Safety of RG2077 in Patients With Multiple Sclerosis

Study Overview
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Brief Summary
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Multiple sclerosis (MS) is an autoimmune disorder. In this disease, the body's immune system attacks and destroys the cells that cover and protect nerves. This study will test the safety of a new drug called RG2077 that is designed to treat MS. The study will not determine whether RG2077 is effective in treating MS, only whether it is safe to use in patients with MS. Study hypothesis: RG2077 will arrest MS if administered early in the course of MS and decrease accumulation of lesions on MRI.

Detailed Description
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Effective treatment of autoimmune disorders is likely to arise not from improved immunosuppression, but from improved understanding of the normal mechanisms that generate and maintain self-tolerance. RG2077 may block a T cell costimulation pathway central to the pathophysiology of MS. A total of 20 patients with MS will be enrolled in this study. Each patient participates in the study for 4 months. The dose-escalation portion of this study evaluated the safety of a single infusion of RG2077 (CTLA4-IgG4m) in 16 patients with MS and is now complete. Patients who participated in the single infusion portion of the study were assigned to one of four groups. Each group received a different dose of RG2077. The second portion of the study will evaluate the safety of 4 doses of RG2077 in 4 additional patients. In the multiple infusion portion of the study, all patients will receive the same dose of RG2077. Patients will be monitored for possible side effects of RG2077.

Official Title
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A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis

Conditions
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Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Drug: RG2077 (CTLA4-IgG4m)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Confirmed diagnosis of MS, defined as an MRI consistent with MS plus two separate clinical events, or one clinical event and MRI consistent with demyelination plus a second MRI demonstrating new lesions Have declined all FDA approved therapies for MS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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>Participants receive Regimen 1 for 4 months | Drug: RG2077 (CTLA4-IgG4m)<br>* RG2077<br>|
| Experimental: 2<br>Participants receive Regimen 2 for 4 months | Drug: RG2077 (CTLA4-IgG4m)<br>* RG2077<br>|
| Experimental: 3<br>Participants receive Regimen 3 for 4 months | Drug: RG2077 (CTLA4-IgG4m)<br>* RG2077<br>|
| Experimental: 4<br>Participants receive Regimen 4 for 4 months | Drug: RG2077 (CTLA4-IgG4m)<br>* RG2077<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment including a MRI, neurological and physical examinations |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS, MRI, Ataxia, CTLA4-IgG4m, Costimulatory Signals, Autoimmune Disorders