Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD
COPD-OMA
2 other identifiers
interventional
334
1 country
23
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2026
Longer than P75 for phase_2
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2025
CompletedFirst Posted
Study publicly available on registry
July 10, 2025
CompletedStudy Start
First participant enrolled
February 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2031
February 17, 2026
February 1, 2026
4.9 years
July 1, 2025
February 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of COPD exacerbations
To determine the efficacy of omalizumab injection in reducing the annualized rate of moderate or severe exacerbations (primary outcome) over the course of 12 months among individuals with COPD having sensitization and exposure to any of a panel of common indoor aeroallergens.
12 months
Study Arms (2)
Omalizumab injection
ACTIVE COMPARATORActive treatment is omalizumab injection, dosed using standardized weight and total IgE based table, as used for asthma treatment
Placebo injection
PLACEBO COMPARATORPlacebo 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.
Interventions
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.
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
You may qualify if:
- Able and willing to provide informed consent.
- 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).
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.collaborator
- American Lung Association Asthma Clinical Research Centerscollaborator
- American Lung Associationcollaborator
- Johns Hopkins Universitylead
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
Study Sites (23)
University of Alabama
Birmingham, Alabama, 35294, United States
University of Arizona- Tuscon
Tucson, Arizona, 85724, United States
University of San Francisco
San Francisco, California, 94143, United States
National Jewish Health
Denver, Colorado, 80206, United States
University of Florida
Jacksonville, Florida, 32209, United States
University of Illinois at Chicago
Chicago, Illinois, 60608, United States
Northwestern University
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins University
Baltimore, Maryland, 21231, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health
Detroit, Michigan, 48202, United States
Mount Sinai, Icahn School of Medicine
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Cornell University
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Vermont
Colchester, Vermont, 05446, United States
Pacific Northwest Airways - VA Puget Sound Healthcare System, Seattle
Seattle, Washington, 98108, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nirupama Putcha
Johns Hopkins School of Medicine
- PRINCIPAL INVESTIGATOR
Elizabeth Sugar, PhD
Johns Hopkins University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- The participant and the study team (e.g., PI, study physician, coordinator), with the exception of an unblinded individual, will remain masked during the study.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2025
First Posted
July 10, 2025
Study Start
February 12, 2026
Primary Completion (Estimated)
January 1, 2031
Study Completion (Estimated)
May 1, 2031
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share