Omalizumab for COPD

(COPD-OMA Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether omalizumab, an antibody therapy, can help people with Chronic Obstructive Pulmonary Disease (COPD) who also have allergies. Participants will receive either omalizumab or a placebo (a look-alike with no active drug) to determine if it improves their condition. The trial suits those diagnosed with COPD, using certain inhaler treatments, and allergic to common indoor allergens like dust mites or pet dander. Participants will engage in the study for about 16 months, including treatment and follow-up. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it does mention that you cannot be on certain biologic medications or high doses of systemic corticosteroids. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that omalizumab is likely to be safe for humans?

Research shows that omalizumab is generally safe and well-tolerated for people with asthma, even those with COPD (Chronic Obstructive Pulmonary Disease). Studies have found that omalizumab can reduce asthma symptoms without causing major side effects. However, one study revealed that about 28% of patients stopped using omalizumab, indicating that some may encounter issues leading to discontinuation.

Another study found that nearly half of the patients did not experience severe asthma attacks after using omalizumab, suggesting it effectively manages symptoms for many. While some might experience mild side effects, serious problems are rare.

Omalizumab is already approved for treating asthma, indicating it has passed safety checks for that condition. Since this trial tests it for COPD with allergies, the safety evidence from asthma patients is encouraging but not a guarantee. Always discuss any concerns with the trial team or your doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for COPD?

Researchers are excited about omalizumab for COPD because it offers a new approach by targeting the immune system, particularly IgE antibodies. Unlike current COPD treatments that mainly focus on bronchodilation and inflammation control, such as bronchodilators and corticosteroids, omalizumab works by binding to IgE, potentially reducing inflammation driven by allergies. This could be particularly beneficial for patients whose COPD symptoms are exacerbated by allergic responses, providing a more tailored treatment option.

What evidence suggests that omalizumab might be an effective treatment for COPD?

Research has shown that omalizumab can help individuals with both asthma and Chronic Obstructive Pulmonary Disease (COPD). Studies found that patients with both conditions experienced improvements after using omalizumab for 48 weeks. In another study, 76% of patients saw benefits within 4 months. This trial will compare the effects of omalizumab injections with placebo injections in COPD patients. Omalizumab reduces the need for healthcare visits for those with breathing problems, suggesting it might also help with COPD. While primarily used for asthma, these findings suggest omalizumab could benefit COPD patients, especially those with allergies. ^{3 4 6 7 8}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8953889/

Omalizumab in middle-aged or older patients with severe ... Clinical improvement was seen already in the first year with significantly increased ACT scores (p < 0.0001) and a significantly decreased ...

2. ejgg.org ejgg.org/articles/a-rare-geriatric-case-omalizumab-as-a-rescue-therapy-for-asthma-chronic-obstructive-pulmonary-disease-overlap/ejgg.galenos.2024.2024-10-3

Omalizumab As a Rescue Therapy For Asthma-Chronic ... Omalizumab is a safe, effective treatment and may contribute to a reduction in healthcare utilization for obstructıve airways dısease due to ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07059091

NCT07059091 | Clinical Trial of Omalizumab for Allergen ... This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies.

4. jacionline.org jacionline.org/article/S0091-6749(18)32730-1/fulltext

Omalizumab effectiveness in asthma-COPD overlap Our analysis of a large-scale, real-world study suggests that patients with ACO treated with omalizumab over 48 weeks experienced improvements ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006295220301726

Effectiveness of omalizumab on patient reported outcomes ... After 4 months of therapy, 76% of the patients were judged to have benefited from omalizumab and were admitted to prolonged treatment. During follow-up, we ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6492364/

Omalizumab and long-term quality of life outcomes in ... Results confirmed the long-term benefits of omalizumab as an add-on therapy in patients with uncontrolled moderate-to-severe allergic asthma.

7. publications.ersnet.org publications.ersnet.org/content/erj/58/suppl65/PA3738

Omalizumab in severe allergic asthma associated with COPD Conclusion: In severe allergic asthma coexisting with COPD, omalizumab was discontinued in 28% of patients. In those who continued, omalizumab use was ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0954611118302191

Real-world safety and efficacy of omalizumab in patients ... Nearly half of all patients (47.96%) were free from asthma exacerbations after therapy. Omalizumab also reduced all events related to asthma exacerbations. No ...