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    Summary
    EudraCT Number:2019-003625-16
    Sponsor's Protocol Code Number:TG1101-RMS303
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-03-03
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-003625-16
    A.3Full title of the trial
    An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis
    A.4.1Sponsor's protocol code numberTG1101-RMS303
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04130997
    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 SponsorTG Therapeutics, 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 supportTG Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBrillance Sp. z o.o.
    B.5.2Functional name of contact pointIzabela Kozdraś-Urbanek
    B.5.3 Address:
    B.5.3.1Street AddressKrólowej Jadwigi 167B
    B.5.3.2Town/ cityKraków
    B.5.3.3Post code30-212
    B.5.3.4CountryPoland
    B.5.4Telephone number+48668166876
    B.5.5Fax number+48327390088
    B.5.6E-mailikozdras@brillance.pl
    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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameUblituximab
    D.3.2Product code TG-1101
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNUBLITUXIMAB
    D.3.9.1CAS number 1174014-05-1
    D.3.9.2Current sponsor codeTG-1101
    D.3.9.3Other descriptive nameLFB-R603, TGTX1101
    D.3.9.4EV Substance CodeSUB182428
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) 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 Yes
    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
    Relapsing Multiple Sclerosis
    E.1.1.1Medical condition in easily understood language
    Relapsing Multiple Sclerosis
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 27.0
    E.1.2Level PT
    E.1.2Classification code 10080700
    E.1.2Term Relapsing multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety and efficacy of ublituximab therapy in subjects with relapsing forms of MS.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Complete the 96-week double-blind TG1101-RMS301 or TG1101-RMS302 study OR complete the final Week 208 visit of the TG1101-RMS201E study.
    2. Investigator believes may benefit from treatment with ublituximab
    3. Are able and willing to provide written informed consent (e.g., before the first infusion) and to comply with the study protocol
    4. Female subjects of child-bearing potential, and male partners must consent to use a medically acceptable method of contraception from consent, throughout the study period, and for 20 weeks after the last dose of ublituximab
    E.4Principal exclusion criteria
    1. Any significant or uncontrolled medical condition or treatment-emergent, clinically significant laboratory abnormality such as:
    a. Absolute neutrophil count < 1.5 x 10e3/µL
    b. Hematocrit < 24%
    c. Platelet count < 150,000 cell/mm3
    d. Hypogammaglobulinemia IgG < 4.0 g/L
    2. Active infection
    3. Ongoing pregnancy (female subjects)
    4. Subjects who discontinued ublituximab treatment or withdrew consent from the TG1101-RMS301 or TG1101-RMS302 study during the 96-week evaluation period OR prior to completing the final Week 208 visit of the TG1101-RMS201E study.
    5. Subjects who have started any disease modifying therapy (DMT), stem cell transplantation, or participation in any other interventional clinical trial after completion of the 96-week visit in the TG1101-RMS301 or TG1101-RMS302 study OR after completing the final Week 208 visit of the TG1101-RMS201E study.
    6. Subjects who have had a confirmed MS relapse within the past 30 days prior to Week 1 Day 1 (W1D1). Following a relapse, subjects must be neurologically stable for at least 30 days prior to screening or W1D1 of the OLE.
    7. Subjects with unstable disease activity
    8. Presence of malignancy, except for surgically excised basal or squamous cell skin lesions
    9. Vaccination with live virus within 2 months of randomization
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints:

    Relapses:
    • Annualized Relapse Rate (ARR) is defined as the number of relapses per-subject year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years).

    MRI parameters:
    • T1 gadolinium enhancing (Gd-enhancing)
    • T1 hypointense lesions
    • T2 lesions
    • Brain atrophy

    Disability:
    • 24-Week Confirmed Disability Progression (CDP)
    • 24-Week Confirmed Disability Improvement (CDI)
    • Mean change from baseline in EDSS score

    No Evidence of Disease Activity (NEDA):
    NEDA is defined as subjects without relapses, MRI activities (no T1 Gd+ lesions and no new/enlarging T2 lesions), and no 24-week confirmed disability progression.
    • The percent of subjects with no evidence of disease activity

    Cognition and Function:
    • Cognition will be measured by Symbol Digit Modalities Test (SDMT)
    • Function will be measured by Multiple Sclerosis Functional Composite (MSFC)

    Safety Endpoints:
    All AEs will be reported and evaluated during the treatment period using National Cancer Institute (NCI) CTCAE version 5.0 grading system; the number and severity of infusion-associated events, defined as infusion related AEs reported during or within 24 hours of an infusion; the number and severity of infectious AEs; any clinically significant changes in laboratory or vital sign measurements; the incidence of anti-drug antibodies (antibodies developed against ublituximab) to assess safety over the entire study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Endpoints will be evaluated in different time points during study according to the flow chart included in the study protocol.
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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
    Immunogenicity
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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
    Continuation study to TG1101-RMS301, TG1101-RMS302 and RMS201E studies.
    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 trial1
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Ukraine
    Belarus
    Georgia
    Russian Federation
    Serbia
    United States
    Croatia
    Poland
    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
    The end of the study is defined as the last subject to complete or withdraw from the EIM.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months10
    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.1.2.1Number of subjects for this age range: 1100
    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 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 state111
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 173
    F.4.2.2In the whole clinical trial 1100
    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)
    Treatment per Standard of Care
    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 Decision2020-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-10
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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