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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.
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 moreAwards & 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.
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].
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].
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,120,060 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I regularly take or will need to take medication that affects my immune system.I am able to understand and sign the consent form.I can follow all study requirements and procedures.You have had a serious allergic reaction to any type of antibody therapy in the past.Women who could become pregnant must have a negative urine pregnancy test at the first visit.
Research Study Groups:
This trial has the following groups:- Group 1: Tozorakimab Dose 1
- Group 2: Tozorakimab Dose 2
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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