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Immune Tolerance in Autoimmune Disease

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, 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 reprogram the immune system to stop the disease-causing immune attack on self-tissue while maintaining the immune system's ability to fight infection. The Immune Tolerance Network (ITN) is also working to identify biomarkers of immune tolerance that may help to identify the right treatment course for future patients.                        

This section contains a list of ITN's autoimmune clinical trials that are currently enrolling participants. To see all of ITN's active and completed studies in autoimmune disease, please visit For Researchers.

Clinical Trials - Autoimmune Disease

Active

Daratumumab For Antiphospholipid Syndrome (DARE-APS)

Principal Investigator:
Doruk Erkan, MD, MPH, Hospital for Special Surgery
Jason Knight, MD, PhD, University of Michigan
A study about the safety of daratumumab in patients with antiphospholipid syndrome (APS), and its effectiveness at reducing the antiphospholipid antibodies that cause APS.
Learn more: Study Summary Clinicaltrials.gov Study Website

Siplizumab in T1DM (DESIGNATE)

Principal Investigator:
Stephen Gitelman, MD , University of California San Francisco
DESIGNATE is a clinical study to identify a safe, metabolically favorable, dosing regimen for siplizumab in patients with type 1 diabetes mellitus.
Learn more: Study Summary Clinicaltrials.gov Study Website

Targeting IL-15 For The Treatment Of Vitiligo (REVEAL)

Principal Investigator:
Brett King, MD, PhD, Yale University
The REVEAL study will investigate whether the experimental study medication, AMG714, can bring back normal color to the skin in vitiligo.
Learn more: Study Summary Clinicaltrials.gov Study Website

Belimumab and Rituximab for Primary Membranous Nephropathy (REBOOT)

Principal Investigator:
Patrick Nachman, MD, University of Minnesota
Ignacio Sanz, MD, Emory University
REBOOT will test whether a combination of, belimumab and rituximab, is safe and if this combination is more effective at blocking the immune attack on the kidney of patients with Primary Membranous Neuropathy (MN).
Learn more: Study Summary Clinicaltrials.gov Study Website

Best Available Therapy Vs. Autologous Hematopoietic Stem Cell Transplant For MS (BEAT MS)

Principal Investigator:
Jeffrey Cohen, MD, Cleveland Clinic
George Georges, MD, Fred Hutchinson Cancer Research Center
Paolo Muraro, MD, PhD, Imperial College London
BEAT-MS is a clinical trial comparing chemotherapy followed by autologous hematopoietic stem cell transplant (AHSCT) – a type of bone marrow transplantation – to the most effective medicines regularly used to treat relapsing MS.
Learn more: Study Summary Clinicaltrials.gov Study Website

T1D Extended Study (T1DES)

Principal Investigator:
Linda DiMeglio, MD, MPH, Indiana University and Riley Hospital for Children, Indianapolis, IN
T1DES is a clinical study for people with type 1 diabetes who were previously enrolled in an ITN clinical study.
Learn more: Study Summary Clinicaltrials.gov Study Website
View All Clinical Trials

The Immune Tolerance Network and is sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.

National Institute of Allergy and Infectious Diseases

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