Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial

Study Purpose

The investigators will perform a double blind, placebo controlled clinical trial with Xolair (omalizumab) at four centers to safely and rapidly desensitize patients with severe peanut allergy. The investigators will determine if pretreatment with anti-IgE mAb (Xolair/omalizumab) can greatly reduce allergic reactions and allow for faster and safer desensitization.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	7 Years - 25 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Moderate to severe peanut allergy-sensitive subjects between the ages of 7 to 25 years old.

- Sensitivity to peanut allergen will be documented by a positive skin prick test result (6 mm diameter wheal or greater) - ImmunoCAP IgE level to peanut > 10 kU/L.

- Sensitivity to peanut allergen based on a double-blind placebo-controlled oral food challenge (DBPCFC) at maximum of cumulative 175 mg of peanut protein dose.

Exclusion Criteria:

- Subjects with a total IgE at screening of < 50 kU/L > 2,000 kU/L.

- Positive reaction to the placebo on DBPCFC.

- Previous reaction to omalizumab.

- Subjects having a history of severe anaphylaxis to peanut requiring intubation or admission to an ICU, frequent allergic or non-allergic urticaria, or history consistent with poorly controlled persistent asthma, or gastrointestinal or gastroesophageal disease.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01781637
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Boston Children's Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lynda C Schneider, MDAndrew MacGinnitie, MD, PhDKari Nadeau, MD, PhDJonathan Spergel, MD, PhDJacqueline Pongracic, MD
Principal Investigator Affiliation	Boston Children's HospitalChildren' Hospital BostonStanford UniversityChildren's Hospital of PhiladelphiaLurie Children's Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Active, not recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Peanut Allergy, Food Allergy

Additional Details

36 subjects will receive Xolair, and 8 subjects will receive placebo. The study will occur at 4 sites: Boston Children's Hospital, Children's Hospital of Philadelphia, Stanford University and Lurie Children's Hospital. Patients will be pre-treated with Xolair or placebo before rapid oral peanut desensitization. Patients will continue to receive Xolair during the 8 subsequent weeks of desensitization, receiving their final dose of Xolair one week after reaching the highest tolerated dose of peanut.

Arms & Interventions

Arms

Experimental: omalizumab group

Patients will receive omalizumab.

Placebo Comparator: placebo

Patients will receive placebo.

Interventions

Drug: - Omalizumab

subcutaneous injection

Drug: - placebo

subcutaneous injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Stanford University, Stanford, California

Status

Address

Stanford University

Stanford, California, 94305

Lurie Children's Hospital, Chicago, Illinois

Status

Address

Lurie Children's Hospital

Chicago, Illinois, 60611

Boston, Massachusetts

Status

Address

Division of Immunology, Children's Hospital Boston

Boston, Massachusetts, 02115

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania

Status

Address

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104

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