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    Summary
    EudraCT Number:2010-019544-39
    Sponsor's Protocol Code Number:20090072
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-06
    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 ConcernedFrance - ANSM
    A.2EudraCT number2010-019544-39
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of AMG 827 in Subjects with Moderate to Severe Crohn’s Disease
    A.4.1Sponsor's protocol code number20090072
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAmgen Inc
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameAMG 827
    D.3.2Product code AMG 827
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAMG 827
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Crohn’s disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10011408
    E.1.2Term Crohns disease aggravated
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of AMG 827 compared with placebo as measured by the
    proportion of subjects achieving Crohn’s Disease Activity Index (CDAI) remission (≤ 150) at week 6.
    E.2.2Secondary objectives of the trial
    • To evaluate the efficacy of AMG 827 as measured by the proportion of subjects with
    a CDAI response (reduction from baseline of ≥ 100) at week 6
    • To evaluate improvement from baseline in CDAI at week 6
    • To evaluate the short term safety profile of AMG 827 in subjects with Crohn’s disease
    • To characterize the pharmacokinetics (PK) of AMG 827 in subjects with Crohn’s disease
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Approximately 15 subjects per treatment arm (approximately 60 subjects total) will be enrolled in a PK substudy where the subjects will visit the clinic for additional
    pharmacokinetic sampling. Participation in the PK substudy is optional. In order to assure treatment balance in the PK substudy, randomization will be stratified by participation in the PK substudy.
    E.3Principal inclusion criteria
    Subject or subject’s legally acceptable representative has provided informed consent.
    Subject is ≥ 18 and ≤ 65 years of age at time of screening.
    Subject has diagnosed ileal, ileo-colonic, or colonic Crohn’s disease for a minimum of 6 months prior to initiating IP.
    Subject has moderately to severely active Crohn’s disease, as defined by a CDAI score ≥ 250 and ≤ 450 at baseline.
    Subject has evidence of active inflammation, as demonstrated by at least one of the following:
    • Endoscopic evidence of inflammation within 12 weeks prior to initiating IP
    • Elevated C-Reactive Protein (CRP) at screening (> ULN as set by central laboratory)
    • Fecal calprotectin assay indicative of active inflammation at screening (> ULN as set by central laboratory).
    Subjects can be receiving the following treatments but the same dose must be maintained as specified below:
    • 5-aminosalicylates, if stable dosage for ≥ 2 weeks prior to initiating IP
    • Prednisone or equivalent up to 20 mg/day, if stable dosage for ≥ 2 weeks prior to initiating IP
    • Budesonide (up to 6 mg/day), if stable dosage for ≥ 2 weeks prior to initiating IP
    • Azathioprine, if stable dosage for ≥ 8 weeks prior to initiating IP
    • 6-mercaptopurine, if stable dosages for ≥ 8 weeks prior to initiating IP
    • Methotrexate, if stable dosages for ≥ 8 weeks prior to initiating IP
    • Oral antibiotics for Crohn’s disease, if stable dosage for ≥ 2 weeks prior to initiating IP.
    Subject has a negative test at screening for hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus.
    Subject, if female and not at least 2 years postmenopausal or surgically sterile, has a negative serum pregnancy test within 4 weeks before initiating IP and a negative urine pregnancy test at baseline.
    Subject has a negative purified protein derivative (PPD; tuberculin) test within 4 weeks before initiating IP. Tuberculin skin tests are considered positive when they have ≥ 5 mm of induration at 48 to 72 hours after test is placed. Subjects with a positive tuberculin skin test (if ≤ 14 mm of induration) are allowed if they meet all of the following criteria:
    • a history of Bacillus Calmette-Guerin vaccination with a negative Quantiferon test in the past year
    • no symptoms per tuberculosis worksheet
    • a negative chest radiograph
    Note: subjects with a history of a positive PPD may refuse a repeat PPD and be
    allowed to continue screening for tuberculosis as above, if there is a history of
    Bacillus Calmette-Guerin vaccination.
    Subject meets regional recommendations for immunizations, eg, US Centers for Disease Control and Prevention (CDC) recommendations for subjects enrolled in the US.
    E.4Principal exclusion criteria
    Disease-specific criteria
    Subject has short bowel syndrome (defined as requiring oral or parenteral supplemental or total nutrition in order to maintain stable body weight, or more than 100 cm of small bowel resected).
    Subject has had stricture with obstructive symptoms within 3 months prior to IP initiation.
    Subject underwent bowel surgery within 12 weeks prior to IP initiation.
    Subject has an ileostomy and/or colostomy.
    Subject has any gastric or intestinal pouch
    Subject has ulcerative colitis.
    Subject has evidence of an infected abscess.
    Subject has bowel perforation or evidence of noninflammatory obstruction during the 6 months prior to IP initiation.
    Subject has stool positive for C. Difficile toxin at screening.
    Other medical conditions
    Subject has any active CTCAE grade 2 or higher infection (including chronic or localized infections) within 6 weeks prior to IP initiation.
    Subject has a serious infection, defined as requiring hospitalization or intravenous antibiotics within 8 weeks prior to IP initiation.
    Subject has recurrent or chronic infections, defined as ≥ 3 infections requiring anti-microbials within the past 12 months prior to IP initiation.
    Subject has had a bone marrow transplant, stem cell transplant, or solid organ transplant
    Subject has one or more significant concurrent medical conditions, including:
    • Diagnosis of type 1 diabetes
    • Hemoglobin A1c > 8.0 in subjects with type 2 diabetes
    • Moderate to severe heart failure (New York Heart Association class III or IV)
    • Myocardial infarction or unstable angina pectoris within the past 12 months prior to IP initiation
    • Uncontrolled hypertension as defined by a resting blood pressure ≥ 150/90 mmHg prior to IP initiation (confirmed by a repeat assessment)
    • Severe chronic pulmonary disease (eg, requiring oxygen therapy)
    • Major chronic inflammatory disease or connective tissue disease (eg, rheumatoid arthritis, psoriasis, systemic lupus erythematosus)
    • Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or melanoma, or history of cancer (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin).
    Subject has any condition that, in the opinion of the investigator, might cause this study to be detrimental to the subject.
    Laboratory abnormalities
    Subject has any of the following laboratory abnormalities at screening:
    • Elevated (> 2x ULN) aspartate aminotransferase (AST) or alanine aminotransferase (ALT)
    • Serum direct bilirubin ≥ 1.5x ULN
    • Hemoglobin < 10 g/dL
    • Platelet count < 125,000 cells/mm3
    • White blood cell count < 3,000 cells/mm3
    • Absolute neutrophil count < 2000 cells/mm3
    • Creatinine clearance < 50 mL/min (Cockroft-Gault formula, calculated value to be provided to sites).
    Any other laboratory abnormality, which, in the opinion of the investigator, will
    prevent the subject from completing the study or will interfere with the interpretation of the study results.
    Washouts and non-permitted drugs
    Subject currently is enrolled in another investigational device or drug study, or is less than 30 days since ending another investigational device or drug study(s), or is receiving other investigational agent(s), prior to IP initiation.
    Subject has used Tysabri (natalizumab) within 1 year prior to IP initiation.
    Subject received other commercially available or experimental biologic agents (eg, ustekinumab), experimental procedures, or live vaccines within 12 weeks prior to IP initiation.
    Subject received an anti-TNF agent within 8 weeks prior to IP initiation.
    Subject received steroid enemas 2 weeks prior to IP initiation.
    Subject received cyclosporine, mycophenolate mofetil, sirolimus (rapamycin), thalidomide or tacrolimus within 4 weeks prior to IP initiation.
    Chronic narcotic use for reasons other than diarrhea.
    General or other
    Female subject is not willing to use highly effective contraception during treatment and for the duration of the study (except if at least 2 years postmenopausal or surgically sterile).
    Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to the subject’s last study visit including the follow-up
    period.
    Subject has known or suspected sensitivity to mammalian cell-derived (ie, from Chinese hamster ovary) products or any components of the study drug.
    Subject will not be available for protocol required study visits, to the best of the
    subject and investigator’s knowledge.
    Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to
    comply with all required study procedures.
    Subject previously has been randomized in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is remission at week 6, as defined by a CDAI score of
    ≤ 150.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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.8.3 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 EEA24
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of study is defined as the last study visit for the last subject. Enrollment is
    anticipated to take approximately 12 months. The anticipated total study duration from the first subject randomized to the last subject’s last visit is approximately 15 months
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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.1.3Elderly (>=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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 216
    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 Decision2010-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-15
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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