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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05742802




Registration number
NCT05742802
Ethics application status
Date submitted
17/01/2023
Date registered
24/02/2023
Date last updated
20/03/2024

Titles & IDs
Public title
Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
Scientific title
A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations (PROSPERO).
Secondary ID [1] 0 0
2022-501063-41-00
Secondary ID [2] 0 0
D9180C00008
Universal Trial Number (UTN)
Trial acronym
PROSPERO
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
Combination Product - Tozorakimab 1
Combination Product - Tozorakimab 2
Combination Product - Placebo

Experimental: Tozorakimab Dose 1 - Injection subcutaneously Tozorakimab via pre-filled syringe.

Experimental: Tozorakimab Dose 2 - Injection subcutaneously Tozorakimab via pre-filled syringe.

Placebo Comparator: Placebo - Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe.


Combination Product: Tozorakimab 1
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.

Combination Product: Tozorakimab 2
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.

Combination Product: Placebo
Participants previously randomised to placebo in one of the predecessor studies will be re-randomised in a 1:1 ratio to the active dose of Tozorakimab or placebo.
Intervention code [1] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first severe COPD exacerbation in former smokers.
Timepoint [1] 0 0
Up to 104 weeks.
Secondary outcome [1] 0 0
Time to first severe COPD exacerbation.
Timepoint [1] 0 0
Up to 104 weeks.
Secondary outcome [2] 0 0
Annualised rate of severe COPD exacerbations.
Timepoint [2] 0 0
Up to 104 weeks.
Secondary outcome [3] 0 0
Time to first moderate-to-severe COPD exacerbation.
Timepoint [3] 0 0
Up to 104 weeks.
Secondary outcome [4] 0 0
Annualised rate of moderate to severe COPD exacerbations.
Timepoint [4] 0 0
Up to 104 weeks.
Secondary outcome [5] 0 0
Time to all-cause death.
Timepoint [5] 0 0
Up to 104 weeks.
Secondary outcome [6] 0 0
Trough serum concentrations of tozorakimab over the treatment period.
Timepoint [6] 0 0
Up to 104 weeks.
Secondary outcome [7] 0 0
Incidence of anti-drug antibodies.
Timepoint [7] 0 0
Up to 104 weeks.

Eligibility
Key inclusion criteria
1. Participants who have completed the treatment period and have not been prematurely
discontinued from IP in the predecessor studies.

2. Participants who received their last dose of IP in the predecessor studies within the
previous 12 weeks and were not withdrawn from the predecessor study.

3. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test
at Visit 1.

4. Participants who are willing to continue using contraceptive methods as agreed to for
the predecessor OBERON or TITANIA studies.

5. Capable of giving signed informed consent.
Minimum age
40 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any clinically significant disorder or abnormal findings (clinical, laboratory,
instrumental, etc) or major physical and/or cognitive impairment - which, in the
opinion of the Investigator, may put the participant at risk because of his/her
participation in the study or impact the interpretation of the study results, or
otherwise make the participation of the participant inappropriate.

2. Participant meeting criteria for IP discontinuation as judged by the Investigator or
the Sponsor.

3. Concurrent enrolment in other interventional clinical studies or treatment with
another IP, with the exception of the OBERON and TITANIA predecessor studies.

4. Known history of:

1. Severe allergic reaction to any monoclonal and polyclonal antibody.

2. Allergy or reaction to any component of the IP formulation.

5. Chronic use (or expected need for chronic use during the study) of immunosuppressive
medications (including, but not limited to, systemic corticosteroids), marketed or
investigational biologic, or another prohibited medication.

6. Involvement in the planning and/or conduct of the study (applies to both staff
employed by the Sponsor and/or staff at the study site).

7. Participants who are not able to comply with the study requirements, procedures, and
restrictions.

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
6/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
19/07/2025
Actual
Sample size
Target
1596
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Frankstown
Recruitment hospital [2] 0 0
Research Site - Macquarie University
Recruitment hospital [3] 0 0
Research Site - Melbourne
Recruitment hospital [4] 0 0
Research Site - Spearwood
Recruitment hospital [5] 0 0
Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
3199 - Frankstown
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6163 - Spearwood
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment outside Australia
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France
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France
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Germany
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Zutphen
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Zwolle
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Godoy Cruz
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent
for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3,
extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with
symptomatic COPD.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05742802
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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
information.center@astrazeneca.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05742802