A Phase 3 interventional study of Amlitelimab and Placebo in Dermatitis Atopic, sponsored by Sanofi. Completed at 167 sites in 14 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI).
The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate to severe AD aged 12 years and older on background TCS and/or TCI.
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).
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 643 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
Subcutaneous injection as per protocol
Drug: Amlitelimab · Drug: Topical corticosteroids · Drug: Topical calcineurin inhibitors
Subcutaneous injection as per protocol
Drug: Amlitelimab · Drug: Topical corticosteroids · Drug: Topical calcineurin inhibitors
Subcutaneous injection as per protocol
Drug: Placebo · Drug: Topical corticosteroids · Drug: Topical calcineurin inhibitors
Pharmaceutical form: Injection solution Route of administration: SC injection
Also known as: SAR445229
Pharmaceutical form: injection solution Route of administration: SC injection
Pharmaceutical form: Topical formulation Route of administration: Topical
Pharmaceutical form: Topical formulation Route of administration: Topical
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
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).
Time frame: Week 24
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
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.
Time frame: Week 24
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
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).
Time frame: Week 24
Proportion of participants reaching EASI-75 at Week 24 (for US and US reference countries only)
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.
Time frame: Week 24
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) and a reduction from baseline of ≥2 points
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).
Time frame: Baseline to Week 24
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
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.
Time frame: Baseline to Week 24
Proportion of participants reaching EASI-75
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.
Time frame: Baseline to Week 20
Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points
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).
Time frame: Baseline to Week 20
Proportion of participants with vIGA-AD 0 (clear)
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).
Time frame: Week 24
Proportion of participants reaching EASI-90
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.
Time frame: Baseline to Week 24
Proportion of participants reaching EASI-100
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.
Time frame: Baseline to Week 24
Proportion of participants with PP-NRS 0 or 1
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.
Time frame: Baseline to Week 2
Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old
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.
Time frame: Baseline to Week 24
Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4
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.
Time frame: Baseline to Week 24
Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old
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.
Time frame: Baseline to Week 24
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
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.
Time frame: Baseline to Week 24
Change in Hospital Anxiety Depression Scale (HADS) from baseline
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.
Time frame: Baseline to Week 24
Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8
HADS-A score ranges 0-21 with higher score indicating a poorer state.
Time frame: Baseline to Week 24
Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline ≥8
HADS-D score ranges 0-21 with higher score indicating a poorer state.
Time frame: Baseline to Week 24
Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline
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.
Time frame: Baseline to Week 24
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
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.
Time frame: Baseline to Week 24
Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline
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.
Time frame: Baseline to Week 24
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
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.
Time frame: Baseline to Week 24
Percent change in weekly average of daily SP-NRS from baseline
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.
Time frame: Baseline to Week 24
Percent change in weekly average of daily SD-NRS from baseline
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.
Time frame: Baseline to Week 24
Percent change in EASI score from baseline
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.
Time frame: Baseline to Week 24
Percent change in weekly average of daily PP-NRS from baseline
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.
Time frame: Baseline to Week 24
Absolute change in weekly average of daily PP-NRS from baseline
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.
Time frame: Baseline to Week 24
Proportion of participants reaching EASI-50
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.
Time frame: Baseline to Week 24
Proportion of participants with EASI ≤7
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.
Time frame: Baseline to Week 24
Change in percent Body Surface Area (BSA) affected by AD from baseline
Time frame: Baseline to Week 24
Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline
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).
Time frame: Baseline to Week 24
Absolute change in SCORAD index from baseline
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).
Time frame: Baseline to Week 24
Proportion of participants with a reduction in SCORAD ≥ 8.7 points from baseline in participants with baseline SCORAD score ≥ 8.7
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).
Time frame: Baseline to Week 24
Change in Patient Oriented Eczema Measure (POEM) from baseline
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.
Time frame: Baseline to Week 24
Proportion of participants with a reduction in POEM ≥4 from baseline in participants with POEM Baseline ≥4
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.
Time frame: Baseline to Week 24
Proportion of participants with rescue medication use
Time frame: Baseline to Week 24
Cumulative amount of topical corticosteroids (TCS) consumption
Time frame: Baseline to Week 24
Percentage of TCS/topical calcineurin inhibitors (TCI) free days
Time frame: Baseline to Week 24
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)
Time frame: Baseline to Week 40
Serum amlitelimab concentrations
Time frame: Baseline to Week 40
Incidence of antidrug antibodies (ADAs) of amlitelimab
Time frame: Baseline to Week 40
Showing the first 100 of 167 sites across 14 countries.
Plan to share: Yes — 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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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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