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    Summary
    EudraCT Number:2009-015532-14
    Sponsor's Protocol Code Number:EMR700692-003
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-02
    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 ConcernedAustria - BASG
    A.2EudraCT number2009-015532-14
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, parallel-group phase II trial to investigate the efficacy and safety of weekly intra-articular (i.a.) injections of 10, 30, and 100 µg of AS902330 for three consecutive weeks in patients with acute cartilage injury of the knee
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    AS902330 in Cartilage Injury Repair (CIR)
    A.3.2Name or abbreviated title of the trial where available
    AS902330 in Cartilage Injury Repair
    A.4.1Sponsor's protocol code numberEMR700692-003
    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 SponsorMerck Serono S.A. - Geneva
    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 supportMerck Serono S.A. - Geneva
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Centre Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Straße 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+49615172 5200
    B.5.5Fax number+49615172 2000
    B.5.6E-mailservice@merck.de
    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 nameAS902330
    D.3.2Product code AS902330
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAS902330
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.IMP: 2
    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 nameAS902330
    D.3.2Product code AS902330
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeAS902330
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 and solvent for solution for injection
    D.8.4Route of administration of the placeboIntraarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Knee Cartilage Injury
    E.1.1.1Medical condition in easily understood language
    Injury of the knee Cartilage. Mains symptoms of cartilage lesions are pain, joint swelling, and loss of function.
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10007710
    E.1.2Term Cartilage injury
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 evaluate the efficacy of three weekly i.a. injections of 10, 30, or 100 µg AS902330 in patients with acute cartilage injury of the knee based on MRI measurements of the defect volume.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to support the efficacy of AS902330 in patients with acute cartilage injury of the knee by morphological and symptomatic outcome scores as well as to confirm its safety and local tolerability.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion, all of the following criteria must be fulfilled:
    · Acute cartilage lesion of ICRS grade 2 to 4 at the femoral condyle of the knee (= target knee)
    · Age: 18 to 45 years
    · Sex: male or female. Women of childbearing potential (i.e. all female patients after
    puberty unless they are post-menopausal for at least two years or surgically sterile)
    must have negative serum and urine pregnancy tests at screening and Visit 1, respectively, and must use a highly effective method of contraception (i.e. two barrier methods or hormonal intrauterine device or use of an oral female contraceptive) from 4 weeks prior to the first dose until 12 weeks after the last dose of trial medication
    · History of pain and effusion of the target knee post-injury
    · Injury within 4 to 12 weeks prior to 1st treatment with IMP
    · Written informed consent prior to any trial-related activity
    E.4Principal exclusion criteria
    • Personal medical history of OA in either knee
    • Any previous surgery on the target knee
    • History of swelling of the target knee along with pain on weight-bearing, or arthroscopy for diagnostic purposes during the 12 months preceding injury
    • Corticosteroid (i.a.) injection into the target knee during the preceding 12 months
    • Any other i.a. injection into the target knee during the preceding 3 months
    • Any concurrent injury (e.g. arthrolith, anterior cruciate ligament rupture, meniscus tear) of the target knee requiring surgical intervention
    • OA or any pre-existing cartilage damage in the target knee, as revealed by MRI
    • Open growth plate, as revealed by MRI
    •Diagnostic arthroscopy after injury and within 4 weeks prior to treatment start
    • Legal incapacity or limited legal capacity
    • Patients who are imprisoned or institutionalized by regulatory or court order
    • Pregnancy or lactation
    • Participation in another clinical trial within the past 30 days
    • Any condition or findings in the medical history or in the pre-trial assessments that in the opinion of the Investigator constitutes a risk or contraindication for participation in the trial or that could interfere with the trial objectives, conduct or evaluation
    • Known hypersensitivity to the trial treatment or diluents
    • Significant renal or hepatic impairment, as indicated by
    o Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (AP) >3 times the upper limit of normal (ULN)
    o Total bilirubin >1.5 times ULN (except in case of Gilbert’s syndrome)
    o Creatinine >1.5 times ULN
    • Hemoglobin <5.5 mmol/L, white blood cell count (WBC) <2.5 x 109/L, or platelets <75 x 109/L).
    • Any suspicion of i.a. infection
    • Any known active infections that may compromise the immune system such as HIV,
    Hepatitis B or C infection
    • History of sarcoma and/or of other active malignancy within five years, except
    adequately treated basal cell or squamous cell carcinoma of the skin
    E.5 End points
    E.5.1Primary end point(s)
    Relative change in cartilage defect volume over 12 months based on central magnetic resonance imaging (MRI).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 52
    E.5.2Secondary end point(s)
    Efficacy (in order of priority):
    (a) The relative and absolute changes in cartilage defect volume and thickness in the target knee from baseline to 6 months and the absolute changes over 12 months
    (b) Changes in the Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score for the integration of rebuilt cartilage and its surface structure at 3, 6 and 12 months
    (c) Changes in the Boston Leeds Osteoarthritis Knee Score (BLOKS) at 12 months
    (d) Changes in the ICRS grades over 6 and 12 months
    (e) The relative and absolute change in cartilage defect volume/thickness in the target knee from baseline to 3 months
    (f) Changes in the symptom scores (Knee Injury and Osteoarthritis Outcome Score [KOOS], International Knee Documentation Committee [IKDC], global evaluation of treatment benefit) at visits over 12 months

    Safety:
    • Systemic and local AEs over 12 months
    • Acute inflammatory events, i.e., increase of pain of at least 30 mm on a 100 mm visual analog scale (VAS) along with selfreported swelling within 3 days post-injection
    • Changes in safety laboratory measurements and vital signs over 12 months
    • Occurrence of FGF18ab
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6 and 12 months
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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 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 trial4
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Canada
    Serbia
    South Africa
    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
    For administrative and safety reporting purposes the end of the study will be defined as the date of the final clinical database lock. This provides for a single and conservative definition across all study sites.
    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 months0
    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 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.1.1Number of subjects for this age range: 0
    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: 128
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 128
    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)
    Subjects will revert back to usual treatment of their condition, i.e., current standard of care.
    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 Decision2010-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-21
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