A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00006) (EMBARK)

AstraZeneca

Status and phase: Enrolling; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Biological: Tezepelumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06883305

D5241C00006

Details and patient eligibility

About

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Full description

This is a Phase 3, 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 inhaled maintenance therapy and having had at least 2 moderate, or 1 severe, COPD exacerbations in the 12 months prior to Visit 1. Subjects will receive monthly subcutaneous injection of one of two different doses of tezepelumab, or placebo, with a maximum treatment duration of 76 weeks and a minimum of 52 weeks. The study also includes a off-treatment safety follow-up period of 12 weeks.

Enrollment: 990 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥40 to ≤80 years old
2. COPD diagnosis ≥1 year,
3. Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC <0.70 at screening
4. Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1
5. ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. 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 screening
7. CAT ≥15 at screening
8. Former or current smokers ≥10 pack-years

Exclusion criteria

1. Clin. important pulmonary disease or radiological findings suggestive of a respiratory disease other than COPD

2. Asthma, incl. pediatric, or ACOS

3. Any unstable disorder that can impact participants safety or study outcomes

4. Tuberculosis requiring treatment within 12 months prior V2

5. Malignancies current or past

   Concomitant therapies:

   • Macrolides (less than 6 months)
   • Systemic immuno-suppressive, -modulating medications

6. LTOT >4.0 L/min or O2 saturation <89% despite LTOT

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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990 participants in 3 patient groups, including a placebo group

Dose 1 of Tezepelumab

Experimental group

Description:

Tezepelumab, SC, Q4W

Treatment:

Biological: Tezepelumab

Dose 2 of Tezepelumab

Experimental group

Description:

Tezepelumab, SC, Q4W

Treatment:

Biological: Tezepelumab

Matching Placebo

Placebo Comparator group

Description:

Matching placebo, SC, Q4W

Treatment:

Other: Placebo