Safety of RG2077 in Patients With Multiple Sclerosis

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: RG2077 (CTLA4-IgG4m)

Study type: Interventional

Funder types: NETWORK; Industry; NIH

Identifiers

NCT00076934

DAIT ITN006AI

NMS02 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

1

Experimental group

Description:

Participants receive Regimen 1 for 4 months

Treatment:

Drug: RG2077 (CTLA4-IgG4m)

2

Experimental group

Description:

Participants receive Regimen 2 for 4 months

Treatment:

Drug: RG2077 (CTLA4-IgG4m)

3

Experimental group

Description:

Participants receive Regimen 3 for 4 months

Treatment:

Drug: RG2077 (CTLA4-IgG4m)

4

Experimental group

Description:

Participants receive Regimen 4 for 4 months

Treatment:

Drug: RG2077 (CTLA4-IgG4m)