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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01097668
Recruitment Status : Completed
First Posted : April 2, 2010
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
Sponsor:
Collaborators:
Aptiv Solutions
ClinStar, LLC
Information provided by (Responsible Party):
Apitope Technology (Bristol) Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Biological: ATX-MS-1467 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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).
Study Start Date : March 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 48 weeks ]
    Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.


Secondary Outcome Measures :
  1. The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI). [ Time Frame: 16 and 20 weeks ]
    Number of new or persisting Gadolinium-enhancing lesions at week 16 and 20 when compared to baseline.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097668


Locations
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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, LLC
Investigators
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Principal Investigator: Jeremy Chataway National Hospital for Neurology and Neurosurgery, London
More Information
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Additional Information:

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Responsible Party: Apitope Technology (Bristol) Ltd.
ClinicalTrials.gov Identifier: NCT01097668    
Other Study ID Numbers: ATX-MS-1467-002
First Posted: April 2, 2010    Key Record Dates
Results First Posted: February 16, 2015
Last Update Posted: February 16, 2015
Last Verified: February 2015
Keywords provided by Apitope Technology (Bristol) Ltd.:
Multiple sclerosis
Immunomodulation
Phase 1
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases