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

Part of paid clinical trials in Stanford, California.

Sponsor
Boston Children's Hospital
Study ID
NCT01781637
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Food Allergy
  • Peanut Allergy

Eligibility Criteria

Sex
ALL
Age
7 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — DRUG
    subcutaneous injection
  • placebo — DRUG
    subcutaneous injection

Study Details

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.

Key Dates

Start date
Jan 31, 2013
Status verified
Feb 2023
Primary completion
Oct 31, 2015
Completion
May 31, 2022

Study Design

Enrollment
36 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: omalizumab group
    Patients will receive omalizumab.
  • Placebo Comparator: placebo
    Patients will receive placebo.

Primary Outcome Measure

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

Locations (4)

FacilityCityStateZIPSite coordinators
Stanford UniversityStanfordCalifornia94305-
Lurie Children's HospitalChicagoIllinois60611-
Division of Immunology, Children's Hospital BostonBostonMassachusetts02115-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-

Find similar trials in Stanford, CA

By research site
Stanford University· Stanford, CALurie Children's Hospital· Chicago, ILDivision of Immunology, Children's Hospital Boston· Boston, MAChildren's Hospital of Philadelphia· Philadelphia, PA

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