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    Summary
    EudraCT Number:2012-004373-80
    Sponsor's Protocol Code Number:ASBI603
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-05
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-004373-80
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects with Acute Spinal Cord Injury
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the effect of a drug called SUN13837 on spinal cord injury and how safe the drug is.
    A.4.1Sponsor's protocol code numberASBI603
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01502631
    A.5.4Other Identifiers
    Name:IND NumberNumber:105,377
    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 SponsorAsubio Pharmaceuticals, 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 supportAsubio Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAsubio Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address399 Thornall Street
    B.5.3.2Town/ cityEdison
    B.5.3.3Post codeNJ 08837
    B.5.3.4CountryUnited States
    B.5.4Telephone number+001201368 5020
    B.5.5Fax number+001201225 1358
    B.5.6E-mailinfo@asubio.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.3.1Product nameSUN13837 Injection
    D.3.2Product code SUN13837
    D.3.4Pharmaceutical form Injection
    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 INNSUN13837
    D.3.9.1CAS number 1080650-67-4
    D.3.9.2Current sponsor codeSUN13837
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 placeboInjection
    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
    Acute spinal cord injury
    E.1.1.1Medical condition in easily understood language
    damage to the spinal cord
    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 17.0
    E.1.2Level HLT
    E.1.2Classification code 10041545
    E.1.2Term Spinal cord and nerve root disorders traumatic
    E.1.2System Organ Class 100000004852
    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 of this study is to determine if treatment of ASCI with SUN13837, when compared with placebo, will result in a greater improvement in measures of overall functional independence by a comparison of the difference in the final mean total Spinal Cord Independence Measure, version III (SCIM III) scores between the 2 treatment groups.
    E.2.2Secondary objectives of the trial
    SECONDARY OBJECTIVES:
    • To determine if treatment of ASCI with SUN13837, when compared with placebo, will result in:
    - greater improvement in Total Motor Score at the final SCIM III assessment
    - greater improvement in self-care and mobility by a comparison of the final mean SCIM III related subscale scores combined
    - greater improvement in AIS grade
    • To evaluate the PK of SUN13837 in ASCI subjects and to evaluate exploratory PK/PD relationships between SUN13837 exposure and selected efficacy endpoints
    • To evaluate the safety of SUN13837 versus placebo using standard measures of safety (physical examinations, vital signs, 12 lead ECGs, clinical laboratory parameters, and AE reporting)

    EXPLORATORY OBJECTIVES:
    To assess differences in:
    - the mean total SCIM III scores between the 2 treatment groups
    - the mean SCIM III subscale scores between the 2 treatment groups
    - the proportion of responders between the 2 treatment groups based on AIS grade and ISNCSCI score
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Acute traumatic injury to the cervical neurological spinal cord as follows:
    a. AIS grade A with a level of injury at either C4, C5, C6, or C7 (for C4, the subject must have at least 1 point of motor activity within the ZPP inclusive of C5 to T1). In addition, the AIS A subject may be included if ALL of the following are present 1) the most caudal intact sensory segment (both pinprick and light touch) is C3, 2) at least one side (right or left) has both intact pinprick and light touch sensation in the C4 dermatome, AND 3) at least 1 point of motor activity within the zone of partial preservation (ZPP) inclusive of C5 to T1
    b. AIS grade B or C with a neurological level of injury at either C3, C4, C5, C6, C7, or C8
    2. Closed single traumatic spinal cord injury occurring within 12 hours of first dosing
    3. Male or female cervical AIS A subjects ≥16 to ≤80 years and male or female cervical AIS B or C subjects ≥16 to ≤70 years
    4. Females of childbearing potential and males must agree to maintain adequate contraception (eg, condoms, intrauterine devices, diaphragm, spermicide, contraceptive patch, oral contraceptive pills, progestin injections, under-skin contraceptive implants, vaginal ring) for the first 35 days of the study
    E.4Principal exclusion criteria
    1. Unable to obtain informed consent (either from the subject or from the subject‘s Legally Authorised Representative)
    2. Women who are breastfeeding (if unwilling to stop for the first 35 days of the study) or are pregnant
    3. Coma or significant impairment in the level of consciousness that interferes with the performance or interpretation of protocol specified assessments
    4. Any disease, concomitant injury, or condition that interferes with the performance or interpretation of the protocol specified assessments
    5. Unable, as determined by the investigator, or unwilling to discontinue use of potent P-glycoprotein (P-gp) inhibitors (cyclosporine A, erythromycin, itraconazole, ketoconazole, nelfinavir, quinidine, reserpine, ritonavir, saquinavir, tacrolimus, and verapamil) for the first 35 days of the study
    6. Unable, as determined by the investigator, or unwilling to discontinue use of potent cytochrome P450 (CYP) 3A4/5 inducers (eg, phenytoin, carbamazepine, oxcarbazepine, phenobarbital, efavirenz, nevirapine, etravirine, rifampicin, modafinil, hyperforin [constituent of St Johns Wort], and cyproterone) for the first 35 days of the study
    7. Renal compromise (serum creatinine greater than 1.5 times the age- and sex-appropriate Upper Limit of Normal (ULN) for the local laboratory) at screening before the first dose of study drug
    8. Severe hepatic dysfunction (serum ALT, AST, and GGT ALL greater than 2.5 times the age- and sex-appropriate ULN) OR hepatic impairment (detectable ascites, serum bilirubin greater than 2 mg/dL, serum albumin less than 3.5 g/dL, and prothrombin time prolonged by more than 6 seconds above the ULN for the local laboratory in the absence of anticoagulant therapy) at screening before the first dose of study drug
    9. Concomitant spinal cord injury or abnormality as determined by routine imaging:
    a. Conclusive radiological evidence of complete spinal cord transection
    b. Multiple injuries to the neurological spinal cord at different levels
    10. History of symptomatic cervical spinal stenosis with myelopathy as a factor confounding subject assessment
    11. Unlikely to be available for follow-up as specified in the protocol
    12. Participated in a previous clinical study and received an investigational product within 30 days of screening
    13. Previous exposure to SUN13837
    14. Allergy to SUN13837 or any of its excipients
    15. Any other issue which, in the opinion of the investigator, will make the subject unsuitable for study participation
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is a comparison of the difference in the mean total SCIM III score between the 2 treatment groups at Day 112 (±7 days).
    E.5.1.1Timepoint(s) of evaluation of this end point
    AIS grades will be recorded at baseline and at Day 112 (±7 days).
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    • Comparison of TMS from baseline to the final SCIM III assessment for placebo and SUN13837 treated subjects
    • Comparison of the mean SCIM III Self Care and Mobility subscale scores for placebo and SUN13837 treated subjects at Day 112 (±7 days)
    • Comparison of AIS grade from baseline to final assessment for placebo and SUN13837 treated subjects

    Supportive and Exploratory Endpoints
    • Mean SCIM III total scores at Day 14 (±2 days); the final dosing day, Day 27 or 28 (±2 days); and Day 56 (±7 days)
    • Comparison of the mean SCIM III Self Care subscale score for placebo and SUN13837 treated subjects at Day 14 (±2 days); the final dosing day, Day 27 or 28 (±2 days); Day 56 (±7 days); and Day 112 (±7 days)
    • Comparison of the mean SCIM III Respiration and Sphincter Management and Mobility subscale scores for placebo and SUN13837 treated subjects at Day 112 (±7 days)
    • Proportion of SUN13837- and placebo-treated subjects who are defined as responders. A responder, based on baseline cervical AIS grade, is defined as a subject who has reached the following outcome at Day 112 (±7 days) as described below.
    • For cervical AIS A subjects at baseline: an improvement of 2 or more motor levels from baseline on either the right or left side. Motor level is determined from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Scale
    • For cervical AIS B or C subjects at baseline: a total Lower Extremity Motor Score (LEMS) of 40 or more points, as determined from the ISNCSCI Scale
    • Proportions of placebo and SUN13837 treated subjects who are responders as per the definition on Day 3 (within 12 hours postdose); Day 14 (±2 days); the final dosing day, Day 27 or 28 (±2 days); and Day 56 (±7 days) for assessment of onset of effect
    • Change in TMS from baseline to Day 3 (within 12 hours postdose); Day 14 (±2 days); the final dosing day, Day 27 or 28 (±2 days); Day 56 (±7 days); and Day 112 (±7 days)
    • Proportions of placebo and SUN13837 treated subjects who improve 1 or more AIS grades from baseline to Day 3 (within 12 hours postdose); Day 14 (±2 days); the final dosing day, Day 27 or 28 (±2 days); Day 56 (±7 days); and Day 112 (±7 days)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy:
    Scores will be recorded on the following days:
    -SCIM III total score: Day 112.
    -Total Motor Score, motor ZPP and AIS grades: baseline and on Days 3, 14, 27 or 28 (the final dosing day), 56 and 112.
    -SCIM III subscales scores: Days 14, 27 or 28, 56 and 112.

    Safety:
    - physical examinations: Days 1, 3, 14, 27 or 28, 56, 112 and and 182.
    - Vital signs, clinical laboratory testing (chemistry, hematology, coagulation, and urinalysis), and ECGs: Days 1, 3, 14, 27 or 28, and 56
    -Where applicable, urine pregnancy testing: pre-dose on Days 1 and 27 or 28.
    -Adverse events will be recorded throughout the duration of the study.

    PK/PD:
    Blood samples will be collected after the following doses: 1st, 3rd (for rich sampling scheme), 14th and (pre-dose) 28th.
    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.8.2.4Number 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    Canada
    Czech Republic
    France
    Poland
    Spain
    United Kingdom
    United States
    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 years2
    E.8.9.1In the Member State concerned months9
    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 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 Yes
    F.1.1Number of subjects for this age range: 3
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    For subjects incapable of giving consent for physical or physiological reasons, or reasons linked to their medical condition, informed consent will be obtained from the subject’s legally authorized representative.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 11
    F.4.2.2In the whole clinical trial 70
    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)
    Patient will revert back to their initial drugs or may opt for surgical management after completion of the study because this drug is not approved for treatment of acute spinal cord injury.
    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 Decision2013-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-21
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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