Omalizumab in the Treatment of Peanut Allergy

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT00949078
Phase
PHASE2
Status
Completed

Conditions

  • Food Allergy
  • Peanut Allergy

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • omalizumab — DRUG
    omalizumab subcutaneously every 2-4 weeks depending on participant weight and total IgE

Study Details

The purpose of this study is to determine if treatment with omalizumab (Xolair, anti-IgE) can eliminate or reduce symptoms of peanut allergy.

Key Dates

Start date
Jul 31, 2009
Status verified
Jun 2017
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011

Study Design

Enrollment
51 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Open Label Omalizumab Group A
    Omalizumab was dosed according to package insert. Patients who have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.
  • Experimental: Open Label Omalizumab Group B
    Omalizumab was dosed according to package insert. Patients who do not have a decrease in peanut allergen induced basophil histamine release (Pn-BHR) to less than 20% of baseline will be assigned to this group.

Primary Outcome Measure

Number of Participants Who Experienced a Decrease in Pn-BHR Area Under the Curve (AUC) of > 80% Compared With Baseline Values Before Week 8 [ Time Frame: up to 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Hospital· Baltimore, MD

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