Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
NCT ID: NCT07059091
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
334 participants
INTERVENTIONAL
2026-01-31
2031-05-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Omalizumab injection
Active treatment is omalizumab injection, dosed using standardized weight and total IgE based table, as used for asthma treatment
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.
Placebo injection
Placebo for omalizumab used in the study will be commercially packaged 0.9% Sodium Chloride Injection, USP (e.g., normal saline). The injection volumes of normal saline administered will be calculated based upon the volume of active omalizumab expected to be administered based upon weight and total IgE level.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Age \>40 years at screening.
* 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 defined with positive skin prick test (SPT) (SPT wheal size at least 3 mm greater than negative control). Positive specific IgE testing within 12 months of randomization to cat, dog, mouse, cockroach, or dust mite will be accepted in lieu of skin prick test if SPT is not interpretable or SPT cannot be safely performed.
* 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).
Exclusion Criteria
* 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 or \>330 lbs; 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.
40 Years
ALL
No
Sponsors
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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
Responsible Party
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Principal Investigators
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Nirupama Putcha
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine
Elizabeth Sugar, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Necole Harris
Role: primary
Alyssandra Rivera
Role: primary
Shannen Rico
Role: primary
Juno Pak
Role: primary
Alexis Luis
Role: primary
Lauren Greene
Role: primary
Jenny Hixon
Role: primary
Jessica Parumoottil
Role: primary
Eric Garcia
Role: primary
Nicole Hall
Role: primary
Kayla Long
Role: primary
Wendy Warshal
Role: primary
Muzhda Hashmi
Role: primary
Maria Wong
Role: primary
Jotti Saroya
Role: primary
Jose Romero
Role: primary
Kaitlin Foy
Role: primary
Tiffany Ditter
Role: primary
Courtney Lehman
Role: primary
Laura Bertrand
Role: primary
Olivia Garrow
Role: primary
Brianna Moss
Role: primary
Other Identifiers
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IRB00498976
Identifier Type: -
Identifier Source: org_study_id