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    Summary
    EudraCT Number:2009-009857-17
    Sponsor's Protocol Code Number:42160443PAI2003
    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:2009-08-19
    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 number2009-009857-17
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Dose-Loading Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-42160443 as Adjunctive Therapy in Subjects With Inadequately Controlled, Moderate to Severe, Chronic Low Back Pain
    A.4.1Sponsor's protocol code number42160443PAI2003
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 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 JNJ42160443
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeJNJ42160443
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 typefully human recombinant monoclonal antibody (IgG2)
    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 injection
    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
    Moderate to severe, chronic, low back pain (LBP) that is not adequately controlled by standard pain therapy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10024891
    E.1.2Term Low back pain
    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 objectives of this study are to evaluate the analgesic effect size over 12 weeks of several doses and dosage regimens of JNJ-42160443 compared with placebo in subjects with moderate to severe, chronic, low back pain (LBP) that is not adequately controlled by standard pain therapy, and to evaluate the safety and tolerability of multiple SC doses of JNJ-42160443 in this population.
    E.2.2Secondary objectives of the trial
    The key secondary objectives of this study are:
    ·Evaluate the efficacy of JNJ-42160443 compared with placebo as measured by back pain disability with subscales and total scores of the Oswestry Disability Index (ODI)
    ·Evaluate the efficacy of JNJ-42160443 compared with placebo as measured by the pain severity and pain interference subscales and total scores from the Brief Pain Inventory (BPI) Short Form
    ·Evaluate the efficacy of JNJ-42160443 compared with placebo as measured by the Patient Global Assessment (PGA)
    ·Evaluate the pharmacokinetics of JNJ-42160043 after multiple dose administrations of JNJ 42160443. A population PK approach will be used to characterize the disposition characteristics of JNJ 42160443 in this study.
    ·Evaluate the immunogenicity (antibodies to JNJ-42160443) associated with JNJ 42160443 treatment
    ·Evaluate the long-term efficacy, safety, and tolerability of JNJ-42160443 in this subject population during the 92-week double-blind extension phase
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    · Potential subjects must satisfy all of the following criteria to be enrolled in the study:
    · Man or woman, 18 to 80 years of age, inclusive
    · Documented clinical diagnosis of moderate to severe, chronic, LBP that must have been present (by history) for at least:
    – ≥20 days/month
    – ≥3 hours/day
    – ≥6 months
    · Have LBP classified by the Quebec Task Force Classification for Spinal Disorders as
    – Category 1: pain without radiation to the extremity or
    – Category 2: pain with radiation proximally to the knee and without neurologic signs
    · Have an average pain intensity score of ≥5 averaged over the last 3 days of pain scores before randomization (Day 1) using an 11-point NRS, where the minimum single assessment score is ≥2. Subjects must have a minimum of 5 out of 6 possible assessments (twice daily assessments for the last 3 days of pain scores).
    · Must be receiving at least 1 of the following analgesic regimens:
    – Stable dose of NSAIDs for a minimum of 5 days each week for the 4 weeks before screening
    – Stable dose of immediate-release opioids for a minimum of 5 days each week for the 4 weeks before screening, but not exceeding 200 mg oral morphine equivalents per day
    – Stable dose of long-acting opioids for the 4 weeks before screening, but not exceeding 200 mg oral morphine equivalents per day; subjects receiving long acting opioids who use immediate-release opioids for breakthrough pain must not exceed, on average, more than 2 doses of immediate-release opioids per day during any 7 day period
    · Have a MMSE score of ≥26 at screening
    · Subjects who are sexually active must consent to utilize and document a medically acceptable and highly effective (<1% per year failure rate) method of contraception throughout the entire study from screening through 6 months after the last dose of study drug
    – Medically acceptable, highly effective methods of contraception that may be used by the subject and/or partner include hormonal oral, transdermal, progestin implant, or injectable contraception, or intrauterine device (IUD), tubectomy or vasectomy
    – For all women of childbearing potential, contraception must be consistently used for at least 3 months before the first dose of study drug through 6 months after the last dose of study drug. The screening phase may be extended up to 3 months to meet this requirement, but baseline safety evaluations must be performed within 3 weeks before the first dose of study drug.
    – Subject or partner may also be postmenopausal (states having not experienced a menstrual period for a minimum of 12 months) or surgically sterile
    – Further, subjects must agree to not donate sperm or eggs or attempt conception (pregnancy) from screening through 6 months after the last dose of study drug
    · Women of childbearing potential must have a negative serum b human chorionic gonadotropin (b hCG) pregnancy test at screening and a negative urine b hCG pregnancy test at randomization (Day 1)
    · Medically stable on the basis of physical examination, medical history, vital signs, clinical laboratory tests, and 12-lead ECG performed at screening
    · Willing/able to comply with study procedures and evaluations specified in the protocol, including the completion of all PRO scales and questionnaires
    · Willing/able to adhere to the prohibitions and restrictions specified in this protocol
    · Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
    · To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Refusal to give consent for this component does not exclude a subject from participation in the clinical study.
    To enter the double-blind extension phase, subjects must meet the following criteria:
    · Must have completed the double-blind efficacy phase of the study
    · Women of childbearing potential must have a negative urine b hCG pregnancy test at the end of the double-blind efficacy phase (Week 13)
    E.4Principal exclusion criteria
    Potential subjects who meet any of the following criteria will be excluded from participating in the study:
    • Have LBP classified by the Quebec Task Force Classification for Spinal Disorders as
    – Category 3: pain with radiation distally beyond the knee and without neurologic signs or
    – Category 4: Pain with radiation to the extremity and with neurologic signs (eg, focal muscular weakness, asymmetry of reflexes, sensory loss in a dermatome)
    • History within the past year of any of the following:
    – Seizure disorder
    – Intrathecal therapy, epidural therapy, and ventricular shunts
    – Mild or moderate traumatic brain injury
    – Stroke
    – Transient ischemic attack
    – Meningitis
    • History of brain injury within the past 15 years consisting of ≥1 of the following, or with residual sequalae suggesting transient changes in consciousness:
    – Brain contusion
    – Intracranial hematoma
    – Either unconsciousness or posttraumatic amnesia lasting more than 24 hours
    • History of epilepsy or multiple sclerosis
    • Current diagnosis of fibromyalgia, complex regional pain syndrome (including reflex sympathetic dystrophy or causalgia), acute spinal cord compression, bowel or bladder dysfunction as a result of cauda equine compression, back pain caused by secondary infection, or pain caused by confirmed or suspected neoplasm
    • Any new or unresolved neurologic deficits, including progressive deficits, within 6 months before screening. Transient neurologic deficits that are resolved within this period can be allowed if approved by the investigator.
    • Active peripheral neuropathy, paresthesia, or dysesthesia, or any other previously diagnosed neurologic condition causing the above noted symptoms, except those related to their lumbosacral radiculopathy
    • History of ocular herpes simplex, HSV pneumonia, or HSV encephalitis
    • History of primary HSV infection and/or recurrent reactivation within the past 2 years or prophylactic therapy for HSV within the past 2 years
    • Currently receiving chronic systemic immunosuppressive therapy
    • Have undergone a surgical procedure for LBP within 6 months before the screening visit or planned surgery for LBP during the 12-week double-blind efficacy phase
    • History of a major surgical procedure (ie, involving general or regional anesthesia), significant trauma, or a nonhealing wound or ulcer within 3 months before the screening visit
    • Have had nerve or plexus block, including epidural steroid injections or facet blocks, within the 4 weeks before the screening visit
    • History of diabetes mellitus or laboratory results consistent with diabetes mellitus (ie, fasting glucose ≥126 mg/dL or ≥7 mmol/L)
    • Alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) ≥2.5 times the upper limit of normal (ULN)
    • Serum creatinine of ≥1.8 mg/dL
    • Have a Body Mass Index (BMI) of >39 kg/m2
    • History of drug or alcohol abuse within the past 5 years
    • History of or suspected human immunodeficiency virus (HIV) infection (Note: HIV testing is not required for this study)
    • Severe depression as defined by a score of ≥29 on the BDI-II at screening
    • Any other chronic pain condition that, in the investigator’s opinion, would interfere with the assessment of chronic LBP (eg, OA, rheumatoid arthritis, postherpetic neuralgia)
    • History of malignancy within the past 2 years, with the exception of basal cell carcinoma that has been successfully treated
    • Uncontrolled cardiovascular disease or hypertension (repeated systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >100 mmHg
    • Prior treatment with experimental NGF inhibitor therapy
    • Known allergies, hypersensitivity, or intolerance to JNJ-42160443 or its excipients or mammalian cell-derived (ie, Chinese hamster ovary) products
    • Received an investigational drug or used an investigational medical device within 30 days before the screening visit (or 5 half-lives of the investigational drug, whichever is longer) or are currently enrolled in an investigational study
    • Pregnant or breast-feeding
    • Pending litigation due to chronic pain or disability
    • Any condition that, in the opinion of the investigator, would compromise the well being of the subject or the study or prevent the subject from meeting or performing study requirements
    • Employees of the investigator or site, with direct involvement in the proposed study or other studies under the direction of that investigator or site, as well as family members of the employees or the investigator
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline to the end of the 12-week double-blind efficacy phase in the average LBP-related pain intensity score.
    Key secondary efficacy evaluations are:
    · ODI subscales and total score
    · BPI Short Form pain severity and pain interference subscales
    · PGA
    Exploratory evaluations are:
    · Rescue medication use
    · Average pain intensity in the last 24 hours for up to 2 significant sources of pain not related to LBP
    · Daily sleep interference assessments
    · MOS Sleep Scale subscales
    · SF-36 Health Survey subscales
    · Work Productivity Questionnaire
    · Subject experience using the STEP interview
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    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 No
    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.8.3 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 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
    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.1.1.1In 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.1.3Elderly (>=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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 360
    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 Decision2009-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
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