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Tezepelumab COPD Exacerbation...

Tezepelumab COPD Exacerbation Study

Last Updated: 2025-02-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-30

Study Completion Date

2024-01-31

Brief Summary

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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)

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Detailed Description

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This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease (COPD) receiving triple inhaled maintenance therapy, and having had 2 or more documented COPD exacerbations in the 12 months prior to Visit 1. Approximately, 338 subjects will be randomized globally. Subjects will be stratified by region and prior number of exacerbations (2 vs. 3 or more). Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection at the study site, over a 52 week treatment period. The study also includes a post-treatment follow-up period of 12 weeks.

Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blinded

Study Groups

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Tezepelumab

Tezepelumab, SC, Q4W

Group Type ACTIVE_COMPARATOR

Tezepelumab

Intervention Type BIOLOGICAL

Tezepelumab subcutaneous injection

Matching Placebo

Matching placebo, SC, Q4W

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo subcutaneous injection

Interventions

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Tezepelumab

Tezepelumab subcutaneous injection

Intervention Type BIOLOGICAL

Placebo

Placebo subcutaneous injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. History of at least 2 documented moderate to severe COPD exacerbations within 2 to 52 weeks prior to enrollment.
3. CAT score of ≥15 at enrollment and on day of randomization.
4. 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

1. Clinically important pulmonary disease other than COPD, as judged by the Investigator (including current or historic asthma diagnosis).
2. 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.
3. Major surgery within 8 weeks before enrollment.
4. History of clinically significant infection requiring antibiotics or antiviral medication within 14 days before enrollment.
5. Pregnant or breastfeeding.
6. The chest/lungs with pathology that precludes the patient's ability to complete the study
7. The patient has active COVID 19 infection during screening period.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers