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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05742802
Registration number
NCT05742802
Ethics application status
Date submitted
17/01/2023
Date registered
24/02/2023
Titles & IDs
Public title
Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).
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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).
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Secondary ID [1]
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2022-501063-41-00
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Secondary ID [2]
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D9180C00008
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Universal Trial Number (UTN)
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Trial acronym
PROSPERO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD)
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Tozorakimab 1
Other interventions - Tozorakimab 2
Other interventions - 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.
Other interventions: 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.
Other interventions: 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.
Other interventions: 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Annualised rate of severe COPD exacerbations in former smokers.
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Assessment method [1]
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The primary efficacy endpoint is the rate of severe COPD exacerbations.
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Timepoint [1]
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Up to 104 weeks.
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Secondary outcome [1]
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The annualised rate of severe COPD exacerbations
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Assessment method [1]
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To be analyzed as a key secondary endpoint in the Overall Population in former or current smokers.
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Timepoint [1]
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Up to 104 weeks.
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Secondary outcome [2]
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Time to First Severe COPD Exacerbations
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Assessment method [2]
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Time to first severe COPD exacerbation over the treatment period. Analyses will be conducted in the former smoker population, followed by the Overall Population in former or current smokers.
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Timepoint [2]
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Up to 104 weeks.
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Secondary outcome [3]
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Time to first moderate-to-severe COPD exacerbation.
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Assessment method [3]
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To explore the extent to which treatment with each dose of Tozorakimab delays the time to first exacerbation compared with placebo.
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Timepoint [3]
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Up to 104 weeks.
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Secondary outcome [4]
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Annualised rate of moderate to severe COPD exacerbations.
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Assessment method [4]
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To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of moderate to severe COPD exacerbations.
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Timepoint [4]
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Up to 104 weeks.
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Secondary outcome [5]
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Time to all-cause death.
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Assessment method [5]
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To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on time to all-cause death.
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Timepoint [5]
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Up to 104 weeks.
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Secondary outcome [6]
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Trough serum concentrations of tozorakimab over the treatment period.
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Assessment method [6]
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Pharmacokinetics: concentrations of Tozorakimab in trough serum.
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Timepoint [6]
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Up to 104 weeks.
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Secondary outcome [7]
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Incidence of anti-drug antibodies.
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Assessment method [7]
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Immunogenicity: presence of Tozorakimab anti-drug antibodies in blood serum.
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Timepoint [7]
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Up to 104 weeks.
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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.
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Minimum age
40
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
6/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
17/08/2026
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Actual
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Sample size
Target
1596
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Accrual to date
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Final
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Recruitment in Australia
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Recruitment hospital [1]
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Research Site - Frankstown
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Research Site - Macquarie University
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Research Site - Spearwood
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Recruitment postcode(s) [1]
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3199 - Frankstown
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Recruitment postcode(s) [2]
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2109 - Macquarie University
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3000 - Melbourne
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6163 - Spearwood
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Recruitment postcode(s) [5]
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2500 - Wollongong
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Recruitment outside Australia
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La Tronche
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Ashkelon
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Israel
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Israel
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Italy
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Bari
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Italy
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Italy
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Italy
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Napoli
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Italy
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Roma
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Italy
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Italy
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Sassari
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Italy
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Statte
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Italy
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Italy
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Tradate
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Italy
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Vercelli
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Italy
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Verona
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Obihiro
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Lima
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Portugal
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Vila Nova de Gaia
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Romania
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Brasov
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Romania
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Romania
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Constanta
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Romania
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Timisoara
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Galdakao
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Spain
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Spain
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Lund
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Hsinchu
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Taiwan
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Taiwan
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Taichung
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Taiwan
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Taiwan
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Yunlin
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Thailand
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Bang Kra So
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Thailand
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Bangkok
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Thailand
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Hat Yai
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Thailand
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Khon Kaen
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Thailand
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Muang,
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Thailand
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Muang
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Thailand
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Mueang
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Thailand
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Mersin
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United Kingdom
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Bradford
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United Kingdom
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Corby
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United Kingdom
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Enfield
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United Kingdom
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High Wycombe
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United Kingdom
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Northwood
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United Kingdom
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Preston
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United Kingdom
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Shipley
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Vietnam
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Hanoi
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0
Vietnam
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State/province [283]
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Ho Chi Minh
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AstraZeneca
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05742802
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
AstraZeneca Clinical Study Information Center
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
1-877-240-9479
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
Query!
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Query!
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/NCT05742802