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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Children's Hospital Boston
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Stanford University
Ann & Robert H Lurie Children's Hospital of Chicago
Information provided by (Responsible Party):
Lynda Schneider, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01781637
First received: January 30, 2013
Last updated: February 3, 2014
Last verified: February 2014
  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.


Condition Intervention Phase
Peanut Allergy
Food Allergy
Drug: Omalizumab
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Omalizumab in Oral Peanut Desensitization

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • The ability of omalizumab-treated subjects to successfully complete the build-up phase of peanut, and tolerate daily 4,000 mg doses of peanut flour after discontinuing omalizumab. [ Time Frame: 14 wks after the start of oral peanut desensitization (wk 26 of study). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The ability of subjects to tolerate an oral dose of 4,000 mg peanut. [ Time Frame: 8 wks after the start of oral peanut desensitization (study wk 20). ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 36
Study Start Date: January 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   7 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781637

Contacts
Contact: Sara Little 617-355-6127 sara.little@childrens.harvard.edu
Contact: Lynda C Schneider, MD

Locations
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Tony Trela       safar.inquiry@stanford.edu   
Principal Investigator: Kari C Nadeau, MD, PhD         
United States, Illinois
Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Maripaz Vazquez, BSN    312-227-6474    MVAZQUEZ@LURIECHILDRENS.ORG   
Principal Investigator: Jacqueline Pongracic, MD         
United States, Massachusetts
Division of Immunology, Children's Hospital Boston Active, not recruiting
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Courtney B Rooney    267-426-8657    ROONEYC@EMAIL.CHOP.EDU   
Principal Investigator: Jonathan Spergel, MD, PhD         
Sponsors and Collaborators
Children's Hospital Boston
Children's Hospital of Philadelphia
Stanford University
Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
Principal Investigator: Lynda C Schneider, MD Children's Hospital Boston
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
  More Information

No publications provided

Responsible Party: Lynda Schneider, Associate Professor, Harvard Medical School, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01781637     History of Changes
Other Study ID Numbers: Peanut 002
Study First Received: January 30, 2013
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital Boston:
Xolair
omalizumab
peanut
oral desensitization

Additional relevant MeSH terms:
Food Hypersensitivity
Hypersensitivity
Peanut Hypersensitivity
Immune System Diseases
Hypersensitivity, Immediate
Omalizumab
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 16, 2014