Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting
Conditions
Keywords
Ataxia, MRI, MS, CTLA4-IgG4m, Costimulatory Signals, Autoimmune Disorders
Brief summary
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
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.
Interventions
DRUGRG2077 (CTLA4-IgG4m)
RG2077
Sponsors
Immune Tolerance Network (ITN)
Repligen Corporation
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessment including a MRI, neurological and physical examinations | Throughout study |
Secondary
| Measure | Time frame |
|---|---|
| Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI | Throughout study |
Countries
United States
Outcome results
None listed