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
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- STATUS
- Recruiting
Summary
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
Description
Patient Inclusion Criteria:
- Ages 18-60
- SPMS diagnosis
- Must be able to walk
- 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
Patient Exclusion Criteria:
- Diagnosed with primary progressive MS
- Treatment with beta-interferon or glatiramer acetate 30 days prior to starting study treatment
- 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 screening
- 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 investigational drug 1 year prior to screening
- 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.
Details
| Condition | Restless Leg Syndrome |
|---|---|
| Clinical Study Identifier | TX136802 |
| Last Modified on | 8 November 2020 |
Eligibility
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