Clinical trial NCT01097668: ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
Official title: SAFETY AND PROOF OF PRINCIPLE STUDY OF ATX-MS-1467 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS: OPEN LABEL UPWARD TITRATION OVER FIVE DOSE LEVELS AND USING TWO ROUTES OF ADMINISTRATION (INTRADERMAL AND SUBCUTANEOUS).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple sclerosis
Immunomodulation
Phase 1
Lead sponsor: Apitope Technology (Bristol) Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Aptiv Solutions
name: ClinStar, LLC
First posted: 2010-04-02
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Safety and Tolerability
timeFrame: 48 weeks
Secondary outcomes:
measure: The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).
timeFrame: 16 and 20 weeks
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Municipal Healthcare Institution "City Clinical Hospital #3", Department of neurology
city: Kazan
country: Russian Federation
facility: State Medical Institution "Republican Clinical Hospital of rehabilitation treatment of Ministry of Healthcare of Tatarstan Republic", Republican clinicodiagnostic center of demyelinating diseases of Ministry of Healthcare of Tatarstan Republic
city: Moscow
country: Russian Federation
facility: State Educational Institution of Higher Professional Education "1st Moscow State Medical University n.a. I.M. Sechenov of Ministry of Healthcare and Social Development of the Russian Federation, Department of new drugs research
city: Rostov-on-Don
country: Russian Federation
facility: State Healthcare Institution 'Rostov Regional Clinical Hospital' Center of Neurology
city: Saint Petersburg
country: Russian Federation
facility: LLC "International Clinic MEDEM", Department of functional diagnostics
city: Saint Petersburg
country: Russian Federation
facility: State Educational Institution of Higher Professional Education "St. Petersburg State Medical University n.a. I.V. Pavlov of Roszdrav", Department of neurology with clinic
city: Samara
country: Russian Federation
facility: State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin", Department of neurosurgery
city: Saratov
country: Russian Federation
facility: State Educational Institution of Higher Professional Education Saratov State Medical University
city: Smolensk
country: Russian Federation
facility: State Educational Institution of Higher Professional Education "Smolensk State Medical Academy of Roszdrav", Department of neurology and neurosurgery based at State Healthcare Institution "Smolensk Regional Clinical Hospital"
city: St Petersburg
country: Russian Federation
facility: St. Petersburg State Healthcare Institution "City multifield hospital #2", Department of neurology #2
city: St Petersburg
country: Russian Federation
facility: Institution of the Russian Academy of Science "Institute of Human Brain of RAS", Neuroimmunology Laboratory
city: Stoke on Trent
country: United Kingdom
facility: North Staffordshire Royal Infirmary
state: Staffordshire
city: London
country: United Kingdom
facility: National Hospital for Neurology & Neurosurgery
city: Nottingham
country: United Kingdom
facility: Queen's Medical Centre
city: Plymouth
country: United Kingdom
facility: Peninsula Medical School
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
Study officials:
affiliation: National Hospital for Neurology and Neurosurgery, London
name: Jeremy Chataway
role: PRINCIPAL_INVESTIGATOR
References: