334
Participants
Start Date
November 30, 2025
Primary Completion Date
January 31, 2031
Study Completion Date
May 31, 2031
Omalizumab (Xolair®)
The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic.
Sodium Chloride (NaCl) 0.9 %
The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic.
Mount Sinai, Icahn School of Medicine, New York
Columbia University, New York
Cornell University, New York
University of Pittsburgh, Pittsburgh
Temple University, Philadelphia
Johns Hopkins University, Baltimore
Duke University Medical Center, Durham
University of Florida, Jacksonville
University of Alabama, Birmingham
Vanderbilt University Medical Center, Nashville
University of Michigan, Ann Arbor
Henry Ford Health, Detroit
University of Iowa, Iowa City
University of Illinois at Chicago, Chicago
Northwestern University, Chicago
Rush University Medical Center, Chicago
University of Kansas Medical Center, Kansas City
Baylor College of Medicine, Houston
National Jewish Health, Denver
University of Arizona- Tuscon, Tucson
University of San Francisco, San Francisco
Pacific Northwest Airways - VA Puget Sound Healthcare System, Seattle, Seattle
University of Vermont, Colchester
Collaborators (1)
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Genentech, Inc.
INDUSTRY
American Lung Association Asthma Clinical Research Centers
OTHER
American Lung Association
OTHER
Johns Hopkins University
OTHER