Omalizumab for COPD

(COPD-OMA Trial)

Recruiting at 22 trial locations

Overseen By Heather Hazucha

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must be taking: Inhaled therapy

Must not be taking: Biologics, Immunotherapy, Epinephrine

Disqualifiers: Asthma, Other lung disease, Transplant, others

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 1

Duration: 12 months

334 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Nirupama Putcha

Principal Investigator

Johns Hopkins School of Medicine

Elizabeth Sugar, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for individuals with Chronic Obstructive Pulmonary Disease (COPD) who also have allergies. Participants will be involved in the study for roughly 16 months, which includes screening, treatment at a clinic, and a follow-up call.

Inclusion Criteria

Able and willing to provide informed consent

Combustible tobacco cigarette exposure >10 pack-years

Participants of childbearing potential must have negative pregnancy test upon study entry

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-3 months

Treatment

Participants receive omalizumab or placebo injections for 12 months

12 months

Monthly clinic visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month

1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

• Omalizumab

Trial Overview The trial is testing omalizumab (Xolair®), an allergy medication, to see if it can benefit people with COPD and allergies. The drug will be compared to a saline solution (NaCl 0.9%) as a control.

How Is the Trial Designed?

Group I: Omalizumab injection Active Control 1 Intervention

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

Group II: Placebo injection Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

American Lung Association Asthma Clinical Research Centers

Collaborator

Trials

5

Recruited

1,900+

American Lung Association

Collaborator

Trials

32

Recruited

11,000+