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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06130566
Registration number
NCT06130566
Ethics application status
Date submitted
8/11/2023
Date registered
14/11/2023
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab Monotherapy Compared With Placebo in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
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Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab Monotherapy by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis
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Secondary ID [1]
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U1111-1275-9715
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Secondary ID [2]
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EFC17559
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Universal Trial Number (UTN)
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Trial acronym
COAST 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dermatitis Atopic
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Amlitelimab
Treatment: Drugs - Placebo
Experimental: Amlitelimab dose 1 - Subcutaneous injection as per protocol
Experimental: Amlitelimab dose 2 - Subcutaneous injection as per protocol
Placebo comparator: Placebo - Subcutaneous injection as per protocol
Treatment: Drugs: Amlitelimab
Injection solution SC injection
Treatment: Drugs: Placebo
Injection solution SC injection
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Intervention code [1]
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Treatment: Drugs
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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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EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of =2 points at Week 24
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Assessment method [1]
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The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
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Timepoint [1]
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Week 24
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Primary outcome [2]
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EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at Week 24
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Assessment method [2]
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The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
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Timepoint [2]
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Week 24
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Primary outcome [3]
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US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of =2 points at Week 24
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Assessment method [3]
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The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
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Timepoint [3]
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Week 24
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Secondary outcome [1]
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Proportion of participants reaching EASI-75 at Week 24 (for US and US reference countries only)
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Assessment method [1]
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The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)
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Assessment method [2]
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The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
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Timepoint [2]
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Baseline to Week 24
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Secondary outcome [3]
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Proportion of participants with =4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS =4
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Assessment method [3]
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The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
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Timepoint [3]
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Baseline to Week 24
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Secondary outcome [4]
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Proportion of participants reaching EASI-75
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Assessment method [4]
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The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.
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Timepoint [4]
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Baseline to Week 20
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Secondary outcome [5]
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Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of =2 points
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Assessment method [5]
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The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).
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Timepoint [5]
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Baseline to Week 20
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Secondary outcome [6]
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Proportion of participants reaching EASI-90
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Assessment method [6]
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The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.
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Timepoint [6]
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Baseline to Week 24
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Secondary outcome [7]
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Proportion of participants reaching EASI-100
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Assessment method [7]
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The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.
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Timepoint [7]
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Baseline to Week 24
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Secondary outcome [8]
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Proportion of participants with PP-NRS 0 or 1
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Assessment method [8]
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The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
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Timepoint [8]
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Baseline to Week 24
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Secondary outcome [9]
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Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age =16 years old
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Assessment method [9]
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The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
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Timepoint [9]
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Baseline to Week 24
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Secondary outcome [10]
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Proportion of participants with a reduction in DLQI =4 from baseline in participants with age =16 years old and with DLQI baseline =4
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Assessment method [10]
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The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
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Timepoint [10]
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Baseline to Week 24
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Secondary outcome [11]
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Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age =12 to <16 years old
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Assessment method [11]
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The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-\<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
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Timepoint [11]
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Baseline to Week 24
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Secondary outcome [12]
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Proportion of participants with a reduction in CDLQI =6 from baseline in participants with age =12 to <16 years old and with CDLQI baseline =6
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Assessment method [12]
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The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-\<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
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Timepoint [12]
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Baseline to Week 24
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Secondary outcome [13]
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Change in Hospital Anxiety Depression Scale (HADS) from baseline
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Assessment method [13]
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The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
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Timepoint [13]
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Baseline to Week 24
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Secondary outcome [14]
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Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A =8
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Assessment method [14]
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HADS-A score ranges 0-21 with higher score indicating a poorer state.
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Timepoint [14]
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Baseline to Week 24
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Secondary outcome [15]
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Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline =8
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Assessment method [15]
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HADS-D score ranges 0-21 with higher score indicating a poorer state.
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Timepoint [15]
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Baseline to Week 24
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Secondary outcome [16]
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Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline
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Assessment method [16]
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The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
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Timepoint [16]
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Baseline to Week 24
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Secondary outcome [17]
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Proportion of participants with a reduction in weekly average of daily SP-NRS =4 from baseline in participants with baseline weekly average of daily SP-NRS =4
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Assessment method [17]
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The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
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Timepoint [17]
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Baseline to Week 24
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Secondary outcome [18]
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Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline
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Assessment method [18]
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The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
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Timepoint [18]
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Baseline to Week 24
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Secondary outcome [19]
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Proportion of participants with a reduction in weekly average of daily SD-NRS =3 from baseline in participants with Baseline weekly average of daily SD-NRS =3
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Assessment method [19]
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The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
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Timepoint [19]
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Baseline to Week 24
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Secondary outcome [20]
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Percent change in EASI score from baseline
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Assessment method [20]
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The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
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Timepoint [20]
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Baseline to Week 24
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Secondary outcome [21]
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Percent change in weekly average of daily PP-NRS from baseline
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Assessment method [21]
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The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
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Timepoint [21]
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Baseline to Week 24
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Secondary outcome [22]
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Absolute change in weekly average of daily PP-NRS from baseline
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Assessment method [22]
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The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
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Timepoint [22]
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Baseline to Week 24
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Secondary outcome [23]
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Proportion of participants reaching EASI-50
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Assessment method [23]
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The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.
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Timepoint [23]
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Baseline to Week 24
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Secondary outcome [24]
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Proportion of participants with EASI =7
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Assessment method [24]
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The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
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Timepoint [24]
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Baseline to Week 24
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Secondary outcome [25]
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Change in percent Body Surface Area (BSA) affected by AD from baseline
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Assessment method [25]
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Timepoint [25]
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Baseline to Week 24
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Secondary outcome [26]
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Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline
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Assessment method [26]
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The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
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Timepoint [26]
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Baseline to Week 24
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Secondary outcome [27]
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Absolute change in SCORAD index from baseline
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Assessment method [27]
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The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
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Timepoint [27]
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Baseline to Week 24
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Secondary outcome [28]
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Proportion of participants with a reduction in SCORAD = 8.7 points from baseline in participants with baseline SCORAD score = 8.7
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Assessment method [28]
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The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
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Timepoint [28]
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Baseline to Week 24
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Secondary outcome [29]
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Change in Patient Oriented Eczema Measure (POEM) from baseline
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Assessment method [29]
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The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.
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Timepoint [29]
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Baseline to Week 24
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Secondary outcome [30]
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Proportion of participants with a reduction in POEM =4 from baseline in participants with POEM Baseline =4
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Assessment method [30]
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The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.
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Timepoint [30]
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Baseline to Week 24
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Secondary outcome [31]
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Proportion of participants with rescue medication use
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Assessment method [31]
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Timepoint [31]
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Baseline to Week 24
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Secondary outcome [32]
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Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs), experienced Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment-Emergent Adverse Events of Special Interest (AESI)
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Assessment method [32]
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Timepoint [32]
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Baseline to Week 40
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Secondary outcome [33]
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Serum amlitelimab concentrations
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Assessment method [33]
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Timepoint [33]
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Baseline to Week 40
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Secondary outcome [34]
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Incidence of antidrug antibodies (ADAs) of amlitelimab
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Assessment method [34]
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Timepoint [34]
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Baseline to Week 40
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Eligibility
Key inclusion criteria
* Participants must be 12 years of age (when signing informed consent form)
* Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
* Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
* v-IGA-AD of 3 or 4 at baseline visit
* EASI score of 16 or higher at baseline
* AD involvement of 10% or more of BSA at baseline
* Weekly average of daily PP-NRS of = 4 at baseline visit.
* Able and willing to comply with requested study visits and procedures
* Body weight =25 kg
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Minimum age
12
Years
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Maximum age
No limit
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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
* Skin co-morbidity that would adversely affect the ability to undertake AD assessments
* Known history of or suspected significant current immunosuppression
* Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline)
* History of solid organ or stem cell transplant
* Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline (1 week in the event of superficial skin infections)
* Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
* Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
* In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
* History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/11/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/12/2025
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Actual
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Sample size
Target
420
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Investigational Site Number : 0360010 - Westmead
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Recruitment hospital [2]
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Investigational Site Number : 0360007 - Woolloongabba
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Recruitment hospital [3]
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Investigational Site Number : 0360008 - East Melbourne
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Recruitment hospital [4]
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Investigational Site Number : 0360006 - Melbourne
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Recruitment hospital [5]
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Investigational Site Number : 0361006 - Traralgon West
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4102 - Woolloongabba
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Recruitment postcode(s) [3]
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0
3002 - East Melbourne
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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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3844 - Traralgon West
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Florida
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Georgia
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Kentucky
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Louisiana
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Massachusetts
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Michigan
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Mississippi
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Missouri
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Country [11]
0
0
United States of America
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State/province [11]
0
0
New York
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Country [12]
0
0
United States of America
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State/province [12]
0
0
North Carolina
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Oregon
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Pennsylvania
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Country [15]
0
0
United States of America
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State/province [15]
0
0
South Carolina
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Texas
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Utah
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Virginia
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Country [19]
0
0
Brazil
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State/province [19]
0
0
Bahia
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Country [20]
0
0
Brazil
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State/province [20]
0
0
Paraná
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Country [21]
0
0
Brazil
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State/province [21]
0
0
Rio Grande Do Sul
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Country [22]
0
0
Brazil
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State/province [22]
0
0
São Paulo
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Country [23]
0
0
Brazil
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State/province [23]
0
0
Rio de Janeiro
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Country [24]
0
0
Brazil
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State/province [24]
0
0
Santo André
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Country [25]
0
0
Canada
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State/province [25]
0
0
Alberta
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Country [26]
0
0
Canada
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State/province [26]
0
0
British Columbia
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Country [27]
0
0
Canada
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State/province [27]
0
0
Ontario
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Country [28]
0
0
Canada
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State/province [28]
0
0
Quebec
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Country [29]
0
0
Canada
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State/province [29]
0
0
Saskatchewan
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Country [30]
0
0
Chile
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State/province [30]
0
0
Reg Metropolitana De Santiago
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Country [31]
0
0
Chile
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State/province [31]
0
0
Valparaíso
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Country [32]
0
0
Chile
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State/province [32]
0
0
Talcahuano
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Country [33]
0
0
China
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State/province [33]
0
0
Beijing
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Country [34]
0
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China
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Chengdu
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China
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Chongqing
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Guangzhou
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Jinan
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France
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Antony
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Nantes
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France
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Reims
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France
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Bad Bentheim
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Kiel
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Mainz
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Münster
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Athens
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Israel
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Israel
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Petah-Tikva
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Korea, Republic of
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Daegu-gwangyeoksi
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Gyeongsangnam-do
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Incheon-gwangyeoksi
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Korea, Republic of
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Seoul-teukbyeolsi
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Korea, Republic of
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Gwangju
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Poland
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Slaskie
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Poland
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Krakow
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Lodz
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Lublin
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Tarnow
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Poland
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Warszawa
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Taiwan
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Taipei
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Address
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Ethics approval
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Summary
Brief summary
This is a parallel group, Phase 3, multinational, multicenter, randomized, double blind, placebo-controlled, 3-arm monotherapy study for treatment of participants diagnosed with moderate to severe atopic dermatitis (AD), whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for SC injection compared with placebo in participants with moderate to severe AD aged 12 years and older. Study details include: At the end of the treatment period, participants will have an option to enter a separate study: the blinded extension study EFC17600 (ESTUARY). For participants not entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 44 weeks including a 2 to 4-week screening, a 24-week randomized double-blind period, and a 16-week safety follow-up. For participants entering the blinded extension Study EFC17600 (ESTUARY), the study duration will be up to 28 weeks including a 2 to 4-week screening and a 24-week randomized double-blind period. The total treatment duration will be up to 24 weeks. The total number of visits will be up to 10 visits (or 9 visits for those entering the blinded extension study EFC17600\] (ESTUARY).
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Trial website
https://clinicaltrials.gov/study/NCT06130566
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Sanofi
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Contact person for public queries
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Trial Transparency email recommended (Toll free for US & Canada)
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Address
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800-633-1610
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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 may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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/NCT06130566