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EXCHANGE


Title Exploring the safety and tolerability of conversion from oral or injectable disease modifying therapies to dosetitrated Oral Siponimod in patients with advancing forms of relapsing multiple sclerosis: A 6-month open label, multicenter Phase IIIb study (EXCHANGE)
Therapeutic Area Multiple Sclerosis
Principal Investigator Deborah Green-LaRoche, MD
Min Age 18 Years
Max Age 65 Years
Gender All
Contact Deborah Green-LaRoche, MD
617-636-7606
neuroresearch@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT03623243

Overview

The purpose of this study is to assess early phase safety and tolerability of transitioning patients from approved oral and injectable RMS DMTs to siponimod. The results of this study will guide clinically relevant decisions related to the transition from frequently used RMS DMTs to siponimod and provide clinically relevant data on safety and tolerability for healthcare providers who are considering transitioning patients from currently approved RMS DMT to siponimod. The primary objective is to evaluate overall safety and tolerability profile of siponimod in advancing RMS patients (including a broader population that had not been previously studied with siponimod who are converting from currently approved oral or injectable RMS DMT).

Study Details

Inclusion Criteria

  • Patients with advancing RMS as defined by the principal investigator
  • Prior history of relapsing MS (RMS), with or without progressive features, according to the 2010 Revised McDonald or Lublin criteria (Lublin et al, 2013)
  • Disability status at screening with an EDSS score of >2.0 to 6.5 (inclusive)

Exclusion Criteria

  • Patients with an active chronic disease (or stable but treated with immune therapy) of the immune system other than MS (e.g., rheumatoid arthritis, scleroderma, Sjogren’s syndrome, Crohn’s disease, ulcerative colitis, etc.) or with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug-induced immune deficiency).
  • Have been treated with any of the medications listed below:
    • Intravenous immunoglobulin within 2 months prior to screening
    • Natalizumab within 12 months prior to screening
    • Daclizumab within 4 months of screening
    • Immunosuppressive/chemotherapeutic medications (e.g., azathioprine, methotrexate) within 6 months prior to screening
    • Cyclophosphamide within 2 years prior to screening
    • Rituximab, ofatumumab, ocrelizumab, ublituximab or cladribine within 2 years prior to randomization
    • Alemtuzumab at any time
    • Any mitoxantrone during previous 2 years prior to randomization or evidence of cardiotoxicity following mitoxantrone or a cumulative life-time dose of more than 60 mg/m2
    • If patients treated with teriflunomide cannot and will not undergo the accelerated elimination process
    • Stem cell transplantation
    • Lymphoid irradiation, bone marrow transplantation or other immunosuppressive treatments with effects potentially lasting over 6 months, at any time.
  • Homozygosity for CYP2C9*3 (to be tested at screening) or refusal to test for CYP2C9*3

Study Requirements

There will be 1 screening visit and 5 study visits by mobile research personnel at your home or a local location which includes a televisit with the study doctor and/or study coordinator. At each visit about 11-15 mL of blood will be taken for testing. Subjects will also need to have an Optical Coherence Tomography test (OCT) completed by an eye doctor in their local area. There will be a follow-up phone call 30 days after the last study visit.