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    Summary
    EudraCT Number:2020-003797-51
    Sponsor's Protocol Code Number:D5680C00003
    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:2020-12-21
    Trial 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 number2020-003797-51
    A.3Full title of the trial
    A Randomised, Double-blind, Placebo-controlled, Dose-response Study of the Efficacy and Safety of MEDI7352 in Subjects with Painful Osteoarthritis of the Knee
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of MEDI7352 in painful osteoarthritis of the knee
    A.4.1Sponsor's protocol code numberD5680C00003
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Desk
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountryUnited States
    B.5.4Telephone number0013028851180
    B.5.6E-mailinformation.center@astrazeneca.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.3.2Product code MEDI7352
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEDI7352
    D.3.9.2Current sponsor codeMEDI7352
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Painful osteoarthritis of the knee
    E.1.1.1Medical condition in easily understood language
    Chronic pain due to progressive degenerative joint disease
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031161
    E.1.2Term Osteoarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of MEDI7352 compared to placebo on chronic pain
    in participants with painful OA of the knee
    E.2.2Secondary objectives of the trial
    To assess the efficacy of MEDI7352 compared to placebo on additional measures of efficacy in participants with painful OA of the knee

    To assess the PK and immunogenicity of MEDI7352 in participants with painful OA of the knee

    To assess the safety and tolerability of MEDI7352 compared with placebo in participants with painful OA of the knee
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males or postmenopausal or surgically sterile females, 18 to 80 years of age
    Men who are biologically capable of having children must use an adequate form of contraception during the treatment period and for 3 months and 20 days after the last IP administration
    BMI ≤ 39 kg/m2
    OA of one knee (ACR criteria)
    Radiological features consistent with a diagnosis of OA
    Pain in the moderate-to-severe range and pain most days in the past 3 months
    Pain must exceed pain experienced in other joints and pain from any concurrent medical conditions
    History of inadequate pain relief from past or ongoing treatment with paracetamol and oral NSAIDs/COX 2 inhibitors unless contraindicated/not tolerated and opoids unless (a) there is no access to opoids as per local standards of care, (b) there is no access to opoids as per local standards of care, or (c) the patient is unwilling to take opoids.
    Mean pain intensity score ≥ 5 in the target knee (11 point NRS)
    Willingness/ability to discontinue analgesic therapy for OA with NSAID or COX 2 inhibitors during the entire study
    E.4Principal exclusion criteria
    Treatment with another biologic therapeutic agent, DMARD or other immunosuppressants
    Previous treatment with any form of anti-NGF; received anti-TNFs or other biological DMARD in the past 12 months, or other immunosuppressants in the past 6 months
    Treatment with strong opioids
    RA
    History of gout
    Comorbid condition known to be associated with other forms of arthritis or joint pathology other than OA
    RPOA, primary osteonecrosis, subchondral insufficiency fractures, avascular necrosis, osteoporotic fractures, hip dislocation, pathological fractures or stress facture or reaction
    Significant trauma to a knee, hip, or shoulder within the previous year
    Candidates unsuitable for joint replacement surgery
    Neuropathic pain or chronic primary pain syndromes eg fibromyalgia
    OA of other major joints that could interfere with assessment of pain
    Clinically significant neuropathy
    Wheelchair required for mobility
    History or current diagnosis of severe major depression, psychotic disorders, somatoform disorders, bipolar disorders. suicidal attempts, hospital admission for depression within the past 5 years or any other of psychiatric illness likely to confound drug effect, pain assessment or ability to complete the study
    Significant cardiovascular disease
    Significant or chronic lung disease
    Diabetes complicated with retinopathy or nephropathy; HBA1c > 8.5
    Known or suspected systemic infection, including HIV, HBV, HCV or TB
    History of an opportunistic infection or residence in areas with endemic fungal infections
    History or evidence of demyelinating disorder or epilepsy
    History of anaphylatic/severe hypersensitivity reactions, history of hypersensitivity to immunisations or immunoglobulins and/or biological therapies, ongoing hypersensitivity reactions
    Lifetime history of haematopoietic malignancies, history of other specified cancers within 5 years, or diagnosis of cancer between screening and randomisation
    TIA in the last 6 months, stroke in the past 12 months
    History of substance abuse within 2 years
    Current active infection, chronic or persistent systemic infection or serious or severe localised or systemic infection within 3 months prior to screening or between screening and randomisation or history of any underlying condition that predisposes to infection
    Any history of severe COVID 19 infection, or any prior COVID-19 infection with unresolved sequelae. Any acute COVID-19 infection, including asymptomatic, mild, or moderate that is not resolved 1 month prior to randomisation
    Current serious or unstable clinically important illness, including respiratory, CV, GI, endocrinologic, immunologic, haematologic, or neurological or other major disease likely to deteriorate or affect safety or ability to complete the study; liver cirrhosis
    Family history of long QT syndrome
    History of intolerability or contraindications to paracetamol
    Surgery to a knee, hip or shoulder within 1 year; non-diagnostic arthroscopy on the target knee joint within 180 days; diagnostic arthroscopy on the target knee within 90 days
    Corticosteroid or intra-articular hyaluronic acid injection on target knee within 12 weeks or corticosteroid injection on a nontarget joint within 12 weeks, or intra-articular hyaluronic acid injection on non target joint within 6 weeks prior to screening; for multiple injections within the year total dose of corticosteroid > 180 mg of triamcinolone, methylprednisolone, or their equivalent
    Intra-artciular platelet-rich plasma treatment on the target joint within 6 months
    Cell therapy on the target joint
    Any medical or surgical procedure or trauma within 28 days of first dose; planned surgical procedure during the study
    Contraindications to MRI
    Clinically important abnormality in physical examination, vital signs, ECG, or clinical laboratory test that may compromise participant safety,ability to complete the study or the integrity of trial data
    Significant hypertension (systolic BP > 165 mmHg and/or diastolic BP > 95 mmHg)
    Orthostatic hypotension. If it is not possible to establish stable supine BP participant is not eligible
    Any clinically significant abnormality in ECG rhythm, conduction, or morphology
    ALT, AST, or ALP > 2 ULN or > 1.5 x ULN total bilirubin
    Creatinine clearance < 50 ml/min
    Clinically significant abnormal findings in coagulation or haematology laboratory tests
    Positive pregnancy test
    Positive screen for drugs of abuse including cannabinoids without documented medical explanation
    Treatment with aspirin > 325 mg/day for CV prophylaxis or treatment with vitamin K dependent anticoagulants
    Administration of COVID-19 vaccine within 30 days prior to randomisation
    E.5 End points
    E.5.1Primary end point(s)
    Change in the weekly average of daily NRS pain scores from baseline to Week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 (NRS pain scores recorded daily)
    E.5.2Secondary end point(s)
    Efficacy:
    Change in the WOMAC pain subscale from baseline to Week 12
    Change in the WOMAC physical function subscale from baseline to Week 12
    Change in the PGA of OA from baseline to Week 12

    Serum concentration of MEDI7352
    Presence of ADA to MEDI7352
    ADA titre

    Safety and tolerability evaluated based on AEs, vital signs, and clinical
    laboratory assessments
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy: Week 12 (assessed at Weeks 1, 2, 4, 6, 8, 10, 12,18)

    Safety and tolerability: Every study visit (Weeks 1, 2, 4, 6, 8, 10,11,12,15,18,21,24,28,32,36)

    Serum concentrations and ADA: Weeks 0, 1, 2, 4, 6, 8, 10, 11, 12, 18, 32
    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 No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 trial5
    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 EEA35
    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
    South Africa
    Estonia
    Poland
    Spain
    Germany
    Denmark
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    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 days2
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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.1.2.1Number of subjects for this age range: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 175
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 243
    F.4.2.2In the whole clinical trial 350
    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)
    No further treatment is planned according to the protocol, beside the discretion of the PI
    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 Decision2021-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-16
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