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Omalizumab in the Treatment of Peanut Allergy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00949078
First Posted: July 30, 2009
Last Update Posted: July 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Johns Hopkins University
  Purpose
The purpose of this study is to determine if treatment with omalizumab (Xolair, anti-IgE) can eliminate or reduce symptoms of peanut allergy.

Condition Intervention Phase
Food Allergy Peanut Allergy Drug: omalizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Omalizumab on Peanut Allergen Induced Cellular and Clinical Responses in Peanut Allergic Adults

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Number of Participants Who Experienced a Decrease in Pn-BHR Area Under the Curve (AUC) of > 80% Compared With Baseline Values Before Week 8 [ Time Frame: up to 6 months ]
    Presence or absence of this change

  • Percent Change in Peanut Specific Immunoglobulin E (IgE) From Baseline to After Pn-BHR Response [ Time Frame: change from baseline to up to 6 months ]
    percentage

  • Peanut Specific Immunoglobulin E (IgE) After Pn-BHR Response [ Time Frame: up to 6 months ]
    kU/L (range)

  • Total Immunoglobulin E (IgE) After Pn-BHR Response [ Time Frame: up to 6 months ]
    kU/L (range)

  • Dose of Peanut Protein Inducing Allergic Symptoms at Oral Food Challenge (OFC) 1 [ Time Frame: up to 8 weeks ]
    mg

  • Dose of Peanut Protein Inducing Allergic Symptoms at OFC 2 [ Time Frame: up to 8 weeks ]
    mg

  • Dose of Peanut Protein Inducing Allergic Symptoms at OFC 3 [ Time Frame: up to 8 weeks ]
    mg

  • Omalizumab Received Before OFC 2 [ Time Frame: up to 6 months ]
    Number of doses

  • Omalizumab Received Before OFC 2 [ Time Frame: up to 6 months ]
    total mg


Enrollment: 51
Study Start Date: July 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label Omalizumab Group A
Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
Drug: omalizumab
omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
Other Name: Xolair
Experimental: Open Label Omalizumab Group B
Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
Drug: omalizumab
omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
Other Name: Xolair

Detailed Description:
The study will evaluate if omalizumab is an effective treatment for peanut allergy. In addition we will further evaluate the role of allergic cells (mast cells and basophils) and IgE in food allergy.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female (non-pregnant), age 18-50
  • Females must be: Surgically sterile (hysterectomy, bilateral oophorectomy, bilateral tubal ligation), OR postmenopausal (at least 1 year since last menses), OR using one of the following medically acceptable forms of birth control throughout the duration of the study:

    • Systemic contraceptives
    • Diaphragm with intravaginal spermicide
    • Cervical cap
    • Intrauterine device
    • Condom with intravaginal spermicide Females in certain categories (not sexually active, vasectomized partner) will be admitted at the discretion of the investigator on a case-by-case basis.

Females, excluding those more than 1 year postmenopausal or who are surgically sterile, must have a negative urine pregnancy test at Visit 1 and other visits specified in this protocol. If a subject becomes pregnant during the study participation, they will be discharged from the study and followed for any adverse events until termination of the pregnancy or delivery is complete. Given that the drug is in pregnancy category B, we will follow the pregnant mother for any adverse events for the duration of the study.

  • Physician diagnosed peanut allergy OR convincing clinical history of peanut allergy with its onset in early childhood.
  • Positive puncture skin test to peanut greater than or equal to 3 mm diluent control
  • Positive ImmunoCAP to peanut ≥0.35 kU/L.
  • In vitro basophil responsiveness to peanut allergen, with greater than 20% histamine release or 10-19% if greater than 50% of an optimal anti-IgE response (at baseline visit).
  • Subjects must have a positive oral food challenge to peanut as defined by having objective signs of a clear allergic reaction at a cumulative dose of peanut protein <1000 mg. Objective allergic signs may include oral urticaria, cutaneous urticaria, rhinorrhea, sneezing, coughing, wheezing, or vomiting.

Exclusion Criteria:

  • Asthma with Forced Expiatory Volume in 1 second (FEV1) < 80% predicted or severe persistent asthma per National Asthma Education and Prevention Program (NAEPP) Standards (2007 National Asthma Education and Prevention Program Expert Panel Report III guidelines) or poorly controlled asthma with oral corticosteroid use for exacerbation in last 6 months.
  • History of severe allergic reaction to peanut requiring intubation or ICU admission.
  • Late onset peanut allergy, defined as subjects who had previously tolerated peanut on a regular basis before their initial reaction.
  • Patients with biopsy proven eosinophilic enteropathy will be excluded.
  • Patients with total serum IgE levels less than 30 IU/mL or greater than 700 IU/mL at the time of enrollment will be excluded.
  • Patients with hematocrit < 32%, White Blood Cell (WBC) count <4000/microliter, platelet < 75000/microliter, creatinine > 141.4 micromolar/L, or Aspartate Aminotransferase (AST) > 100 IU/L will be excluded if these abnormalities are present at the time of enrollment.
  • Body weight less than 30 kg or greater than 150 kg at enrollment will be excluded.
  • Patients with plans to become pregnant or breastfeed will be excluded from the study. Patients must indicate they will use methods to avoid pregnancy.
  • Other significant medical conditions (e.g., liver, gastrointestinal, kidney, cardiovascular, pulmonary disease, or blood disorders), which, in the opinion of the Investigator, make the subject unsuitable for induction of food reactions.
  • Current or prior use of omalizumab in the past 12 months.
  • Use of non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator (not including corticosteroids) or biologic therapy within the past year.
  • Use of beta-blockers (oral or ocular), angiotensin-converting enzyme (ACE) inhibitors, or angiotensin-receptor blockers (ARB) within 72 hours prior to either of the qualification Oral Food Challenge (OFC).
  • Use of antihistamines (within 3 days for short acting and 5 days for long acting) prior to the screening OFC.
  • Use of antihistamines (within 3 days for short acting and 5 days for long acting) prior to the study OFC. These procedures should be rescheduled when off antihistamines for the required time.
  • Inability to discontinue antihistamines for routine study tests.
  • History of ischemic cardiovascular disease (i.e., previous Myocardial Infarction, angina etc) or uncontrolled hypertension.
  • Significant upper respiratory tract infection (URI) within 7 days of any OFC; OFCs should be rescheduled within 7 days following resolution of URI.
  • Mental illness or history of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
  • Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
  • Use of any investigational drugs within 8 weeks of participation.
  • Any contraindication to omalizumab including patients with a previous hypersensitivity to omalizumab.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00949078


Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Robert A Wood, MD Johns Hopkins University
Study Director: Sarbjit Saini, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00949078     History of Changes
Other Study ID Numbers: NA_00026397
1U19AI070345 ( U.S. NIH Grant/Contract )
First Submitted: July 29, 2009
First Posted: July 30, 2009
Results First Submitted: February 22, 2017
Results First Posted: July 12, 2017
Last Update Posted: July 12, 2017
Last Verified: June 2017

Keywords provided by Johns Hopkins University:
peanut
allergy

Additional relevant MeSH terms:
Hypersensitivity
Food Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents