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    Summary
    EudraCT Number:2012-001431-31
    Sponsor's Protocol Code Number:EMR700692-007
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-27
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-001431-31
    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 30 mcg and 100 mcg AS902330 given as one cycle of three intra-articular knee injections once a week for three weeks as an adjunct treatment to patients following microfracture surgery for cartilage injury of the knee.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II Trial of AS902330 as Adjunct to Microfracture in Cartilage Injury
    A.3.2Name or abbreviated title of the trial where available
    Phase II Trial of AS902330 as Adjunct to Microfracture in Cartilage Injury
    A.4.1Sponsor's protocol code numberEMR700692-007
    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 KGaA
    B.1.3.4CountryGermany
    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 KGaA
    B.4.2CountryGermany
    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+496151725200
    B.5.5Fax number+496151722000
    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 30mcg
    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.3.8INN - Proposed INNSprifermin
    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 100mcg
    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.3.8INN - Proposed INNSprifermin
    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 number100
    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
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for concentrate for solution for injection/infusion
    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 15.1
    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 effect of AS902330 intra-articular (i.a.) knee injections as adjunct to microfracture (MFx) surgery on the composition of the refilled cartilage in the target knee, as measured by delayed gadolinium-enhanced magnetic resonance imaging of cartilage (dGEMRIC) T1 relaxation time at 6 months after MFx surgery.
    E.2.2Secondary objectives of the trial
    To further support the efficacy and safety of AS902330 as an adjunct to MFx for cartilage injury repair through symptomatic outcomes and quantitative magnetic resonance imaging (MRI) measurement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • adults subjects; 18 to 60 years old of either sex with symptomatic knee cartilage injury who are eligible for MFx surgery on the femoral articular surfaces, with intact subchondral bone.
    • Intraoperative inclusion criteria require that there be one or two focal chondral lesions per target knee and that each lesion satisfy all of the following criteria after peripheral debridement to healthy cartilage: (1) area between 1 and 4 cm2 (inclusive), (2) depth ≤ 6 mm, and (3) arthroscopic confirmation that the lesion is a non-osteochondritis dissecans (OCD) lesion between International Cartilage Repair Society (ICRS) grades I and III (D); a grade III non-OCD lesion is equivalent to an Outerbridge grade IV lesion with minimal subchondral bone loss.
    • Subjects must have moderate to severe pain in the target knee prior to surgery, with an average score ≥ 4.0 on the NRS of pain intensity over 7 consecutive days within 30 (+15) days before surgery.
    • Subjects must be willing to comply with postoperative and routine clinical and radiographic evaluations, and to follow a standardized rehabilitation program.
    • Women of childbearing potential must use a form of contraception with a failure rate of less than 1% per year for the first 24 months of the trial. The use of contraception is also recommended throughout the remaining duration of the trial, due to the planned MRI scans involving gadolinium contrast medium (which is contraindicated in case of pregnancy or breastfeeding) and also because of potential confounding effects of pregnancy on symptoms and trial assessments.
    • Written informed consent must be obtained prior to any trial-related activity.
    E.4Principal exclusion criteria
    Main exclusion criteria include specified previous knee surgeries and procedures, more than two chondral lesions or presence of bipolar (or “kissing”) lesions in the target knee, need for concurrent partial meniscectomy, need for any other major concomitant procedure affecting the target knee or for bilateral knee surgery, osteoarthritis in the target knee, body mass index (BMI) > 35 kg/m², malalignment of the target knee of > 5 degrees measured from the mechanical axis, concomitant conditions or treatments that the investigator considers to constitute a risk or contraindication for participation in the trial or that could interfere with the trial objectives, conduct or evaluation, contraindications to MRI scanning, pregnancy or breastfeeding, regular smoking of more than 10 cigarettes or equivalent per day within the past 6 months, participation in another clinical trial within the past 30 days (or 5 half-lives of the investigated compound,whichever is longer), and legal incapacity or limited legal capacity.
    E.5 End points
    E.5.1Primary end point(s)
    Composition of the refilled cartilage, at 6 months post-MFx surgery as measured by the dGEMRIC T1 relaxation time.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be assessed at 6 months
    E.5.2Secondary end point(s)
    Efficacy (in order of priority):
    •Composition of the refilled cartilage, as measured by dGEMRIC T1 relaxation time, at each MRI assessment time point beyond Month 6 post-MFx surgery.
    •Reduction in subject-reported knee pain intensity and improvement in subject-reported knee function as measured by change from baseline in the KOOS sub-scores for Pain and activities of daily living (ADL) at each KOOS time point.
    •Change from baseline in (a) the (subject-reported) Total KOOS score, (b) each of the three other dimensions of the KOOS sub-scores (Other Symptoms, Knee-related Quality of Life, and Function in Sports and Recreational Activities [FSR]), and (c) the Total KOOS minus the FSR sub-score, at each KOOS time point.
    •Change from baseline in subject-reported knee pain using an NRS pain diary at each NRS time point
    •Changes from baseline in the subject-reported LEAS at each LEAS time point.
    •Changes from baseline in the physician-reported Lysholm Knee Scale score at each Lysholm time point.
    •Composition of the refilled cartilage as evaluated through T2 mapping at each MRI time point.
    •Composition of the refilled cartilage as evaluated through T1 rho (non-contrast) imaging at each MRI time point.
    •Volume of refilled cartilage at each MRI time point.
    •Cartilage fill as assessed by MOCART scores at each MOCART time point.
    •6-minute walk test at each specified walk-test time point (as an objective measure of function).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) At 12, 18, 24, 36, 48 & 60 months
    - Composition of the refilled cartilage, by dGEMRIC T1 relaxation time
    - Change from baseline in the KOOS sub-scores for Pain and ADL
    - Composition of the refilled cartilage through T2 mapping
    - Composition of the refilled cartilage through T1 rho (non-contrast) imaging
    - Volume of the refilled cartilage
    - Cartilage fill by MOCART

    2) At 9, 12, 18, 24, 30, 36, 42, 48, 54 & 60 months
    - Change from baseline in Total KOOS score; each of the 3 other dimensions of the KOOS sub-scores, and Total KOOS minus the FSR sub-score
    - Change from baseline in subject-reported knee pain using an NRS pain diary
    - Change from baseline in the subject-reported LEAS
    - Change from baseline in the physician-reported Lysholm Knee Scale score
    - 6-minute walk test
    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 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 trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    Belgium
    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
    For administrative and safety reporting purposes, the end of the trial will be defined as the date of the final clinical database lock at the end of the Extended Follow-up Period. This provides for a single and conservative definition across all trial sites.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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 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: 36
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 6
    F.4.2.2In the whole clinical trial 36
    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 who have completed the trial or have withdrawn early should be managed in accordance with the investigator’s clinical judgment, as appropriate for each subject’s individual medical needs.
    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 Decision2013-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-10
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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