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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06455449




Registration number
NCT06455449
Ethics application status
Date submitted
28/09/2023
Date registered
12/06/2024

Titles & IDs
Public title
A Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
Scientific title
A Multicenter, Parallel-group, Double-blind, 2-Arm, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab Administered as Subcutaneous Injection and Added to Standard of Care Compared With Placebo Added to Standard of Care in Adult Participants With Idiopathic Inflammatory Myopathies (Polymyositis and Dermatomyositis)
Secondary ID [1] 0 0
D3463C00003
Universal Trial Number (UTN)
Trial acronym
JASMINE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Polymyositis, Dermatomyositis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Anifrolumab (blinded)
Other interventions - Placebo
Other interventions - Anifrolumab (unblinded, open label)

Experimental: Anifrolumab (subcutaneous weekly injection) - Anifrolumab subcutaneous injection once weekly

Placebo comparator: Placebo (subcutaneous weekly injection) - Matched placebo control subcutaneous injection once weekly


Other interventions: Anifrolumab (blinded)
Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks

Other interventions: Placebo
Matched placebo delivered subcutaneously, once weekly for 52 weeks

Other interventions: Anifrolumab (unblinded, open label)
At Week 52, all study participants on anifrolumab or placebo will receive open label anifrolumab once weekly for an additional 52 weeks
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total Improvement Score (TIS) = 40 response
Timepoint [1] 0 0
52 week
Secondary outcome [1] 0 0
Manual Muscle Testing 8 (MMT-8)
Timepoint [1] 0 0
52 week
Secondary outcome [2] 0 0
Oral corticosteroid dose = 7.5 mg/day
Timepoint [2] 0 0
52 week
Secondary outcome [3] 0 0
Moderate improvement in disease activity in participants with polymyositis (PM)
Timepoint [3] 0 0
52 week
Secondary outcome [4] 0 0
Moderate improvement in disease activity in dermatomyositis (DM) participants.
Timepoint [4] 0 0
52 week
Secondary outcome [5] 0 0
Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)
Timepoint [5] 0 0
8 week
Secondary outcome [6] 0 0
Core Set Measures (CSMs)
Timepoint [6] 0 0
52 week
Secondary outcome [7] 0 0
Cutaneous Dermatomyositis Activity Investigator Global Assessment (CDA-IGA)
Timepoint [7] 0 0
8, 24, & 52 week
Secondary outcome [8] 0 0
5-D itch
Timepoint [8] 0 0
8, 24, & 52 week
Secondary outcome [9] 0 0
Total Improvement Score (TIS) = 20 Response
Timepoint [9] 0 0
8 week
Secondary outcome [10] 0 0
Cumulative Corticosteroid Use
Timepoint [10] 0 0
24, 52 week
Secondary outcome [11] 0 0
TIS = 60 Response
Timepoint [11] 0 0
52 week

Eligibility
Key inclusion criteria
Capable of giving informed consent.



1. 18 - 75 years old
2. Body weight 40 kg - = 100 kg
3. Must have "probable" or "definite" diagnosis of PM or DM according to the 2017 ACR/EULAR classification criteria for adult myositis.
4. Moderate or severe disease activity per core set measurements.
5. Currently receiving oral prednisone or other polymyositis or dermatomyositis treatments at a stable dose.
6. No history of active tuberculosis or severe COVID-19.
7. Male and female participants must follow contraception guidelines.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants with documented inclusion body myositis (IBM), immune mediation necrotizing myositis (IMNM), juvenile myositis (if diagnosed within 10 years prior to signing the ICF), drug-induced myositis, cancer associated myositis, amyopathic DM, and non inflammatory myopathies (eg, muscular dystrophies).
2. PM and DM patients at a high risk of malignancy.
3. Participants with rapidly progressive interstitial lung disease.
4. Participants with severe muscle damage or permanent weakness due to non-PM or non-DM conditions (i.e. stroke) as per the investigator's opinion.
5. Any history of severe case of herpes zoster infection
6. History of cancer (except adequately treated basal cell carcinoma or cervical cancer in-situ), immunodeficiency, HIV, HBV, active HCV .
7. Any clinical cytomegalovirus or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.
8. Opportunistic infection requiring hospitalization or IV antimicrobial treatment within 3 years prior to randomization.
9. Recent non-opportunistic infection requiring hospitalization or anti-infective treatment.
10. Recent or concurrent enrollment in another clinical study with an investigational product.
11. Lactating, breastfeeding, or pregnant females or females who intend to become pregnant or begin breastfeeding

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
20/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
4/08/2028
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Nedlands
Recruitment hospital [3] 0 0
Research Site - New Lambton
Recruitment hospital [4] 0 0
Research Site - Woodville South
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment postcode(s) [3] 0 0
2310 - New Lambton
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
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United States of America
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Florida
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United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
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Kansas
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United States of America
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Michigan
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United States of America
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Ohio
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United States of America
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Texas
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United States of America
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Wisconsin
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Austria
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Graz
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Merksem
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Brazil
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Joinville
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Brazil
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Juiz de Fora
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Brazil
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Pelotas
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Brazil
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Porto Alegre
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Brazil
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Salvador
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Brazil
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Sao Jose Do Rio Preto
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Brazil
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Sao Paulo
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Bulgaria
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Haskovo
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Stara Zagora
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Canada
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Alberta
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Canada
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Quebec
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China
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Beijing
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China
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Chongqing
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China
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Dongguan
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China
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Guangzhou
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China
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Hangzhou
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China
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Hengyang
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China
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Jining
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China
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Nanjing
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China
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Shanghai
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China
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Wenzhou
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China
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Zhengzhou
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Czechia
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Praha 2
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Denmark
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Aarhus N
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Denmark
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Copenhagen
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Odense C
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France
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Angers
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France
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Brest Cedex 2
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France
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Le Mans Cedex
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Lille Cedex
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Paris Cedex 13
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France
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Paris
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Reims
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Rouen
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Herne
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Dehradun
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India
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Gurugram
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India
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Hyderabad
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India
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Kolkata
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India
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Mumbai
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India
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Mysuru
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India
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New Delhi
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India
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Puducherry
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India
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Secunderabad
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Afula
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Ramat Gan
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Italy
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Ancona
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Italy
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Bari
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Italy
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Catania
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Italy
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Milano
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Italy
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Padova
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Italy
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Palermo
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Italy
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Pavia
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Italy
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Pisa
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Italy
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Roma
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Asahikawa-shi
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Bunkyo-ku
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Chiba-shi
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Fukuoka-shi
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Iruma-Gun
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Kawachinagano-shi
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Omura-shi
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Sendai-shi
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Shinjuku-ku
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Tachikawa-shi
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Japan
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Yotsukaido-shi
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Korea, Republic of
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Daejeon
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Seoul
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Mexico
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Bialystok
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Kraków
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Poznan
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Lódz
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Barcelona
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Cordoba
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L'Hospitalet de Llobregat
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La Coruña
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Madrid
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Sabadell
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Spain
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Valladolid
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Sweden
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Stockholm
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Sweden
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Uppsala
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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United Kingdom
State/province [125] 0 0
Edinburgh
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United Kingdom
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London
Country [127] 0 0
United Kingdom
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Wolverhampton
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Vietnam
State/province [128] 0 0
Ha Noi
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Vietnam
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Hanoi
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Vietnam
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Ho Chi Minh city
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Vietnam
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Ho Chi Minh
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Vietnam
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Hochiminh city

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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: Statistical analysis plan (SAP)
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.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified 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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


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/NCT06455449