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    Summary
    EudraCT Number:2018-002523-42
    Sponsor's Protocol Code Number:D5680C00002
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-06
    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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2018-002523-42
    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 diabetic neuropathy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of MEDI7352 in painful diabetic neuropathy
    A.4.1Sponsor's protocol code numberD5680C00002
    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 SponsorAstraZenecaAB
    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 AddressKarlebyhus Astraallen
    B.5.3.2Town/ citySodertalje
    B.5.3.3Post codeSE-151 85
    B.5.3.4CountrySweden
    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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 solution 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
    Painful diabetic neuropathy
    E.1.1.1Medical condition in easily understood language
    Pain resulting from diabetes causing damage to nerves
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10012680
    E.1.2Term Diabetic neuropathy
    E.1.2System Organ Class 10029205 - Nervous system 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 versus placebo on chronic pain in subjects with painful diabetic neuropathy (PDN) currently taking standard of care medication for their PDN pain.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of MEDI7352 in subjects with PDN
    To assess the pharmacokinetics , pharmacodynamics and immunogenicity of MEDI7352 in subjects with PDN
    To characterise the dose-response relationship of MEDI7352 on chronic pain in subjects with PDN
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male, or postmenopausal or surgically sterile female, 18 to 80 years of age
    Post-menopausal women must have had ≥ 12 months of spontaneous amenorrhea and a negative pregnancy test within 7 days of treatment. Surgically sterile women must have had a hysterectomy, bilateral ovariectomy (oophorectomy), or bilateral tubal ligation
    Males who are biologically capable of having children must use of adequate contraception for the duration of the treatment period and for 3 months after the last administration of study drug
    Body mass index of ≤42 kg/m2
    Chronic PDN persistent for 6 months or longer not adequately controlled by standard of care treatments
    Pain (beginning in the feet and with relatively symmetrical onset for 6 months or greater) due to bilateral peripheral neuropathy caused by either type 1 or type 2 diabetes mellitus, with bilateral decrease or absent reflexes at the ankles, or bilateral decrease of a sensory sign in the distal lower extremities
    Mean pain intensity score ≥4, as measured on an 11 point NRS for a minimum of 7 days prior to Day 1
    Willing and able to discontinue all NSAID or COX-2 analgesic therapy during study
    Subjects taking medication for the treatment of PDN consistent with standard of care which has been stable for at least 3 months and are willing to maintain this dosing regimen for the duration of the study and use only protocol specified rescue medications
    Treatment for non-excluded medical conditions must be stable for at least 28 days before Day 1 and expected to remain stale for the duration of the study

    E.4Principal exclusion criteria
    Treatment with another biologic therapeutic agent
    Previous treatment with any form of anti-NGF or anti-TNF therapy
    Participation in another clinical study within 60 days or 5 half lves prior to screening
    Plasma donation within 28 days of screening or any blood donation or blood loss >500 mL within 2 months of screening
    Allogeneic bone marrow or stem cell transplant
    Non-leukocyte-depleted whole blood transfusion within 120 days of the genetic research sample collection, if participating in the optional genetic research
    Poor venous access such that IV drug delivery would be difficult
    Involvement in the planning and/or conduct of the study
    Presence of other clinically significant neuropathy (eg, hereditary neuropathy, inflammatory neuropathy) or other clinically significant disorder (eg, nerve compression injury) involving abnormal peripheral sensation, with an aetiology considered to be distinct from that of PDN, and likely to interfere with assessment of peripheral nerve function
    History of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy, or analgesia-induced arthropathy
    Diagnosis of clinically significant OA currently affecting a major joint in the upper or lower extremity or axial spine; or other degenerative disease affecting any joint where there is an identified risk of osteonecrosis, rapidly progressing OA, subchondral insufficiency fractures, neurogenic arthropathy or analgesia-induced arthropathy
    Chronic pain condition, other than PDN, likely to interfere with the evaluation of PDN pain
    Major psychiatric disorder likely to confound interpretation of drug effect, affect pain assessment or ability to complete the study
    Significant cardiovascular disease, congestive heart failure, clinically significant stenosis or occlusion of a carotid or vertebral artery or clinically significant arrhythmias
    Significant or chronic lung disease, including severe or unstable COPD or severe or unstable asthma
    Known or suspected systemic infection, including HIV, HBV, HCV, or tuberculosis
    History or evidence of any significant autoimmune disease or disorder, including inflammatory bowel disease, multiple sclerosis, or systemic lupus erythematosus
    History of severe allergy/hypersensitivity reactions or history of hypersensitivity to immunisations or immunoglobulins
    History of cancer within 5 years except non-metastatic basal cell carcinoma of the skin, carcinoma in situ of the cervix, or non-progressive prostate cancer
    Transient ischaemic attack or stroke in the last 3 years
    History of alcohol or recreational drug dependence within 2 years except nicotine dependence
    Myocardial infarction, hospitalisation for unstable angina or arrhythmia or unexplained syncope within 1 year
    Clinically important infection, including chronic, persistent, or acute infection, within 3 months of screening or between screening and randomisation
    Current serious or unstable clinically important illness, including avascular necrosis, respiratory, cardiovascular, gastrointestinal, endocrinologic (excluding well-controlled type 1 or type 2 diabetes), immunologic, haematologic, neurologic, or other major disease likely to detieriorate or affect ability to complete the study
    Any significant medical or surgical procedure or trauma within 28 days of Day 1, or planned to be undertaken within the timeframe of the clinical trial, that will likely affect the subject’s safety or ability to complete the study, or the scientific integrity of the study data
    Clinically important abnormality in physical examination, vital signs, or clinical laboratory test at screening that could affect the subject’s safety or ability to complete the study, or the integrity of the clinical trial data
    Poorly controlled hypertension (defined as systolic blood pressure [SBP] of >150 mmHg and/or diastolic blood pressure [DBP] of >90 mmHg measured in the clinic) or orthostatic hypotension (defined as a sustained reduction of SBP of at least 20 mmHg and/or a DBP reduction of at least 10 mmHg within 3 minutes of standing from a supine position)
    Prolonged QTcF of >470 msec or family history of long QT syndrome, or shortened QTcF of <360 msec or family history of short QT syndrome, or any clinically significant abnormality in ECG rhythm, conduction, or morphology
    Haemoglobin A1C >8.5%
    Aspartate aminotransferase or alanine aminotransferase >1.5 × the upper limit of normal
    Screening creatinine clearance of <60 mL/min
    Clinically significant abnormal findings in coagulation or haematology laboratory tests
    Positive pregnancy test
    Positive drug screen for drugs of abuse
    E.5 End points
    E.5.1Primary end point(s)
    Change in the weekly average of the average daily NRS pain scores from the baseline of MEDI7352 compared to placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    Efficacy:
    Change in the weekly average of the average daily pain score (NRS) from baseline
    Percentage of subjects who have achieved ≥30% and ≥50% reductions in the weekly average of the average daily pain score from baseline
    Change in Galer Neuropathic Pain Scale (NPS) from baseline
    Change in Daily Sleep Interference Scale (DSIS) from baseline
    Proportion of subjects who have ‘improved’, ‘much improved,’ or ‘very much improved’ relative to baseline on the Patient Global Impression of Change (PGIC)
    Change in the 36-item Short-Form Health Survey (SF-36) from baseline
    Change in the amount of rescue medication used from baseline
    Safety and tolerability: AEs and SAEs, physical examinations, neuropathy strength and deep tendon reflex assessments, vital signs, ECG, clinical laboratory testing , motor and sensory nerve conduction, concomitant medication assessment, injection site reaction and infusion reaction assessments
    PK, PD and immunogenicity:
    PK parameters of MEDI7352
    Free and/or total NGF
    Anti-drug antibodies (ADA)
    Dose response:
    Change in the weekly average of the average daily NRS pain scores from the baseline week to Week 12 versus dose
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change in the weekly average of the average NRS score from baseline:Weeks 2, 4, 6, 8, and 10 of treatment and the week before the follow-up visit
    Change in the weekly average of the average daily NRS scores from the baseline versus dose: Week 12
    Percentage of subjects who have achieved ≥30% and ≥50% reductions in the weekly average of the average daily pain score from baseline: Weeks 4, 8, and 12 of treatment and the week before follow-up
    Change in NPS, DSIS, PGIC : Days 28, 56, and 84 , week 18
    Change in SF-36 : Day 84
    Change in the amount of rescue medication :Week 12
    NGF, PK, vital signs: Days 1,14,28,42,56,70,71,77,84, week 18
    ADAs: Day 14,28,56,70,84, week 18
    Safety assessments: Days 1, 14,28,42,56,70, 84, Week 18
    Motor and sensory nerve conduction: Week 18
    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 No
    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 trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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.1.1.1In 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: 163
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 108
    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 state128
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 224
    F.4.2.2In the whole clinical trial 271
    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)
    Standard clinical practice
    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 Decision2019-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-10
    P. End of Trial
    P.End of Trial StatusOngoing
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