What side effects are associated with this type of intervention?

Common treatments for COPD, including inhaled corticosteroids (ICS), long-acting beta agonists (LABA), and long-acting muscarinic antagonists (LAMA), generally have side effects such as oral thrush, hoarseness, and increased risk of pneumonia for ICS; tremors, palpitations, and muscle cramps for LABA; and dry mouth, constipation, and urinary retention for LAMA. For treatments similar to Tozorakimab, such as other monoclonal antibodies, side effects can include injection site reactions, headache, nasopharyngitis, and potential increased risk of infections. The incidence of treatment-emergent adverse events is generally similar between treatment and placebo groups.

What prior FDA approvals exist?

The FDA has approved several treatments for Chronic Obstructive Pulmonary Disease (COPD), including long-acting β2-agonists (LABAs) like olodaterol, long-acting muscarinic antagonists (LAMAs) such as tiotropium, and combination therapies like umeclidinium/vilanterol and indacaterol/glycopyrronium. These treatments aim to improve lung function, reduce exacerbations, and enhance the quality of life for COPD patients. While Tozorakimab, an Anti-IL-33 Monoclonal Antibody, is currently under investigation, it represents a novel approach targeting the inflammatory pathways involved in COPD, differing from the bronchodilators and combination therapies that are currently approved.

What other types of research exist?

Promising novel alternatives to Tozorakimab for COPD patients include: 1) Dupilumab (an IL-4 receptor alpha antagonist) which has shown potential in reducing exacerbations in COPD patients with type 2 inflammation, 2) Benralizumab (an IL-5 receptor alpha-directed cytolytic monoclonal antibody) which targets eosinophilic inflammation, and 3) Roflumilast (a phosphodiesterase-4 inhibitor) which has been effective in reducing exacerbations in severe COPD patients with chronic bronchitis. These alternatives offer different mechanisms of action and may provide additional options for personalized treatment strategies.

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Monoclonal Antibodies

Tozorakimab for COPD (TITANIA 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

Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment

Participant must be ≥ 40 years of age and capable of giving signed informed consent.

Must not have

Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.

Participants who have evidence of active TB.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 52, or over 52 weeks

Awards & highlights

Summary

This trial is testing injections of a drug called tozorakimab in adults with COPD who have frequent flare-ups. These patients are already on other inhaled treatments but still experience significant symptoms. The drug aims to reduce lung inflammation and prevent these flare-ups.

Who is the study for?

Adults over 40 with COPD, a smoking history of at least 10 pack-years, and who've had multiple flare-ups in the past year can join. They must have been on stable inhaled therapy for 3 months and give consent. Excluded are those with other significant lung diseases, recent drug use or infections, unstable health conditions, certain cancer histories, or previous tozorakimab treatment.

What is being tested?

The trial is testing two doses of Tozorakimab against a placebo in people with COPD to see if it's safe and effective. Participants will receive injections under the skin while continuing their usual inhaler medications.

What are the potential side effects?

While specific side effects for Tozorakimab aren't listed here, common ones for similar treatments include injection site reactions, increased risk of infections due to immune system changes, fatigue, headaches and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had at least 2 moderate or 1 severe COPD flare-ups in the last year.

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I am 40 years or older and can sign a consent form.

Exclusion Criteria

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

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I have been diagnosed with heart or lung blood pressure issues.

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I have active tuberculosis.

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I have a significant lung condition that is not COPD.

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My scans show a lung problem not caused by COPD that's affecting my breathing.

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I have had hepatitis B or C, but hepatitis C has been cured.

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I haven't had a serious infection or pneumonia in the weeks before joining the study.

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I had a severe COPD flare-up requiring steroids, antibiotics, or hospital stay within the last 2 weeks.

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I do not have active liver disease or jaundice.

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I have had a serious COVID-19 infection in the last 6 months.

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I am suspected of or confirmed to have COVID-19.

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I have previously been treated with tozorakimab.

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I have a stable heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 52, or over 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 52, or over 52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52, or over 52 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

Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.

Secondary study objectives

Annualized rate of healthcare resource utilization in former smokers.

Annualized rate of moderate to severe COPD exacerbations in former or current smokers.

Annualized rate of severe COPD exacerbations in former smokers.

+18 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Tozorakimab Dose 2Experimental Treatment1 Intervention

Dosing subcutaneously tozorakimab Dose 2

Group II: Tozorakimab Dose 1Experimental Treatment1 Intervention

Dosing subcutaneously tozorakimab Dose 1 and placebo

Group III: PlaceboPlacebo Group1 Intervention

Dosing subcutaneously with equivalent volume to tozorakimab

0 / 14Eligibility 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

Common treatments for Chronic Obstructive Pulmonary Disease (COPD) include bronchodilators, inhaled corticosteroids, and newer biologic agents like tozorakimab. Bronchodilators, such as long-acting beta agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), relax the muscles around the airways, improving airflow and easing breathing. Inhaled corticosteroids reduce airway inflammation, decreasing the frequency and severity of exacerbations. Tozorakimab, an anti-IL-33 monoclonal antibody, targets the IL-33 pathway involved in the inflammatory response in COPD, aiming to reduce inflammation and prevent exacerbations. These treatments are essential for managing symptoms, reducing exacerbations, and improving the quality of life for COPD patients.

Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial.Oxidative stress enhances the expression of IL-33 in human airway epithelial cells.