RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Johns Hopkins University • ClinicalTrials.gov ID: NCT07059091

Registry updated: 2026-09-04

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Description

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.

Interventions

Omalizumab (Xolair®) (Drug)
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 % (Drug)
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.

Eligibility criteria

Inclusion Criteria: * Able and willing to provide informed consent. * Age ≥ 40 years at screening. * Primary combustible tobacco cigarette exposure \>10 pack-years. * Self-report of physician diagnosis of COPD and currently on dual or triple long-acting inhaled therapy (ICS/LABA/LAMA, ICS/LABA, LABA/LAMA). * COPD Assessment Test (CAT) score of ≥ 15 OR history of at least one documented moderate (requiring treatment with oral corticosteroids) or severe (requiring ED visit or hospitalization) COPD exacerbation in the past year. * Participants of childbearing potential must have negative pregnancy test upon study entry. * Female (and male) participants with reproductive potential must agree to use FDA approved methods of contraception for duration of study. * Post-bronchodilator FEV1/FVC ratio \< 0.7 and FEV1% predicted \< 80%. * Sensitization to one or more of five common indoor allergens including cat, dog, mouse, cockroach, dust mite confirmed with specific IgE. Positive specific IgE testing within 12 months of randomization to cat, dog, mouse, cockroach, or dust mite will be accepted * Exposure to the same allergen to which individual is sensitized based on measurement in home settled dust (1 U/g cockroach, 1 μg/g mouse, 2 μg/g dust mite, (Der f 1), 8 μg/g for cat and dog). * Participants on a stable dose for \>6 months will be allowed to enroll Exclusion Criteria: * Inability or unwillingness of a participant to give written informed consent or comply with study protocol. * Live in a location other than home (i.e., care facility) * Actively breastfeeding. * Current asthma diagnosis. * Other lung disease (cystic fibrosis, pneumoconiosis, bronchiectasis or otherwise) that is considered the primary respiratory diagnosis and would interfere with participation in the study * Reduced life expectancy due to other disease that in the opinion of the investigator may interfere with participation in the study. * Participants with severe medical condition(s) that in the view of the investigator prohibits participation in the study. * Received or listed for a lung transplant. * Surgical or bronchoscopic lung volume reduction surgery in the 12 months prior to screening. * History of infection or active infection due to Mycobacterium tuberculosis * Active parasitic infection diagnosed and/or treated within 6 months of randomization * Currently receiving allergen immunotherapy. * History of anaphylaxis from medications, foods or otherwise. * Current active prescription for epinephrine autoinjector for treatment of severe chronic urticaria. * Known sensitivity to study drug(s) or another biologic medication. * Use of any other investigational agent for COPD in the last 90 days. If the other investigational agent being used is a biologic agent, this must be washed out for 6 months prior to randomization. * Active use of biologic medication (monoclonal antibody) for treatment of respiratory disease in the past 6 months (benralizumab, omalizumab, mepolizumab, resilizumab, dupliumab, tezepelumab, or other similar medication or use of biologic medication for treatment of any non-respiratory disease in the past 3 months. * Use of chronic systemic corticosteroids at doses above 10mg daily prednisone or the equivalent. * Use of systemic corticosteroid course for acute exacerbation of COPD within 4 weeks of randomization. * Weight \< 66 lbs (30kg) or \>330 lbs (150 kg); and total IgE \< 30 IU/mL or \>700 IU/mL; or no available dosing recommendation based on weight and total IgE level. * No ICS in background regimen for individuals with blood eosinophil count of \>300 and systemic steroid requiring exacerbation in the past year, except in case of contraindication to ICS such as thrush, osteoporosis, or pneumonia in the past year. * Participants who have been on a stable GLP-1 agonist dose for less than 6 months prior to randomization.

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Allergies

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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