What side effects are associated with this type of intervention?

Common treatments for COPD include long-acting beta-agonists (LABAs), long-acting muscarinic antagonists (LAMAs), inhaled corticosteroids (ICS), and combination therapies. Side effects of these treatments can include upper respiratory tract infections, nasopharyngitis, headache, and injection site reactions. Monoclonal antibodies like Tozorakimab, which target specific interleukins to reduce inflammation, are generally well tolerated but can cause similar side effects such as upper respiratory infections and injection site reactions. Serious adverse events are rare but can include hypersensitivity reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Obstructive Pulmonary Disease (COPD), including bronchodilators, inhaled corticosteroids, and combination inhalers. While specific monoclonal antibodies targeting interleukin-33 like Tozorakimab are still under investigation, other biologics such as roflumilast (a phosphodiesterase-4 inhibitor) and chronic azithromycin therapy have been suggested for patients with recurrent exacerbations. These treatments aim to reduce inflammation and manage symptoms in COPD patients.

What other types of research exist?

Promising novel alternatives to Tozorakimab for COPD patients include monoclonal antibody therapies targeting interleukin-8 (IL-8), as suggested by the pilot study indicating improved dyspnea in COPD patients. Further investigation into these therapies is supported by the study results.

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Monoclonal Antibodies

Tozorakimab for COPD (PROSPERO Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Known history of chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 104 weeks.

Awards & highlights

Pivotal Trial

Summary

This trial is testing Tozorakimab, a medication that aims to reduce lung inflammation, in adults aged 40 and older with COPD. The goal is to see if it can help them breathe better and have fewer symptoms.

Who is the study for?

This trial is for adults with symptomatic COPD who've completed the OBERON or TITANIA studies without early discontinuation. They must have taken their last dose within 12 weeks and agree to continue using contraception. Excluded are those with significant health issues, involvement in study planning, inability to follow study requirements, known allergies to trial drugs, or use of certain immunosuppressives.

What is being tested?

The trial tests Tozorakimab's long-term safety and effectiveness against a placebo in managing COPD symptoms. It's a phase 3 extension from previous studies (OBERON/TITANIA), maintaining a double-blind approach where neither participants nor researchers know who receives the actual drug versus placebo.

What are the potential side effects?

While specific side effects aren't listed here, monoclonal antibodies like Tozorakimab can cause allergic reactions, infusion-related discomforts, immune system changes leading to increased infection risk or inflammation of organs.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I regularly take or will need to take medication that affects my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 104 weeks.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 104 weeks.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 104 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Annualised rate of severe COPD exacerbations in former smokers.

Secondary study objectives

Annualised rate of moderate to severe COPD exacerbations.

Incidence of anti-drug antibodies.

The annualised rate of severe COPD exacerbations

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Tozorakimab Dose 2Experimental Treatment1 Intervention

Injection subcutaneously Tozorakimab via pre-filled syringe.

Group II: Tozorakimab Dose 1Experimental Treatment1 Intervention

Injection subcutaneously Tozorakimab via pre-filled syringe.

Group III: PlaceboPlacebo Group1 Intervention

Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, inhaled corticosteroids, and monoclonal antibodies targeting specific cytokines. Bronchodilators, such as long-acting beta agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), work by relaxing the muscles around the airways, making it easier to breathe. Inhaled corticosteroids reduce inflammation in the airways, decreasing the frequency and severity of exacerbations. Monoclonal antibodies, like Tozorakimab, target specific cytokines such as interleukin-33 to reduce inflammation and immune response. These treatments are crucial for COPD patients as they help improve lung function, reduce symptoms, and prevent exacerbations, thereby enhancing the quality of life and reducing the risk of hospitalization.

Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial.Interleukin-33 promotes inflammatory cytokine production in chronic airway inflammation.[Novel therapeutics for COPD].