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)

Dermatitis Atopic Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallelgroup, 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06181435
• Other study ID #: EFC17560
• Secondary ID: 2023-506557-38U1
• Status: Recruiting
• Phase: Phase 3
• Start date: December 21, 2023
• Est. completion date: February 3, 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: February 3, 2026
• Est. primary completion date: October 14, 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 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.

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

Locations

Country	Name	City	State
Argentina	Investigational Site Number : 0320021	Berazategui	Buenos Aires
Argentina	Investigational Site Number : 0320001	Buenos Aires
Argentina	Investigational Site Number : 0320002	Caba	Buenos Aires
Argentina	Investigational Site Number : 0320009	Caba	Ciudad De Buenos Aires
Argentina	Investigational Site Number : 0320016	Caba	Buenos Aires
Argentina	Investigational Site Number : 0320006	Rosario	Santa Fe
Argentina	Investigational Site Number : 0320007	Rosario	Santa Fe
Argentina	Investigational Site Number : 0320015	Rosario	Santa Fe
Bulgaria	Investigational Site Number : 1002008	Gabrovo
Bulgaria	Investigational Site Number : 1002004	Pleven
Bulgaria	Investigational Site Number : 1002005	Sofia
China	Investigational Site Number : 1560004	Beijing
China	Investigational Site Number : 1560030	Beijing
China	Investigational Site Number : 1560022	Chengdu
China	Investigational Site Number : 1560025	Guangzhou
China	Investigational Site Number : 1560002	Hangzhou
China	Investigational Site Number : 1560006	Hangzhou
China	Investigational Site Number : 1560029	Hangzhou
China	Investigational Site Number : 1560007	Jinan
China	Investigational Site Number : 1560024	Ningbo
China	Investigational Site Number : 1560001	Shanghai
China	Investigational Site Number : 1560026	Shenyang
China	Investigational Site Number : 1560023	Wenzhou
China	Investigational Site Number : 1560003	Wuxi
China	Investigational Site Number : 1560028	ZhenJiang
Czechia	Investigational Site Number : 2032106	Kutna Hora
Czechia	Investigational Site Number : 2030010	Olomouc
Czechia	Investigational Site Number : 2032104	Ostrava
Czechia	Investigational Site Number : 2030011	Praha
Czechia	Investigational Site Number : 2030006	Praha 6
Denmark	Investigational Site Number : 2080002	Aalborg
Denmark	Investigational Site Number : 2080001	Aarhus N
Denmark	Investigational Site Number : 2080003	Herlev
Italy	Investigational Site Number : 3800008	Pisa
Italy	Investigational Site Number : 3800018	Rozzano	Lombardia
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
Portugal	Investigational Site Number : 6200001	Lisboa
Portugal	Investigational Site Number : 6200004	Lisboa
Portugal	Investigational Site Number : 6200003	Porto
South Africa	Investigational Site Number : 7100009	Claremont
South Africa	Investigational Site Number : 7100001	Durban
South Africa	Investigational Site Number : 7100012	Durban
South Africa	Investigational Site Number : 7100004	Reiger Park
Spain	Investigational Site Number : 7240018	Granada
Spain	Investigational Site Number : 7240012	Las Palmas de Gran Canaria	Las Palmas
Spain	Investigational Site Number : 7242503	Madrid	Madrid, Comunidad De
Sweden	Investigational Site Number : 7520006	Alvsjo
Sweden	Investigational Site Number : 7520001	Örebro
Turkey	Investigational Site Number : 7920001	Akdeniz
Turkey	Investigational Site Number : 7920005	Istanbul
Turkey	Investigational Site Number : 7920006	Istanbul
Turkey	Investigational Site Number : 7920004	Kayseri
Turkey	Investigational Site Number : 7920007	Samsun
United Kingdom	Investigational Site Number : 8260006	Glasgow
United Kingdom	Investigational Site Number : 8260004	Leicester
United Kingdom	Investigational Site Number : 8260003	Portsmouth	Hampshire
United States	Care Access Research Site Number : 8401134	Arlington	Virginia
United States	Bexley Dermatology Research Site Number : 8401051	Bexley	Ohio
United States	OmeraNY Clinical Trials, LLC Site Number : 8401156	Brooklyn	New York
United States	Velocity Clinical Research, Springdale Site Number : 8401153	Cincinnati	Ohio
United States	Columbia Dermatology & Aesthetics, LLC Site Number : 8401166	Columbia	South Carolina
United States	AllerVie Clinical Research Site Number : 8401104	Columbus	Georgia
United States	Pediatric Skin Research, LLC (Vial Network) Site Number : 8401198	Coral Gables	Florida
United States	Axis Clinicals Site Number : 8401196	Fargo	North Dakota
United States	Javara Inc. /Privia Medical Group Georgia, LLC Site Number : 8401190	Fayetteville	Georgia
United States	Velocity Clinical Research, Hampton Site Number : 8401154	Hampton	Virginia
United States	Care Access Research, Hoboken Site Number : 8401132	Hoboken	New Jersey
United States	Skin Care Research Site Number : 8401071	Hollywood	Florida
United States	Center for Clinical Studies, LTD. LLP Site Number : 8401063	Houston	Texas
United States	Torrance Clinical Research Institute Site Number : 8401027	Lomita	California
United States	Dermatology Research Associates Site Number : 8401092	Los Angeles	California
United States	Care Access Research Columbia Site Number : 8401126	Marriottsville	Maryland
United States	Savin Medical Group, LLC Site Number : 8401085	Miami	Florida
United States	Allergy & Asthma Associates of Southern California dba Southern California Research Site Number : 8401079	Mission Viejo	California
United States	Sienna Dermatology Site Number : 8401148	Missouri City	Texas
United States	Advanced Research Institute Site Number : 8401057	Ogden	Utah
United States	Accel Research - Nona Pediatric Center Site Number : 8401081	Orlando	Florida
United States	Cura Clinical Research Site Number : 8401142	Oxnard	California
United States	Dermatology Associates of Plymouth Meeting Site Number : 8401147	Plymouth Meeting	Pennsylvania
United States	NuLine Clinical Trial Center Site Number : 8401161	Pompano Beach	Florida
United States	Health Concepts Site Number : 8401059	Rapid City	South Dakota
United States	Progressive Clinical Research Site Number : 8401016	San Antonio	Texas
United States	Clinical Science Institute Site Number : 8401028	Santa Monica	California
United States	Center for Dermatology and Plastic Surgery/ CCT Research Site Number : 8401119	Scottsdale	Arizona
United States	Jordan Valley Dermatology Center Site Number : 8401036	South Jordan	Utah
United States	Clinical Research Trials of Florida, Inc Site Number : 8401023	Tampa	Florida
United States	Eclipse Clinical Research Site Number : 8401158	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  China,  Czechia,  Denmark,  Italy,  Japan,  Portugal,  South Africa,  Spain,  Sweden,  Turkey,  United Kingdom, 

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 24
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	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
Secondary	Serum amlitelimab concentrations		Baseline to Week 40
Secondary	Incidence of antidrug antibodies (ADAs) of amlitelimab		Baseline to Week 40