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

NCT ID: NCT01097668

Last Updated: 2015-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2013-07-31

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.

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intradermal injection

Injections will be given by the intradermal route

Group Type: EXPERIMENTAL

ATX-MS-1467

Intervention Type: BIOLOGICAL

Disease specific immune modulating treatment for multiple sclerosis

Subcutaneous injection

Injections will be given by the subcutaneous route

Group Type: EXPERIMENTAL

ATX-MS-1467

Intervention Type: BIOLOGICAL

Disease specific immune modulating treatment for multiple sclerosis

Interventions

ATX-MS-1467

Disease specific immune modulating treatment for multiple sclerosis

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aptiv Solutions

INDUSTRY

Sponsor Role: collaborator

ClinStar, LLC

INDUSTRY

Sponsor Role: collaborator

Apitope Technology (Bristol) Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy Chataway

Role: PRINCIPAL_INVESTIGATOR

National Hospital for Neurology and Neurosurgery, London

Locations

Municipal Healthcare Institution "City Clinical Hospital #3", Department of neurology

Chelyabinsk, , Russia

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', , Russia

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, , Russia

State Healthcare Institution 'Rostov Regional Clinical Hospital' Center of Neurology

Rostov-on-Don, , Russia

LLC "International Clinic MEDEM", Department of functional diagnostics

Saint Petersburg, , Russia

St. Petersburg State Healthcare Institution "City multifield hospital #2", Department of neurology #2

Saint Petersburg, , Russia

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, , Russia

Institution of the Russian Academy of Science "Institute of Human Brain of RAS", Neuroimmunology Laboratory

Saint Petersburg, , Russia

State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin", Department of neurosurgery

Samara, , Russia

State Educational Institution of Higher Professional Education Saratov State Medical University

Saratov, , Russia

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, , Russia

North Staffordshire Royal Infirmary

Stoke-on-Trent, Staffordshire, United Kingdom

National Hospital for Neurology & Neurosurgery

London, , United Kingdom

Queen's Medical Centre

Nottingham, , United Kingdom

Peninsula Medical School

Plymouth, , United Kingdom

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Countries

Russia; United Kingdom

Related Links

http://www.apitope.com

sponsor

Other Identifiers

ATX-MS-1467-002

Identifier Type: -

Identifier Source: org_study_id