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| Sponsor: | Apitope Technology (Bristol) Ltd. |
|---|---|
| Collaborators: |
Aptiv Solutions (UK) ClinStar Europe LLC (Russia) |
| Information provided by (Responsible Party): | Apitope Technology (Bristol) Ltd. |
| ClinicalTrials.gov Identifier: | NCT01097668 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Relapsing Remitting Multiple Sclerosis |
Biological: ATX-MS-1467 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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). |
| Estimated Enrollment: | 40 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations| Contact: Sophie Bresson | Sophie.Bresson@aptivsolutions.com |
| Russian Federation | |
| Municipal Healthcare Institution "City Clinical Hospital #3", Department of neurology | Recruiting |
| Chelyabinsk, Russian Federation, 454136 | |
| Contact: Galina Belskaya 7 902 893 38 44 nervugmado@yandex.ru | |
| Principal Investigator: Galina Belskaya | |
| 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 | Recruiting |
| Kazan, Russian Federation, 420021 | |
| Principal Investigator: Farit A Khabirov | |
| 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 | Recruiting |
| Moscow, Russian Federation, 119991 | |
| Principal Investigator: Sergei Fitilev | |
| State Healthcare Institution 'Rostov Regional Clinical Hospital' Center of Neurology | Recruiting |
| Rostov-on-Don, Russian Federation, 344015 | |
| Principal Investigator: Yurg V Trinitatskiy | |
| LLC "International Clinic MEDEM", Department of functional diagnostics | Recruiting |
| Saint Petersburg, Russian Federation, 191025 | |
| Principal Investigator: Olga A Amelina | |
| State Educational Institution of Higher Professional Education "St. Petersburg State Medical University n.a. I.V. Pavlov of Roszdrav", Department of neurology with clinic | Recruiting |
| Saint Petersburg, Russian Federation, 197022 | |
| Principal Investigator: Alexander A Skoromets | |
| State Healthcare Institution "Samara Regional Clinical Hospital n.a. M.I. Kalinin", Department of neurosurgery | Recruiting |
| Samara, Russian Federation, 443095 | |
| Principal Investigator: Irina E Poverennova | |
| State Educational Institution of Higher Professional Education Saratov State Medical University | Recruiting |
| Saratov, Russian Federation, 410012 | |
| Principal Investigator: Nikolay S Makarov | |
| 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" | Recruiting |
| Smolensk, Russian Federation | |
| Principal Investigator: Natalia Maslova | |
| St. Petersburg State Healthcare Institution "City multifield hospital #2", Department of neurology #2 | Recruiting |
| St Petersburg, Russian Federation, 194354 | |
| Principal Investigator: Semen V Perfiliev | |
| Institution of the Russian Academy of Science "Institute of Human Brain of RAS", Neuroimmunology Laboratory | Recruiting |
| St Petersburg, Russian Federation, 197376 | |
| Principal Investigator: Igor D Stolyarov | |
| United Kingdom | |
| North Staffordshire Royal Infirmary | Completed |
| Stoke on Trent, Staffordshire, United Kingdom, ST4 7LN | |
| National Hospital for Neurology & Neurosurgery | Recruiting |
| London, United Kingdom, WC1N 3BG | |
| Contact: Raju Kapoor +44 7971 923 784 raj.kapoor@uclh.nhs.uk | |
| Principal Investigator: Jeremy Chataway | |
| Queen's Medical Centre | Completed |
| Nottingham, United Kingdom, NG7 2UH | |
| Peninsula Medical School | Completed |
| Plymouth, United Kingdom, PL6 8BX | |
| Royal Hallamshire Hospital | Recruiting |
| Sheffield, United Kingdom, S10 2 JF | |
| Contact: Basil Sharrack +44(0)114 2712096 Basil.Sharrack@sth.nhs.uk | |
| Contact: Julie Kemp +44(0)114 2712096 Julie.Kemp@sth.nhs.uk | |
| Principal Investigator: Basil Sharrack | |
| Principal Investigator: | Jeremy Chataway | National Hospital for Neurology and Neurosurgery London |
More Information
| Responsible Party: | Apitope Technology (Bristol) Ltd. |
| ClinicalTrials.gov Identifier: | NCT01097668 History of Changes |
| Other Study ID Numbers: | ATX-MS-1467-002 |
| Study First Received: | March 31, 2010 |
| Last Updated: | February 26, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency Russian Republic: Ministry of Health and Social Development of the Russian Federation |
|
Multiple sclerosis Immunomodulation Phase 1 |
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Relapsing-Remitting Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes |