Trial record 1 of 1 for:    Peanut Reactivity Reduced by Oral Tolerance in an anti-IgE Clinical
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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

January 30, 2013
February 3, 2014
January 2013
October 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01781637 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Peanut Reactivity Reduced by Oral Tolerance in an Anti-IgE Clinical Trial
Phase 2 Study of Omalizumab in Oral Peanut Desensitization

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Peanut Allergy
  • Food Allergy
  • Drug: Omalizumab
    subcutaneous injection
    Other Name: Xolair
  • Drug: placebo
    subcutaneous injection
  • Experimental: omalizumab group
    Patients will receive omalizumab.
    Intervention: Drug: Omalizumab
  • Placebo Comparator: placebo
    Patients will receive placebo.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
36
October 2015
October 2015   (final data collection date for primary outcome measure)

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.
Both
7 Years to 25 Years
No
Contact: Sara Little 617-355-6127 sara.little@childrens.harvard.edu
Contact: Lynda C Schneider, MD
United States
 
NCT01781637
Peanut 002
Yes
Lynda Schneider, Children's Hospital Boston
Children's Hospital Boston
  • Children's Hospital of Philadelphia
  • Stanford University
  • Ann & Robert H Lurie Children's Hospital of Chicago
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
Children's Hospital Boston
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP