- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00949078
Omalizumab in the Treatment of Peanut Allergy
Effects of Omalizumab on Peanut Allergen Induced Cellular and Clinical Responses in Peanut Allergic Adults
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
Other Names:
|
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.
|
omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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up to 6 months
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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
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change from baseline to up to 6 months
|
Peanut Specific Immunoglobulin E (IgE) After Pn-BHR Response
Time Frame: up to 6 months
|
kU/L (range)
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up to 6 months
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Total Immunoglobulin E (IgE) After Pn-BHR Response
Time Frame: up to 6 months
|
kU/L (range)
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up to 6 months
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Dose of Peanut Protein Inducing Allergic Symptoms at Oral Food Challenge (OFC) 1
Time Frame: up to 8 weeks
|
mg
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up to 8 weeks
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Dose of Peanut Protein Inducing Allergic Symptoms at OFC 2
Time Frame: up to 8 weeks
|
mg
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up to 8 weeks
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Dose of Peanut Protein Inducing Allergic Symptoms at OFC 3
Time Frame: up to 8 weeks
|
mg
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up to 8 weeks
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Omalizumab Received Before OFC 2
Time Frame: up to 6 months
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Number of doses
|
up to 6 months
|
Omalizumab Received Before OFC 2
Time Frame: up to 6 months
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total mg
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up to 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sarbjit Saini, MD, Johns Hopkins University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NA_00026397
- 1U19AI070345 (U.S. NIH Grant/Contract)
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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