NCT07059091

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 334 (estimated)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)
• Allergies

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-02-12
• Primary completion: 2031-01-01
• Completion: 2031-05-01
• First posted: 2025-07-10
• Last updated: 2026-02-17

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study