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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
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
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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
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Secondary ID [1]
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0
2021-003698-70
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Secondary ID [2]
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D346BC00001
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Universal Trial Number (UTN)
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Trial acronym
LAVENDER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cutaneous Lupus Erythematosus
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0
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Condition category
Condition code
Human Genetics and Inherited Disorders
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0
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0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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0
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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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
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Assessment method [1]
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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.
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Timepoint [1]
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At Week 24
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Primary outcome [2]
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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
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Assessment method [2]
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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.
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Timepoint [2]
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At Week 24
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Secondary outcome [1]
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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
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Assessment method [1]
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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.
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Timepoint [1]
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0
At Week 24
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Secondary outcome [2]
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Stage 1 and Stage 2 (US): Number of participants who achieve a CLA-IGA-R OMC score of 0.
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Assessment method [2]
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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.
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Timepoint [2]
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0
At Week 24
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Secondary outcome [3]
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Stage 1 and Stage 2 (US): Number of participants with CLA-IGA-R follicular activity score of 0
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Assessment method [3]
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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.
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Timepoint [3]
0
0
At Week 24
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Secondary outcome [4]
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Stage 1 and Stage 2 (EU/ROW): Percent change from baseline in total CLASI-A erythema score
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Assessment method [4]
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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
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Timepoint [4]
0
0
At Week 24
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Secondary outcome [5]
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Stage 1 and Stage 2 (EU/ROW): Percent change from baseline in total CLASI-A scale/hypertrophy score
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Assessment method [5]
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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.
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Timepoint [5]
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0
At Week 24
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Secondary outcome [6]
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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
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Assessment method [6]
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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.
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Timepoint [6]
0
0
At Week 24
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Secondary outcome [7]
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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
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Assessment method [7]
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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.
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Timepoint [7]
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0
At Week 12
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Secondary outcome [8]
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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
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Assessment method [8]
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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.
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Timepoint [8]
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0
At Week 12
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Secondary outcome [9]
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Stage 1 and Stage 2 (EU/ROW): Number of participants with CLASI-70 response
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Assessment method [9]
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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.
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Timepoint [9]
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0
At Week 12
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Secondary outcome [10]
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Stage 1 and Stage 2 (US/EU/ROW): Change from baseline in Skindex-29+3 domain scores
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Assessment method [10]
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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.
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Timepoint [10]
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At Week 24
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Secondary outcome [11]
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Stage 1 and Stage 2 (US/EU/ROW): Serum trough (pre-dose) concentrations of anifrolumab
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Assessment method [11]
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The Ctrough of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated.
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Timepoint [11]
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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)
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Secondary outcome [12]
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Stage 1 and Stage 2 (US/EU/ROW): Number of participants with positive antidrug antibody
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Assessment method [12]
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The immunogenicity of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated.
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Timepoint [12]
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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)
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Secondary outcome [13]
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Stage 1 and Stage 2 (US/EU/ROW): Percent change from baseline in suppression of the Interferon 21-gene
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Assessment method [13]
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The pharmacodynamics of subcutaneously administered anifrolumab in participants with chronic and/or subacute CLE will be evaluated.
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Timepoint [13]
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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)
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Secondary outcome [14]
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Stage 2 (US/EU/ROW): Number of participants with = 7-point reduction from baseline in CLASI-A total score
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Assessment method [14]
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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.
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Timepoint [14]
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0
At Week 24
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Secondary outcome [15]
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Stage 2 (US): Number of participants who are CLA-IGA-R erythema responders from Week 24 up to and including Week 52
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Assessment method [15]
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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.
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Timepoint [15]
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Up to Week 52
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Secondary outcome [16]
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Stage 2 (EU): Number of participants who are CLASI-70 responders up to and including Week 52
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Assessment method [16]
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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.
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Timepoint [16]
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Up to Week 52
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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/
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Minimum age
18
Years
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Maximum age
70
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
Exclusion criteria may apply
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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 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
29/06/2024
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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
11/01/2028
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Actual
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Sample size
Target
460
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Box Hill
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Recruitment hospital [2]
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Research Site - Clayton
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Research Site - Malvern
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Research Site - Melbourne
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Research Site - Westmead
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Recruitment hospital [6]
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Research Site - Woolloongabba
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Recruitment postcode(s) [1]
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3128 - Box Hill
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment postcode(s) [3]
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3144 - Malvern
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment postcode(s) [5]
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2145 - Westmead
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Recruitment postcode(s) [6]
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04102 - Woolloongabba
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Connecticut
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Florida
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Massachusetts
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Michigan
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New York
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Ohio
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Oregon
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Texas
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Virginia
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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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0
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Argentina
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Quilmes
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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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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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Salvador
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Bulgaria
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Sofia
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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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Chengdu
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China
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Chongqing
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China
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Guangzhou
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China
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Hangzhou
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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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Wuhan
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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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France
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Bois Guillaume
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France
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Chambray Les Tours
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France
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Lille Cedex
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France
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Lyon Cedex 03
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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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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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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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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
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Milano
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Italy
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Napoli
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Italy
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Rome
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Italy
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Torrette
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Japan
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Fukuoka-Shi
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Japan
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Kita-gun
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Japan
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Nagoya
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Japan
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Okayama-shi
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Japan
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Omura-shi
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Japan
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Sapporo
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Korea, Republic of
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Seoul
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Mexico
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Cuernavaca
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Mexico
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Guadalajara
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Mexico
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San Luis Potosi
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Netherlands
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Rotterdam
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Papatoetoe
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Philippines
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Iloilo City
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Lipa
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Manila
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Poland
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Katowice
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Olsztyn
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Ossy
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Poznan
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Poland
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Warszawa
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Serbia
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Belgrade
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Serbia
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Kragujevac
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South Africa
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Cape Town
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South Africa
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Johannesburg
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Spain
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Barcelona
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Spain
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Granada
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Spain
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Las Palmas de Gran Canaria
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Spain
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Madrid
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Spain
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Sevilla
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Spain
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Vigo
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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United Kingdom
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Cambridge
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United Kingdom
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Leeds
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Commercial sector/industry
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Parexel
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Ethics approval
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Summary
Brief summary
This study aims to evaluate the efficacy and safety of subcutaneous (SC) anifrolumab versus placebo in adult participants with cutaneous lupus erythematosus (CLE).
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Trial website
https://clinicaltrials.gov/study/NCT06015737
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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AstraZeneca Clinical Study Information Center
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Phone
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1-877-240-9479
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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 Vivli.org. All requests 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 approved.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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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/NCT06015737