Ongoing, Recruiting Therapeutic Confirmatory (Phase Iii) Chronic Obstructive Pulmonary Disease (COPD)

A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

EU CTIS ID: 2024-517457-27-00

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 valueduring screening.
  • 4. Documented regular dose of triple inhaled maintanence therapy (ICS+LABA+LAMA), or dual therapy (LABA+LAMA, ICS+LABA,ICS+LAMA) if triple inhaled therapy is considered not appropriate, for at least 3 consecutive months before Visit 1.
  • 5. Documented history ≥2 moderate or ≥1 severe COPD exacerbations within 12 months before Visit1. 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 significantbronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated withobesity, lung cancer, alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia), or anotherdiagnosed pulmonary or systemic disease that is associated with elevated peripheral EOS (eg,allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangiitis,hypereosinophilic syndrome).
  • 10. LTOT with signs and/or symptoms of cor pulmonale and/or right ventricular failure, or LTOT > 4.0litres/minute (L/min) at rest or an oxyhaemoglobin saturation < 89% despite LTOT.
  • 11. Use, or need for chronic use, of any non-invasive positive pressure ventilation device. Stable use ofnon-invasive ventilation for the treatment of Obstructive Sleep Apnoea is permitted.
  • 12. Maintenance treatment with macrolides or other antibiotics for COPD if the duration of thetreatment is < 6 consecutive months before Visit 1.
  • 2. Radiological findings suggestive of a respiratory disease other than COPD that is significantlycontributing to the participant’s respiratory symptoms. Radiological findings of pulmonary nodulessuspicious for lung cancer, as per applicable guidance, (eg, ACR Lung-RADS v2022, (Christensen etal 2024)) without appropriate follow 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 valueduring screening.
  • 4. Documented regular dose of triple inhaled maintanence therapy (ICS+LABA+LAMA), or dual therapy (LABA+LAMA, ICS+LABA,ICS+LAMA) if triple inhaled therapy is considered not appropriate, for at least 3 consecutive months before Visit 1.
  • 5. Documented history ≥2 moderate or ≥1 severe COPD exacerbations within 12 months before Visit1. 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 months before Visit 1) have a history of atleast 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 significantbronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated withobesity, lung cancer, alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia), or anotherdiagnosed pulmonary or systemic disease that is associated with elevated peripheral EOS (eg,allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangiitis,hypereosinophilic syndrome).
  • 10. LTOT with signs and/or symptoms of cor pulmonale and/or right ventricular failure, or LTOT > 4.0litres/minute (L/min) at rest or an oxyhaemoglobin saturation < 89% despite LTOT.
  • 11. Use, or need for chronic use, of any non-invasive positive pressure ventilation device. Stable use ofnon-invasive ventilation for the treatment of Obstructive Sleep Apnoea is permitted.
  • 12. Maintenance treatment with macrolides or other antibiotics for COPD if the duration of thetreatment is < 6 consecutive months before Visit 1.
  • 2. Radiological findings suggestive of a respiratory disease other than COPD that is significantlycontributing to the participant’s respiratory symptoms. Radiological findings of pulmonary nodulessuspicious for lung cancer, as per applicable guidance, (eg, ACR Lung-RADS v2022, (Christensen etal 2024)) without appropriate follow 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 andonwards versions) guidelines or other accepted guidelines, past physician diagnosed asthmaincluding 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 theinvestigator or the sponsor and/or could: − 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 duration of the study and/or comply withthe study visit schedule and procedures
  • 6. Unstable cardiovascular disorder (including but not limited to ischemic heart disease, arrhythmia,cardiomyopathy, severe right and/or left heart failure (NYHA class IV)), renal failure, uncontrolledhypertension, as defined by the Investigator, or any other relevant cardiovascular disorder or ECGabnormality that in the Investigator’s judgment may put the participant at risk or negatively affectthe 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, localisedsquamous cell carcinoma of the skin, or in situ carcinoma of the cervix provided when a curativetherapy was completed at least 12 months before Visit 1.
  • 9. Treatment with systemic immunosuppressive/immunomodulating medications includingmaintenance use of SCS within the last 12 weeks or 5 half-lives before Visit 1 or during thescreening for other reasons than COPD exacerbation. Expected need for chronic use during thestudy for any reason.

The study team makes the final eligibility decision.

Where it's taking place

  • Hungary
  • France
  • Netherlands
  • Belgium
  • Bulgaria
  • Denmark
  • Romania
  • Greece
  • Sweden
  • Thailand
  • Hong Kong
  • Japan
  • Vietnam
  • Peru
  • Israel
  • South Africa
  • New Zealand
  • Argentina
  • United States
  • Turkey

+ 2 more site(s).

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, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Hungary; France; Netherlands; Belgium; Bulgaria; Denmark and 16 more locations. Enter your location above to see the nearest site and check your eligibility.

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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.