12-week Safety Evaluation of Oral CS-0777 in Multiple Sclerosis Patients

Study Overview
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Brief Summary
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This is a 12-week study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of oral CS-0777 in patients with Multiple Sclerosis.

Official Title
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An Open-label, Escalating-dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral CS-0777, Administered for 12 Weeks, in Patients With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: CS-0777 tablets
* Drug: CS-0777 tablets
* Drug: CS-0777 tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of clinically isolated syndrome or a relapsing form(s) of MS, based on Poser or McDonald criteria (may include patients with secondary progressive disease) Clinical relapse within the past 3 years or a gadolinium enhancing lesion on a brain MRI scan within the past 12 months Baseline EDSS score of 0 - 6.5 Female subjects who are sexually active, unless sterile or post-menopausal for at least 1 year, must be willing to use double-barrier contraception Exclusion Criteria: Primary progressive MS Any medical condition that predisposes to immunocompromise History of malignancy, tuberculosis, invasive fungal infections, herpes zoster infection (or shingles), or other opportunistic infection, or any current active infection Concurrent diagnosis of any other autoimmune disease (eg, rheumatoid arthritis or lupus) Treatment with cyclophosphamide or mitoxantrone within 6 months of study initiation Treatment with cyclosporine, azathioprine, methotrexate or other immunosuppressant within 3 months of study initiation Treatment with interferon beta or glatiramer acetate within 2 months of study initiation Prior treatment with natalizumab or rituximab

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: CS-0777 tablets<br>* 0.1 mg, once-weekly, for 12 weeks<br>|
| Experimental: 2<br> | Drug: CS-0777 tablets<br>* 0.3 mg, once-weekly or once every 2 weeks, for 12 weeks<br>|
| Experimental: 3<br> | Drug: CS-0777 tablets<br>* 0.6 mg, once-weekly or once every 2 weeks, for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability. |  | 12 weeks, with 4 weeks to follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic response (lymphocyte counts Pharmacokinetics Exploratory efficacy based on brain MRI lesions) |  | 12 weeks, with 4 weeks to follow up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, relapsing, secondary progressive, clinically isolated syndrome, MRI