Safety of RG2077 in Patients With Multiple Sclerosis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00076934 |
Recruitment Status :
Completed
First Posted : February 9, 2004
Last Update Posted : March 27, 2017
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting | Drug: RG2077 (CTLA4-IgG4m) | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis |
Study Start Date : | January 2003 |
Actual Study Completion Date : | February 2006 |

Arm | Intervention/treatment |
---|---|
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 |
- Safety assessment including a MRI, neurological and physical examinations [ Time Frame: Throughout study ]
- Number of gadolinium (GD) enhancing lesions and T2 lesion volume on MRI [ Time Frame: Throughout study ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076934
United States, Massachusetts | |
Brigham and Women's Hospital/Harvard Medical School | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Samia J. Khoury, MD | Brigham and Women's Hospital |
Study Data/Documents: Individual Participant Data Set

ImmPort study identifier is SDY661

ImmPort study identifier is SDY661

TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available.

TrialShare is a clinical trials research portal developed by the Immune Tolerance Network (ITN) that makes data from the consortium's clinical trials publicly available.
Publications of Results:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00076934 |
Other Study ID Numbers: |
DAIT ITN006AI NMS02 ( Other Identifier: ITN ) |
First Posted: | February 9, 2004 Key Record Dates |
Last Update Posted: | March 27, 2017 |
Last Verified: | March 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Participant level data and additional relevant materials are available to the public in: 1.) the Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts; and 2.) TrialShare, the Immune Tolerance Network (ITN) Clinical Trials Research Portal. |
Ataxia MRI MS |
CTLA4-IgG4m Costimulatory Signals Autoimmune Disorders |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS |
Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |