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

Dermatitis Atopic Clinical Trial

— COAST 1  

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 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: NCT06130566
• Other study ID #: EFC17559
• Secondary ID: U1111-1275-97152
• Status: Recruiting
• Phase: Phase 3
• Start date: November 8, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: May 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: December 30, 2025
• Est. primary completion date: September 9, 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:

• 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 (1 week in the event of superficial skin infections)
• 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
Injection solution SC injection
• Placebo
Injection solution SC injection

Locations

Country	Name	City	State
Australia	Investigational Site Number : 0360008	East Melbourne	Victoria
Australia	Investigational Site Number : 0360006	Melbourne	Victoria
Australia	Investigational Site Number : 0361006	Traralgon West	Victoria
Australia	Investigational Site Number : 0360010	Westmead	New South Wales
Australia	Investigational Site Number : 0360007	Woolloongabba	Queensland
Canada	Investigational Site Number : 1240033	Ajax	Ontario
Canada	Investigational Site Number : 1240031	Edmonton	Alberta
Canada	Investigational Site Number : 1240029	London	Ontario
Canada	Investigational Site Number : 1240034	Ottawa	Ontario
Canada	Investigational Site Number : 1240028	Regina	Saskatchewan
Canada	Investigational Site Number : 1240036	Saskatoon	Saskatchewan
Canada	Investigational Site Number : 1240040	Surrey	British Columbia
Canada	Investigational Site Number : 1240035	Toronto	Ontario
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 : 1520010	Santiago	Reg Metropolitana De Santiago
Chile	Investigational Site Number : 1520006	Vina del Mar	Valparaíso
China	Investigational Site Number : 1560042	Beijing
Israel	Investigational Site Number : 3760001	Haifa
Israel	Investigational Site Number : 3760003	Jerusalem
Korea, Republic of	Investigational Site Number : 4100002	Ansan-si	Gyeonggi-do
Korea, Republic of	Investigational Site Number : 4100008	Daegu	Daegu-gwangyeoksi
Korea, Republic of	Investigational Site Number : 4100012	Gwangju
Korea, Republic of	Investigational Site Number : 4100006	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100010	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100011	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100013	Seoul	Seoul-teukbyeolsi
Korea, Republic of	Investigational Site Number : 4100009	Suwon	Gyeonggi-do
Korea, Republic of	Investigational Site Number : 4100003	Yangsan-si	Gyeongsangnam-do
Taiwan	Investigational Site Number : 1580001	Taipei
United States	Metro Boston Clinical Partners Site Number : 8401128	Brighton	Massachusetts
United States	Chear Center LLC Site Number : 8401123	Bronx	New York
United States	Vial Health @DermDox Dermatology Site Number : 8401031	Camp Hill	Pennsylvania
United States	Onsite Clinical Solutions, LLC - Piedmont Plastics & Dermatology Site Number : 8401124	Charlotte	North Carolina
United States	Velocity Clinical Research - Covington - PPDS Site Number : 8401137	Covington	Louisiana
United States	Cleaver Medical Group Dermatology Site Number : 8401139	Cumming	Georgia
United States	Dermatology Treatment and Research Center Site Number : 8401164	Dallas	Texas
United States	Revival Research Corporation - Michigan - ClinEdge - PPDS Site Number : 8401012	Doral	Florida
United States	First OC Dermatology Site Number : 8401025	Fountain Valley	California
United States	Center for Dermatology Clinical Research Site Number : 8401018	Fremont	California
United States	Direct Helpers Medical Center Inc Site Number : 8401056	Hialeah	Florida
United States	Encore Medical Research Hollywood Site Number : 8401030	Hollywood	Florida
United States	Sunwise Clinical Research Site Number : 8401022	Lafayette	California
United States	Velocity Clinical Research Lafayette Site Number : 8401152	Lafayette	Louisiana
United States	Skin Sciences, PLLC Site Number : 8401039	Louisville	Kentucky
United States	Skin Care Physicians of Georgia Site Number : 8401034	Macon	Georgia
United States	Florida International Research Center Site Number : 8401091	Miami	Florida
United States	Sadick Research Group Site Number : 8401050	New York	New York
United States	Virginia Dermatology Skin Cancer Center Site Number : 8401047	Norfolk	Virginia
United States	Northridge Clinical Trials Site Number : 8401080	Northridge	California
United States	Clinical Research Philadelphia Site Number : 8401193	Philadelphia	Pennsylvania
United States	Paddington Testing Company Site Number : 8401041	Philadelphia	Pennsylvania
United States	Oregon Medical Research Center Site Number : 8401017	Portland	Oregon
United States	Sky Integrative Medical Center/SKYCRNG Site Number : 8401058	Ridgeland	Mississippi
United States	Texas Dermatology and Laser Specialists Site Number : 8401131	San Antonio	Texas
United States	Scottsdale Clinical Trials Site Number : 8401149	Scottsdale	Arizona
United States	Stryde Research Epiphany Dermatology Site Number : 8401185	Southlake	Texas
United States	CCT Research at Springville Dermatology Site Number : 8401106	Springville	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Chile,  China,  Israel,  Korea, Republic of,  Taiwan, 

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 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
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 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
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 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 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