Xolair Enhances Oral Desensitization in Peanut Allergic Patients

NCT ID: NCT01290913

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-09-30

Brief Summary

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

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.

We will follow the patients for 5 years following study completion.

Conditions

Peanut Allergy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

omalizumab, oral desensitization

Patients receive omalizumab along with oral peanut desensitization.

Group Type: EXPERIMENTAL

Omalizumab

Intervention Type: DRUG

Omalizumab is an antibody that helps decrease allergic responses in the body

Interventions

Omalizumab

Omalizumab is an antibody that helps decrease allergic responses in the body

Intervention Type: DRUG

Other Intervention Names

Xolair

Eligibility 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lynda Schneider

OTHER

Sponsor Role: lead

Responsible Party

Lynda Schneider

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rima T Rachid, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital, Harvard Medical School

Lynda Schneider, MD

Role: STUDY_DIRECTOR

Children's Hospital, Harvard Medical School

Locations

Children's Hospital Boston, Harvard Medical School

Boston, Massachusetts, United States

Countries

United States

References

Abdel-Gadir A, Schneider L, Casini A, Charbonnier LM, Little SV, Harrington T, Umetsu DT, Rachid R, Chatila TA. Oral immunotherapy with omalizumab reverses the Th2 cell-like programme of regulatory T cells and restores their function. Clin Exp Allergy. 2018 Jul;48(7):825-836. doi: 10.1111/cea.13161. Epub 2018 May 29.

Reference Type: DERIVED

PMID: 29700872 (View on PubMed)

Other Identifiers

Xolair and Peanut Allergy

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CHB10090470

Identifier Type: -

Identifier Source: org_study_id