Xolair Enhances Oral Desensitization in Peanut Allergic Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dale T Umetsu, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01290913
First received: February 4, 2011
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

This is a pilot feasibility study, using Xolair pretreatment for oral peanut desensitization.


Condition Intervention Phase
Peanut Allergy
Drug: Omalizumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Xolair Enhances Oral Desensitization in Peanut Allergic Patients

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • ability of a patient to tolerate rapid oral peanut desensitization to a dose of 500 mg peanut (cumulative dose, 1,000 mg). [ Time Frame: First day of desensitization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ability of a patient to tolerate rapid oral peanut desensitization to a dose of 4,000 mg of peanut. [ Time Frame: after 7-8 wks of desensitization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 11
Study Start Date: February 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: omalizumab, oral desensitization Drug: Omalizumab

Detailed Description:

We hypothesize that pretreatment with anti-IgE mAb will greatly reduce the side effects and allergic reactions that occur during oral desensitization to peanut and will enhance the development of oral tolerance in patients with severe peanut allergy.

  Eligibility

Ages Eligible for Study:   7 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with severe peanut allergy, between the ages of 7-25 years, having a history of significant clinical symptoms within 1 hr of peanut ingestion.
  2. Total IgE >50 kU/L but <2,0000 kU/L.
  3. Sensitivity to peanut will be documented by a positive skin prick test result and RAST test to peanut, with 20 kU/L as a lower limit for eligibility.
  4. Patients must also fail a double blind food challenge with peanut at a dose of 100 mg or less (after a cumulative dose of 186 mg), with minimal or no reactions to the placebo challenge.
  5. All female subjects of childbearing potential will be required to provide a urine sample for pregnancy testing that must be negative one week before being allowed to participate in the study.
  6. Subjects must be planning to remain in the study area during the trial.
  7. Subjects and/or their parents must be trained on the proper use of the Epi-Pen to be allowed to enroll in the study.

Exclusion Criteria:

Due to the risk of serious systemic anaphylactic reactions to peanut in this study, we will exclude:

  1. Patients with acute infections, autoimmune disease, severe cardiac disease, and those who are treated with beta-adrenergic antagonistic drugs (beta-blockers, which increase the risk of more serious symptoms of anaphylaxis).
  2. Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent urticaria, or history consistent with poorly controlled persistent asthma.
  3. Total IgE > 2,000 IU/mL.
  4. Subjects with unstable angina, significant arrhythmia, uncontrolled hypertension, chronic sinusitis, or other chronic or immunological diseases that in the mind of the investigator might interfere with the evaluation or administration of the test drug or pose additional risk to the subject e.g. gastrointestinal or gastroesophageal disease, chronic infections, scleroderma, hepatic and gallbladder disease, chronic non-allergic pulmonary disease.
  5. Subject with an FEV1 or PEF less than 80% predicted with or without controller medication (if able to perform the maneuver) at screening, the oral desensitization visit, or food challenge visit.
  6. Subjects who have received an experimental drug in the last 30 days prior to admission into this study or who plan to use an experimental drug during the study, who are current users of oral, intramuscular, or intravenous corticosteroids, or tricyclic antidepressants, or who are using medication that could induce adverse gastrointestinal reactions during the study.
  7. Subjects refusing to sign the EpiPen Training Form.
  8. Pregnant or breast-feeding females.
  9. Subjects with severe food associated eczema, dermatitis herpetiformis, eosinophilic esophagitis, eosinophilic enteritis, proctocolitis, food protein induced enterocolitis syndrome (FPIES) or other gastrointestinal diseases. These requirements are necessary to limit the study to patients with primarily IgE mediated peanut allergy, and to exclude patients with peanut sensitivity mediated by cellular/T cell (non-IgE mediated) mechanisms.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01290913

Locations
United States, Massachusetts
Children's Hospital Boston, Harvard Medical School
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Dale T Umetsu, MD, PhD Children's Hospital, Harvard Medical School
Study Director: Lynda Schneider, MD Children's Hospital, Harvard Medical School
  More Information

No publications provided

Responsible Party: Dale T Umetsu, Professor, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01290913     History of Changes
Other Study ID Numbers: CHB10090470, Xolair and Peanut Allergy
Study First Received: February 4, 2011
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Boston:
peanut allergy
Xolair

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

ClinicalTrials.gov processed this record on August 25, 2014