168
Participants
Start Date
April 30, 2003
Primary Completion Date
May 31, 2005
Study Completion Date
May 31, 2005
omalizumab
A minimum equivalent dose of 0.016 mg/kg/IgE (IU/mL) every 4 weeks will be administered. Omalizumab is administered in two separate phases. In the pre-treatment period omalizumab will be administered to condition the participants to an immune tolerance state. Omalizumab will be also administered after RIT and during the maintenance immunotherapy phase.
Placebo omalizumab
The placebo for omalizumab will contain the excipients and diluents of the omalizumab.
Ragweed rush immunotherapy (RIT)
RIT will consist of a series of injections containing ragweed extract. The series of injections will have progressively greater amounts of ragweed extract: starting from the 1:1000 dilution of the maintenance vial and progressing to the 0.3 mL of 1:10 dilution of the maintenance vial or the maximally tolerated amount.
Placebo rush immunotherapy (RIT)
The placebo for rush immunotherapy will contain the diluents and histamine.
Ragweed immunotherapy (IT)
Participants will receive weekly maintenance IT dosing for a total of 12 weeks.
Placebo immunotherapy (IT)
The placebo for immunotherapy will contain the diluents and histamine.
University of Iowa, Iowa City
University of Wisconsin, Madison
Creighton University, Omaha
Immune Tolerance Network (ITN)
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH