Recruiting
Phase 2

Omalizumab

Sponsor:

Johns Hopkins University

Code:

NCT07059091

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Allergies

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Omalizumab (Xolair®)

Sodium Chloride (NaCl) 0.9 %

Study Details

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Allergies

Study ID

NCT07059091

Start date

Feb 12, 2026

Status verified date

Sep, 2026

Completion date

May, 2031

Anticipated

Primary completion date

Jan, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

334 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Omalizumab injection

Active treatment is omalizumab injection, dosed using standardized weight and total IgE based table, as used for asthma treatment

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.

Interventions

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.

Primary outcome measure

  • Rate of COPD exacerbations [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Kayla Long

410-502-9048klong33@jhu.edu

Heather Hazucha

410-502-0585hhazuch1@jhu.edu

Locations

University of Arizona- Tuscon

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Alyssandra Rivera

520-626-6387arivera59@arizona.edu

Principal Investigator:

Fernando Martinez

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Jenny Hixon

312-926-0975j-franzen@northwestern.edu

Principal Investigator:

Ravi Kalhan

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Nicole Hall

913-588-1987nhall@kumc.edu

Principal Investigator:

Mario Castro

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21231

Contacts

Kayla Long

410-502-9048klong33@jhu.edu

Principal Investigator:

Niru Putcha

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Wendy Warshal

734-232-2841warshal@med.umich.edu

Principal Investigator:

MeiLan Han

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Jotti Saroya

212-305-0251tks2127@cumc.columbia.edu

Principal Investigator:

Emily DiMango

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Francine McGonagle

215-707-2682Francine.McGonagle@tuhs.temple.edu

Principal Investigator:

Nathaniel Marchetti

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Tiffany Ditter

412-648-6276dittertl2@upmc.edu

Principal Investigator:

Frank Sciurba

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Laura Bertrand

713-798-2681laura.bertrand@bcm.tmc.edu

Principal Investigator:

Nicola Hanania

University of Vermont

Recruiting

Colchester, Vermont, United States, 05446

Contacts

Olivia Garrow

802-847-2160olivia.johnson@uvmhealth.org

Principal Investigator:

Anne Dixon

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • lung disease
  • COPD
  • allergies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-04.