Open Actively Recruiting

Tezepelumab COPD Exacerbation Study

About

Brief Summary

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2a Study to Explore the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
40 Years
Maximum Age
80 Years

Inclusion Criteria:

  • History of moderate to very severe physician-diagnosed COPD for at least 12 months prior to enrolment with a post-bronchodilator FEV1/FVC<0.70 and a post-bronchodilator FEV1 ≥20% and ≤80% of predicted normal value.
  • History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment.
  • CAT score of ≥15 at enrollment and on day of randomization.
  • Documented treatment with triple therapy for COPD (medium or high dose ICS/LABA/LAMA) throughout the year prior to enrollment. The dose of ICS should be stable for 3 months prior to enrollment.

Exclusion Criteria:

  • Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
  • 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.
  • Major surgery within 8 weeks before enrollment.
  • History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment.
  • Pregnant or breastfeeding.
  • The chest/lungs with pathology that precludes the patient's ability to complete the study
  • The patient has active COVID 19 infection during screening period.

Join this Trial

Contact our clinical trial navigators for opportunities that may be suitable for you
Study Stats
Protocol No.
20-000352
Category
Pulmonary Disease
Contact
Roslynn Marzan-McGill
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04039113
For detailed technical eligibility, visit ClinicalTrials.gov.