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    Summary
    EudraCT Number:2014-000221-20
    Sponsor's Protocol Code Number:Nano-Cl_iv
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-25
    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 ConcernedAustria - BASG
    A.2EudraCT number2014-000221-20
    A.3Full title of the trial
    Treatment of Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis with RNS60 Administered Intravenously – a Phase IIa Clinical Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis with RNS60 Administered Intravenously – a Phase IIa Clinical Trial
    A.4.1Sponsor's protocol code numberNano-Cl_iv
    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 SponsorUniversity Hospital Zürich
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRevalesio Corp.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInnsbruck Medical University
    B.5.2Functional name of contact pointClinical Department of Neurology
    B.5.3 Address:
    B.5.3.1Street AddressAnichstrasse 35
    B.5.3.2Town/ cityInnsbruck
    B.5.3.3Post code6020
    B.5.3.4CountryAustria
    B.5.4Telephone number+4351250424279
    B.5.5Fax number+4351250423852
    B.5.6E-mailneurology@i-med.ac.at
    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 nameRNS60
    D.3.2Product code RNS60
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 Yes
    D.3.11.13.1Other medicinal product typeChemically, RNS60 is composed of saline and oxygen. RNS60 meets the USP monograph for 0.9% Sodium Chloride for Injection. RNS60 does not contain an active pharmaceutical ingredient or substance.
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Clinically Isolated Syndrome and Relapsing-remitting Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Clinically Isolated Syndrom and Relapsing-remitting Multiple sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    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 efficacy of RNS60 administered intravenously on MRI measurements of inflammatory disease activity in CIS and RR-MS patients.
    E.2.2Secondary objectives of the trial
    To determine the safety and tolerability of RNS60 administered intravenously in CIS and RR-MS.
    - To assess the efficacy of RNS60 on secondary and tertiary outcome parameters consisting of clinical and MRI efficacy measures.
    - To determine the efficacy of RNS60 on autoreactive T cells and other immune parameters and biomarkers.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Clinically isolated Syndrome or Relapsing-remitting MS (45, 46)

    • Age 18 to 55 years inclusive

    • EDSS at screening ≤ 5.5.

    • Disease duration ≤ 10 years

    • Patients are not eligible for standard therapies, or opted not to start or continue with any of the standard therapies.

    • Patients are able to provide signed informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.

    • To be eligible to proceed to the treatment phase of the study, patients must have ≥ two CELs in the three sequential baseline MRI scans (average of ≥0.66 CELs).

    • Patients cannot have a relapse during 30 days before initiation of treatment. If a relapse occurs during this period and eligibility criteria are otherwise fulfilled, treatment (day one) will be delayed until at least 30 days after receiving steroids. If corticosteroids are administered, the MRI during that period will not be considered. An additional MRI will be added at 4 weeks following the completion of corticosteroids, to maintain a total of three MRIs that are analyzed in the baseline period. In the event of relapse, the baseline period will be prolonged, as necessary, to meet these criteria.
    E.4Principal exclusion criteria
    • Diagnosis of secondary-progressive or primary-progressive MS, as defined by published diagnostic criteria (46).

    • Abnormal screening/baseline blood tests exceeding any of the limits defined below:

    • Serum alanine transaminase or aspartate transaminase levels, which are greater than three times the upper limit of normal values.
    • Total white blood cell count < 3 000/mm3
    • Platelet count < 85 000/mm3
    • Serum creatinine level > 2.0 mg/dl, if serum creatinine level > 1.2 mg/dl, glomerular filtration rate must be determined, patients are excluded if it is <30ml/minute
    • Positive pregnancy test
    • Any other significant clinical abnormality

    • Pregnant or breast-feeding female.

    • History or signs of immunodeficiency.

    • Concurrent clinically significant (as determined by the investigators) cardiac, immunological, pulmonary, neurological, renal or other major disease.

    • Inability to complete an MRI (contraindications for MRI include but are not restricted to known allergy to gadolinium contrast dyes, renal impairment which would contraindicate gadolinium injection, claustrophobia, weight ≥o140 kg, pacemaker, cochlear implants, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, etc.).

    • Patients with cognitive impairments, who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.

    • If prior treatments were administered, the patient must be off treatment for the required period prior to enrollment as defined in the protocol.

    • Prior treatment with other investigational drugs or procedures will be evaluated individually by the investigators.

    • History of alcohol or drug abuse within the 5 years prior to enrolment.

    • Female patients who are not post-menopausal or surgically sterile who are not using an acceptable method of contraception. Acceptability of various methods of contraception will be at the discretion of the investigator. Documentation that the patient is post-menopausal or surgically sterile must be available prior to enrolment.

    • Male patients who are not surgically sterile and not practicing adequate contraception. Acceptability of various methods of contraception will be at the discretion of the investigator and will be discussed in details with all male patients during the informed consent procedure. Documentation that the patient is surgically sterile must be available prior to enrolment.

    • Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient returning for follow-up visits on schedule.

    • Previous participation in this study.

    • Enrolment of the investigator, his/her family members, employees and other dependent persons.
    E.5 End points
    E.5.1Primary end point(s)
    The change in the mean number of CELs during weeks 8-16 (3 MRIs) compared to the mean total number of CELs during the three baseline MRIs (weeks -8 - 0; 3 MRIs).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    1) Safety and tolerability measured by the occurrence of adverse events and serious adverse events (see stopping rules).
    2) The average number of CELs in monthly MRIs at weeks 4-16 after treatment initiation compared to 3 monthly baseline MRIs prior to treatment (weeks -8 – 0).
    3) The cumulative number of newly appearing T2 lesions (weeks 8-16 compared to weeks -8 - 0).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Weeks 16, 24 and 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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    baseline-to-treatment comparison
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    Switzerland
    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 years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 10
    F.1.3Elderly (>=65 years) No
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 16
    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)
    None
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-10-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-29
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