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

February 13, 2026 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is for people 40 years and older with COPD who also have allergens in their home that they are allergic to, like pet dander, cockroaches or dust mites.

Study Type

Interventional

Enrollment (Estimated)

334

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Not yet recruiting
        • University of Alabama
        • Principal Investigator:
          • Michael Wells
        • Contact:
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Not yet recruiting
        • University of Arizona- Tuscon
        • Contact:
        • Principal Investigator:
          • Fernando Martinez
    • California
      • San Francisco, California, United States, 94143
        • Not yet recruiting
        • University of San Francisco
        • Contact:
        • Principal Investigator:
          • Stephanie Christenson
    • Colorado
      • Denver, Colorado, United States, 80206
        • Not yet recruiting
        • National Jewish Health
        • Contact:
        • Principal Investigator:
          • Barry Make
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Not yet recruiting
        • University of Florida
        • Principal Investigator:
          • Vandana Seeram
        • Contact:
          • Alexis Luis
          • Phone Number: Alexis.Luis@ja 904-244-0908
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Ravi Kalhan
      • Chicago, Illinois, United States, 60612
        • Not yet recruiting
        • Rush University Medical Center
        • Contact:
        • Principal Investigator:
          • James Moy
      • Chicago, Illinois, United States, 60608
        • Not yet recruiting
        • University of Illinois at Chicago
        • Contact:
        • Principal Investigator:
          • Lynn Gerald
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa
        • Contact:
        • Principal Investigator:
          • Alejandro Comellas
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • University of Kansas Medical Center
        • Contact:
        • Principal Investigator:
          • Mario Castro
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Niru Putcha
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Not yet recruiting
        • University of Michigan
        • Contact:
        • Principal Investigator:
          • MeiLan Han
      • Detroit, Michigan, United States, 48202
        • Not yet recruiting
        • Henry Ford Health
        • Principal Investigator:
          • Alan Baptist
        • Contact:
    • New York
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Columbia University
        • Contact:
        • Principal Investigator:
          • Emily DiMango
      • New York, New York, United States, 10032
        • Not yet recruiting
        • Cornell University
        • Contact:
        • Principal Investigator:
          • Robery Kaner
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Mount Sinai, Icahn School of Medicine
        • Contact:
        • Principal Investigator:
          • Linda Rogers
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Not yet recruiting
        • Duke University Medical Center
        • Contact:
        • Principal Investigator:
          • Loretta Que
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Not yet recruiting
        • Temple University
        • Contact:
        • Principal Investigator:
          • Nathaniel Marchetti
      • Pittsburgh, Pennsylvania, United States, 15213
        • Not yet recruiting
        • University of Pittsburgh
        • Contact:
        • Principal Investigator:
          • Frank Sciurba
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Not yet recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • Katherine Cahill
    • Texas
      • Houston, Texas, United States, 77030
        • Not yet recruiting
        • Baylor College of Medicine
        • Contact:
        • Principal Investigator:
          • Nicola Hanania
    • Vermont
      • Colchester, Vermont, United States, 05446
        • Not yet recruiting
        • University of Vermont
        • Principal Investigator:
          • Anne Dixon
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98108
        • Not yet recruiting
        • Pacific Northwest Airways - VA Puget Sound Healthcare System, Seattle
        • Contact:
        • Principal Investigator:
          • Laura Freemster

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

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 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omalizumab injection
Active treatment is omalizumab injection, dosed using standardized weight and total IgE based table, as used for asthma treatment
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.
Placebo Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of COPD exacerbations
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)
Genentech, Inc.
American Lung Association
American Lung Association Asthma Clinical Research Centers

Investigators

  • Principal Investigator: Nirupama Putcha, Johns Hopkins School of Medicine
  • Principal Investigator: Elizabeth Sugar, PhD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2026

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

May 1, 2031

Study Registration Dates

First Submitted

July 1, 2025

First Submitted That Met QC Criteria

July 1, 2025

First Posted (Actual)

July 10, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00498976
  • 1U01AI177195 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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