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    Summary
    EudraCT Number:2017-004049-26
    Sponsor's Protocol Code Number:MTX-071-P02
    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:2017-10-25
    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 number2017-004049-26
    A.3Full title of the trial
    Lopain (MTX-071 / resiniferatoxin)

    An open label, single dose phase Ib/IIa study to determine the safety and clinical effects of intra-articular injections of low doses of Lopain (MTX-071) in patients with chronic osteoarthritic knee joint pain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lopain (MTX-071 / resiniferatoxin)
    Study to determine the safety and clinical effects of intra-articular injections of low doses of Lopain (MTX-071) in patients with chronic osteoarthritic knee joint pain
    A.4.1Sponsor's protocol code numberMTX-071-P02
    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 SponsorMestex
    B.1.3.4CountrySwitzerland
    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 supportMestex AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSGS Belgium NV - Life Science Services
    B.5.2Functional name of contact pointKristof Lesneuck
    B.5.3 Address:
    B.5.3.1Street AddressLange Beeldekensstraat 267
    B.5.3.2Town/ cityAntwerp
    B.5.3.3Post code2060
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32(0)3217 25 60
    B.5.6E-mailkristof.lesneuck@sgs.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 nameLopain
    D.3.2Product code MTX-071
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNResiniferatoxin
    D.3.9.1CAS number 57444-62-9
    D.3.9.2Current sponsor codeRTX
    D.3.9.3Other descriptive nameRESINIFERATOXIN
    D.3.9.4EV Substance CodeSUB178982
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.4
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronic osteoarthritic knee-joint pain
    E.1.1.1Medical condition in easily understood language
    Pain due to degenerative lesions of the knee joint
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10031161
    E.1.2Term Osteoarthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 is to document the safety and tolerability of intra-articular injections of low doses of MTX-071 based on the incidence, nature and severity of AES /SAEs potentially causally related with the study medication.
    E.2.2Secondary objectives of the trial
    • to document the pain-relieving effect (based on VAS) and its duration,
    • to investigate the pain-relieving effect (based on WOMAC score) and its duration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent
    • Otherwise healthy (or with stable medical conditions) men or women with knee osteoarthritis aged between 45 and 75 years (extremes included).
    • At least 40 mm on motion and at least 10 mm at rest on the 100 mm-VAS (Visual Analog Scale) for average osteoarthritic joint pain in the knee to be studied during the last 2 days, with or without pain medication.
    • Previous assessment (e.g. radiography, MRI or arthroscopy) showing a Kellgren Lawrence Grade 2 – 4 severity.
    • Female patients of childbearing potential or female partners of childbearing potential of male patients must agree to use a reliable contraceptive method for at least three months after the injection of MTX-071.
    • Subject is highly likely to comply with the protocol and complete the study.
    E.4Principal exclusion criteria
    • Previous exposure to the study drug of the target knee.
    • Any contra-indication as per summary of product characteristic for the premedication used for the concerning patient
    • Surgery of the target knee within 6 months before study start or planned for any time during the next 6 months.
    • Any injection into the knee to be studied within the preceding month or trauma to the knee not yet healed.
    • History of uncontrolled cardiovascular, renal, and/or other disease or malignancy.
    • History of severe allergic or anaphylactic reactions.
    • Pregnancy or wanting to become pregnant during the study.
    • Major bleeding disorder encompassing, but not limited to coagulopathy and any current antithrombotic and anticoagulant. Low dose acetylsalicylic acid for cardiovascular prevention can be allowed in consultation with the medical monitor.
    • Clinically significant (upon the discretion of the investigator) deviation from the normal laboratory values.
    • Clinically significant (at the discretion of the investigator) abnormal ECG.
    • History of drug/chemical/
    substance/alcohol abuse within the past 2 years prior to screening.
    • Significant (upon the discretion of the investigator) symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within the past 2 weeks prior to study medication administration.
    • Patients positive for human immunodeficiency virus (HIV) antibody, hepatitis C antibody, or for hepatitis B virus surface antigen (HBsAg).
    • Patients who had a corticosteroid injection in the knee to be studied within 3 months prior to baseline or are planned to get a corticosteroid injection within 4 weeks following the injection of MTX-071.
    • Systemic (except inhaled) immunosuppressant agent within 6 months prior to study medication administration.
    • Experimental agent within 30 days or ten half-lives, whichever is longer, prior to study medication administration.
    • Any other condition, which in the opinion of the investigator, precludes the subject’s participation in the trial.
    • Patients who are dependent on the sponsor or investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Occurence of adverse events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuous assessment up to 6 months after injection.
    E.5.2Secondary end point(s)
    Safety and efficacy endpoints.
    E.5.2.1Timepoint(s) of evaluation of this end point
    during the trial
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 No
    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.8.2.4Number of treatment arms in the trial4
    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 concerned3
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state24
    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)
    see protocol
    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 Decision2017-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-24
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