Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 21.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must be between 40-80 years of age. 2) Weight =40 kg at screening visit. 3) History of moderate to very severe physician-diagnosed COPD for at least 12 months prior to enrolment with a post-bronchodilator FEV1 =20% and =80% of predicted normal value. 4) History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment. 5) CAT score of =15 at enrollment and day of randomization. 6) Subjects should have evidence of having been treated with triple (medium or high dose ICS/LABA/LAMA) therapy for COPD throughout the year prior to enrollment, the dose should be stable for 3 months prior to screening visit. 7) Current smoker or ex-smoker with a tobacco history of =10 pack-years. 8) If on allergen-specific immunotherapy, subjects must be on a maintenance dose and schedule for at least 2 months prior to screening visit. 9) If on theophylline or roflumilast, subjects must be on maintenance treatment for at least 12 months prior to screening visit and on stable dose 3 months prior to screening visit. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 135 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 203
Exclusion criteria
Exclusion criteria: 1) Clinically important pulmonary disease other than COPD. 2) Current or previous asthma diagnosis. 3) Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious (including risk factors for pneumonia), endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable. 4) Treatment with systemic corticosteroids and/or antibiotics, and/or hospitalization for a COPD exacerbation within 14 days prior to enrolment (Visit 1) or during screening period. 5) History of clinically significant infection (excluding pneumonia), acute upper or lower respiratory infection, requiring antibiotics or antiviral medication within 14 days prior to enrolment (Visit 1) or during the screening period. 6) History of pneumonia requiring antibiotics or antiviral medication within 28 days prior to enrolment (Visit 1) or during the screening period. 7) History of allergy or reaction to any component of tezepelumab. 8 History of anaphylaxis to any other biologic therapy. 9) History of alcohol or drug abuse within the past year. 10) History of cancer. 11) Subjects with tuberculosis (TB) 12) Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures requiring general anaesthesia. 13) Pregnant or breastfeeding. 14) Subjects randomized in the current or previous Tezepelumab studies. 15) The chest/lungs with pathology that precludes the patient's ability to complete the study. 16) The patient has active COVID 19 infection during the screening period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of tezepelumab SC Q4W as compared with placebo on COPD exacerbations in adults with moderate to very severe COPD;Secondary Objective: To evaluate the effect of tezepelumab SC Q4W compared with placebo on: 1. Time to first moderate or severe exacerbation. 2. Severe COPD exacerbations. 3. Pre-bronchodilator lung function. 4. Respiratory health status/health-related quality of life. 5. Pharmacokinetics and immunogenicity; not compared with placebo.;Primary end point(s): 1) Rate of moderate or severe COPD exacerbations.;Timepoint(s) of evaluation of this end point: Rate ratio of moderate or severe COPD exacerbation vs placebo over 52 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints: 1) Time to first moderate or severe COPD exacerbation. 2) Rate of severe COPD exacerbations 3) Change from baseline in pre-brohchodilator (BD) forced expiratory volume in 1 second (FEV1) 4) Change from baseline in SGRQ score and CAT. Proportion of subjects achieving an MCID of 4 units or more in SGRQ total score. 5) Evaluate pharmacokinetics (serum trough concentration) and immunogenicity (incidence of anti-drug antibodies(ADA)) of tezepelumab.;Timepoint(s) of evaluation of this end point: Key Secondary Endpoints: 1) over 52 weeks 2) over 52 weeks 3) at week 52 4) at week 52 5) over 52 weeks | — |
Countries
Canada, Denmark, France, Germany, Israel, Korea, Republic of, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactStudy Information Center
AstraZeneca AB
Outcome results
None listed