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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52, or over 52 weeks
Awards & highlights

OBERON Trial Summary

This trial is testing a new COPD medication to see if it is effective and safe.

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.Check my eligibility
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.See study design
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.

OBERON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 40 years or older and can sign a consent form.
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I've 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.
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I have been diagnosed with COPD for over a year.
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I've had at least 2 moderate or 1 severe COPD flare-ups in the last year.
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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.

OBERON Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers.
Secondary outcome measures
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

OBERON 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

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,268 Previous Clinical Trials
288,611,418 Total Patients Enrolled

Media Library

Tozorakimab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05166889 — Phase 3
Chronic Obstructive Pulmonary Disease Research Study Groups: Tozorakimab Dose 2, Tozorakimab Dose 1, Placebo
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Tozorakimab Highlights & Side Effects. Trial Name: NCT05166889 — Phase 3
Tozorakimab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05166889 — Phase 3
Chronic Obstructive Pulmonary Disease Patient Testimony for trial: Trial Name: NCT05166889 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled positions in this trial for new patients seeking treatment?

"The information available on clinicaltrials.gov suggests that this study is currently enrolling patients. This trial was first posted on January 3rd, 2022 and was updated November 2nd, 2022. In total, 1272 people are needed across 59 different sites."

Answered by AI

Is this research project enrolling young adults?

"In order for an individual to be eligible for this particular trial, they must be between 40 and 130 years old. Out of the 515 total clinical trials, 36 are for patients below the age of 18 and 479 are for those above 65."

Answered by AI

Are there a lot of different places in Canada conducting this clinical trial?

"This trial is being hosted at 59 sites which are situated in and around Huntsville, Thornhill, Tacoma, and many other places. If you're interested in enrolling, try to pick a location that is close to you to reduce the amount of travel required."

Answered by AI

Do I fit the criteria to partake in this research?

"To qualify for this study, applicants must be over 40 years old and have a documented diagnosis of COPD that is at least one year old. In addition, they should be using inhaled dual or triple therapy at a stable dose for at least 3 months, have a post-BD FEV1/FVC of less than 0.70, and a post-BD FEV1 that is more than 20% of the predicted normal value. Furthermore, applicants must have a documented history of two moderate or one severe COPD exacerbation within the 12 months prior to enrolment, a smoking history of 10 pack-years or more,"

Answered by AI

Is Tozorakimab putting patients at risk?

"Tozorakimab is rated as a 3 in terms of safety by our team at Power. This is due to the fact that Tozorakimab is a Phase 3 trial, showing some efficacy as well as multiple rounds of supportive data in terms of safety."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
Illinois
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Research Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Copd getting worse. Medication not very effective anymore. I been told I have COPD my blood oxygen is 65 my breath test was 76.
PatientReceived 2+ prior treatments
I am using symbicort and combivent and need more to help with the copd.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How many trips to Long Island are part of this trial?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations
2022. "Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05166889.
All > Copd
~336 spots leftby Jun 2025
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