Multiple Sclerosis Clinical Trial
— Abili-TOfficial title:
A Phase 2 Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of Tcelna in Subjects With Secondary Progressive Multiple Sclerosis
The purpose of this study is to determine whether Tcelna (imilecleucel-T, autologous T-Cell Immunotherapy) is effective in the treatment of secondary progressive multiple sclerosis (SPMS).
Status | Completed |
Enrollment | 183 |
Est. completion date | October 2016 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Diagnosed with MS as defined by the modified McDonald criteria - SPMS defined as relapsing-remitting disease with recent progression in MS-related neurological deficits - EDSS score 3.0 - 6.0, inclusively - Presence of myelin reactive T-cells Exclusion Criteria: - Diagnosed with primary progressive MS - Treatment with beta-interferon, glatiramer acetate or dimethyl fumarate 30 days prior to screening - Treatment with ACTH, any over-the-counter or prescription corticosteroids 60 days prior to screening - Treatment with IVIG, plasmapheresis or cytopheresis 90 days prior to screening - Treatment with mitoxantrone, teriflunomide, fingolimod, natalizumab, azathioprine, cyclosporine, methotrexate or mycophenolate mofetil 1 year prior to baseline - Any prior treatment with cladribine, cyclophosphamide, total lymphoid irradiation, T cell or T cell receptor products, or any therapeutic monoclonal antibody, except natalizumab - Previous treatment with any other MS investigational drug 1 year prior to screening - All non-MS investigational drugs must have a minimum washout of 30 days prior to screening or 5 half-lives, whatever is the longest period of time. - HIV or hepatitis infection - History of cancer - Any other significant medical condition that, in the opinion of the investigator, could cause CNS tissue damage or limit its repair. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Recherche Sepmus Inc. | Greenfield Park | Quebec |
Canada | Montreal Neurological Institute and Hospital | Montreal | Quebec |
Canada | University of Ottawa | Ottawa | Ontario |
United States | Shepherd Center | Atlanta | Georgia |
United States | Alta Bates Summit Medical Center, The Research and Education Development Institute | Berkeley | California |
United States | Saint Elizabeth's Medical Center | Boston | Massachusetts |
United States | Fletcher Allen Health Care - Neurology Service | Burlington | Vermont |
United States | Carolinas Medical Center Neurology | Charlotte | North Carolina |
United States | PMG Research of Charlotte | Charlotte | North Carolina |
United States | The Neurological Institute, PA | Charlotte | North Carolina |
United States | Neurology Specialists, Inc | Dayton | Ohio |
United States | Fort Wayne Neurological Center | Fort Wayne | Indiana |
United States | The Maxine Mesinger MS Clinic/Baylor College of Medicine | Houston | Texas |
United States | Josephson Wallack Munshower Neurology, PC | Indianapolis | Indiana |
United States | Swedish Neuroscience Institute | Issaquah | Washington |
United States | University of Kansas Medical Center | Kansas City | Kansas |
United States | Associates in Neurology | Lexington | Kentucky |
United States | Neurology Associates, P.A. | Maitland | Florida |
United States | Providence Medical Group - Medford | Medford | Oregon |
United States | University of Miami | Miami | Florida |
United States | Collier Neurologic Specialists, LLC | Naples | Florida |
United States | Hampton Roads Neurology | Newport News | Virginia |
United States | Consultants In Neurology, Ltd. | Northbrook | Illinois |
United States | Neurological Services of Orlando | Orlando | Florida |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | HOPE Research Institute | Phoenix | Arizona |
United States | Island Neurological Assoicates, PC | Plainview | New York |
United States | Providence St. Vincent Medical Center - Northwest MS Center | Portland | Oregon |
United States | Neurological Associates, Inc | Richmond | Virginia |
United States | Central Texas Neurology | Round Rock | Texas |
United States | Integra Clinical Research, LLC | San Antonio | Texas |
United States | Swedish Neuroscience Institute | Seattle | Washington |
United States | University Hospital and Medical Center Stony Brook New York | Stony Brook | New York |
United States | Meridien Research | Tampa | Florida |
United States | Northwest NeuroSpecialists, LLC | Tucson | Arizona |
United States | Vero Beach Neurology | Vero Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
Opexa Therapeutics, Inc. |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Brain Atrophy | The percentage of brain volume change (atrophy) as measured on 24 month MRIs calculated by the central MRI facility. | 2 Years | Yes |
Secondary | Disease Progression | The percentage of subjects with sustained progression with definitions of sustained effect at 3 months and 6 months. | 2 Years | Yes |
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