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

NCT01097668 | Completed Phase 1 Results DMC

• 1 other identifier: ATX-MS-1467-002
• Study Type: interventional
• Target: 43
• Locations: 2 countries
• Sites: 16

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

Keywords

Multiple sclerosis; Immunomodulation; Phase 1

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

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

  48 weeks

Secondary Outcomes (1)

• The Effect of ATX-MS-1467 on Brain Magnetic Resonance Imaging (MRI).

  16 and 20 weeks

Study Arms (2)

Intradermal injection

EXPERIMENTAL

Injections will be given by the intradermal route

Biological: ATX-MS-1467

Subcutaneous injection

EXPERIMENTAL

Injections will be given by the subcutaneous route

Biological: ATX-MS-1467

Interventions

ATX-MS-1467 BIOLOGICAL

Disease specific immune modulating treatment for multiple sclerosis

Intradermal injection; Subcutaneous injection

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. HLA DRB1\*15 positive.
• \. 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.
• \. Disease duration equal to or less than 10 years (from the first clinical event).
• \. At least one documented relapse in the previous 12 months or two relapses within the previous 24 months prior to screening.
• \. Must be in a clinically stable or improving neurological state during the 28 days preceding Screening.
• \. EDSS score \< 5.5.

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Apitope Technology (Bristol) Ltd.: lead
• Aptiv Solutions: collaborator
• ClinStar, LLC: collaborator

Study Sites (16)

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

Chelyabinsk, 454136, Russia

Location

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', 420021, Russia

Location

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, 119991, Russia

Location

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

Rostov-on-Don, 344015, Russia

Location

LLC "International Clinic MEDEM", Department of functional diagnostics

Saint Petersburg, 191025, Russia

Location

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

Saint Petersburg, 194354, Russia

Location

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, 197022, Russia

Location

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

Saint Petersburg, 197376, Russia

Location

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

Samara, 443095, Russia

Location

State Educational Institution of Higher Professional Education Saratov State Medical University

Saratov, 410012, Russia

Location

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

Location

North Staffordshire Royal Infirmary

Stoke-on-Trent, Staffordshire, ST4 7LN, United Kingdom

Location

National Hospital for Neurology & Neurosurgery

London, WC1N 3BG, United Kingdom

Location

Queen's Medical Centre

Nottingham, NG7 2UH, United Kingdom

Location

Peninsula Medical School

Plymouth, PL6 8BX, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2 JF, United Kingdom

Location

Related Links

• sponsor

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

ATX-MS-1467

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Chief Executive Officer
• Organization: Apitope Technology (Bristol) Ltd

keith.martin@apitope.com

+44(0)117 3707720

Study Officials

• Jeremy Chataway

  National Hospital for Neurology and Neurosurgery, London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 2, 2010
• Study Start: March 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 16, 2015
• Results First Posted: February 16, 2015

Record last verified: 2015-02

Locations

GB (5); RU (11)