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    Summary
    EudraCT Number:2008-008392-34
    Sponsor's Protocol Code Number:20062017
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-18
    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 ConcernedLatvia - SAM
    A.2EudraCT number2008-008392-34
    A.3Full title of the trial
    A Multi-center, Randomized, Double-blind, Placebo-controlled Study of AMG 785 in Skeletally Mature Adults with a Fresh Unilateral Tibial Diaphyseal Fracture Status Post Definitive Fracture Fixation with an Intramedullary Nail - Study To Assess Healing of Repaired Tibias with SclerosTin Antibody (STARTT)
    A.3.2Name or abbreviated title of the trial where available
    Study To Assess Healing of Repaired Tibias with SclerosTin Antibody (STARTT)
    A.4.1Sponsor's protocol code number20062017
    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 SponsorAmgen Inc
    B.1.3.4CountryUnited States
    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.3.1Product nameAMG 785
    D.3.2Product code AMG 785
    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.3.8INN - Proposed INNAMG 785
    D.3.9.2Current sponsor codeAMG 785
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 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 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
    Acceleration of fracture healing
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level PT
    E.1.2Classification code 10043827
    E.1.2Term Tibia fracture
    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
    To investigate the effect of AMG 785 compared to placebo on time to radiographic healing of fresh tibial diaphyseal fractures.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of AMG 785 compared to placebo on
    • Physical functioning as measured by Short Form (36) Health Survey Physical Functioning subscale (SF-36 PF)
    • Incidence of unplanned revision surgery
    • Time to clinical healing as determined by the ability to bear weight on the fractured limb and the absence of pain at the fracture site (Functional Index in Trauma, FIX-IT)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Study Title:

    Dual energy X-ray Absorptiometry (DXA) sub-study,

    Date, Version:

    25 March 2009, Amendment 1

    Related Objectives:

    To investigate the percent change from baseline in lumbar spine BMD at Week 52.

    E.3Principal inclusion criteria
    Skeletally mature adults, age ≥ 18 to ≤ 85 years at randomization, with radiographically closed growth plates.

    Fresh unilateral closed or Gustilo type I or type II open tibia diaphyseal fracture (fracture line must not extend into the ankle or knee joint) as the primary injury.

    For closed fractures: Definitive fracture fixation with reamed IM nailing (modern, statically, interlocking nail) performed no later than 14 days after injury.

    For Gustilo type I/II open fractures: Definitive fracture fixation with reamed or unreamed IM nailing (modern, statically, interlocking nail) performed no later than 24 hours after injury.
    E.4Principal exclusion criteria
    Major polytrauma or significant axial trauma, with injury severity score >16

    Head-injury, as defined by Glasgow Coma Scale <13 at time of randomization

    Associated fracture of the lower extremity or any other condition that, in the opinion of the surgeon, will delay the subject’s ability to bear weight beyond the normal time expected for a tibial shaft fracture

    Use of bone grafts at the time of definitive fracture fixation

    History of pathological fracture or metabolic or bone disease that may interfere with the interpretation of the results, such as Paget’s disease, rheumatoid arthritis, osteomalacia, osteogenesis imperfecta, osteopetrosis, ankylosing spondylitis, Cushing’s disease, hyperprolactinemia

    History of symptomatic spinal stenosis that has not been surgically corrected. If surgically corrected, the subject must be asymptomatic to be eligible for the study

    History of facial nerve paralysis

    Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical carcinoma in situ) within the last 5 years

    History of solid organ or bone marrow transplants

    Evidence of any of the following per subject report, chart review or local laboratory result (currently or within the past 5 years):
    • Elevated transaminases (a) Serum aspartate aminotransferase (AST; serum glutamate-oxaloacetic transaminase [SGOT]) ≥ 2.0 x upper limits of normal; (b) Serum alanine aminotransferase (ALT; serum glutamate-pyruvate transaminase [SGPT]) ≥ 2.0 x upper limits of normal
    • Significantly impaired renal function as determined by a derived creatinine clearance of ≤ 30 mL/min using the Modification of Diet in Renal Disease equation (Levey et al, 1999). The estimated glomerular filtration rate is calculated as follows: estimated glomerular filtration rate (mL/min/1.73m2) = 186 x [Serum creatinine (mg/dL)]-1.154 x [Age]-0.203 x [0.742 if subject is female] x [1.210 if subject is black].

    Per subject report, chart review or local laboratory result, evidence of current hypercalcemia or hypocalcemia, outside of 1.1x the normal range set by the local laboratory

    Known to have tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen

    Use of the following agents affecting bone metabolism:
    • Intravenous bisphosphonates at any time
    • Denosumab at any time
    • Fluoride (for osteoporosis) within the past 24 months
    • Oral bisphosphonates, parathyroid hormone or strontium within the past 12 months
    • Calcitonin, selective estrogen receptor modulators, systemic oral or transdermal estrogen within the past three months (estrogen-containing contraceptive therapy is permitted)
    • Systemic glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than 10 days) within the past three months
    • Tibolone within the past three months
    • BMP-2 or BMP-7 at the time of definitive fracture fixation

    Current use of anticoagulants (doses for deep vein thrombosis prophylaxis are permitted)

    General
    • Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
    • Previous enrollment in an AMG 785 clinical study
    • Subject of child-bearing potential who is pregnant (eg, positive human chorionic gonadotropin test) or is breast-feeding
    • Females of childbearing potential: Subject refuses to use an effective contraception (or true abstinence) in order to achieve a highly effective contraception result during treatment with study drug and for an additional 3 months after the end of treatment with study drug (ie, 3 months after the week 12 study visit)
    • Known intolerance to calcium supplements or vitamin D products
    • Known sensitivity to mammalian cell derived drug products
    • Any kind of disorder that, in the opinion of the investigator,
    − compromises the ability of the subject (or legally acceptable representative) to give written informed consent
    − prevents the subject from complying with study procedures
    − prevents the subject from completing the study
    − interferes with the interpretation of the study results
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the time to radiographic healing for the AMG 785 and placebo groups, defined as bridging of three out of four cortices. Radiographic fracture healing will be determined by a panel of independent reviewers (orthopaedic/trauma surgeons and radiologists) blinded to treatment.
    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 No
    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 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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 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
    End of study (EOS) is defined as the date the last eligible subject completes the final study visit at Week 52.
    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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 248
    F.4.2.2In the whole clinical trial 400
    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 Decision2009-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-26
    P. End of Trial
    P.End of Trial StatusCompleted
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