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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06015737




Registration number
NCT06015737
Ethics application status
Date submitted
1/08/2023
Date registered
29/08/2023
Date last updated
26/06/2025

Titles & IDs
Public title
A 2-stage, Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus
Scientific title
A Multicenter, Randomized, Double Blind, Placebo Controlled, Phase III Study to Evaluate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus Who Are Refractory and/or Intolerant to Antimalarial Therapy
Secondary ID [1] 0 0
2021-003698-70
Secondary ID [2] 0 0
D346BC00001
Universal Trial Number (UTN)
Trial acronym
LAVENDER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cutaneous Lupus Erythematosus 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

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

Experimental: Stage 1: Anifrolumab - The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.

Placebo comparator: Stage 1: Placebo - The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.

Experimental: Stage 2: Anifrolumab - The participants will receive anifrolumab as a SC injection from Week 0/Day 1 up to and including week 51.

Placebo comparator: Stage 2: Placebo - The participant will receive placebo as a SC injection from Week 0/Day 1 to Week 23. From Week 24 the participants will receive anifrolumab up to and including Week 51.


Other interventions: Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).

Other interventions: Placebo
Matching placebo solution for injection in aPFS.

Other interventions: Anifrolumab
Anifrolumab will be provided as a solution for injection in accessorized pre-filled syringe (aPFS).

Other interventions: Placebo
Matching placebo solution for injection in aPFS.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Stage 1 and Stage 2 (United States [US]): Number of participants with Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R) erythema score of 0 or 1 and at least a 2- point reduction relative to baseline
Assessment method [1] 0 0
The CLA-IGA-R is an assessment tool that scores the three key disease components (erythema; other morphological characteristics \[OMC\] and follicular activity) of CLE independently. The CLA-IGA-R erythema is scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4 (0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE). On all IGA scales, a decrease in score relates to an improvement in signs and symptoms. CLA-IGA-R erythema responder is defined as a participant who achieves a CLA-IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline. Otherwise, the participant is considered a non-responder.
Timepoint [1] 0 0
At Week 24
Primary outcome [2] 0 0
Stage 1 and Stage 2 (European Union [EU]/Rest of the World [ROW]: Number of participants with a 70% reduction relative to baseline in the Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) score
Assessment method [2] 0 0
CLASI is a validated index used for assessing the cutaneous lesions of SLE. The CLASI instrument will be used at each study visit to capture individual skin manifestation scores. CLASI-70 responder (Yes/No) is defined as a participant who achieves a 70% reduction relative to baseline in CLASI-A score. Otherwise, the participant is considered a non-responder.
Timepoint [2] 0 0
At Week 24
Secondary outcome [1] 0 0
Stage 1 and Stage 2 (US): Number of participants who achieve a CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline
Assessment method [1] 0 0
The CLA-IGA-R is an assessment tool that scores the three key disease components (erythema; OMC and follicular activity) of CLE independently. The CLA-IGA-R OMC is scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE. Assessment of CLA-IGA-R OMC score captures other morphological changes in CLE patients. A decrease in score relates to an improvement in signs and symptoms. A responder (yes/no) is defined as a participant who achieves a CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline. Otherwise, the participant is considered a non-responder.
Timepoint [1] 0 0
At Week 24
Secondary outcome [2] 0 0
Stage 1 and Stage 2 (US): Number of participants who achieve a CLA-IGA-R OMC score of 0.
Assessment method [2] 0 0
The CLA-IGA-R is an assessment tool that scores the three key disease components (erythema; OMC and follicular activity) of CLE independently. The CLA-IGA-R OMC is scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE. CLA-IGA-R OMC complete response is defined as a participant who scores 0. Otherwise, the participant is a non-responder. Only participants with CLA-IGA-OMC = 3 at baseline will be included in the analysis.
Timepoint [2] 0 0
At Week 24
Secondary outcome [3] 0 0
Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R follicular activity score of 0
Assessment method [3] 0 0
The CLA-IGA-R is a tool that scores the three key disease components (erythema; OMC and follicular activity) of CLE independently. CLA-IGA-R follicular activity provides a global clinical assessment on a 2-point binary scale ranging from 0 to 1, where 0 indicates absent and 1 indicates present. On all IGA scales, a decrease in score relates to an improvement in signs and symptoms. A responder (yes/no) is defined as a participant who achieves a CLA-IGA-R follicular activity score of 0. Otherwise, the participant is a non-responder. Only participants with follicular activity score of 1 at baseline will be included in the analysis.
Timepoint [3] 0 0
At Week 24
Secondary outcome [4] 0 0
Stage 1 and Stage 2 (EU/ROW): Percent change from baseline in total CLASI-A erythema score
Assessment method [4] 0 0
The Cutaneous Lupus Erythematosus Disease Area and Severity Index-Activity (CLASI-A) is a validated index used for assessing the cutaneous lesions of SLE. The CLASI-A erythema score is interpreted as follows: 0-absent; 1-pink; faint erythema; 2-red; 3-dark red; purple/violaceous/crusted/ hemorrhagic
Timepoint [4] 0 0
At Week 24
Secondary outcome [5] 0 0
Stage 1 and Stage 2 (EU/ROW): Percent change from baseline in total CLASI-A scale/hypertrophy score
Assessment method [5] 0 0
The CLASI-A is a validated index used for assessing the cutaneous lesions of SLE. CLASI-A Scale/Hypertrophy can be measured as 0, 1, and 2 where 0 is absent, 1 is scale, and 2 is verrucuos and hypertrohic.
Timepoint [5] 0 0
At Week 24
Secondary outcome [6] 0 0
Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline, or a CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline
Assessment method [6] 0 0
The CLA-IGA-R is a tool that scores the three key disease components (erythema; OMC and follicular activity) of CLE independently. The CLA-IGA-R erythema and OMC are scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE. A responder (yes/no) is defined as a participant who achieves either a CLA-IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline, or a CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline. Otherwise, the participant is a non-responder. On all IGA scales, a decrease in score relates to an improvement in signs and symptoms.
Timepoint [6] 0 0
At Week 24
Secondary outcome [7] 0 0
Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline
Assessment method [7] 0 0
The CLA-IGA-R is a tool that scores the three key disease components (erythema; OMC and follicular activity) of CLE independently. The CLA-IGA-R erythema is scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4 (0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE). A responder is defined as a participant who achieves a CLA-IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline. Otherwise, the participant is a non-responder. On all IGA scales, a decrease in score relates to an improvement in signs and symptoms.
Timepoint [7] 0 0
At Week 12
Secondary outcome [8] 0 0
Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline
Assessment method [8] 0 0
The CLA-IGA-R is a tool that scores the three key disease components (erythema; OMC, and follicular activity) of CLE independently. The CLA-IGA-R OMC is scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4 (0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE). A responder (yes/no) is defined as a participant who achieves a CLA- IGA-R OMC score of 0 or 1 and at least a 1-point reduction relative to baseline. Otherwise, the participant is a non-responder. On all IGA scales, a decrease in score relates to an improvement in signs and symptoms.
Timepoint [8] 0 0
At Week 12
Secondary outcome [9] 0 0
Stage 1 and Stage 2 (EU/ROW): Number of participants with CLASI-70 response
Assessment method [9] 0 0
The CLASI is a validated index used for assessing the cutaneous lesions of SLE. CLASI-70 responder is defined as a participant who achieves a 70% reduction relative to baseline in CLASI-A score. Otherwise, the participant is considered a non-responder.
Timepoint [9] 0 0
At Week 12
Secondary outcome [10] 0 0
Stage 1 and Stage 2 (US/EU/ROW): Change from baseline in Skindex-29+3 domain scores
Assessment method [10] 0 0
The Skindex-29+3 is based on a previous instrument, the Skindex-29 and has been modified to include items related to CLE. The instrument consists of 33 items, which are used to calculate 4 domains: Symptoms (7 items), Emotions (10 items), Functioning (12 items), and Lupus-specific (3 items). The remaining item asks the participants to rate how often they worry about side effects from treatment; however, this item is not used to calculate the domain scores. The response options are on a 5-point verbal rating scale, ranging from 1 (Never) to 5 (All the time). The instrument has a recall period of the previous 4 weeks. Each domain score ranges from 0 to 100 points, with higher scores indicating worse health-related quality of life. The symptom domain in the Skindex-29+3 evaluates the symptom burden of the disease and includes symptom concepts such as pain, itching, burning, stinging, and sensitivity.
Timepoint [10] 0 0
At Week 24
Secondary outcome [11] 0 0
Stage 1 and Stage 2 (US/EU/ROW): Serum trough (pre-dose) concentrations of anifrolumab
Assessment method [11] 0 0
The Ctrough of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated.
Timepoint [11] 0 0
Double-blind: Pre-dose on Day 1 (Week 0), Weeks 1, 4, 12, 24; Open-label: Weeks 40, and 52 or early discontinuation visit [EDV] and follow-up visit (13 Weeks after last dose)
Secondary outcome [12] 0 0
Stage 1 and Stage 2 (US/EU/ROW): Number of participants with positive antidrug antibody
Assessment method [12] 0 0
The immunogenicity of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated.
Timepoint [12] 0 0
Double-blind: Pre-dose on Day 1 (Week 0), Weeks 4, 12, and 24; Open-label: Pre-dose on Weeks 40, and 52 or EDV and follow-up visit (13 weeks after last dose)
Secondary outcome [13] 0 0
Stage 1 and Stage 2 (US/EU/ROW): Percent change from baseline in suppression of the Interferon 21-gene
Assessment method [13] 0 0
The pharmacodynamics of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated.
Timepoint [13] 0 0
Double-blind: Day 1 (Week 0), Week 1, 4, 12, and 24; Open-label; Week 40 and 52 or EDV and follow-up visit (13 weeks after last dose)
Secondary outcome [14] 0 0
Stage 2 (US/EU/ROW): Number of participants with = 7-point reduction from baseline in CLASI-A total score
Assessment method [14] 0 0
The CLASI is a validated index used for assessing the cutaneous lesions of SLE. It consists of 2 separate scores: i) activity of the disease, and ii) measure of damage. The CLASI instrument will be used at each study visit to capture individual skin manifestation scores. A 7-point reduction CLASI-A is established as clinically meaningful improvement in disease for CLE and as being impactful for patients. Achieving a CLASI-A total score of 9 or below is an accepted threshold for mild disease.
Timepoint [14] 0 0
At Week 24
Secondary outcome [15] 0 0
Stage 2 (US): Number of participants who are CLA-IGA-R erythema responders from Week 24 up to and including Week 52
Assessment method [15] 0 0
The CLA-IGA-R is an assessment tool that scores the three key disease components (erythema; OMC and follicular activity) of CLE independently. The CLA-IGA-R erythema is scored on a five-point binary scale that provides a global clinical assessment ranging from 0 to 4, where 0 indicates clear, 1 is almost clear, 2 is mild, 3 is moderate, and 4 indicates severe CLE. On all IGA scales, a decrease in score relates to an improvement in signs and symptoms. Assessment of CLA-IGA-R erythema score captures changes in erythema, a clinically important feature in CLE patients. A responder is defined as a participant who achieves a CLA- IGA-R erythema score of 0 or 1 and at least a 2-point reduction relative to baseline. Otherwise, the participant is a non-responder. Amongst participants randomized to anifrolumab during the double-blind treatment period, the number of participants who maintained a CLA-IGA-R erythema response from Week 24 up to Week 52 will be evaluated.
Timepoint [15] 0 0
Up to Week 52
Secondary outcome [16] 0 0
Stage 2 (EU): Number of participants who are CLASI-70 responders up to and including Week 52
Assessment method [16] 0 0
The CLASI is a validated index used for assessing the cutaneous lesions of SLE. CLASI-70 responder is defined as a participant who achieves a 70% reduction relative to baseline in CLASI-A score. Otherwise, the participant is considered a non-responder. Amongst participants randomized to anifrolumab during the double-blind treatment period, the number of participants who maintained a CLASI-70 response from Week 24 up to Week 52 will be evaluated.
Timepoint [16] 0 0
Up to Week 52

Eligibility
Key inclusion criteria
Key inclusion criteria:

* Participants must have a confirmed diagnosis of CLE. Diagnosis must be clinically and histologically confirmed with the following:

* CLASI-A total score = 10 points at Screening and confirmed at randomization.
* CLA-IGA-R erythema score of = 3 and CLA-IGA-R-OMC score of = 1 at Screening and confirmed at randomization.
* Inadequate response or intolerant to antimalarial therapy.
* Participants should have no medical history or signs or symptoms of active or prior tuberculosis infection (TB) and the same should reflect in chest radiograph or a chest CT scan result.
* Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Participants should have a coronavirus disease 2019 (COVID-19) negative PCR or antigen test result as per local policies at Screening.

Key exclusion criteria:

* History or evidence of suicidal ideation.
* Severe or life-threatening Systemic lupus erythematosus (SLE).
* Active SLE or Sjögren's Syndrome.
* Any active skin conditions other than CLE that may interfere with the study.
* History of recurrent infection requiring hospitalization and IV antibiotics.
* COVID-19 infection
* Any history of an anaphylactic reaction to human proteins, or monoclonal antibodies.
* At screening, if participants do not meet the eligibility criteria assessed based on laboratory test results e.g tests for total bilirubin, serum creatinine etc.

NOTE: Other protocol defined Inclusion/
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria may apply

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 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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Box Hill
Recruitment hospital [2] 0 0
Research Site - Clayton
Recruitment hospital [3] 0 0
Research Site - Kogarah
Recruitment hospital [4] 0 0
Research Site - Malvern
Recruitment hospital [5] 0 0
Research Site - Melbourne
Recruitment hospital [6] 0 0
Research Site - Westmead
Recruitment hospital [7] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3168 - Kogarah
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
04102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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United States of America
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Illinois
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Indiana
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Nebraska
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New Jersey
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New York
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North Carolina
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Oregon
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Texas
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Virginia
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Washington
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Argentina
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Ciudad de Buenos Aires
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Argentina
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Córdoba
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Argentina
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Quilmes
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Argentina
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Rosario
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Argentina
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San Miguel
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Austria
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Sankt Pölten
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Austria
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Wien
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Belgium
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Bruxelles
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Belgium
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Leuven
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Belgium
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Liège
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Brazil
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Belo Horizonte
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Brazil
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Porto Alegre
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Brazil
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Rio de Janeiro
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Bulgaria
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Sofia
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Chile
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Osorno
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Chile
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Santiago
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China
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Baotou
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China
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Beijing
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China
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Changchun
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China
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Changsha
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China
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Chengdu
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Chongqing
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Guangzhou
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China
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Hangzhou
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China
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Heilongjiang
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China
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Jinan
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China
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Kunming
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China
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Nanchang
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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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Shenzhen
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China
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Shijiazhuang
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China
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Urumqi
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China
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Wuhan
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China
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Zhuzhou
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Colombia
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Barranquilla
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Colombia
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Bogota
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Colombia
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Chia
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Denmark
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Aarhus
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Bois Guillaume
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Bordeaux
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France
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Chambray Les Tours
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France
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Dijon
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France
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Lille Cedex
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France
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Lyon
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France
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Montivilliers
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France
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Nantes
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France
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Nice
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France
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Paris
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France
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Poitiers
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France
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Toulouse Cedex 9
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Essen
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Kiel
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Germany
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Leipzig
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Germany
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Mainz
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Germany
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Marburg
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Germany
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Regensburg
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Germany
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Wuppertal
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Greece
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Athens
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Italy
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Brescia
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Italy
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Cona
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Italy
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Florence
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Italy
State/province [104] 0 0
Marche
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Italy
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Milano
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Italy
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Napoli
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Italy
State/province [107] 0 0
Reggio Emilia
Country [108] 0 0
Italy
State/province [108] 0 0
Roma
Country [109] 0 0
Italy
State/province [109] 0 0
Rome
Country [110] 0 0
Japan
State/province [110] 0 0
Bunkyo-ku
Country [111] 0 0
Japan
State/province [111] 0 0
Chuo-ku
Country [112] 0 0
Japan
State/province [112] 0 0
Fukuoka-Shi
Country [113] 0 0
Japan
State/province [113] 0 0
Itabashi
Country [114] 0 0
Japan
State/province [114] 0 0
Kanazawa-shi
Country [115] 0 0
Japan
State/province [115] 0 0
Kita-gun
Country [116] 0 0
Japan
State/province [116] 0 0
Nagasaki-shi
Country [117] 0 0
Japan
State/province [117] 0 0
Nagoya-shi
Country [118] 0 0
Japan
State/province [118] 0 0
Nagoya
Country [119] 0 0
Japan
State/province [119] 0 0
Okayama-shi
Country [120] 0 0
Japan
State/province [120] 0 0
Omura-shi
Country [121] 0 0
Japan
State/province [121] 0 0
Ono
Country [122] 0 0
Japan
State/province [122] 0 0
Osaka-shi
Country [123] 0 0
Japan
State/province [123] 0 0
Sapporo
Country [124] 0 0
Japan
State/province [124] 0 0
Suita
Country [125] 0 0
Japan
State/province [125] 0 0
Wakayama
Country [126] 0 0
Japan
State/province [126] 0 0
Yokohama-shi
Country [127] 0 0
Japan
State/province [127] 0 0
Yokohama
Country [128] 0 0
Japan
State/province [128] 0 0
Yotsukaido-shi
Country [129] 0 0
Korea, Republic of
State/province [129] 0 0
Seoul
Country [130] 0 0
Mexico
State/province [130] 0 0
Ciudad de Mexico
Country [131] 0 0
Mexico
State/province [131] 0 0
Cuernavaca
Country [132] 0 0
Mexico
State/province [132] 0 0
Guadalajara
Country [133] 0 0
Mexico
State/province [133] 0 0
San Luis Potosi
Country [134] 0 0
Mexico
State/province [134] 0 0
Veracruz
Country [135] 0 0
Mexico
State/province [135] 0 0
Zapopan
Country [136] 0 0
Netherlands
State/province [136] 0 0
Amsterdam
Country [137] 0 0
Netherlands
State/province [137] 0 0
Breda
Country [138] 0 0
Netherlands
State/province [138] 0 0
Nijmegen
Country [139] 0 0
Netherlands
State/province [139] 0 0
Rotterdam
Country [140] 0 0
New Zealand
State/province [140] 0 0
Hamilton
Country [141] 0 0
New Zealand
State/province [141] 0 0
Papatoetoe
Country [142] 0 0
Philippines
State/province [142] 0 0
Iloilo City
Country [143] 0 0
Philippines
State/province [143] 0 0
Lipa
Country [144] 0 0
Philippines
State/province [144] 0 0
Manila
Country [145] 0 0
Poland
State/province [145] 0 0
Gdynia
Country [146] 0 0
Poland
State/province [146] 0 0
Katowice
Country [147] 0 0
Poland
State/province [147] 0 0
Kielce
Country [148] 0 0
Poland
State/province [148] 0 0
Olsztyn
Country [149] 0 0
Poland
State/province [149] 0 0
Ossy
Country [150] 0 0
Poland
State/province [150] 0 0
Poznan
Country [151] 0 0
Poland
State/province [151] 0 0
Rzeszów
Country [152] 0 0
Poland
State/province [152] 0 0
Warszawa
Country [153] 0 0
Portugal
State/province [153] 0 0
Braga
Country [154] 0 0
Portugal
State/province [154] 0 0
Coimbra
Country [155] 0 0
Portugal
State/province [155] 0 0
Lisboa
Country [156] 0 0
Portugal
State/province [156] 0 0
Porto
Country [157] 0 0
Romania
State/province [157] 0 0
Bucharest
Country [158] 0 0
Romania
State/province [158] 0 0
Bucuresti
Country [159] 0 0
Romania
State/province [159] 0 0
Craiova
Country [160] 0 0
Romania
State/province [160] 0 0
Iasi
Country [161] 0 0
Romania
State/province [161] 0 0
Targu Mures
Country [162] 0 0
Serbia
State/province [162] 0 0
Belgrade
Country [163] 0 0
Serbia
State/province [163] 0 0
Kragujevac
Country [164] 0 0
Slovakia
State/province [164] 0 0
Košice
Country [165] 0 0
Slovakia
State/province [165] 0 0
Piestany
Country [166] 0 0
Slovakia
State/province [166] 0 0
Svidnik
Country [167] 0 0
South Africa
State/province [167] 0 0
Cape Town
Country [168] 0 0
South Africa
State/province [168] 0 0
Johannesburg
Country [169] 0 0
South Africa
State/province [169] 0 0
Stellenbosch
Country [170] 0 0
Spain
State/province [170] 0 0
Barcelona
Country [171] 0 0
Spain
State/province [171] 0 0
Castellon de la Plana
Country [172] 0 0
Spain
State/province [172] 0 0
Granada
Country [173] 0 0
Spain
State/province [173] 0 0
L'Hospitalet de Llobregat
Country [174] 0 0
Spain
State/province [174] 0 0
La Coruña
Country [175] 0 0
Spain
State/province [175] 0 0
Las Palmas de Gran Canaria
Country [176] 0 0
Spain
State/province [176] 0 0
Madrid
Country [177] 0 0
Spain
State/province [177] 0 0
Majadahonda
Country [178] 0 0
Spain
State/province [178] 0 0
Salamanca
Country [179] 0 0
Spain
State/province [179] 0 0
Sevilla
Country [180] 0 0
Spain
State/province [180] 0 0
Valencia
Country [181] 0 0
Spain
State/province [181] 0 0
València
Country [182] 0 0
Spain
State/province [182] 0 0
Vigo
Country [183] 0 0
Taiwan
State/province [183] 0 0
Kaohsiung
Country [184] 0 0
Taiwan
State/province [184] 0 0
Taichung
Country [185] 0 0
Taiwan
State/province [185] 0 0
Taipei
Country [186] 0 0
Thailand
State/province [186] 0 0
Bangkok
Country [187] 0 0
Thailand
State/province [187] 0 0
Hat Yai
Country [188] 0 0
Thailand
State/province [188] 0 0
Khlong Luang
Country [189] 0 0
Thailand
State/province [189] 0 0
Khon-Kaen
Country [190] 0 0
Turkey
State/province [190] 0 0
Istanbul
Country [191] 0 0
Turkey
State/province [191] 0 0
Karsiyaka
Country [192] 0 0
Turkey
State/province [192] 0 0
Kayseri
Country [193] 0 0
Turkey
State/province [193] 0 0
Samsun
Country [194] 0 0
United Kingdom
State/province [194] 0 0
Cambridge
Country [195] 0 0
United Kingdom
State/province [195] 0 0
Leeds
Country [196] 0 0
United Kingdom
State/province [196] 0 0
London
Country [197] 0 0
United Kingdom
State/province [197] 0 0
Newcastle upon Tyne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 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
Email 0 0
information.center@astrazeneca.com
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.