Safety of RG2077 in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00076934
• Other study ID #: DAIT ITN006AI
• Secondary ID: NMS02
• Status: Completed
• Phase: Phase 1
• First received: February 6, 2004
• Last updated: March 23, 2017
• Start date: January 2003
• Est. completion date: February 2006

Study information

• Verified date: March 2017
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• RG2077 (CTLA4-IgG4m)
RG2077

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital/Harvard Medical School	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Immune Tolerance Network (ITN), Repligen Corporation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Viglietta V, Bourcier K, Buckle GJ, Healy B, Weiner HL, Hafler DA, Egorova S, Guttmann CR, Rusche JR, Khoury SJ. CTLA4Ig treatment in patients with multiple sclerosis: an open-label, phase 1 clinical trial. Neurology. 2008 Sep 16;71(12):917-24. doi: 10.12 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessment including a MRI, neurological and physical examinations		Throughout study
Secondary	Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI		Throughout study

External Links

•   Division of Allergy, Immunology, and Transplantation (DAIT) website
•   Immune Tolerance Network (ITN) website
•   National Institute of Allergy and Infectious Diseases (NIAID) website