Autoimmune diseases occur when the immune system mistakenly flags certain cells in the body as foreign invaders. The resulting attack can cause irreparable damage to critical organs and tissues. For example, in multiple sclerosis, it’s the myelin coating that insulates nerve cells; in lupus, it can be any number of organs or systems that are damaged. Currently, many of the primary methods to treat patients with autoimmune disease utilize immune suppressors, which help reduce the inflammatory attack on tissues but can put patients at higher risk for developing infections.
Immune tolerance therapies are designed to stop, or even prevent, the autoimmune disease while leaving the body's disease-fighting abilities intact. These tolerance therapies essentially reprogram the immune system, so that a short course of treatment will have long-lasting, perhaps lifelong effects. While immune tolerance therapies are mainly experimental, the Immune Tolerance Network (ITN) believes that targeted reprogramming of the immune system holds a great deal of promise to effectively treat autoimmune diseases with fewer side effects than current drugs.
The clinical heterogeneity of the more than 80 autoimmune diseases presents a significant challenge with respect to the development of therapies designed to re-establish self-tolerance. The ITN’s approach to tolerance in autoimmune diseases attempts to address these challenges through a coordinated program of clinical studies aimed at establishing proof-of-principle either in diseases where a self-antigen has been identified, the target organ is accessible for further study or the disease pathogenesis has been relatively well established.
Given the complex nature of these diseases, and following the approaches being developed in the transplant and allergy portfolios, the ITN builds on results from ongoing trials by developing combination approaches affecting humoral and cellular, as well as adaptive and innate, immune responses. This includes combinations that ablate or anergize effector responses, deviate induced responses and boost regulatory responses. Because combination therapy trials can be logistically and scientifically challenging, the ITN has adopted the use of smaller, mechanistically-based studies as a first step in evaluating promising combinations and establishing a mechanistic plan that will inform on the pathways of tolerance.
Principal Investigator:
Samia Khoury | Harvard University | Boston, MA
ACCLAIM is a Phase II clinical research trial of the safety and efficacy of abatacept in adults with relapsing-remitting multiple sclerosis (RRMS). The study is testing whether abatacept works differently from most other MS treatments, as it is more specific in the immune cells that it targets.
Category:
Autoimmune Disease
|
Specific Category:
Multiple Sclerosis
|
Status:
Complete
Learn more:
Principal Investigator:
Betty Diamond | The Feinstein Institute for Medical Research | Manhasset, NY
David Wofsy | University of California San Francisco | San Francisco, CA
This study is for people with systemic lupus who have developed complications in their kidneys, called 'lupus nephritis.' The study will determine whether adding the experimental medication abatacept to standard cyclophosphamide therapy is more effective in improving lupus nephritis than standard cyclophosphamide therapy by itself.
Category:
Autoimmune Disease
|
Specific Category:
Lupus
|
Status:
Complete
Learn more:
(
ITN033AI
|
HALT-MS
)
Principal Investigator:
Richard Nash | University of Washington School of Medicine | Seattle, WA
The HALT-MS study is investigating an experimental treatment of intensive immunosuppression followed by a transplant of the participant’s own stem cells, to see whether it can stabilize multiple sclerosis. Bone marrow CD34+ stem cells are collected from the participant, and transplanted back into the body following treatment with high doses of chemotherapy drugs. This study is for individuals with relapsing-remitting or progressive-relapsing MS, who have experienced relapses while on other MS treatments.
Category:
Autoimmune Disease
|
Specific Category:
Multiple Sclerosis
|
Status:
Complete
Learn more:
Principal Investigator:
John Stone | Johns Hopkins University | Baltimore, MD
Antineutrophil cytoplasmic antibodies (ANCA)-associated vasculitis is the most common type of small blood vessel inflammation in adults. ANCA-associated vasculitis includes Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA). Rituximab is a man-made antibody used to treat certain types of cancer. The purpose of this study is to determine the effectiveness of rituximab in treating adults with WG and MPA.
Category:
Autoimmune Disease
|
Specific Category:
ANCA Positive Vasculitis
|
Status:
Complete
Learn more:
(
ITN020AI
|
STAYCIS
)
Principal Investigator:
Scott Zamvil | University of California San Francisco | San Francisco, CA
Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop problems related to the central nervous system, which controls the nerves in the body. Some of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease of the nervous system. The purpose of this study is to determine if the drug atorvastatin is helpful to CIS patients.
Category:
Autoimmune Disease
|
Specific Category:
Clinically Isolated Syndrome
|
Status:
Complete
Learn more:
(
ITN011AI
|
PART
)
Principal Investigator:
Marcus Clark | University of Chicago | Chicago, IL
hOKT3gamma1 (Ala-Ala) is a man-made antibody that is commonly used to prevent organ rejection. The purpose of this study is to determine whether hOKT3gamma1 (Ala-Ala) is safe and effective in psoriatic arthritis patients who are unable to control their arthritis with methotrexate or azathioprine.
Category:
Autoimmune Disease
|
Specific Category:
Psoriatic Arthritis
|
Status:
Complete
Learn more:
Principal Investigator:
Samia Khoury | Harvard University | Boston, MA
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.
Category:
Autoimmune Disease
|
Specific Category:
Multiple Sclerosis
|
Status:
Complete
Learn more:
No items found.
