ATX-MS-1467 in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: ATX-MS-1467
Intervention description: Subjects will receive ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: ATX-MS-1467 (MSC2358825A); Relapsing Multiple Sclerosis; Magnetic resonance imaging (MRI); M2736

Summary:

      This is a multi-center, open-label, single arm, baseline-controlled Phase 2a trial to
      evaluate the clinical and biological effects of ATX-MS-1467 in subjects with relapsing
      multiple sclerosis (MS) and to assess the maintenance of any such effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female out-patients aged 18 to 65 years of age inclusive at the time of
             informed consent

          -  Willing and able to provide written informed consent and to comply with the
             requirements of the protocol assessments/procedures

          -  Relapsing MS (relapsing-remitting multiple sclerosis [RRMS], secondary progressive
             multiple sclerosis [SPMS], as defined by the revised McDonald criteria [2010]) (11)

          -  Clinical evidence of recent MS activity and radiological activity on gadolinium
             (Gd)-enhanced magnetic resonance imaging (MRI) defined as defined in the protocol

          -  Expanded disability status scale (EDSS) score 0-5.5

          -  Human leukocyte antigen-beta chain (HLA-DRB)1*15 positive

          -  Neurological stability in the 30 days prior to Visit 5 (Study Day 1)

          -  Prior vaccination against tuberculosis (TB)

          -  If female, unless post-menopausal (for at least 2 years) or surgically sterilized,
             must be willing to use two highly effective methods of contraception throughout the
             entire duration of the trial and for 90 days following the last dose of ATX-MS-1467

          -  If male, must be willing to use two highly effective methods of contraception
             throughout the entire duration of the trial and for 90 days following the last dose of
             ATX-MS-1467

        Exclusion Criteria:

          -  Primary progressive MS

          -  Inability to comply with MRI scanning, including contra-indications to MRI such as
             known allergy to gadolinium contrast dyes, claustrophobia, presence of a pacemaker,
             cochlear implants, ferromagnetic devices or clips, intracranial vascular clips,
             insulin pumps, nerve stimulators

          -  Previous treatment with beta-interferon, plasma exchange, intravenous gamma globulin
             within the 8 weeks prior to study Day 1 (Visit 5), steroids (administered via the oral
             and/or parenteral routes) or adrenocorticotropic hormone within the 30 days prior to
             the Visit 2 MRI scan, glatiramer acetate, cytotoxic agents

          -  Prior exposure to dimethyl fumurate (BG-12) or dirucotide, any disease-related T cell
             vaccine or peptide-tolerizing agent for the treatment of MS, including ATX-MS-1467

          -  Use of any investigational drug or experimental procedure for MS (including cytokine
             or anticytokine therapy) within the 30 days prior to screening (Visit 1)

          -  Inadequate liver function as defined in the protocol.

          -  Lymphocyte count less than (<)500 per micro liter (/mcL) or neutrophil count < 1500
             mcL at screening or at any of the pre-treatment visits (Visits 2-4)

          -  Major medical illness as defined in the protocol

          -  Known history of active or chronic infectious disease or any disease which compromises
             immune function

          -  Any renal condition that would preclude the administration of gadolinium

          -  History of malignancy, including both solid tumor and hematological malignancies, but
             excluding basal cell and in situ squamous cell carcinomas of the skin that have been
             excised and resolved, in situ cervical cancer or prostatic cancer with normal
             prostatic specific antigen

          -  Clinical evidence of severe uncontrolled depression, active suicidal ideation or
             suicide attempt

          -  Any other significant medical or psychiatric conditions that, in the opinion of the
             Investigator, would preclude participation in the trial or impair the ability to give
             informed consent

          -  Major surgery in the 4 weeks prior to screening (Visit 1)

          -  Known hypersensitivity to the trial medication or diluents

          -  Participation in another clinical trial within the 30 days prior to screening (Visit
             1)

          -  Pregnancy, lactation or a positive pregnancy test during screening (urine dipstick) or
             at Visit 4 (serum beta-human chorionic gonadotrophin [beta-hCG]), or intention to
             become pregnant or to breast-feed during the course of the trial

          -  Legal incapacity or limited legal capacity