FAI-3

Research

Research

Clinical Research

Clinical research involves the study of new medicines and treatments in order to understand if they are safe and how well they work. Many early studies are small and do not require a placebo group. However, if those early studies are successful, then typically larger studies must be done in which some of the patients in the study are randomly assigned a placebo. These types of studies are required by the FDA in order for new treatments to be approved for use in routine practice.

Before a clinical research study can begin, the study plan must be presented to a group of physicians, other healthcare workers and community members who evaluate it for patient safety. Once the study is approved, subjects who meet the entry criteria are invited to take part.

Being Selected for a Study 

If you are interested in participating in one of our studies, we encourage you to join our secured, HIPAA-compliant study registry at this link. If you have questions, please call us at (919) 962-4405. 

If you or your child meet a study’s criteria, you will be contacted and have all of your questions answered prior to giving permission through written informed consent. Depending on the age of your child, s/he may also sign the consent document.

It is always the choice of the patient and his or her family whether to enroll in a study. Your decision not to enroll in a study will NOT affect the clinical care you or your child receives at UNC. 

Basic Science Research

Researchers within the UNCFAI conduct laboratory studies on both mice and human patient specimens. They collect and analyze blood samples to better understand the allergic response and how we might halt, reverse, and hopefully one day prevent food allergy. Much of the work done in our lab is to evaluate the treatment responses of clinical trial participants.

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Current Studies

Enrolling:

  1. Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children Ages 4 to 17 Years (RAMSES). [more]
  2. A Phase 1, Randomized , Placebo-Controlled study to evaluate safety, tolerability and Immune response in adults allergic to peanut after receiving intradermal or intramuscular adminstration of ASP0892 (ARA-LAMP_vax), a single multivalent peanut (Ara h1, h2, h3) lysosomal associated membrane protein DNA plasmid vaccine (ASTELLAS) [more]
  3. A randomized, double-blind, placebo-controlled, multi-centre study to assess the safety, tolerability and immunologic effects of HAL-MPE1 subcutaneous immunotherapy in adult and paediatric subjects with peanut allergy (HAL-MPE1) [more]

Ongoing, but closed to enrollment:

  1. Sublingual immunotherapy for newly-diagnosed young patients with peanut allergy [more]
  2. Long-Term Assessment of Safety and Therapeutic Benefit of Viaskin Peanut Epicutaneous Treatment in Peanut-Allergic Children: A 6 month randomization, double-blind, placebo-controlled phase III Study Followed by an open label active treatment (REALISE STUDY) [more]
  3. Double-blinded, placebo-controlled study of oral immunotherapy for peanut allergy in young children through the Immune Tolerance Network (IMPACT) [more]
  4. Randomized withdrawal of sublingual immunotherapy for peanut allergic patients (TLC) [more]
  5. Epicutaneous (on the skin) immunotherapy for peanut allergy in children and adults (CoFAR6) [more]
  6. Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Oral Immunotherapy (ARC) [more]
  7. Baked egg or egg oral immunotherapy for children with egg allergy (CoFAR7) [more]
  8. Eosinophilic esophagitis databank (CoFAR5) [more]
  9. Efficacy and Safety of Viaskin Peanut in Children With Immunoglobulin E (IgE)-Mediated Peanut Allergy (PEPITES) [more]
  10. Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults (PALISADES) [more]
Completed studies or studies in data analysis
  1. High- and low-dose oral immunotherapy for newly-diagnosed young patients with peanut allergy (DEVIL) [more]
  2. Double-blinded, placebo-controlled study of oral immunotherapy for patients with peanut anaphylaxis [more]
  3. Treatment of peanut allergic patients with Xolair and oral immunotherapy [more]
  4. Double-blinded, placebo-controlled study of sublingual immunotherapy for peanut allergic patients [more]
  5. Double-blinded, placebo-controlled study of oral immunotherapy for egg allergic patients (CoFAR3) [more]
  6. Desensitization study of peanut allergic patients [more]
  7. The natural history of peanut allergy in high-risk children [more]
  8. Mechanisms of desensitization during peanut oral immunotherapy [more]

Future studies:

Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children (RAMSES)


 

FAQ

    • A: Although early research from our group and others is promising, many questions remain unanswered. Occasionally in medical research promising findings from early studies are not confirmed in larger, more rigorous studies.

      We do believe that oral immunotherapy may offer some degree of protection from accidental reactions (i.e., desensitization) as long as the treatment is continued. However, the process involves a significant daily commitment for years, and perhaps for life. In addition, some food-allergic patients cannot continue on the treatment due to side effects. Finally, the effect of the treatment might not be permanent. It is, therefore, premature to consider this approach curative or even viable for use in the clinic.
    • A: The current standard of medical care for food-allergic patients consists of strict avoidance of the allergen, education of caregivers at school or childcare settings and administration of emergency medications in the event of accidental exposure. When we see patients in our clinical practice, we follow these standard-of-care guidelines put forth by the National Institutes of Health, which currently recommend against the use of food allergen immunotherapy in non-research settings.

      Although many research groups are developing new treatments, all are investigational at this time and should only be administered in research settings by experienced investigators. We feel that neither our approaches, nor any others, are currently ready for use in the clinic or at home.
    • A: Thank you for your interest in participating in food allergy research. If you are interested in participating in one of our studies, we encourage you to join our secured, HIPAA-compliant study registry at this link. Please contact us if you have further questions.
    • A: We appreciate your enthusiasm for our work, but in our experience, this type of research cannot be done safely over long distances. As such, we are only able to accommodate families who live in the surrounding areas. Due to the high demand for involvement in our studies, we currently maintain a waitlist for our studies and give preference to those already living in our community.
    • A: We are always interested in beginning new studies and, at any given time, have several in development. Although we do not have immediate plans to study other food allergens it may be possible in the future.
    • A: Please consider joining a local or national food allergy support group to help raise awareness of the problem. You can also write your congressman or congresswoman to advocate for increased food allergy research funding, or consider organizing a fundraiser of your own. If you would like to find out more about making a contribution in support of the food allergy research being done at UNC, please contact the N.C. Children’s Promise at (919) 843-3948.