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 (COAST 2)

Phase 3

Active, not recruiting

• Conditions: Dermatitis Atopic
• Interventions: Drug: Placebo; Drug: Amlitelimab

• Registration Number: NCT06181435
• Lead Sponsor: Sanofi

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-13
• Study Start: 2023-12-21
• Study First Posted: 2023-12-26
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-26
• Last Update Posted: 2025-06-29
• Primary Completion: 2025-11-26
• Study Completion: 2026-03-17

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 589

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

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

• 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
• 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 patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Subcutaneous injection as per protocol
Amlitelimab dose 1	Amlitelimab	Subcutaneous injection as per protocol
Amlitelimab dose 2	Amlitelimab	Subcutaneous injection as per protocol

Primary Outcome Measures

Name	Time	Method
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	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.
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	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).
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	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).

Secondary Outcome Measures

Name	Time	Method
Percent change in weekly average of daily PP-NRS from baseline	Baseline to Week 24	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.
Change in percent Body Surface Area (BSA) affected by AD from baseline	Baseline to Week 24
Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline	Baseline to Week 24	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).
Absolute change in SCORAD index from baseline	Baseline to Week 24	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).
Proportion of participants with a reduction in SCORAD ≥ 8.7 points from baseline in participants with baseline SCORAD score ≥ 8.7	Baseline to Week 24	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).
Proportion of participants reaching EASI-75 at Week 24 (for US and US reference countries only)	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. EASI-75 is 75% reduction from baseline in EASI score.
Change in Patient Oriented Eczema Measure (POEM) from baseline	Baseline to Week 24	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.
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	Baseline to 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).
Proportion of participants reaching EASI-75	Baseline to Week 20	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.
Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points	Baseline to Week 20	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).
Proportion of participants with vIGA-AD 0 (clear)	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).
Percent change in weekly average of daily SD-NRS from baseline	Baseline to Week 24	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.
Percent change in EASI score from baseline	Baseline to 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.
Absolute change in weekly average of daily PP-NRS from baseline	Baseline to Week 24	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.
Proportion of participants reaching EASI-50	Baseline to 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. EASI-50 is 50% reduction from baseline in EASI score.
Proportion of participants reaching EASI-100	Baseline to 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. EASI-100 is 100% reduction from baseline in EASI score.
Proportion of participants with PP-NRS 0 or 1	Baseline to Week 24	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.
Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old	Baseline to Week 24	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.
Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4	Baseline to Week 24	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.
Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old	Baseline to Week 24	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.
Proportion of participants with a reduction in POEM ≥4 from baseline in participants with POEM Baseline ≥4	Baseline to Week 24	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.
Proportion of participants with rescue medication use	Baseline to Week 24
Percentage of participants who experience Treatment-Emergent Adverse Events (TEAEs), experience Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment- Emergent Adverse Events of Special Interest (AESI)	Baseline to Week 40
Serum amlitelimab concentrations	Baseline to Week 40
Incidence of antidrug antibodies (ADAs) of amlitelimab	Baseline to Week 40
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	Baseline to Week 24	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
Change in Hospital Anxiety Depression Scale (HADS) from baseline	Baseline to Week 24	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.
Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8	Baseline to Week 24	HADS-A score ranges 0-21 with higher score indicating a poorer state.
Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline ≥8	Baseline to Week 24	HADS-D score ranges 0-21 with higher score indicating a poorer state.
Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline	Baseline to Week 24	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.
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	Baseline to Week 24	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.
Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline	Baseline to Week 24	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.
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	Baseline to Week 24	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.
Percent change in weekly average of daily SP-NRS from baseline	Baseline to Week 24	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.
Proportion of participants with EASI ≤7	Baseline to 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.
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	Baseline to Week 24	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.
Proportion of participants reaching EASI-90	Baseline to 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. EASI-90 is 90% reduction from baseline in EASI score.

Trial Locations

Locations (142)

Center for Dermatology and Plastic Surgery- Site Number : 8401119; 🇺🇸 Scottsdale, Arizona, United States

Eclipse Clinical Research- Site Number : 8401158; 🇺🇸 Tucson, Arizona, United States

Torrance Clinical Research- Site Number : 8401027; 🇺🇸 Lomita, California, United States

Dermatology Research Associates - Los Angeles- Site Number : 8401092; 🇺🇸 Los Angeles, California, United States

Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079; 🇺🇸 Mission Viejo, California, United States

Cura Clinical Research - Oxnard- Site Number : 8401142; 🇺🇸 Oxnard, California, United States

Clinical Science Institute- Site Number : 8401028; 🇺🇸 Santa Monica, California, United States

University of Connecticut Health Center- Site Number : 8401115; 🇺🇸 Farmington, Connecticut, United States

Pediatric Skin Research- Site Number : 8401198; 🇺🇸 Coral Gables, Florida, United States

Skin Care Research - Hollywood- Site Number : 8401071; 🇺🇸 Hollywood, Florida, United States

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