FARE Clinical Trial Finder

Simplify your search for a clinical trial and help researchers discover new therapies. The FARE Clinical Trial Finder links patients with food allergy and healthy, non-patient volunteers to actively recruiting food allergy studies.

Reduction of Peanut Reactivity and Immune Modulation With Anti-IgE Therapy

Study Purpose

This pilot study is will examine the pathways involved in allergic response, primarily in food allergy; specifically peanut allergy. We will also study non-allergic donors as well as patients with atopic disorders, primarily as control subjects. We believe that this study will lead to discovery of significant pathways involved in the allergic pathway that can be explored in more detail during follow-up studies in order to address mechanistic questions that cannot be answered in a pilot trial. We believe that such a pilot study represents the ideal approach to identify effective therapeutic interventions and to simultaneously better understand the underlying mechanistic properties involved in the allergy cascade. We think that this study forms the basis for a novel avenue of research into the pathogenesis of allergic pathways, a disease that is still associated with significant morbidity and mortality.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria for Groups 1-3: Group 1: Peanut allergic individuals (n=20)

  • - 18-65 years of age - Positive ImmunoCAP test (Optional) - Documented elevated total IgE levels, peanut positivity or another antigen/allergen specific elevated IgE (ie common indoor/outdoor allergens) - Experienced at least one of the following symptoms within 60 minutes of exposure: - Skin-related symptom (i.e., hives and edema) - Respiratory-related symptom (i.e., wheezing, throat tightness, repetitive coughing, and dyspnea) - Gastrointestinal-related symptom (i.e., vomiting and diarrhea) Group 2: Allergic/atopic individuals (not allergic to peanut; n=20) - 18-65 years of age.
  • - Positive ImmunoCAP test (Optional) - Documented elevated total IgE levels or an indoor/outdoor antigen/allergen (other than peanut) specific elevated IgE (ie common indoor/outdoor allergens).
  • - Experienced at least one of the following symptoms within 60 minutes of exposure: - Skin-related symptom (i.e., hives and edema).
  • - Respiratory-related symptom (i.e., wheezing, throat tightness, repetitive coughing, and dyspnea).
  • - Gastrointestinal-related symptom (i.e., vomiting and diarrhea) Group 3: Non-allergic individuals (healthy controls; n=20) - 18-65 years of age.
  • - Negative ImmunoCAP test (Optional) - Documented absence or low total IgE levels, or negativity for an antigen/allergen specific elevated IgE (ie common indoor/outdoor allergens).
  • - Has not experienced at least one of the following symptoms within 60 minutes of exposure to a particular substance: - Skin-related symptom (i.e., hives and edema).
  • - Respiratory-related symptom (i.e., wheezing, throat tightness, repetitive coughing, and dyspnea).
  • - Gastrointestinal-related symptom (i.e., vomiting and diarrhea) Exclusion Criteria for Groups 1-3: - Prior therapy with anti-IgE - Steroid use greater than 10 mg/d prednisone or equivalent 30 days prior to enrollment - Any immunosuppressive drug use within 3 months prior to screening (mycophenolate mofetil, hydroxychloroquine, azathioprine, methotrexate, leflunomide, rituximab, cyclophosphamide, intravenous immunoglobulin, plasmapheresis) - Ongoing chronic infection (viral, bacterial or fungal) including known HIV, Hepatitis B/C - Acute infection receiving any antibiotics within 30 days prior to screening - Probiotics (greater than estimated 109 cfu or organisms per day) within 30 days prior to enrollment (with the exception of fermented beverages, milks or yogurts).
- Malignancy within one year prior to screening (with the exception of non-metastatic squamous or basal cell skin carcinomas and cervical carcinoma if received curative surgical treatment) - Known illicit drug or alcohol abuse - Pregnancy

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02194530
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Weill Medical College of Cornell University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Odelya Pagovich, MD
Principal Investigator Affiliation Weill Cornell Medical College, NY
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peanut Allergy
Additional Details

The study aims to characterize the pathways involved in the allergic response, primarily in food allergy; specifically peanut allergy. We will also study non-allergic donors as well as patients with atopic disorders, primarily as control subjects. All eligible study participants will have documented elevated total IgE levels, peanut positivity or another antigen/allergen specific elevated IgE (ie common indoor/outdoor allergens) prior to being enrolled in the study. Our study will focus on allergic as well as non-allergic individuals. We plan on collecting samples from a total of 60 patients during one time point (peanut allergic individuals, non-atopic/allergic individuals, atopic individuals-other than peanut allergy). We believe that such a pilot study represents the ideal approach to identify effective therapeutic interventions and to simultaneously better understand the underlying mechanistic properties involved in the allergy cascade. We plan to obtain a detailed history prior to enrollment as well as objective data (ie SPT as well as Immunocap testing results). There will be 3 study groups and studies will be performed on approximately 20 peanut allergic patients, 20 non-allergic controls, and 20 allergic/atopic (non-peanut allergic, but allergic to indoor/outdoor allergen) individuals. There will be one blood draw required at each visit (weeks 0, 4, 8). Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10-mL tubes and one EDTA tube. We plan to assess the levels of total IgE and IgG as well as antigen specific IgG and IgE in the peripheral blood of patients. We will specifically perform ELISA testing that detects these levels. We will also perform in vitro CD4+ T cell proliferation assays. For this purpose, patients' peripheral T cells will be isolated with a combination of magnetic beads and flow cytometric sorting.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York, New York

Status

Address

Department of Genetic Medicine, Weill Cornell Medicine

New York, New York, 10021

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