This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Omalizumab in the Treatment of Peanut Allergy

This study has been completed.
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Robert A. Wood, Johns Hopkins University Identifier:
First received: July 29, 2009
Last updated: March 28, 2016
Last verified: March 2016
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: Intervention Model: Single Group Assignment
Masking: 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 Robert A. Wood, Johns Hopkins University:

Primary Outcome Measures:
  • Proportion of participants who have a four-fold increase in the dose of peanut protein needed to induce positive challenge (with final threshold dose >1000 mg) at the 6 month oral food challenge [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Reduction of peanut-allergen induced basophil histamine release in vitro in subjects treated with omalizumab [ Time Frame: 6 months ]
  • Changes in dose of peanut protein needed to induce a positive challenge at the second oral food challenge compared to baseline [ Time Frame: 1-2 months ]
  • Changes in skin test reactivity on omalizumab therapy and up to 6 months during drug withdrawal. [ Time Frame: 12 months ]
  • Changes in free and total peanut-specific IgE and total IgE as well as the ratio of peanut-specific IgE to total IgE on omalizumab therapy and up to 6 months after drug withdrawal [ Time Frame: 12 ]
  • Changes in basophil markers CD203c, CD63, CD69/ST2, and basogranulin, as well as tryptase during oral food challenges on omalizumab therapy [ Time Frame: 6 months ]
  • Changes in the indirect effects of serum on basophil histamine release on omalizumab therapy and up to 6 months after drug withdrawal [ Time Frame: 12 months ]

Enrollment: 15
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 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.

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

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 FEV1 < 80% predicted or severe persistent asthma per NAEP 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%, WBC count <4000/microliter, platelet < 75000/microliter, creatinine > 141.4 micromolar/L, or 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 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 MI, 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00949078

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)
Principal Investigator: Robert A Wood, MD Johns Hopkins University
Study Director: Sarbjit Saini, MD Johns Hopkins University
  More Information

Responsible Party: Robert A. Wood, Professor of Pediatrics, Johns Hopkins University Identifier: NCT00949078     History of Changes
Other Study ID Numbers: AADCRC-JHU-02
1U19AI070345 ( US NIH Grant/Contract Award Number )
Study First Received: July 29, 2009
Last Updated: March 28, 2016

Keywords provided by Robert A. Wood, Johns Hopkins University:

Additional relevant MeSH terms:
Food Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents processed this record on June 23, 2017