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Monoclonal Antibodies

Tezepelumab for COPD (EMBARK Trial)

Tucson, AZ
Phase 3
Waitlist Available
Led By Dave Singh, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 40 to 80 years old
Diagnosed with COPD for at least 1 year
Must not have
Clinical important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD
Long-term oxygen therapy (LTOT) >4.0 L/min or oxygen saturation <89% despite LTOT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 24, week 36, week 52
Awards & highlights
Pivotal Trial

Summary

This trial will test a new drug called Tezepelumab in adults with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD) to see if it is effective and

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Who is the study for?
This trial is for adults with moderate to very severe COPD, a chronic lung disease that obstructs airflow. Participants should meet specific health criteria but the provided information does not detail these requirements.Check my eligibility
What is being tested?
The study tests Tezepelumab's effectiveness and safety against a placebo in improving COPD symptoms. It's a phase 3 trial, meaning it's at an advanced stage of testing with more participants to confirm its efficacy and monitor side effects.See study design
What are the potential side effects?
While specific side effects are not listed, common reactions to new respiratory drugs may include headache, throat irritation, coughing, or allergic reactions. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 80 years old.
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I have been diagnosed with COPD for over a year.
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I have been on COPD medication for at least 3 months.
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I had at least 2 moderate or 1 severe flare-up of my lung condition last year.
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I have smoked at least 10 pack-years.
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My lung function is reduced but not severely.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a lung condition that is not COPD.
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I need more than 4 liters per minute of oxygen or my oxygen levels stay below 89% despite using oxygen.
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I have asthma or asthma-COPD overlap syndrome.
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I have or had cancer before.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 24, week 36, week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 24, week 36, week 52 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 moderate or severe COPD exacerbations
Secondary study objectives
Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL.
Annualised rate of severe COPD exacerbations
Change from baseline in post-BD FEV1
+9 more

Side effects data

From 2020 Phase 3 trial • 150 Patients • NCT03406078
16%
Nasopharyngitis
12%
Upper respiratory tract infection
8%
Bronchitis bacterial
8%
Asthma
5%
Bronchitis
5%
Oral candidiasis
5%
Myalgia
4%
Fall
4%
Headache
3%
Hypertension
1%
Cataract
1%
Supraventricular tachycardia
1%
Inguinal hernia
1%
Intervertebral discitis
1%
Pneumonia
1%
Septic shock
1%
Incisional hernia
1%
Arthralgia
1%
Acute kidney injury
1%
Nephrolithiasis
1%
Sinusitis
1%
Cardiac arrest
1%
Cardiac failure
1%
Invasive breast carcinoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tezepelumab
Placebo

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: Dose 2 of TezepelumabExperimental Treatment1 Intervention
Tezepelumab, SC, Q4W
Group II: Dose 1 of TezepelumabExperimental Treatment1 Intervention
Tezepelumab, SC, Q4W
Group III: Matching PlaceboPlacebo Group1 Intervention
Matching placebo, SC, Q4W
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tezepelumab
2018
Completed Phase 3
~2430

Find a Location

Closest Location:Research Site· Winfield, IL· 26 miles

Who is running the clinical trial?

AmgenIndustry Sponsor
1,506 Previous Clinical Trials
1,431,978 Total Patients Enrolled
AstraZenecaLead Sponsor
4,485 Previous Clinical Trials
290,537,439 Total Patients Enrolled
Dave Singh, MDPrincipal InvestigatorDivision of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom
20 Previous Clinical Trials
2,809 Total Patients Enrolled
~660 spots leftby Mar 2029
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