ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: ATX-MS-1467
Intervention description: Disease specific immune modulating treatment for multiple sclerosis
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple sclerosis; Immunomodulation; Phase 1

Summary:

      Phase 1 study to assess the safety and biological activity of ATX-MS-1467 in patients with
      relapsing forms of multiple sclerosis. This will be an open label upward dose titration
      involving injections on 9 occasions, each two weeks apart. After dosing is complete there
      will be a 22 week follow up period. Blood samples will be drawn throughout the study to
      monitor safety and the body's response to the injections and MRI scans will be performed on
      several occasions to follow the course of the multiple sclerosis during the trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. Patients who have definite relapsing multiple sclerosis disease as defined by the
             McDonald criteria (McDonald et al., 2001 and 2005) and as assessed by a neurologist.

             2. HLA DRB1*15 positive.

             3. High baseline levels of T-cell proliferation in response to myelin basic protein,
             defined as >1000 cpm with a >3 stimulation index compared to background.

             4. Disease duration equal to or less than 10 years (from the first clinical event).

             5. At least one documented relapse in the previous 12 months or two relapses within
             the previous 24 months prior to screening.

             6. Must be in a clinically stable or improving neurological state during the 28 days
             preceding Screening.

             7. EDSS score < 5.5.

        Exclusion Criteria:

          -  1. Subjects treated with β-interferon, plasma exchange, intravenous gamma globulin
             within the 3 months prior to Study Day 1 2. Subjects treated with glatiramer acetate
             at any time in the past 3. Subjects who have been treated with parenteral steroids or
             adrenocorticotropic hormone within 3 months days prior to Study Day 1 4. Prior
             treatment with: cytotoxic agents (including but not limited to cladribine,
             mitoxantrone, cyclophosphamide, azathioprine, methotrexate), fingolimod, laquinimod,
             teriflunomide, total lymphoid irradiation, stem cell or bone marrow transplantation,
             or monoclonal antibody therapy (including natalizumab, daclizumab, alemtuzumab) 5.
             Prior use of disease related T-cell vaccine or peptide-tolerising agent to treat MS 6.
             Use of any investigational drug or experimental procedure within 6 months prior to
             Study Day 1 including cytokine or anti-cytokine therapy