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    Summary
    EudraCT Number:2010-023762-49
    Sponsor's Protocol Code Number:B2421003
    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:2011-07-05
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2010-023762-49
    A.3Full title of the trial
    A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, SPONSOR UNBLINDED, PLACEBO-CONTROLLED, MULTIPLE DOSE STUDY TO EVALUATE THE PHARMACODYNAMICS, PHARMACOKINETICS AND SAFETY OF ANRUKINZUMAB IN PATIENTS WITH ACTIVE ULCERATIVE COLITIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the safety and how anrukinzumab (IMA-638) works in the body for patients with Ulcerative Colitis
    A.3.2Name or abbreviated title of the trial where available
    IMA-638 Ulcerative Colitis Study
    A.4.1Sponsor's protocol code numberB2421003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01284062
    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, USA
    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-05230917
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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-05230917
    D.3.9.3Other descriptive nameNot applicable
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ulcerative Colitis
    E.1.1.1Medical condition in easily understood language
    Ulcerative colitis - which is a disease of the large intenstine (colon) that causes open sores (ulcers) in the colon.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    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 is to characterize the change in the Pharmacodynamic (PD) biomarker, fecal calprotectin, during treatment with anrukinzumab.
    E.2.2Secondary objectives of the trial
    • Characterization of the PK profile and total IL 13 of three multiple escalating IV doses of anrukinzumab versus placebo.
    • Determination of the safety, tolerability and immunogenicity of anrukinzumab in patients with active UC.
    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 patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    2. Patients are willing and able to participate in the study, complete patient assessments, attend scheduled clinic visits, and comply with all protocol requirements as evidenced by written informed consent.
    3. Male and/or female patients between the ages of ≥18 and ≤65 years at the time of informed consent.
    4. Positive histological diagnosis of UC. A biopsy report must be available in the patient’s source documentation. In addition, a report documenting disease duration and extent of disease (eg, proctosigmoiditis, left sided colitis and pancolitis) based upon prior colonoscopy must also be available in source documentation. A colonoscopy with biopsy will need to be performed if this documentation is not available.
    5. Diagnosis of active UC determined within the screening period as defined by a Mayo score ≥4 and <10 points and with an endoscopic sub score (based upon flexible sigmoidoscopy) of ≥2 points.
    6. Fecal calprotectin ≥100 mg/kg within the screening period. The screening fecal calprotectin may be repeated once during the screening period with results available and reviewed prior to the baseline visit.
    7. Subjects that are taking 5 ASA prior to screening must be on a stable dose for at least two (2) weeks prior to their first screening visit.
    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.
    • 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 patient'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 the following highly effective methods of contraception for the duration of the study (defined as the time of the signing of the informed consent form through the conclusion of patient participation). Contraceptive methods considered acceptable for use in this study include:
    • Established use of oral, injected, transdermal or implanted hormonal methods of contraception.
    • Double barrier contraception: use of condom and occlusive diaphragm (cap 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.
    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 for the duration of the study (defined as the time of the signing of the informed consent form through the conclusion of patient participation). 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 before study Day 1.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. Indeterminate colitis, ischemic colitis, fulminant colitis and Crohn’s disease.
    2. UC confined to proctitis or disease confined to the rectum only.
    3. Any previous colonic or likely to require colonic surgery within the duration of the study. Any other abdominal surgery within 12 weeks or likely to require abdominal surgery within the duration of the study.
    4. 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.).
    5. 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. Patients 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 (GFT GIT) and T SPOT® TB test.
    • 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 for the Mantoux tuberculin test as well as the official test reading must be obtained and available in the patient's study file.
    • An IGRA is preferred for patients with a prior Bacillus Calmette Guérin (BCG) vaccination (to be tested by a site’s local lab). Documentation of the IGRA product used and the test result must be in the patient’s source documentation.
    6. Active enteric infections, pseudomembranous colitis, salmonella, shigella campylobacter or other GI bacterial, fungal or parasitic infection or known active invasive fungal infections such as histoplasmosis (stool culture and sensitivity, ova & parasites as well as Clostridium difficile toxins A and B may be tested by the site’s local lab). Any underlying disease that could predispose the patient to infections or history of serious infection (requiring parenteral antibiotic and/or hospitalization) within 4 weeks before the baseline visit. Pyoderma gangrenosum is allowed.
    7. Preexisting demyelinating disorder including multiple sclerosis or new onset seizures, unexplained sensory, motor, or cognitive/behavioral or neurological deficits.
    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 acute or unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, immunologic [eg, Felty syndrome], or infectious illness) that, in the investigator’s judgment, will substantially increase the risk to the patient 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. Known history of human immunodeficiency virus (HIV) based on documented history with positive serological test or positive HIV screen test performed locally at the time of screening. A negative HIV test result within 12 months of the screening period will be accepted. Documentation of the negative test result must be located and available in the source documentation.
    10. Presence of a transplanted organ.

    For the full list of Exclusion Criteria please refer to the protocol
    E.5 End points
    E.5.1Primary end point(s)
    • Fold change from baseline in fecal calprotectin at Week 14.

    Note: Fold change is defined as (post-treatment measurement)/(baseline measurement), which is related to percent change from baseline by the following equation: Percent change from baseline = 100% x (fold change-1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 14
    E.5.2Secondary end point(s)
    Pharmacokinetic Endpoints
    • The PK of anrukinzumab will be characterized from data obtained at pre specified time points up to 32 weeks. The pharmacokinetic parameters including AUC and half life will be estimated using noncompartmental analysis and additional parameters may be estimated using population PK analysis.
    Pharmacodynamic Endpoints
    • Fold change from baseline in fecal calprotectin at Weeks 2, 4, 8, and 12.
    • Total IL 13 (free IL 13 and IL 13 complexed with anrukinzumab) measured at pre specified time points up to 32 weeks.
    Safety Endpoints
    • The frequency of on treatment adverse events, serious adverse events and withdrawals due to adverse events will be summarized.
    • Frequency of ADAs and Nabs, if observed, at pre specified timepoints up to 32 weeks.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints are defined within the secondary end points
    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
    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 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 Yes
    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 Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Hungary
    Netherlands
    Poland
    Romania
    Spain
    United States
    E.8.7Trial has a data monitoring committee No
    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 years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days4
    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: 80
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 80
    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 Decision2012-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-22
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