Immunological Data Discovery Index
Immunological Data Discovery Index
| identifier: | ITN006AI |
| description: |
This is an open-label, dose escalation, safety study. An initial group of 16 subjects who are diagnosed with relapsing-remitting MS will be enrolled over a period of approximately 18 months. The 16 subjects will be divided amongst four dose groups. Each dose group (2.0 mg/kg, 10.0 mg/kg, 20.0 mg/kg and 35.0 mg/kg) will consist of 4 subjects per group. Each subject will receive one IV infusion of RG2077. The first four subjects will start at the lowest dose level. Once all subjects at a dose level have undergone a safety assessment at Month 1, including a MRI, a neurological examination and physical examination, and no significant adverse effects have been observed enrollment will proceed at the next dose level. An interim safety report will be generated after the completion (Visit 7) of the 20.0 mg/kg dose group. Patients will be treated with RG2077 at 35.0 mg/kg only if the interim analysis indicates there are no safety risks to the patients at the lower dose levels.
If an interim analysis of data from the 35 mg/kg single infusion dose group indicates there are no safety risks, an additional group of four subjects will be enrolled and will receive multiple infusions (4 doses) of RG2077 at 10.0 mg/kg.
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| privacy: |
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.
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| aggregation: |
instance of dataset
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| availability: |
available with registration
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| relatedIdentifiers: |
Khoury
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| acknowledges: |
National Institute of Allergy and Infectious Diseases (NIAID)
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| primaryPublications: |
18794494 |
| isAbout: |
Drug: RG2077 (CTLA4-IgG4m)
RG2077
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| authorizations: |
registration required
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| accessURL: |
https://clinicaltrials.gov/show/NCT00076934 |
| landingPage: |
https://www.itntrialshare.org/project/Studies/ITN006AIPUBLIC/Study%20Data/begin.view? |
| study type: | Interventional |
| study phase: | Phase 1 |
| subject gender: | Sexes Eligible for Study: All |
| subject age: | 18 Years to 55 Years (Adult) |
| study category: | Autoimmune |
| study type: | Interventional |
| name: |
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
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| fullName: |
Samia J. Khoury, MD
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| affiliations: |
Brigham and Women's Hospital
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| roles: |
Principal Investigator
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| name: |
Safety of RG2077 in Patients With Multiple Sclerosis
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| size: |
20
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| output: |
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 ]
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| identifier: |
NC
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| selectionCriteria: |
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
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| name: |
A Phase I Study: Safety of RG2077 (CTLA4-IgG4m) in Patients With Relapsing-Remitting Multiple Sclerosis
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| studyGroups: |
Experimental: 1
Participants receive Regimen 1 for 4 months
Intervention: Drug: RG2077 (CTLA4-IgG4m)
Experimental: 2
Participants receive Regimen 2 for 4 months
Intervention: Drug: RG2077 (CTLA4-IgG4m)
Experimental: 3
Participants receive Regimen 3 for 4 months
Intervention: Drug: RG2077 (CTLA4-IgG4m)
Experimental: 4
Participants receive Regimen 4 for 4 months
Intervention: Drug: RG2077 (CTLA4-IgG4m)
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| description: |
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.
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.
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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| location: |
United States
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| startDate: |
2003-01-01
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| name: |
ITN TrialShare
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| homePage: |
https://www.itntrialshare.org |
