Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076934
Status:
COMPLETED
Last Update Posted:
2017-03-27
First Post:
2004-02-06
Brief Title:
Safety of RG2077 in Patients With Multiple Sclerosis
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Phase I Study Safety of RG2077 CTLA4-IgG4m in Patients With Relapsing-Remitting Multiple Sclerosis
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multiple sclerosis MS is an autoimmune disorder In this disease the bodys 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NMS02 | OTHER | ITN | None |