Omalizumab in the Treatment of Peanut Allergy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Johns Hopkins University.
Recruitment status was Active, not recruiting
Information provided by:
Johns Hopkins University
First received: July 29, 2009
Last updated: June 22, 2011
Last verified: July 2009
The purpose of this study is to determine if treatment with omalizumab (Xolair, anti-IgE) can eliminate or reduce symptoms of peanut allergy.
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Effects of Omalizumab on Peanut Allergen Induced Cellular and Clinical Responses in Peanut Allergic Adults
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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reduction of peanut-allergen induced basophil histamine release in vitro in subjects treated with omalizumab [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Changes in skin test reactivity on omalizumab therapy and up to 6 months during drug withdrawal. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2011 (Final data collection date for primary outcome measure)
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
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00949078
|Johns Hopkins Hospital
|Baltimore, Maryland, United States, 21287 |
Johns Hopkins University
||Robert A Wood, MD
||Johns Hopkins University
||Sarbjit Saini, MD
||Johns Hopkins University
||Robert Wood, MD, Johns Hopkins Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 29, 2009
||June 22, 2011
||United States: Food and Drug Administration
Keywords provided by Johns Hopkins University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Immune System Diseases
Respiratory System Agents