A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (EMBARK)

Conditions

Chronic obstructive pulmonary disease (COPD)

Brief summary

Annualised rate of moderate or severe COPD exacerbations up to 76 weeks

Detailed description

1. Change from baseline in pre-BD FEV1 at Week 52, 3. Change from baseline in the SGRQ total score over 52 weeks, 4. Annualised rate of moderate or severe COPD exacerbations up to 76 weeks among participants with screening EOS ≥ 300 cells/μL., 5. Annualised rate of severe COPD exacerbations requiring ER visits and/or hospitalisations up to 76 weeks., 6. Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 52 weeks., 7. Change from baseline in the CAT total score over 52 weeks, 8. Participants achieving a clinically meaningful improvement frombaseline in CAT total score (2-point score decrease) over 52 weeks., 9. Time to first moderate to severe COPD exacerbation up to 76 weeks, 10. Time to first severe COPD exacerbation up to 76 weeks, 11. PK: Serum trough concentrations, 12. Immunogenicity: Incidence of anti-drug antibodies and neutralising antibodies, 2. Change from baseline in post-BD FEV1 at Week 52.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGTezspire 210 mg solution for injection in pre-filled syringe

DRUGTezepelumab-placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annualised rate of moderate or severe COPD exacerbations up to 76 weeks	—

Secondary

Measure	Time frame
1. Change from baseline in pre-BD FEV1 at Week 52, 3. Change from baseline in the SGRQ total score over 52 weeks, 4. Annualised rate of moderate or severe COPD exacerbations up to 76 weeks among participants with screening EOS ≥ 300 cells/μL., 5. Annualised rate of severe COPD exacerbations requiring ER visits and/or hospitalisations up to 76 weeks., 6. Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 52 weeks., 7. Change from baseline in the CAT total score over 52 weeks, 8. Participants achieving a clinically meaningful improvement frombaseline in CAT total score (2-point score decrease) over 52 weeks., 9. Time to first moderate to severe COPD exacerbation up to 76 weeks, 10. Time to first severe COPD exacerbation up to 76 weeks, 11. PK: Serum trough concentrations, 12. Immunogenicity: Incidence of anti-drug antibodies and neutralising antibodies, 2. Change from baseline in post-BD FEV1 at Week 52.	—

Measure

Time frame

1. Change from baseline in pre-BD FEV1 at Week 52, 3. Change from baseline in the SGRQ total score over 52 weeks, 4. Annualised rate of moderate or severe COPD exacerbations up to 76 weeks among participants with screening EOS ≥ 300 cells/μL., 5. Annualised rate of severe COPD exacerbations requiring ER visits and/or hospitalisations up to 76 weeks., 6. Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 52 weeks., 7. Change from baseline in the CAT total score over 52 weeks, 8. Participants achieving a clinically meaningful improvement frombaseline in CAT total score (2-point score decrease) over 52 weeks., 9. Time to first moderate to severe COPD exacerbation up to 76 weeks, 10. Time to first severe COPD exacerbation up to 76 weeks, 11. PK: Serum trough concentrations, 12. Immunogenicity: Incidence of anti-drug antibodies and neutralising antibodies, 2. Change from baseline in post-BD FEV1 at Week 52.

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Countries

Czechia, Denmark, Germany, Italy, Poland, Slovakia, Spain

Outcome results

None listed