- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02194530
Reduction of Peanut Reactivity and Immune Modulation With Anti-IgE Therapy
Pilot Study to Collect Blood From Research Subjects Allergic and Non-allergic to Peanut to Study Immune Modulation With Anti-IgE Therapy in Mice
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Mei Wang, CCRP
- Phone Number: 646-962-4590
- Email: mew2001@med.cornell.edu
Study Locations
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New York
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New York, New York, United States, 10021
- Department of Genetic Medicine, Weill Cornell Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Peanut allergic individuals
20 individuals will be recruited for this group.
Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube.
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Allergic/atopic individuals (not peanut)
Subjects should not be allergic to peanut.
20 individuals will be recruited for this group.
Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube.
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Non-allergic individuals
20 individuals will be recruited for this group.
Each blood draw will require 105 ml of whole blood to be collected in ten heparinized 10 mL tubes and one EDTA tube.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood test to determine peanut allergy and peanut specific IgE and IgG
Time Frame: 1 year
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There will be one blood draw 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.
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Ronald G Crystal, MD, Weill Cornell Medical College, NY
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1405015102
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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