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

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

CD40L-CD40 Pathway In Rheumatoid Arthritis (CONTROL-RA)

Principal Investigator:

William St. Clair, MD , Duke University

The goal of CONTROL-RA is to see how the experimental study drug, VIB4920, affects control of rheumatoid arthritis (RA).

Learn more: Study Summary Clinicaltrials.gov Study Website

VIB4920 for Active Lupus Nephritis (VIBRANT)

Principal Investigator:

Betty Diamond, MD , Feinstein Institute for Medical Research

David Wofsy, MD , University of California San Francisco School of Medicine

Maria Dall'Era, MD , University of California San Francisco School of Medicine

The goal of the VIBRANT trial is to determine if treating lupus nephritis with VIB4920 in addition to standard therapy is more effective than treating lupus nephritis with standard therapy alone.

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