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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ATX-MS-1467
Sponsored by
Apitope Technology (Bristol) Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Remitting Multiple Sclerosis focused on measuring Multiple sclerosis, Immunomodulation, Phase 1

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Municipal Healthcare Institution "City Clinical Hospital #3", Department of neurology
  • 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
  • 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
  • State Healthcare Institution 'Rostov Regional Clinical Hospital' Center of Neurology
  • LLC "International Clinic MEDEM", Department of functional diagnostics
  • State Educational Institution of Higher Professional Education "St. Petersburg State Medical University n.a. I.V. Pavlov of Roszdrav", Department of neurology with clinic
  • State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin", Department of neurosurgery
  • State Educational Institution of Higher Professional Education Saratov State Medical University
  • 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"
  • St. Petersburg State Healthcare Institution "City multifield hospital #2", Department of neurology #2
  • Institution of the Russian Academy of Science "Institute of Human Brain of RAS", Neuroimmunology Laboratory
  • North Staffordshire Royal Infirmary
  • National Hospital for Neurology & Neurosurgery
  • Queen's Medical Centre
  • Peninsula Medical School
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intradermal injection

Subcutaneous injection

Arm Description

Injections will be given by the intradermal route

Injections will be given by the subcutaneous route

Outcomes

Primary Outcome Measures

Safety and Tolerability
Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.

Secondary Outcome Measures

The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).
Number of new or persisting Gadolinium-enhancing lesions at week 16 and 20 when compared to baseline.

Full Information

First Posted
March 31, 2010
Last Updated
February 3, 2015
Sponsor
Apitope Technology (Bristol) Ltd.
Collaborators
Aptiv Solutions, ClinStar, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01097668
Brief Title
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apitope Technology (Bristol) Ltd.
Collaborators
Aptiv Solutions, ClinStar, LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Remitting Multiple Sclerosis
Keywords
Multiple sclerosis, Immunomodulation, Phase 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intradermal injection
Arm Type
Experimental
Arm Description
Injections will be given by the intradermal route
Arm Title
Subcutaneous injection
Arm Type
Experimental
Arm Description
Injections will be given by the subcutaneous route
Intervention Type
Biological
Intervention Name(s)
ATX-MS-1467
Intervention Description
Disease specific immune modulating treatment for multiple sclerosis
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
Occurrence of treatment emergent Adverse Events (AE), Serious Adverse Events, and laboratory abnormalities up to week 48 compared to baseline.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).
Description
Number of new or persisting Gadolinium-enhancing lesions at week 16 and 20 when compared to baseline.
Time Frame
16 and 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Chataway
Organizational Affiliation
National Hospital for Neurology and Neurosurgery, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Municipal Healthcare Institution "City Clinical Hospital #3", Department of neurology
City
Chelyabinsk
ZIP/Postal Code
454136
Country
Russian Federation
Facility Name
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
Kazan
ZIP/Postal Code
420021
Country
Russian Federation
Facility Name
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
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
State Healthcare Institution 'Rostov Regional Clinical Hospital' Center of Neurology
City
Rostov-on-Don
ZIP/Postal Code
344015
Country
Russian Federation
Facility Name
LLC "International Clinic MEDEM", Department of functional diagnostics
City
Saint Petersburg
ZIP/Postal Code
191025
Country
Russian Federation
Facility Name
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
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin", Department of neurosurgery
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
State Educational Institution of Higher Professional Education Saratov State Medical University
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
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
Smolensk
Country
Russian Federation
Facility Name
St. Petersburg State Healthcare Institution "City multifield hospital #2", Department of neurology #2
City
St Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Institution of the Russian Academy of Science "Institute of Human Brain of RAS", Neuroimmunology Laboratory
City
St Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
North Staffordshire Royal Infirmary
City
Stoke on Trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 7LN
Country
United Kingdom
Facility Name
National Hospital for Neurology & Neurosurgery
City
London
ZIP/Postal Code
WC1N 3BG
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Peninsula Medical School
City
Plymouth
ZIP/Postal Code
PL6 8BX
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2 JF
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.apitope.com
Description
sponsor

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

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