Completed

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

What is being tested

RG2077 (CTLA4-IgG4m)

Drug

Who is being recruted

Ataxia+10

+ Autoimmune Diseases

+ Demyelinating Diseases

From 18 to 55 Years

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: January 2003

See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2003

Actual date on which the first participant was enrolled.

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.

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

NCT00076934

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AtaxiaAutoimmune DiseasesDemyelinating DiseasesImmune System DiseasesMultiple SclerosisNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNSMultiple Sclerosis, Relapsing-RemittingDyskinesias

Criteria

2 inclusion criteria required to participate

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants receive Regimen 1 for 4 months

Group II

Experimental

Participants receive Regimen 2 for 4 months

Group III

Experimental

Participants receive Regimen 3 for 4 months

Group IV

Experimental

Participants receive Regimen 4 for 4 months

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Brigham and Women's Hospital/Harvard Medical School

Boston, United StatesOpen Brigham and Women's Hospital/Harvard Medical School in Google Maps

CompletedOne Study Center