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

  • STATUS
    Recruiting
Updated on 8 November 2020

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
Clinical Study IdentifierTX136802
Last Modified on8 November 2020

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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