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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

March 31, 2010
August 17, 2013
March 2010
July 2013   (final data collection date for primary outcome measure)
Adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Occurrence of treatment related AEs, SAEs, and laboratory abnormalities compared to baseline.
Same as current
Complete list of historical versions of study NCT01097668 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
ATX-MS-1467 in Patients With Relapsing Forms of Multiple Sclerosis
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).

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsing Remitting Multiple Sclerosis
Biological: ATX-MS-1467
Disease specific immune modulating treatment for multiple sclerosis
  • Experimental: Intradermal injection
    Injections will be given by the intradermal route
    Intervention: Biological: ATX-MS-1467
  • Experimental: Subcutaneous injection
    Injections will be given by the subcutaneous route
    Intervention: Biological: ATX-MS-1467
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation,   United Kingdom
 
NCT01097668
ATX-MS-1467-002
Yes
Apitope Technology (Bristol) Ltd.
Apitope Technology (Bristol) Ltd.
  • Aptiv Solutions
  • ClinStar Europe LLC (Russia)
Principal Investigator: Jeremy Chataway National Hospital for Neurology and Neurosurgery, London
Apitope Technology (Bristol) Ltd.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP