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    Summary
    EudraCT Number:2009-015017-48
    Sponsor's Protocol Code Number:CACZ885C2201
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-16
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-015017-48
    A.3Full title of the trial
    A randomized, double blind, placebo and Naproxen controlled, multi-center, study to determine the safety, tolerability, pharmacokinetics and effect on pain of a single intra-articular administration of Canakinumab (anti-IL1β antibody) in patients with osteoarthritis in the knee
    A.3.2Name or abbreviated title of the trial where available
    C2201
    A.4.1Sponsor's protocol code numberCACZ885C2201
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 Yes
    D.2.1.1.1Trade name ILARIS
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameCanakinumab
    D.3.2Product code ACZ885
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCANAKINUMAB
    D.3.9.1CAS number 914613-48-2
    D.3.9.2Current sponsor codeACZ885
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant human monoclonal antibody
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Naproxen Hexal
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameNaproxen
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNAPROXEN
    D.3.9.1CAS number 22204-53-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntraarticular use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Osteoarthritis of the knee
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A: To determine the safety and tolerability of single ascending doses of an intra-articular administration of ACZ885 in subjects with osteoarthritis in the knee.

    Part B: To evaluate the clinical benefit in subjects with osteoarthritis in the knee, as measured by the change in the pain by using 100 mm VAS scale from baseline to day 4 (primary) and in the Western Ontario and McMaster osteoarthritis Index (WOMAC) pain subscale from baseline to week 4 (step-down primary) of a single administration of ACZ885 (i.a.) in comparison to placebo.
    E.2.2Secondary objectives of the trial
    Part B only:
    1) To evaluate the clinical benefit in subjects with osteoarthritis in the knee, as measured by the change in the pain by using VAS score and in the WOMAC pain subscale as well as the WOMAC function subscale and WOMAC stiffness subscale from baseline up to week 12 (at each clinical visit), of a single administration of ACZ885 (i.a.) in comparison to placebo.
    2) To estimate the percentage of responders at each post baseline visit in the pain 100 mm VAS scale as achievement of ≥ 50% reduction from baseline.
    3) To characterize the amount of rescue analgesic used and time to analgesic reintroduction.
    4) To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) profiling of ACZ885 and assess the PK / PD relationships following intra-articular administration.
    5) To determine the physician’s global assessment of the status of treatment response (post-dose at each clinical visit) using a 5 point Likert scale.
    [...]
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent must be obtained before any assessment is performed.
    • Male and female patients aged 40 - 80 years (inclusive).
    • Diagnosis of knee osteoarthritis in the index knee (in patients with bilateral osteoarthritis, the more symptomatic knee will be used) as determined by the American College of Rheumatology criteria (Altman R. et al, 1986); Kellgren-Lawrence grade (KLG) 2 to 3.
    • Radiographic evidence of tibiofemoral compartment osteoarthritis of the index knee within 6 months before screening (using weight bearing anteroposterior radiographs) is required.
    • BMI ≤ 45 kg/m2.

    Part A only:
    • Patients must be willing to discontinue all non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication (including opiods) taken for any condition, including their knee pain 24 hours before the baseline visit and until the assessment on Day 4. Rescue medication is allowed as described in Section 5.5.6.
    Patients must also be willing to abstain from any intra-articular (i.a.) or peri-articular injections to the knee or surgery during the treatment period (12 weeks), except for the assigned study product.

    Part B only:
    • Pain in the index knee during the last 24 hours defined as a level of ≥ 40 mm on a 100-mm VAS at baseline. The patients should also have had pain in the affected knee on most days over the last month.
    • Patients who are willing to discontinue all non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication taken for any condition, including their knee pain for 5 half lives of the current NSAID being used (3-7 days) before the baseline visit (see Section 5.5.6 and 5.5.7 for rescue and concomitant medication details).
    Patients who are on stable dose of opioids for at least 1 month before screening can continue to take their opioid at this stable dose throughout the study. The use of opioids must be documented in the eCRF.
    Patients must also be willing to abstain from any intra-articular (i.a.) or peri-articular injections to the knee or surgery during the treatment period (12 weeks), except for the assigned study product.
    • Patients who, if they are currently taking low dose aspirin (325 mg/day or less; as anti-coagulants), are willing to remain on a stable dose one month prior to screening and throughout the study.
    E.4Principal exclusion criteria
    Patients should not have rheumatoid arthritis (clinical assessment) or any connective tissue like disease (Lupus erythematosus, Sjögren Syndrome, or other autoimmune diseases).
    • Secondary osteoarthritis with history and/or any evidence in the index knee of the following diseases: septic arthritis, inflammatory joint disease, gout, Paget’s disease of the bone, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemachromatosis, Wilson’s disease, primary osteochondromatosis, juvenile chronic arthritis with continued activity in adulthood, heritable disorders (e.g. hypermobility). Patients with secondary osteoarthritis following menisectomy or injuries of a collateral or cruciate ligament are not excluded.
    • USE OF OTHER BIOLOGICS OR INVESTIGATIONAL DRUGS AT THE TIME OF ENROLLMENT, OR WITHIN 30 DAYS OR 5 HALF-LIVES OF ENROLLMENT, WHICHEVER IS LONGER, OR INSTRUCTED BY LOCAL REGULATIONS.
    • SUBJECTS WITH KNOWN HYPERSENSITIVITY TO ANY BIOLOGICAL AGENTS (ANTIBODY OR SOLUBLE RECEPTOR), INCLUDING CANAKINUMAB.
    • PATIENTS WITH CONTRAINDICATIONS TO KNEE INJECTIONS (E.G. CUTANEOUS INFECTIONS AT THE KNEE, PSORIASIS AROUND THE KNEE, SEVERE COAGULOPATHY) ARE EXCLUDED.
    • PATIENTS WITH JOINT EFFUSION WHERE THERE IS SUSPICION OF AN INFECTED JOINT (E.G., FEVER, SUDDEN CHANGE IN EFFUSION SIZE OR JOINT PAIN, ETC.), SHOULD HAVE THE INFUSION ASPIRATED AND CULTURED PRIOR TO INCLUSION IN THE STUDY. IF THE CULTURE IS NEGATIVE, PATIENTS WOULD BE ELIGIBLE FOR PARTICIPATION.
    • Presence or history of underlying metabolic, endocrine, hematologic, pulmonary, cardiac, blood, renal, hepatic, infectious, psychiatric or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in a study of an immunomodulatory therapy.
    • Evidence of tuberculosis (TB) as DEFINED BY LOCAL GUIDELINES/ LOCAL MEDICAL PRACTICE (at screening).
    • Subjects with evidence of hepatic (ALT, AST AST ≥ 150% ULN or blood coagulation disorders (i.e. hemophilia, etc), anemia, idiopathic thrombocytopenic purpura, or gastrointestinal disorder: severe hepatic disease (Child-Pugh >9), history of alcohol and drug abuse; disease of gall bladder and pancreas; active peptic ulceration within the previous 6 months, gastrointestinal bleeding within the last 1 year (except history of minor lower gastro-intestinal tract bleeding, such as from hemorrhoids or anal fissures) or history of severe gastro-esophageal reflux disease or severe hiatus hernia; inflammatory bowel disease.
    • Hemoglobin less than 10 g/dl (women) or 12 g/dl (men) at screening.
    • Presence of severe renal function impairment (e.g. Estimated GFR (eGFR) using Modification of Diet in Renal Disease (MDRD) formula as of < 30 ml/min within past 6 months). History of renal trauma, glomerulonephritis, patients with one kidney, or renal failure requiring regular dialysis treatment.
    • History of malignancy within the previous 5 years (other than basal cell carcinoma or adequately treated carcinoma-in-situ of the cervix) REGARDLESS OF WHETHER THERE IS EVIDENCE OF LOCAL RECURRENCE OF METASTASES.
    • A positive HIV (ELISA and Western blot) test result, Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
    • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
    • Female patients being physiologically capable of becoming pregnant UNLESS they are:
    a. Female patients whose career, lifestyle, or sexual orientation precludes intercourse with a male partner
    b. Female patients whose partners have been sterilized by vasectomy or other means
    c. Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1, reliable contraception should be maintained throughout the study and for 3 months after the ACZ885 i.a. injection.

    Part B only:
    • Subjects with known contra-indications to Naproxen (e.g. heart or circulation problems, history of ulcer disease etc.), analgesics, antipyretics or NSAIDs.
    • Any kind of index knee surgery within the last year. Observational arthroscopy, arthroscopic surgery or lavage of the knee within the last 6 months.
    • Subjects who have experienced, any time in the past, asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic-type reaction after taking acetylsalicylic acid (ASA)/ aspirin or NSAIDs
    • Any history of prior peptic ulcer disease or prior NSAID gastrointestinal complications for the past 5 years.
    E.5 End points
    E.5.1Primary end point(s)
    Part A: To determine the safety and tolerability of single ascending doses of an intra-articular administration of ACZ885 in subjects with osteoarthritis in the knee.

    Part B: To evaluate the clinical benefit in subjects with osteoarthritis in the knee, as measured by the change in the pain by using 100 mm VAS scale from baseline to day 4 (primary) and in the Western Ontario and McMaster osteoarthritis Index (WOMAC) pain subscale from baseline to week 4 (step-down primary) of a single administration of ACZ885 (i.a.) in comparison to placebo.
    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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I/II POC study
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 159
    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 Decision2010-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-28
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