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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01781637
Recruitment Status : Active, not recruiting
First Posted : February 1, 2013
Results First Posted : May 3, 2017
Last Update Posted : December 23, 2020
Children's Hospital of Philadelphia
Stanford University
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Lynda Schneider, Boston Children's Hospital

Brief Summary:
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.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Omalizumab in Oral Peanut Desensitization
Study Start Date : January 2013
Actual Primary Completion Date : October 2015
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arm Intervention/treatment
Experimental: omalizumab group
Patients will receive omalizumab.
Drug: Omalizumab
subcutaneous injection
Other Name: Xolair

Placebo Comparator: placebo
Patients will receive placebo.
Drug: placebo
subcutaneous injection

Primary Outcome Measures :
  1. Tolerance of 2000 mg 6 Weeks After Last Dose of Omalizumab/Placebo [ Time Frame: 6 weeks after last dose of omalizumab/placebo ]

Secondary Outcome Measures :
  1. Pass 4000 mg OFC 12 Weeks After Last Dose of Omalizumab/Placebo [ Time Frame: 12 weeks after last dose of omalizumab/placebo ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01781637

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United States, California
Stanford University
Stanford, California, United States, 94305
United States, Illinois
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
United States, Massachusetts
Division of Immunology, Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Boston Children's Hospital
Children's Hospital of Philadelphia
Stanford University
Ann & Robert H Lurie Children's Hospital of Chicago
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Principal Investigator: Lynda C Schneider, MD Boston Children's Hospital
Study Chair: Andrew MacGinnitie, MD, PhD Children' Hospital Boston
Study Chair: Kari Nadeau, MD, PhD Stanford University
Study Chair: Jonathan Spergel, MD, PhD Children's Hospital of Philadelphia
Study Chair: Jacqueline Pongracic, MD Lurie Children's Hospital
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Responsible Party: Lynda Schneider, Professor, Harvard Medical School, Boston Children's Hospital Identifier: NCT01781637    
Other Study ID Numbers: Peanut 002
First Posted: February 1, 2013    Key Record Dates
Results First Posted: May 3, 2017
Last Update Posted: December 23, 2020
Last Verified: December 2020
Keywords provided by Lynda Schneider, Boston Children's Hospital:
oral desensitization
Additional relevant MeSH terms:
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Food Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Nut and Peanut Hypersensitivity
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents