ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborators:
Aptiv Solutions
ClinStar Europe LLC (Russia)
Information provided by (Responsible Party):
Apitope Technology (Bristol) Ltd.
ClinicalTrials.gov Identifier:
NCT01097668
First received: March 31, 2010
Last updated: August 17, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Biological: ATX-MS-1467
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Apitope Technology (Bristol) Ltd.:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    Occurrence of treatment related AEs, SAEs, and laboratory abnormalities compared to baseline.


Secondary Outcome Measures:
  • MRI scans [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
    General MRI evaluation of brain lesions for numbers of gadolinium enhancing lesions during the study.

  • Injection site reactions [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]
    Injection site reactions as reported by the subjects in the diary card.

  • Immunology [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
    Proliferation responses to myelin basic protein and cytokine release


Enrollment: 42
Study Start Date: March 2010
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intradermal injection
Injections will be given by the intradermal route
Biological: ATX-MS-1467
Disease specific immune modulating treatment for multiple sclerosis
Experimental: Subcutaneous injection
Injections will be given by the subcutaneous route
Biological: ATX-MS-1467
Disease specific immune modulating treatment for multiple sclerosis

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097668

Locations
Russian Federation
Municipal Healthcare Institution "City Clinical Hospital #3", Department of neurology
Chelyabinsk, Russian Federation, 454136
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
Kazan, Russian Federation, 420021
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
Moscow, Russian Federation, 119991
State Healthcare Institution 'Rostov Regional Clinical Hospital' Center of Neurology
Rostov-on-Don, Russian Federation, 344015
LLC "International Clinic MEDEM", Department of functional diagnostics
Saint Petersburg, Russian Federation, 191025
State Educational Institution of Higher Professional Education "St. Petersburg State Medical University n.a. I.V. Pavlov of Roszdrav", Department of neurology with clinic
Saint Petersburg, Russian Federation, 197022
State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin", Department of neurosurgery
Samara, Russian Federation, 443095
State Educational Institution of Higher Professional Education Saratov State Medical University
Saratov, Russian Federation, 410012
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"
Smolensk, Russian Federation
St. Petersburg State Healthcare Institution "City multifield hospital #2", Department of neurology #2
St Petersburg, Russian Federation, 194354
Institution of the Russian Academy of Science "Institute of Human Brain of RAS", Neuroimmunology Laboratory
St Petersburg, Russian Federation, 197376
United Kingdom
North Staffordshire Royal Infirmary
Stoke on Trent, Staffordshire, United Kingdom, ST4 7LN
National Hospital for Neurology & Neurosurgery
London, United Kingdom, WC1N 3BG
Queen's Medical Centre
Nottingham, United Kingdom, NG7 2UH
Peninsula Medical School
Plymouth, United Kingdom, PL6 8BX
Royal Hallamshire Hospital
Sheffield, United Kingdom, S10 2 JF
Sponsors and Collaborators
Apitope Technology (Bristol) Ltd.
Aptiv Solutions
ClinStar Europe LLC (Russia)
Investigators
Principal Investigator: Jeremy Chataway National Hospital for Neurology and Neurosurgery, London
  More Information

Additional Information:
No publications provided

Responsible Party: Apitope Technology (Bristol) Ltd.
ClinicalTrials.gov Identifier: NCT01097668     History of Changes
Other Study ID Numbers: ATX-MS-1467-002
Study First Received: March 31, 2010
Last Updated: August 17, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russian Republic: Ministry of Health and Social Development of the Russian Federation

Keywords provided by Apitope Technology (Bristol) Ltd.:
Multiple sclerosis
Immunomodulation
Phase 1

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014