A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)

NCT06878261
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
990
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Lead sponsor
AstraZeneca
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Start date
2025-03-25
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Number of sites
284
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Summary
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)
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Acronym
JOURNEY
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Short title
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
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Official title
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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2029-06-05
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First posted
2025-03-14
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Registry last updated
2026-10-09
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Primary completion date
2029-03-13
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Start date
2025-03-25
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Participants
990
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Participant count basis
Estimated
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Planned participants
990
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Protocol amendments
1
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Number of sites
284
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06878261
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ClinicalTrials.gov ID
NCT06878261
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masking description
Double-blinded
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Annualised rate of moderate or severe COPD exacerbations

    Timeframe: Baseline up to 76 weeks

    The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo.

  1. Change from baseline in post-BD FEV1

    Timeframe: From baseline to Week 52

    Change from baseline in post-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration

  2. Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)

    Timeframe: From baseline to Week 52

    Change from baseline in pre-BD FEV1 at Week 52 compared to placebo. FEV1 is defined as the volume of air exhaled from the lungs in the first second of a forced expiration

  3. Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score

    Timeframe: From baseline over 52 weeks

    Change from baseline in the SGRQ total score over 52 weeks compared to placebo. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.

  4. Annualised rate of moderate or severe COPD exacerbations among participants with EOS ≥ 300 cells/µL collected during screening visit.

    Timeframe: Baseline up to 76 weeks

    The annualised moderate or severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo among participants with EOS ≥ 300 cells/µL collected during screening visit.

  5. Annualised rate of severe COPD exacerbations

    Timeframe: Baseline up to 76 weeks

    The annualised severe COPD exacerbation rate (based on exacerbations reported by the investigator) up to 76 weeks treatment period compared to placebo

  6. Annualised rate of COPD exacerbations requiring ER visit and/or hospitalisation

    Timeframe: Baseline up to 76 Weeks

    The annualised rate of COPD exacerbation requiring ER visit and/or hospitalisation up to 76 weeks treatment period compared to placebo.

  7. Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score

    Timeframe: From baseline over 52 weeks

    Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 52 weeks. SGRQ is a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with lower scores indicating better health status.

  8. Change from baseline in the COPD assessment Test (CAT) total score

    Timeframe: From baseline over 52 weeks

    Change from baseline in the CAT total score over 52 weeks CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.

  9. Clinical meaningful improvement in COPD Assessment Test (CAT) total score

    Timeframe: From baseline over 52 weeks

    Participants achieving a clinically meaningful improvement from baseline in CAT total score (2-point score decrease) over 52 weeks. CAT is an 8-item PRO that measures the impact of COPD on the health status of patients with COPD. The CAT has a scoring range of 0-40 with higher scores indicative of greater COPD impact on health status.

  10. Time to first moderate or severe COPD exacerbation

    Timeframe: Baseline up to 76 weeks

    Time to first occurrence of moderate or severe COPD exacerbation up to 76 weeks

  11. Time to first severe COPD exacerbation

    Timeframe: Baseline up to 76 weeks

    Time to first occurrence of severe COPD exacerbation up to 76 weeks

  12. Pharmacokinetics (PK): Serum trough concentrations

    Timeframe: Baseline, Week 24, Week 36, Week 52

    Serum trough concentrations

  13. Immunogenicity of anti-drug antibodies (ADA)

    Timeframe: Baseline, Week 24, Week 36, Week 52

    Incidence of anti-drug antibodies

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
40 Years
Maximum age
80 Years
Healthy volunteers
No

  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

  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

Sources for eligibility
clinicaltrials.gov

  • Research SiteBirmingham, United StatesNot yet recruiting
  • Research SiteCullman, United StatesRecruiting
  • Research SitePhoenix, United StatesRecruiting
  • Research SiteScottsdale, United StatesRecruiting
  • Research SiteInglewood, United StatesWithdrawn
  • Research SiteLos Angeles, United StatesSuspended
  • Research SitePalo Alto, United StatesRecruiting
  • Research SiteRedding, United StatesRecruiting
  • Research SiteSan Diego, United StatesSuspended
  • Research SiteNew Britain, United StatesRecruiting
  • Research SiteWilmington, United StatesRecruiting
  • Research SiteBay Pines, United StatesRecruiting
  • Research SiteBoynton Beach, United StatesRecruiting
  • Research SiteClearwater, United StatesCompleted
  • Research SiteFleming Island, United StatesSuspended
  • Research SiteJacksonville, United StatesRecruiting
  • Research SiteLeesburg, United StatesRecruiting
  • Research SiteMargate, United StatesWithdrawn
  • Research SiteMiami, United StatesRecruiting
  • Research SiteMiami, United StatesSuspended
  • Research SiteMiami Lakes, United StatesSuspended
  • Research SiteOcala, United StatesRecruiting
  • Research SitePalmetto Bay, United StatesSuspended
  • Research SiteWinter Park, United StatesRecruiting
  • Research SiteAdairsville, United StatesSuspended

And 259 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (1)