Xolair Enhances Oral Desensitization in Peanut Allergic Patients

• ClinicalTrials.gov Identifier: NCT01290913
• Recruitment Status: Completed
• First Posted: February 7, 2011
• Results First Posted: February 20, 2015
• Last Update Posted: April 7, 2015
• Sponsor: Lynda Schneider
• Information provided by (Responsible Party): Lynda Schneider, Boston Children's Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Peanut Allergy	Drug: Omalizumab	Phase 1; Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Xolair Enhances Oral Desensitization in Peanut Allergic Patients
• Study Start Date: February 2011
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: omalizumab, oral desensitization; Patients receive omalizumab along with oral peanut desensitization.	Drug: Omalizumab; Omalizumab is an antibody that helps decrease allergic responses in the body; Other Name: Xolair

Outcome Measures

Primary Outcome Measures :

1. Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 500 mg Peanut Flour (Cumulative Dose, 1,000 mg) [ Time Frame: First day of desensitization ]
   To tolerate refers to the ability of the patient to ingest the challenge dose of 500 mg peanut flour (1000 mg cumulatively) with either no or mild symptoms.

Secondary Outcome Measures :

1. Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 4,000 mg of Peanut Flour. [ Time Frame: after 7-8 wks of desensitization ]
   To tolerate refers to the ability of the patient to ingest the final challenge of 4000mg peanut flour, with either no or mild symptoms.

Eligibility Criteria

• Ages Eligible for Study: 7 Years to 25 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Massachusetts

Children's Hospital Boston, Harvard Medical School

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Lynda Schneider

Investigators

• Principal Investigator: Rima T Rachid, MD; Children's Hospital, Harvard Medical School
• Study Director: Lynda Schneider, MD; Children's Hospital, Harvard Medical School

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Lynda Schneider, Associate Professor, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT01290913
• Other Study ID Numbers: CHB10090470; Xolair and Peanut Allergy ( Other Grant/Funding Number: TRF )
• First Posted: February 7, 2011
• Results First Posted: February 20, 2015
• Last Update Posted: April 7, 2015
• Last Verified: March 2015

Keywords provided by Lynda Schneider, Boston Children's Hospital:

peanut allergy; Xolair

Additional relevant MeSH terms:

Peanut Hypersensitivity; Hypersensitivity; Immune System Diseases; Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Omalizumab; Anti-Allergic Agents; Anti-Asthmatic Agents; Respiratory System Agents