.1Primary end point(s)
    Any subject who receives at least 1 dose of investigational product will be included in the evaluation for safety. The frequency of on-treatment AEs, withdrawals due to AEs, and SAEs will be reported. Percent of subjects that develop ADAs and NAbs will be reported, if observed, at baseline (Week 12 [Day 84] visit of B0151003) or when tested every 8 weeks through Week 76 (FSE).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evalution of the end points will occur during each visit detailed in the protocol
    E.5.2Secondary end point(s)
    PK:For the serum concentration data obtained from all subjects at visits every 4 weeks up to Week 76 (FSE) in this study will be combined and compared with serum concentration data collected from the same subjects that participated in the previous study (B0151003). The combined data may be analyzed using the population PK methodology as appropriate.
    PK/PD: Pharmacodynamic (PD) parameters will be assessed through blood samples collected at baseline (Week 12 [Day 84] visit of B0151003) and Week 4 (Visit 2), and then every 4 weeks up to Week 76 (FSE) to measure high sensitivity C-reactive protein (hsCRP), total IL-6, and free IL-6. Not all IL-6 samples collected at all time will be analyzed; some may be stored for future analysis. Also, stool samples will be collected at baseline (Week 12 [Day 84] visit of B0151003) and Week 4 (Visit 2), and then every 8 weeks through Week 44 (Visit 12) to measure fecal calprotectin. Exploratory PK/PD modeling may be performed to define dose and exposure response relationships for PD biomarkers (eg, free and total IL-6) and clinical efficacy endpoints (eg, HBI scores). Results of the exploratory analysis (if conducted) would be reported separately from the clinical study report, but the data listing will be provided in final report.

    Efficacy: Any subject who receives at least 1 dose of investigational product will be included in the evaluation for efficacy. The HBI will be used to assess disease activity.
    • Change in the HBI will be used to assess clinical efficacy during this open label extension study.
    • Remission will be defined as an HBI activity score of less than 5.
    • Response at the baseline in the current study (B0151005) is defined as a decrease of ≥70 Crohn’s Disease Activity Index (CDAI) points at Week 12 in the previous study B0151003. Response at a certain later time point is defined as meeting either of the following two conditions:
    1. Being a responder at baseline and never relapsed by that time point. (See Table 1 for the definition of relapse).
    2. Having a HBI score decrease of ≥3 points at that time point from the baseline of either the current study (B0151005) or the previous study B0151003. This condition applies to patients that are non-responders at baseline or relapse after baseline.
    Note: The change from the baseline of the previous study B0151003 will be calculated by (Δ HBI1003 + Δ HBI1005), where Δ HBI1005 is the change from the baseline of the current study (B0151005), and Δ HBI1003 is the change from baseline to Week 12 in the previous study B0151003. The ΔHBI1003 calculations will be performed in the CRF Health Trial Manager and be provided to the investigator through the online report tool.
    • A non responder will be defined as subject that does not have a response as defined above.
    • A relapse is only measured in subjects who have had a response. Relapse is defined as an increase of ≥3 points in the HBI from the lowest measured HBI on study and the total HBI score being ≥8. The time to relapse will be captured. In subjects that relapse, the dose may be escalated and the HBI score will be assessed at the subject’s next study visit to evaluate response.
    The following analyses will be performed to explore efficacy stratified by responder/non-responder status from study B0151003:
    • Proportion of subjects in remission (HBI <5).
    • Proportion of subjects with a response (as defined above).
    • Percent of subjects requiring dose escalation.
    • Percent of subjects discontinued from the study by Week 16.
    • Percent of subjects remaining in the study.
    • Time to relapse.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints defined within 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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned6
    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
    Australia
    Belgium
    Brazil
    Canada
    Denmark
    France
    Germany
    Greece
    Hungary
    Ireland
    Israel
    Italy
    New Zealand
    Romania
    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
    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 months9
    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 months9
    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: 144
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 160
    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)
    This open label extension (OLE) study (B0151005) provides for up to an additional 40 weeks of treatment beyond the 12 weeks of treatment provided in study B0151003. No additional treatment beyond this open-label extension is planned.
    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 Decision2011-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-03-01
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