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Safety of RG2077 in Patients With Multiple Sclerosis

This study has been completed.
Sponsor:
Collaborators:
Immune Tolerance Network (ITN)
Repligen Corporation
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00076934
First received: February 6, 2004
Last updated: February 6, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
 Drug: RG2077 (CTLA4-IgG4m)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Safety assessment including a MRI, neurological and physical examinations [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2003
Study Completion Date: February 2006
Arms Assigned Interventions
Experimental: 1
Participants receive Regimen 1 for 4 months
 Drug: RG2077 (CTLA4-IgG4m)
RG2077
Experimental: 2
Participants receive Regimen 2 for 4 months
 Drug: RG2077 (CTLA4-IgG4m)
RG2077
Experimental: 3
Participants receive Regimen 3 for 4 months
 Drug: RG2077 (CTLA4-IgG4m)
RG2077
Experimental: 4
Participants receive Regimen 4 for 4 months
 Drug: RG2077 (CTLA4-IgG4m)
RG2077

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076934

Locations
United States, Massachusetts
Brigham and Women's Hospital/Harvard Medical School
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network (ITN)
Repligen Corporation
Investigators
Principal Investigator: Samia J. Khoury, MD Brigham and Women's Hospital
  More Information

Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00076934     History of Changes
Other Study ID Numbers: DAIT ITN006AI
Study First Received: February 6, 2004
Last Updated: February 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Ataxia
MRI
MS
 CTLA4-IgG4m
Costimulatory Signals
Autoimmune Disorders

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013