Safety of RG2077 in Patients With Multiple Sclerosis

Phase 1

Completed

• Conditions: Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis
• Interventions: Drug: RG2077 (CTLA4-IgG4m)

• Registration Number: NCT00076934
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2004-02-06
• Study First Submitted QC: 2004-02-06
• Study First Posted: 2004-02-09
• Study Completion: 2006-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-23
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	RG2077 (CTLA4-IgG4m)	Participants receive Regimen 3 for 4 months
1	RG2077 (CTLA4-IgG4m)	Participants receive Regimen 1 for 4 months
4	RG2077 (CTLA4-IgG4m)	Participants receive Regimen 4 for 4 months
2	RG2077 (CTLA4-IgG4m)	Participants receive Regimen 2 for 4 months

Primary Outcome Measures

Name	Time	Method
Safety assessment including a MRI, neurological and physical examinations	Throughout study

Secondary Outcome Measures

Name	Time	Method
Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI	Throughout study

Trial Locations

Locations (1)

Brigham and Women's Hospital/Harvard Medical School; 🇺🇸 Boston, Massachusetts, United States