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Clinical Trials

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.

Active

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

Measuring Allospecific Impact of Belatacept/Carfilzomib Desensitization (ADAPT)

Principal Investigator:
Stuart Knechtle, MD, Duke University Hospital
The goal of the ADAPT study is to study whether using two drugs, carfilzomib and belatacept, together can lower the number of plasma cells in “highly sensitized” people on the kidney transplant waiting list.
Learn more: Study Summary Clinicaltrials.gov Study Website

Daratumumab plus belatacept desensitization trial (ATTAIN)

Principal Investigator:
Flavio G. Vincenti, MD, University of California, San Francisco Medical Center
The goal of ATTAIN is to study whether using two drugs, daratumumab and belatacept, together can lower the number of plasma cells in “highly sensitized” people on the kidney transplant waiting list.
Learn more: Study Summary Clinicaltrials.gov Study Website

Grass Pollen Immunotherapy Plus Dupilumab For Tolerance Induction (GRADUATE)

Principal Investigator:
Stephen R. Durham, MD, Imperial College, London
GRADUATE is a clinical research trial, which will test whether a novel drug called Dupixent® given with grass pollen immunotherapy will help the immunotherapy work in a shorter treatment period and remain effective after the completion of treatment.
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

Tolerance by Engaging Antigen During Cellular Homeostasis (TEACH)

Principal Investigator:
Allan Kirk, MD, PhD, Duke University School of Medicine
TEACH is a clinical trial investigating whether cells from the kidney donor's bone marrow, called mesenchymal stromal cells (MSCs) will allow kidney transplant recipients to stop immunosuppressive medications.
Learn more: Study Summary Clinicaltrials.gov Study Website

Vaginal Microbiome Exposure and Immune Responses in C-section Infants (ACTIVATE)

Principal Investigator:
Hugh Sampson, MD , Icahn School of Medicine at Mount Sinai , New York
Jose Clemente, PhD , Icahn Institute for Genomics and Multiscale Biology , New York
ACTIVATE is a clinical trial investigating the impact of the infant microbiome on allergy development.
Learn more: Study Summary Clinicaltrials.gov Study Website

Liver Transplantation with Tregs at MGH and UCSF (LITTMUS)

Principal Investigator:
James Markman, MD, PhD, Massachusetts General Hospital , Boston, MA;
Sandy Feng, MD, PhD, University of California San Francisco , San Francisco, CA
LITTMUS is a clinical research study testing a new approach to achieve transplant tolerance using the liver transplant recipient’s own T regulatory cells (Tregs).
Learn more: Study Summary Clinicaltrials.gov Study Website

Follow up of LEAP Participants and Their Families (LEAP Trio)

Principal Investigator:
Gideon Lack, Evelina Childrens Hospital, London, UK
LEAP Trio is a follow-up to the LEAP study of early peanut consumption. LEAP Trio will investigate the durability of tolerance to peanut allergen in LEAP participants at age 12, development of peanut allergy in younger siblings of LEAP participants, and parental characteristics that may impact development of food allergy.
Learn more: Study Summary Clinicaltrials.gov Study Website

Evaluation Of Brentuximab Vedotin For Diffuse Cutaneous Systemic Sclerosis (BRAVOS)

Principal Investigator:
David Fox, MD , University of Michigan , Ann Arbor, MI
Dinesh Khanna, MD , University of Michigan , Ann Arbor, MI
BRAVOS is a clinical trial evaluating Brentuximab Vendotin treatment for Diffuse Cutaneous Systemic Sclerosis.
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

Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation (OPTIMAL)

Principal Investigator:
James Markmann, MD, PhD, Massachusettes General Hospital, Boston, MA
OPTIMAL is a clinical trial that will be investigating immunosuppression withdrawal in liver transplant recipients.
Learn more: Study Summary Clinicaltrials.gov Study Website

Completed

Rituximab Plus Cyclophosphamide followed by Belimumab (CALIBRATE)

Principal Investigator:
Betty Diamond, MD, Feinstein Institute, Manhasset, NY
David Wofsy, MD, University of California San Francisco, San Francisco, CA
The objective of the CALIBRATE study is to determine if treating lupus nephritis with a combination of rituximab (Rituxan®) and cyclophosphamide (Cytoxan®), or a combination of rituximab and cyclophosphamide followed by treatment with belimumab (Benlysta®) is safe and if this drug combination can block the immune system attacks on the kidney.
Learn more: Study Summary Clinicaltrials.gov Study Website

Cat Pilot Study - Environmental Exposure Chamber (EEC) vs. Nasal Allergen Challenge (NAC) (CAT EEC Study)

Principal Investigator:
Stephen Durham, MD, Imperial College London, London, UK
Piyush Patal, MD, Inflamax Research, Ontario, Canada
The goal of the CAT EEC study is to directly compare allergic responses to cat by environmental exposure chamber vs. nasal allergen challenge to better understand and employ these methods as allergy evaluation tools in clinical trials.
Learn more: Study Summary Clinicaltrials.gov

Preserving Beta-Cell Function with Tocilizumab in New-Onset Type 1 Diabetes (EXTEND)

Principal Investigator:
Carla Greenbaum, MD, Benaroya Research Institute, Seattle, WA
Jane Buckner, MD, Benaroya Research Institute, Seattle, WA
EXTEND is a clinical research study that will test whether a therapy called tocilizumab (Actemra®) can stop the immune system from attacking the remaining beta cells and possibly extend the ability to naturally produce insulin in individuals recently diagnosed with type 1 diabetes.
Learn more: Study Summary Clinicaltrials.gov Study Website

Anti-TSLP Plus Antigen-Specific Immunotherapy For Induction Of Tolerance In Individuals With Cat Allergy (CATNIP)

Principal Investigator:
Jonathan Corren, MD, University of California, Los Angeles, Los Angeles, CA
CATNIP is a clinical research trial, which will test whether a novel therapeutic approach, cat immunotherapy combined with an investigational new drug called MEDI9929/AMG 157 (an anti-TSLP antibody being co-developed by Amgen and Medimmune) can lead to lasting tolerance to cat allergen. This study will implement the concept referred to as “allergen-plus,” which aims to enhance the disease-modifying mechanisms of allergen-specific immunotherapy by combining it with other anti-inflammatory or immune-modulating agents.
Learn more: Study Summary Clinicaltrials.gov Study Website

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

Principal Investigator:
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.
Learn more: Study Summary Clinicaltrials.gov Study Website

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

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