A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids (SHORE)

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids

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).

Study Overview

• Status: Recruiting
• Conditions: Dermatitis Atopic
• Intervention / Treatment: Drug: Amlitelimab; Drug: Topical corticosteroids; Drug: Topical calcineurin inhibitors; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 496
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Trial Transparency email recommended (Toll free for US & Canada); Phone Number: option 6 800-633-1610; Email: Contact-US@sanofi.com

Study Locations

• Canada
  • Quebec, Canada, G1W 4R4
    • Recruiting
    • Investigational Site Number : 1240006
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Recruiting
      • Investigational Site Number : 1240041
  • Ontario
    • Richmond Hill, Ontario, Canada, L4E 4L6
      • Recruiting
      • Investigational Site Number : 1240038
    • Waterloo, Ontario, Canada, N2J 1C4
      • Recruiting
      • Investigational Site Number : 1241107
• Chile
  • Reg Metropolitana De Santiago
    • Osorno, Reg Metropolitana De Santiago, Chile, 5311523
      • Recruiting
      • Investigational Site Number : 1520009
    • Santiago, Reg Metropolitana De Santiago, Chile, 8420383
      • Recruiting
      • Investigational Site Number : 1520001
    • Santiago, Reg Metropolitana De Santiago, Chile, 7500588
      • Recruiting
      • Investigational Site Number : 1520008
    • Santiago, Reg Metropolitana De Santiago, Chile, 7580206
      • Recruiting
      • Investigational Site Number : 1520002
    • Santiago, Reg Metropolitana De Santiago, Chile, 7640881
      • Recruiting
      • Investigational Site Number : 1520003
    • Santiago, Reg Metropolitana De Santiago, Chile, 8380465
      • Recruiting
      • Investigational Site Number : 1520005
  • Valparaíso
    • Vina del Mar, Valparaíso, Chile, 2552577
      • Recruiting
      • Investigational Site Number : 1520006
• Japan
  • Hokkaido
    • Obihiro-Shi, Hokkaido, Japan, 080-0013
      • Recruiting
      • Investigational Site Number : 3923114
  • Kagoshima
    • Kagoshima-Shi, Kagoshima, Japan, 890-0063
      • Recruiting
      • Investigational Site Number : 3923108
  • Kanagawa
    • Yokohama-Shi, Kanagawa, Japan, 221-0825
      • Recruiting
      • Investigational Site Number : 3923113
  • Saitama
    • Iruma-gun, Saitama, Japan, 350-0495
      • Recruiting
      • Investigational Site Number : 3920002
  • Tokyo
    • Chuo-ku, Tokyo, Japan, 104-0031
      • Recruiting
      • Investigational Site Number : 3920004
    • Minato-Ku, Tokyo, Japan, 108-0014
      • Recruiting
      • Investigational Site Number : 3923107
    • Tachikawa-shi, Tokyo, Japan, 190-0023
      • Recruiting
      • Investigational Site Number : 3920001
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Recruiting
      • Cahaba Dermatology Site Number : 8401066
  • Arkansas
    • Fort Smith, Arkansas, United States, 72916
      • Recruiting
      • Johnson Dermatology Site Number : 8401076
  • California
    • Encino, California, United States, 91436
      • Recruiting
      • Encino Research Center Site Number : 8401042
    • Huntington Beach, California, United States, 92647
      • Recruiting
      • Marvel Clinical Research Site Number : 8401102
    • Los Angeles, California, United States, 90057
      • Recruiting
      • LA Universal Research Center Site Number : 8401064
    • Palmdale, California, United States, 93551
      • Recruiting
      • Cura Clinical Research Site Number : 8401141
  • Florida
    • Hollywood, Florida, United States, 33021
      • Recruiting
      • Skin Care Research Site Number : 8401071
    • Miami, Florida, United States, 33126
      • Recruiting
      • Clever Medical Research, LLC Site Number : 8401160
    • Saint Petersburg, Florida, United States, 33705
      • Recruiting
      • Global Clinical Professionals (GCP) Site Number : 8401045
    • Tampa, Florida, United States, 33613
      • Recruiting
      • Avita Clinical Research Site Number : 8401073
  • Georgia
    • Dawsonville, Georgia, United States, 30534
      • Recruiting
      • Cleaver Medical Group Dermatology Site Number : 8401138
  • Illinois
    • Skokie, Illinois, United States, 60077
      • Recruiting
      • NorthShore University HealthSystem Clinical Trials Center Site Number : 8401038
  • Indiana
    • Indianapolis, Indiana, United States, 46250
      • Recruiting
      • Dawes Fretzin Clinical Research Group, LLC Site Number : 8401015
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Recruiting
      • Respiratory Medicine Research Institute of Michigan, PLC Site Number : 8401078
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Recruiting
      • Skin Specialists Site Number : 8401068
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Recruiting
      • Jubilee Clinical Research - Clinedge - PPDS Site Number : 8401054
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Recruiting
      • ALLCUTIS Research, LLC Site Number : 8401082
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74137
      • Recruiting
      • Essential Medical Research, LLC Site Number : 8401183
  • Pennsylvania
    • Sugarloaf, Pennsylvania, United States, 18249
      • Recruiting
      • DermDox Dermatology Centers Site Number : 8401031
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Recruiting
      • Clinical Research Center of the Carolinas Site Number : 8401067
  • Texas
    • Missouri City, Texas, United States, 77459
      • Recruiting
      • Sienna Dermatology Site Number : 8401148
    • San Antonio, Texas, United States, 78218
      • Recruiting
      • Texas Dermatology and Laser Specialists Site Number : 8401131
    • San Antonio, Texas, United States, 78258
      • Recruiting
      • Discovery Clinical Trials - San Antonio - Stone Oak Parkway Site Number : 8401026
    • Sugar Land, Texas, United States, 77479
      • Recruiting
      • Complete Dermatology Site Number : 8401061
  • Utah
    • Bountiful, Utah, United States, 84010
      • Recruiting
      • Cope Family Medicine/CTT Research Site Number : 8401114

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 inadequate response 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 potential participation in a clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amlitelimab dose 1; Subcutaneous injection as per protocol	Drug: Amlitelimab; Pharmaceutical form: Injection solution Route of administration: SC injection; Other Names: SAR445229; Drug: Topical corticosteroids; Pharmaceutical form: Topical formulation Route of administration: Topical; Drug: Topical calcineurin inhibitors; Pharmaceutical form: Topical formulation Route of administration: Topical
Experimental: Amlitelimab dose 2; Subcutaneous injection as per protocol	Drug: Amlitelimab; Pharmaceutical form: Injection solution Route of administration: SC injection; Other Names: SAR445229; Drug: Topical corticosteroids; Pharmaceutical form: Topical formulation Route of administration: Topical; Drug: Topical calcineurin inhibitors; Pharmaceutical form: Topical formulation Route of administration: Topical
Placebo Comparator: Placebo; Subcutaneous injection as per protocol	Drug: Topical corticosteroids; Pharmaceutical form: Topical formulation Route of administration: Topical; Drug: Topical calcineurin inhibitors; Pharmaceutical form: Topical formulation Route of administration: Topical; Drug: Placebo; Pharmaceutical form: injection solution Route of administration: SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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).	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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).	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.	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.	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).	Baseline to Week 20
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline to Week 24
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	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).	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).	Baseline to Week 24
Proportion of participants with rescue medication use		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)		Baseline to Week 40
Serum amlitelimab concentrations		Baseline to Week 40
Incidence of antidrug antibodies (ADAs) of amlitelimab		Baseline to Week 40
Cumulative amount of topical corticosteroids (TCS) consumption		Baseline to Week 24
Percentage of TCS/topical calcineurin inhibitors (TCI) free days		Baseline to Week 24
Change in Dermatology Quality of Life 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.	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.	Baseline to Week 24
Change in Children Dermatology Quality of Life 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.	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.	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.	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.	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.	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.	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).	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.	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.	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.	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.	Baseline to Week 2

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): January 21, 2026

Study Registration Dates

• First Submitted: January 16, 2024
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Dermatitis, Atopic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Calcineurin Inhibitors
• Other Study ID Numbers: EFC17561; 2023-506558-20 (Registry Identifier: CTIS); U1111-1275-9760 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No