A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (EMBARK)
EU CTIS ID: 2024-517458-90-00
What this study is testing
To compare the effect of tezepelumab with placebo on moderate or severe COPD exacerbations in participants with moderate to very severe COPD
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Adult participants 40 to 80 years of age at the time of signing the informed consent.
- 2. Documented physician-diagnosed COPD for at least 12 months before Visit 1.
- 3. A post-BD FEV1/FVC < 0.70 and a post-BD FEV1 ≥ 20% and ≤70% of the predicted normal value during screening.
- 4. Documented regular dose of triple inhaled maintenance therapy (ICS+LABA+LAMA), or dualtherapy (LABA+LAMA, ICS+LABA, ICS+LAMA) if triple therapy is considered not appropriate, for atleast 3 consecutive months before Visit 1.
- 5. Documented history ≥2 moderate or ≥1 severe COPD exacerbations within 12 months before Visit 1. At least 1 of the 2 moderate exacerbations must have been treated with SCS. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy.
- 6. EOS ≥ 150 cells/μL during the screening period.
You likely can't join if
- 1. Clinically important lung disease other than COPD (eg, active lung infection, clinically significant bronchiectasis, pulmonary fibrosis,cystic fibrosis, hypoventilation syndrome associated with obesity,lung cancer, alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia), or another diagnosed pulmonary or systemic disease that is associated with elevated peripheral EOS (eg, allergic bronchopulmonary aspergillosis/mycosis, eosinophilicgranulomatosis with polyangiitis, hypereosinophilic syndrome).
- 10. LTOT with signs and/or symptoms of cor pulmonale and/or rightventricular failure, or LTOT > 4.0 litres/minute (L/min) at rest oran oxyhaemoglobin saturation < 89% despite LTOT.
- 11. Use, or need for chronic use, of any non-invasive positive pressure ventilation device. Stable use of non-invasive ventilation for the treatment of Obstructive Sleep Apnoea is permitted.
- 12. Maintenance treatment with macrolides or other antibiotics forCOPD if the duration of the treatment is < 6 consecutive months before Visit 1.
- 2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant’s respiratory symptoms. Radiological findings of pulmonary nodulessuspicious for lung cancer, as per applicable guidance, (eg, ACRLung-RADS v2022, (Christensen et al 2024)) without appropriatefollow up before Visit 2.
- 3. Radiological findings suggestive of acute respiratory infection, if confirmed clinically.
See the full eligibility criteria
Who can join
- 1. Adult participants 40 to 80 years of age at the time of signing the informed consent.
- 2. Documented physician-diagnosed COPD for at least 12 months before Visit 1.
- 3. A post-BD FEV1/FVC < 0.70 and a post-BD FEV1 ≥ 20% and ≤70% of the predicted normal value during screening.
- 4. Documented regular dose of triple inhaled maintenance therapy (ICS+LABA+LAMA), or dualtherapy (LABA+LAMA, ICS+LABA, ICS+LAMA) if triple therapy is considered not appropriate, for atleast 3 consecutive months before Visit 1.
- 5. Documented history ≥2 moderate or ≥1 severe COPD exacerbations within 12 months before Visit 1. At least 1 of the 2 moderate exacerbations must have been treated with SCS. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy.
- 6. EOS ≥ 150 cells/μL during the screening period.
- 7. CAT total score ≥ 15 at Visit 1.
- 8. Current or former smokers (with smoking cessation ≥ 6 monthsbefore Visit 1) have a history of at least 10 pack-years of tobacco smoking (1 pack year = 20 cigarettes smoked per day for 1 year).
What rules you out
- 1. Clinically important lung disease other than COPD (eg, active lung infection, clinically significant bronchiectasis, pulmonary fibrosis,cystic fibrosis, hypoventilation syndrome associated with obesity,lung cancer, alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia), or another diagnosed pulmonary or systemic disease that is associated with elevated peripheral EOS (eg, allergic bronchopulmonary aspergillosis/mycosis, eosinophilicgranulomatosis with polyangiitis, hypereosinophilic syndrome).
- 10. LTOT with signs and/or symptoms of cor pulmonale and/or rightventricular failure, or LTOT > 4.0 litres/minute (L/min) at rest oran oxyhaemoglobin saturation < 89% despite LTOT.
- 11. Use, or need for chronic use, of any non-invasive positive pressure ventilation device. Stable use of non-invasive ventilation for the treatment of Obstructive Sleep Apnoea is permitted.
- 12. Maintenance treatment with macrolides or other antibiotics forCOPD if the duration of the treatment is < 6 consecutive months before Visit 1.
- 2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant’s respiratory symptoms. Radiological findings of pulmonary nodulessuspicious for lung cancer, as per applicable guidance, (eg, ACRLung-RADS v2022, (Christensen et al 2024)) without appropriatefollow up before Visit 2.
- 3. Radiological findings suggestive of acute respiratory infection, if confirmed clinically.
- 4. Current physician diagnosed asthma according to the Global Initiative for Asthma (GINA 2024 and onwards versions) guidelines or other accepted guidelines, past physician diagnosed asthma including paediatric asthma, or asthma-COPD overlap syndrome.
- 5. Any unstable disorder, including, but not limited to, cardiovascular,gastrointestinal, hepatic, renal, neurological, musculoskeletal,infectious, endocrine, metabolic, haematological, immune,psychiatric, or major physical/or cognitive impairment that is not stable in the opinion of the investigator or the sponsor and/orcould: − Affect the safety of the participant throughout the study − Influence the findings of the study or their interpretation − Impede the participant’s ability to complete the entire durationof the study and/or comply with the study visit schedule and procedures
- 6. Unstable cardiovascular disorder (including but not limited toischemic heart disease, arrhythmia, cardiomyopathy, severe right and/or left heart failure (NYHA class IV)), renal failure,uncontrolled hypertension, as defined by the Investigator, or anyother relevant cardiovascular disorder or ECG abnormality that in the Investigator’s judgment may put the participant at risk or negatively affect the outcome of the study.
- 7. Tuberculosis requiring treatment in the last 12 months before Visit 2. Local guidelines for diagnosis and treatment should be followed.
- 8. Malignancy, current or past (within 5 years before Visit 1), except for basal cell carcinoma, localised squamous cell carcinoma of thes kin, or in situ carcinoma of the cervix provided when a curative therapy was completed at least 12 months before Visit 1.
- 9. Treatment with systemic immunosuppressive/immunomodulatingmedications including maintenance use of SCS within the last 12 weeks or 5 half-lives before Visit 1 or during the screening for other reasons than COPD exacerbation. Expected need for chronicuse during the study for any reason.
The study team makes the final eligibility decision.
Where it's taking place
- Spain
- Denmark
- Germany
- Poland
- Mexico
- India
- Philippines
- Malaysia
- United States
- Korea, Republic of
- Chile
- Brazil
- Canada
- China
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Spain; Denmark; Germany; Poland; Mexico; India and 9 more locations. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from EU CTIS. The study team decides eligibility, and your own doctor gives medical advice.