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.

A Study to Determine the Immunogenicity and Oral Tolerance to Keyhole Limpet Hemocyanin (KLH) (TAKE)

Principal Investigator:

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.

Category: 

Autoimmune Disease

|

Specific Category: 

|

Status: 

Completed

Persistence of Oral Tolerance to Peanut (LEAP-ON)

Principal Investigator:

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.

Category: 

Allergy & Asthma

|

Specific Category: 

|

Status: 

Completed

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

Principal Investigator:

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.

Category: 

Allergy & Asthma

|

Specific Category: 

Peanut Allergy

|

Status: 

Completed

Post-transplant Cyclophosphamide (ACCEPTOR)

Principal Investigator:

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.

Category: 

Transplantation

|

Specific Category: 

Kidney Transplantation

|

Status: 

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.

Category: 

Autoimmune Disease

|

Specific Category: 

Lupus

|

Status: 

Completed

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.

Category: 

Transplantation

|

Specific Category: 

Liver Transplantation

|

Status: 

Active

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.

Category: 

Allergy & Asthma

|

Specific Category: 

Cat Allergy

|

Status: 

Completed

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.

Category: 

Type 1 Diabetes

|

Specific Category: 

|

Status: 

Completed

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.

Category: 

Autoimmune Disease

|

Specific Category: 

Psoriasis

|

Status: 

Completed

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.

Category: 

Allergy & Asthma

|

Specific Category: 

Cat Allergy

|

Status: 

Completed

No items found.