Xolair Enhances Oral Desensitization in Peanut Allergic Patients

NCT01290913 | Completed Phase 1 Results DMC

• 2 other identifiers: CHB10090470Xolair and Peanut Allergy
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peanut Allergy

Keywords

peanut allergy; Xolair

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 500 mg Peanut Flour (Cumulative Dose, 1,000 mg)

  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.

  First day of desensitization

Secondary Outcomes (1)

• Number of Participants That Tolerated Rapid Oral Peanut Desensitization to a Dose of 4,000 mg of Peanut Flour.

  after 7-8 wks of desensitization

Study Arms (1)

omalizumab, oral desensitization

EXPERIMENTAL

Patients receive omalizumab along with oral peanut desensitization.

Drug: Omalizumab

Interventions

Omalizumab DRUG

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

Also known as: Xolair

omalizumab, oral desensitization

Eligibility Criteria

• Age: 7 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• Total IgE \>50 kU/L but \<2,0000 kU/L.
• 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.
• 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.
• 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.
• Subjects must be planning to remain in the study area during the trial.
• Subjects and/or their parents must be trained on the proper use of the Epi-Pen to be allowed to enroll in the study.

You may not qualify if:

• Due to the risk of serious systemic anaphylactic reactions to peanut in this study, we will exclude:
• 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).
• 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.
• Total IgE \> 2,000 IU/mL.
• 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.
• 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.
• 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.
• Subjects refusing to sign the EpiPen Training Form.
• Pregnant or breast-feeding females.
• 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.

Sponsors & Collaborators

• Lynda Schneider: lead

Study Sites (1)

Children's Hospital Boston, Harvard Medical School

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 29700872 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Clinical Coordinator
• Organization: Boston Children's Hospital

sara.little@childrens.harvard.edu

6173556127

Study Officials

• Rima T Rachid, MD

  Children's Hospital, Harvard Medical School

  PRINCIPAL INVESTIGATOR

• Lynda Schneider, MD

  Children's Hospital, Harvard Medical School

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 7, 2011
• Study Start: February 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 7, 2015
• Results First Posted: February 20, 2015

Record last verified: 2015-03

Locations

US (1)