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

Dermatitis Atopic Clinical Trial

— SHORE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06224348
• Other study ID #: EFC17561
• Secondary ID: 2023-506558-20U1
• Status: Recruiting
• Phase: Phase 3
• Start date: January 18, 2024
• Est. completion date: January 21, 2026

Study information

• Verified date: June 2024
• Source: Sanofi
• Contact: Trial Transparency email recommended (Toll free for US & Canada)
• Phone: 800-633-1610
• Email: Contact-US[@]sanofi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 496
• Est. completion date: January 21, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis Atopic
• Dermatitis, Atopic

Intervention

Drug:
• Amlitelimab
Pharmaceutical form: Injection solution Route of administration: SC injection
• Placebo
Pharmaceutical form: injection solution Route of administration: SC injection
• Topical corticosteroids
Pharmaceutical form: Topical formulation Route of administration: Topical
• Topical calcineurin inhibitors
Pharmaceutical form: Topical formulation Route of administration: Topical

Locations

Country	Name	City	State
Argentina	Investigational Site Number : 0320004	Buenos Aires
Argentina	Investigational Site Number : 0320005	Caba	Ciudad De Buenos Aires
Argentina	Investigational Site Number : 0320010	Caba	Buenos Aires
Argentina	Investigational Site Number : 0320011	Caba	Buenos Aires
Argentina	Investigational Site Number : 0320019	Caba	Buenos Aires
Argentina	Investigational Site Number : 0320008	Capital Federal	Buenos Aires
Argentina	Investigational Site Number : 0320020	San Miguel de Tucuman
Brazil	Instituto Bahiano de Imunoterapia - IBIS Site Number : 0760002	Salvador	Bahia
Brazil	Faculdade de Medicina do ABC Site Number : 0760001	Santo André
Canada	Investigational Site Number : 1240006	Quebec
Canada	Investigational Site Number : 1240038	Richmond Hill	Ontario
Canada	Investigational Site Number : 1240030	Surrey	British Columbia
Canada	Investigational Site Number : 1240012	Toronto	Ontario
Canada	Investigational Site Number : 1241107	Waterloo	Ontario
Canada	Investigational Site Number : 1240041	Winnipeg	Manitoba
Chile	Investigational Site Number : 1520009	Osorno	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520001	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520002	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520003	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520005	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520008	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520011	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520010	Santiago de Chile
Chile	Investigational Site Number : 1520012	Talcahuano
Chile	Investigational Site Number : 1520006	Vina del Mar	Valparaíso
China	Investigational Site Number : 1560060	Chengdu
China	Investigational Site Number : 1560043	Fuzhou
China	Investigational Site Number : 1560006	Hangzhou
China	Investigational Site Number : 1560044	Hangzhou
China	Investigational Site Number : 1560051	Nanchang
China	Investigational Site Number : 1560041	Shenyang
China	Investigational Site Number : 1560003	Wuxi
France	Investigational Site Number : 2500009	Nantes
France	Investigational Site Number : 2500002	Toulouse
Japan	Investigational Site Number : 3920004	Chuo-ku	Tokyo
Japan	Investigational Site Number : 3923109	Habikino-shi
Japan	Investigational Site Number : 3920002	Iruma-gun	Saitama
Japan	Investigational Site Number : 3923108	Kagoshima-Shi	Kagoshima
Japan	Investigational Site Number : 3920006	Kobe-shi	Hyogo
Japan	Investigational Site Number : 3920003	Kyoto-shi	Kyoto
Japan	Investigational Site Number : 3923102	Kyoto-shi
Japan	Investigational Site Number : 3923107	Minato-Ku	Tokyo
Japan	Investigational Site Number : 3923114	Obihiro-Shi	Hokkaido
Japan	Investigational Site Number : 3923110	Sakai-shi	Osaka
Japan	Investigational Site Number : 3923106	Shimotsuga-gun	Tochigi
Japan	Investigational Site Number : 3920001	Tachikawa-shi	Tokyo
Japan	Investigational Site Number : 3923113	Yokohama-Shi	Kanagawa
Turkey	Investigational Site Number : 7920001	Akdeniz
Turkey	Investigational Site Number : 7920010	Ankara
Turkey	Investigational Site Number : 7920005	Istanbul
Turkey	Investigational Site Number : 7920006	Istanbul
Turkey	Investigational Site Number : 7920009	Istanbul
Turkey	Investigational Site Number : 7920004	Kayseri
Turkey	Investigational Site Number : 7920008	Sahinbey
Turkey	Investigational Site Number : 7920007	Samsun
United States	Cahaba Dermatology Site Number : 8401066	Birmingham	Alabama
United States	Cope Family Medicine/CTT Research Site Number : 8401114	Bountiful	Utah
United States	DermDox Dermatology Centers Site Number : 8401031	Camp Hill	Pennsylvania
United States	Clinical Research Center of the Carolinas Site Number : 8401067	Charleston	South Carolina
United States	Cleaver Medical Group Dermatology Site Number : 8401138	Dawsonville	Georgia
United States	Encino Research Center Site Number : 8401042	Encino	California
United States	Johnson Dermatology Site Number : 8401076	Fort Smith	Arkansas
United States	Skin Care Research Site Number : 8401071	Hollywood	Florida
United States	Marvel Clinical Research Site Number : 8401102	Huntington Beach	California
United States	Dawes Fretzin Clinical Research Group, LLC Site Number : 8401015	Indianapolis	Indiana
United States	Jubilee Clinical Research - Clinedge - PPDS Site Number : 8401054	Las Vegas	Nevada
United States	Tanner Clinic Site Number : 8401151	Layton	Utah
United States	Dermatology and Skin Cancer Lee's Summit Site Number : 8401157	Lee's Summit	Missouri
United States	LA Universal Research Center Site Number : 8401064	Los Angeles	California
United States	SMS Clinical Research Site Number : 8401182	Mesquite	Texas
United States	Clever Medical Research, LLC Site Number : 8401160	Miami	Florida
United States	Sienna Dermatology Site Number : 8401148	Missouri City	Texas
United States	Velocity Clinical Research- New Orleans Site Number : 8401155	New Orleans	Louisiana
United States	Icahn School of Medicine at Mount Sinai Site Number : 8401129	New York	New York
United States	Skin Specialists Site Number : 8401068	Omaha	Nebraska
United States	Cura Clinical Research Site Number : 8401141	Palmdale	California
United States	ALLCUTIS Research, LLC Site Number : 8401082	Portsmouth	New Hampshire
United States	Global Clinical Professionals (GCP) Site Number : 8401045	Saint Petersburg	Florida
United States	Discovery Clinical Trials - San Antonio - Stone Oak Parkway Site Number : 8401026	San Antonio	Texas
United States	Texas Dermatology and Laser Specialists Site Number : 8401131	San Antonio	Texas
United States	NorthShore University HealthSystem Clinical Trials Center Site Number : 8401038	Skokie	Illinois
United States	Jordan Valley Dermatology Center Site Number : 8401036	South Jordan	Utah
United States	Complete Dermatology Site Number : 8401061	Sugar Land	Texas
United States	Avita Clinical Research Site Number : 8401073	Tampa	Florida
United States	Oakland Medical Research Center Site Number : 8401116	Troy	Michigan
United States	Essential Medical Research, LLC Site Number : 8401183	Tulsa	Oklahoma
United States	Respiratory Medicine Research Institute of Michigan, PLC Site Number : 8401078	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Chile,  China,  France,  Japan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.	Baseline to Week 24
Secondary	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
Secondary	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.	Baseline to Week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in percent Body Surface Area (BSA) affected by AD from baseline		Baseline to Week 24
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of participants with rescue medication use		Baseline to Week 24
Secondary	Cumulative amount of topical corticosteroids (TCS) consumption		Baseline to Week 24
Secondary	Percentage of TCS/topical calcineurin inhibitors (TCI) free days		Baseline to Week 24
Secondary	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
Secondary	Serum amlitelimab concentrations		Baseline to Week 40
Secondary	Incidence of antidrug antibodies (ADAs) of amlitelimab		Baseline to Week 40