Clinical Trials

The research supported by the Immune Tolerance Network (ITN) has unlocked new therapeutic approaches and discovered new biomarkers that promise to change the way physicians treat patients. Explore ITN clinical trials below by using a search term or by sorting the specific trial categories. If you have questions or want more information about ITN clinical trials, contact us.

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A Cooperative Clinical Study of Abatacept in Multiple Sclerosis (ACCLAIM)

Protocol Chair:
Samia Khoury, Harvard Medical School, 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.

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A Research Trial of Aralast in New Onset Diabetes (RETAIN)

Protocol Chair:
Gordon Weir, Joslin Diabetes Center, Boston, MA

Terry Strom, Beth Israel Deconess, Boston, MA

The RETAIN study is evaluating a protein called alpha-1 antitrypsin (AAT) in recently diagnosed type 1 diabetes patients.

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Abatacept and Cyclophosphamide Combination Therapy for Lupus Nephritis (ACCESS)

Protocol Chair:
David Wofsy, University of California, San Francisco, CA

Betty Diamond, Feinstein Institute, Manhasset, NY

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.

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Associating Renal Transplantation With the ITN Signature of Tolerance (ARTIST)

Protocol Chair:
Kenneth Newell, Emory University, Atlanta, GA

Laurence Turka, Harvard Medical School, Boston, MA

Anil Chandraker, Harvard Medical School, Boston, MA

This is an observational study for people who have received a kidney transplant within the past 1 to 5 years. Researchers in this study are looking for a certain pattern of genes and cells in the blood that has been found in a group of rare transplant patients who do not need immunosuppression.

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ATG and Rituximab in Renal Transplantation (RESTARRT)

Protocol Chair:
James Markmann, MD, Massachusetts General Hospital

The purpose of the RESTARRT study is see if a combination of two drugs, (ATG and rituximab), given at the time of the transplant surgery, will help reduce or eliminate the need for long-term immunosuppressive medication.

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Autoimmunity-Blocking Antibody for Tolerance in Recently Diagnosed Type 1 Diabetes (AbATE)

Protocol Chair:
Kevan Herold, Yale University, New Haven, CT

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) can halt the progression of type 1 diabetes in patients diagnosed within the past 60 days.

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Cytokine Production in Children with Pre-Clinical and Clinical Type 1 Insulin Dependent Diabetes Mellitus (ABBA)

Protocol Chair:
Jorma Ilonen, University of Turku, Turku, Finland

This clinical trial is being performed in collaboration with the Finnish Diabetes Prediction and Prevention project and is studying individuals in various stages of prediabetes who receive intranasal insulin as part of a secondary prevention trial. The ITN is funding the support of additional laboratory studies to identify biomarkers that can predict the onset of type 1 diabetes and to learn more about the natural history of the disease.

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Efficacy of Ustekinumab followed by Abatacept for the Treatment of Psoriasis Vulgaris (PAUSE)

Protocol Chair:
James Krueger, MD, PhD , Rockefeller University , New York, NY

Summary unavailable.

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Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant (A-WISH)

Protocol Chair:
Abraham Shaked, University of Pennsylvania, Philidelphia, PA

In order to prevent organ rejection, patients receiving liver transplants currently require life-long treatment with immune system-suppressing medications. However, these medications can cause long-term side effects, such as infection, kidney problems, diabetes and cancer. This study is investigating whether liver transplant recipients can slowly be taken off these drugs under medical supervision.

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High Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT-MS)

Protocol Chair:
Richard A. Nash, Fred Hutchinson Cancer Research Center, 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.

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Immunosuppressive Medications for Participants in ITN005CT (EXIIST)

Protocol Chair:
Daniel C. Brennan, MD, Washington University, St. Louis, MO

This study is for participants who have received up to three islet cell infusions as a previous participant in the ITN005CT study. Study participants will receive a maintenance immunosuppressive treatment regimen consisting of a combination of orally administered drugs (tacrolimus (Prograf®), sirolimus (Rapamune®), mycophenolate mofetil (MMF, Cellcept®), and/or mycophenolic acid (MPA, Myfortic®).) This protocol provides a way to supply these immunosuppressive medications to subjects whose islets continue to function and make C-peptide.

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Inducing Remission in New Onset T1DM with Alefacept (Amevive®) (T1DAL)

Protocol Chair:
Mark Rigby, MD, PhD, Indiana University/Riley Hospital for Children, Indianapolis, IN

The purpose of this trial is to test whether a drug called alefacept will slow or halt destruction of the beta cells in the pancreas. If the destruction of the beta cells is stopped, the patients might be able to produce insulin on their own longer which could stop or slow the progression of their type 1 diabetes.

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Long-Term Effects of Sublingual Grass Therapy (GRASS)

Protocol Chair:
Stephen Durham, MD, Imperial College, London, United Kingdom

GRASS is a clinical research study looking at long-term immunity from the symptoms of hay fever. The study is testing the effectiveness of two commercially available tolerance-increasing treatments.

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Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (IMPACT)

Protocol Chair:
Wesley Burks, MD │ UNC Chapel Hill │ Chapel Hill, NC

IMPACT is a clinical research study testing whether daily oral exposure to a peanut product can modify peanut allergy in young children.

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Persistence of Oral Tolerance to Peanut (LEAP-ON)

Protocol Chair:
Gideon Lack, MD , Evelina Children's Hospital , London, UK

This is a follow-on study to the ITN’s LEAP trial to evaluate the persistence of tolerance to peanut, and whether continued consumption of peanuts throughout life is required in order to be able to safely eat peanuts without reacting.

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Post-transplant Cyclophosphamide (ACCEPTOR)

Protocol Chair:
Lode Swinnen, Johns Hopkins Hospital, Baltimore, MD

Ephraim Fuchs, Johns Hopkins Hospital, Baltimore, MD

Robert Montgomery, Johns Hopkins Hospital, Baltimore, MD

This trial is a phase II, single arm, open-label, single center study to assess the ability of a specialized pre-transplant conditioning regimen, bone marrow transplantation and high dose post-transplant cyclophosphamide to induce tolerance and enable long-term discontinuation of immunosuppression in six kidney transplant recipients.

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Proleukin® and Rapamune® in Type 1 Diabetes Mellitus (IL2-RAPA)

Protocol Chair:
Carla Greenbaum, Benaroya Research Institute, Seattle, WA

This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within the previous 3-48 months. The study is testing whether two immune system modifying drugs are safe when used in combination and if they have immune altering effects that indicate they can halt the progression of type 1 diabetes.

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Promoting Tolerance to Peanut in High-Risk Children (LEAP)

Protocol Chair:
Gideon Lack, Evelina Children's Hospital, London, United Kingdom

Infants who suffer from eczema or egg allergy have a 1 in 5 chance of developing peanut allergy by age 5. This study is evaluating whether consuming or avoiding peanut early in life can reduce the risk of peanut allergy in these high risk children.

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Renal Allograft Tolerance through Mixed Chimerism (Mixed Chimerism)

Protocol Chair:
David H. Sachs, MD, Harvard Medical School

This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a relative with the same (or nearly the same) blood cell type as the transplant recipient. An investigational medication will be given prior to and after the transplant to help protect the transplanted kidney from attack by the body's immune system.

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Rituximab for the Treatment of Wegener's Granulomatosis and Microscopic Polyangiitis (RAVE)

Protocol Chair:
John H. Stone, Johns Hopkins University

Ulrich Specks, Mayo Clinic

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.

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