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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06878261




Registration number
NCT06878261
Ethics application status
Date submitted
3/03/2025
Date registered
14/03/2025

Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe COPD (D5241C00007)
Scientific 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
Secondary ID [1] 0 0
D5241C00007
Universal Trial Number (UTN)
Trial acronym
JOURNEY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Tezepelumab
Other interventions - Placebo

Experimental: Dose 1 of Tezepelumab - Tezepelumab, SC, Q4W

Experimental: Dose 2 of Tezepelumab - Tezepelumab, SC, Q4W

Placebo comparator: Matching Placebo - Matching placebo, SC, Q4W


Treatment: Other: Tezepelumab
Tezepelumab subcutaneous injection

Other interventions: Placebo
Placebo subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Annualised rate of moderate or severe COPD exacerbations
Timepoint [1] 0 0
Baseline up to 76 weeks
Secondary outcome [1] 0 0
Change from baseline in pre-dose/pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1)
Timepoint [1] 0 0
From baseline to Week 52
Secondary outcome [2] 0 0
Change from baseline in the St. George's Respiratory Questionnaire (SGRQ) total score
Timepoint [2] 0 0
From baseline over 52 weeks
Secondary outcome [3] 0 0
Annualised rate of moderate or severe COPD exacerbations among participants with EOS = 300 cells/µL.
Timepoint [3] 0 0
Baseline up to 76 weeks
Secondary outcome [4] 0 0
Annualised rate of severe COPD exacerbations
Timepoint [4] 0 0
Baseline up to 76 weeks
Secondary outcome [5] 0 0
Clinical meaningful improvement in St. George's Respiratory Questionnaire (SGRQ) total score
Timepoint [5] 0 0
From baseline over 52 weeks
Secondary outcome [6] 0 0
Change from baseline in the COPD assessment Test (CAT) total score
Timepoint [6] 0 0
From baseline over 52 weeks
Secondary outcome [7] 0 0
Clinical meaningful improvement in COPD Assessment Test (CAT) total score
Timepoint [7] 0 0
From baseline over 52 weeks
Secondary outcome [8] 0 0
Time to first moderate to severe COPD exacerbation
Timepoint [8] 0 0
Baseline up to 76 weeks
Secondary outcome [9] 0 0
Time to first severe COPD exacerbation
Timepoint [9] 0 0
Baseline up to 76 weeks
Secondary outcome [10] 0 0
Change from baseline in post-BD FEV1
Timepoint [10] 0 0
From baseline to Week 52
Secondary outcome [11] 0 0
Pharmacokinetics (PK): Serum trough concentrations
Timepoint [11] 0 0
Baseline, Week 24, Week 36, Week 52
Secondary outcome [12] 0 0
Immunogenicity of anti-drug antibodies (ADA)
Timepoint [12] 0 0
Baseline to Week 52

Eligibility
Key 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 =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
6. EOS = 150 cells/µL during screening
7. CAT =15 at screening
8. Former or current smokers =10 pack-years
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/06/2029
Actual
Sample size
Target
990
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Frankston
Recruitment hospital [2] 0 0
Research Site - Garran
Recruitment hospital [3] 0 0
Research Site - Spearwood
Recruitment hospital [4] 0 0
Research Site - Woodville South
Recruitment postcode(s) [1] 0 0
3199 - Frankston
Recruitment postcode(s) [2] 0 0
2605 - Garran
Recruitment postcode(s) [3] 0 0
6163 - Spearwood
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
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Arizona
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California
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Indiana
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Kansas
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Vermont
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Hatyai
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Rayong
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Vietnam
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Hanoi
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Vietnam
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Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Amgen
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MeiLan Han, MD
Address 0 0
University of Michigan Health, Pulmonary & Critical Care Medicine,
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06878261