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Monoclonal Antibodies
Tozorakimab for COPD (OBERON 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
Participant must be ≥ 40 years of age and capable of giving signed informed consent.
Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
Must not have
Clinically important pulmonary disease other than COPD
Radiological findings suggestive of a respiratory disease other than COPD that is contributing to the participant's respiratory symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52, or over 52 weeks
Awards & highlights
Pivotal Trial
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 history of frequent flare-ups, and on stable inhaled medication can join this trial. They must have a significant smoking history and symptoms like coughing and phlegm. People with other serious lung diseases, recent severe infections or exacerbations, unstable health conditions, or past use of the study drug are excluded.
What is being tested?
The trial is testing two doses of Tozorakimab against a placebo in people with COPD to see if it helps reduce symptoms and prevent flare-ups. Participants will receive injections under the skin while continuing their usual inhaler therapy.
What are the potential side effects?
Possible side effects may include reactions at the injection site, increased risk of infections due to immune system changes, liver issues indicated by jaundice during screening tests, or any significant abnormal findings that could affect safety.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 40 years or older and can sign a consent form.
Select...
I've had at least 2 moderate or 1 severe COPD flare-ups in the last year.
Select...
I am 40 years or older and can sign a consent form.
Select...
I have been diagnosed with COPD for over a year.
Select...
I've had at least 2 moderate or 1 severe COPD flare-ups in the last year.
Select...
I have been on a stable dose of inhaled dual or triple therapy for my condition for at least 3 months.
Select...
I am 40 years or older and can sign a consent form.
Select...
I've had at least 2 moderate or 1 severe COPD flare-ups in the last year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a significant lung condition that is not COPD.
Select...
My scans show a lung problem not caused by COPD.
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I do not have any unstable health conditions that could affect my safety or participation in the study.
Select...
I had a severe COPD flare-up treated with steroids or antibiotics, or I was hospitalized for it within the last 2 weeks.
Select...
I am currently suspected of or confirmed to have COVID-19.
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I have had a serious COVID-19 infection in the last 6 months.
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I have a heart condition that changes or gets worse quickly.
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I have been diagnosed with heart or lung blood pressure issues.
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I have active liver disease or jaundice.
Select...
I currently have active tuberculosis (TB).
Select...
I have previously been treated with tozorakimab.
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
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 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
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tozorakimab
2024
Completed Phase 1
~50
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, corticosteroids, and biologic agents. Bronchodilators, such as beta agonists and muscarinic antagonists, work by relaxing the muscles around the airways, making it easier to breathe.
Corticosteroids reduce inflammation in the airways, decreasing swelling and mucus production. Biologic agents, like monoclonal antibodies, target specific inflammatory pathways.
For example, Tozorakimab, an anti-IL-33 monoclonal antibody, aims to block the IL-33 pathway, which is involved in the inflammatory response in COPD. This targeted approach can potentially reduce exacerbations and improve lung function, offering a more tailored treatment option for patients with severe COPD.
Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial.Advances in the management of chronic obstructive pulmonary disease.
Safety and efficacy of itepekimab in patients with moderate-to-severe COPD: a genetic association study and randomised, double-blind, phase 2a trial.Advances in the management of chronic obstructive pulmonary disease.
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,397 Previous Clinical Trials
289,120,627 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently suspected of or confirmed to have COVID-19.I have active liver disease or jaundice.I currently have active tuberculosis (TB).I have previously been treated with tozorakimab.I've had at least 2 moderate or 1 severe COPD flare-ups in the last year.I am 40 years or older and can sign a consent form.I am 40 years or older and can sign a consent form.I have asthma, had it in the past, or have symptoms of both asthma and COPD.I do not have any unstable health conditions that could affect my safety or participation in the study.I have been diagnosed with COPD for over a year.I've had at least 2 moderate or 1 severe COPD flare-ups in the last year.I have been on a stable dose of inhaled dual or triple therapy for my condition for at least 3 months.You have a smoking history of at least 10 pack-years.I have been diagnosed with COPD for at least a year.I have a significant lung condition that is not COPD.I had a severe COPD flare-up treated with steroids or antibiotics, or I was hospitalized for it within the last 2 weeks.I have had a serious COVID-19 infection in the last 6 months.I have been diagnosed with COPD for at least a year.I am 40 years or older and can sign a consent form.I have been on a stable dose of inhaled dual or triple therapy for my condition for at least 3 months.My scans show a lung problem not caused by COPD.I have had hepatitis B or C, but hepatitis C has been cured.I haven't had a serious infection or pneumonia in the weeks before joining the study.I have a heart condition that changes or gets worse quickly.I have been diagnosed with heart or lung blood pressure issues.I have not had cancer in the last 5 years, except for certain skin cancers or cervical pre-cancer treated successfully over a year ago.I have been on a stable dose of inhaled dual or triple therapy for my condition for at least 3 months.You have a lung function test result of less than 70% of predicted normal value.I've had at least 2 moderate or 1 severe COPD flare-ups in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Tozorakimab Dose 2
- Group 2: Tozorakimab Dose 1
- 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.
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT05166889 — Phase 3
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