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RECRUITING
NCT07059091
PHASE2

Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

Summary

This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies. Each participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one month after your final clinic visit.

Official title: Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (COPD-OMA)

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

334

Start Date

2026-02-12

Completion Date

2031-05

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

Locations (23)

University of Alabama

Birmingham, Alabama, United States

University of Arizona- Tuscon

Tucson, Arizona, United States

University of San Francisco

San Francisco, California, United States

National Jewish Health

Denver, Colorado, United States

University of Florida

Jacksonville, Florida, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johns Hopkins University

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health

Detroit, Michigan, United States

Mount Sinai, Icahn School of Medicine

New York, New York, United States

Columbia University

New York, New York, United States

Cornell University

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Temple University

Philadelphia, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

University of Vermont

Colchester, Vermont, United States

Pacific Northwest Airways - VA Puget Sound Healthcare System, Seattle

Seattle, Washington, United States