Building on clinical trial and laboratory research insights from the past decade, the ITN has focused and deliberate strategies to achieving tolerance in each disease area. The research supported by the 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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James Krueger, MD, PhD, Rockefeller University, New York, NY
PAUSE is a clinical trial testing the effectiveness of ustekinumab (STELARA ®) followed by an investigational drug, abatacept, for the treatment of psoriasis. The main goal of the study is to determine the efficacy of abatacept to induce prolonged remission.
Lode Swinnen, MD, 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.
Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (IMPACT)
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.
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.
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.
A Study to Determine the Immunogenicity and Oral Tolerance to Keyhole Limpet Hemocyanin (KLH) (TAKE)
Lloyd Mayer, MD, Mount Sinai Medical Center, New York, NY
The purpose of this study is to determine whether Immucothel, a Keyhole Lymphocyte Antigen (KLH) product, can trigger an immune response when ingested orally and create "oral tolerance" to KLH. If not, Immucothel will be tested with another agent to enhance the immune response.
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.
James Markmann, MD, Massachusetts General Hospital, Boston, MA
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.
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.
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.
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.
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.
A Screening Study for Identification of Tolerance Markers in Liver Transplant Recipients Who Received Campath-1H Immunosuppression
Andreas Tzakis, MD, Jackson Memorial Hospital, Miami, FL
Panagiotis Tryphonopoulos, MD, University of Miami, Miami, FL
This study aims to identify which study participants - all of whom previously received a liver transplant under Campath-1H immunosuppression - exhibit specific tolerogenic genotypes. Our hypothesis is that patients who exhibit these genotypes might be good candidates for future immunosuppression withdrawal.
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.
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.
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.
Jack Antel, Montreal Neurological Institute, Montreal, Quebec, Canada
This study aims to evaluate the safety and tolerability of a 5 mg dose of the study drug, NBI-5788, for treatment of relapsing-remitting multiple sclerosis patients. A prior phase 2 trial conducted with this drug demonstrated suggestive evidence of treatment benefit with a 5 mg dose of NBI-5788.
Cytokine Production in Children with Pre-Clinical and Clinical Type 1 Insulin Dependent Diabetes Mellitus (ABBA)
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.
Kenneth Newell, Emory University, Atlanta, GA
Immunosuppressive drugs are all that separate transplant recipients from rejecting their transplanted organs. The ITN Registry of Tolerant Kidney Transplant Recipients is searching for those rare kidney transplant recipients who have stopped their immunosuppression, but for some reason have not rejected their transplants. If you have received a kidney transplant and have been off all immunosuppressive medications for 1 year and have good kidney function, or if you received your kidney from an identical twin, you may be eligible to participate.
Florian Kern, Institut für Medizinische Immunologie, Berlin, Germany
This study seeks to optimize and standardize an existing assay which allows the T-cell response directed against in transplant recipients who undergo immune tolerance induction. This study employs a rapid laboratory test that would enable the transplant physicians to look at the patient's immune response to this model virus.