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)

March 18, 2026 updated by: Sanofi

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

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).

Study Overview

Status

Completed

Conditions

Dermatitis Atopic

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

589

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1425
    - Investigational Site Number : 0320002
  - Buenos Aires, Argentina, 1055
    - Investigational Site Number : 0320016
  - Buenos Aires, Argentina, 1121
    - Investigational Site Number : 0320001
  - Buenos Aires, Argentina, 1425
    - Investigational Site Number : 0320009
- Buenos Aires
  - Berazategui, Buenos Aires, Argentina, 1886
    - Investigational Site Number : 0320021
  - Pilar, Buenos Aires, Argentina, 1629
    - Investigational Site Number : 0320017
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, 2000
    - Investigational Site Number : 0320006
  - Rosario, Santa Fe Province, Argentina, 2000
    - Investigational Site Number : 0320007
  - Rosario, Santa Fe Province, Argentina, 2000
    - Investigational Site Number : 0320015
Bulgaria
- - Gabrovo, Bulgaria, 5300
    - Investigational Site Number : 1002008
  - Pleven, Bulgaria, 5800
    - Investigational Site Number : 1002004
  - Sofia, Bulgaria, 1431
    - Investigational Site Number : 1002005
Chile
- Los Ríos Region
  - Valdivia, Los Ríos Region, Chile, 5110683
    - Investigational Site Number : 1520004
- Reg Metropolitana de Santiago
  - Santiago, Reg Metropolitana de Santiago, Chile, 7640881
    - Investigational Site Number : 1520003
  - Santiago, Reg Metropolitana de Santiago, Chile, 7500505
    - Investigational Site Number : 1520013
  - Santiago, Reg Metropolitana de Santiago, Chile, 7750495
    - Investigational Site Number : 1520014
- Región de Valparaíso
  - Quillota, Región de Valparaíso, Chile, 2260877
    - Investigational Site Number : 1520015
China
- - Beijing, China, 100191
    - Investigational Site Number : 1560004
  - Beijing, China, 100730
    - Investigational Site Number : 1560030
  - Chengdu, China, 610041
    - Investigational Site Number : 1560022
  - Guangzhou, China, 510018
    - Investigational Site Number : 1560021
  - Guangzhou, China, 510080
    - Investigational Site Number : 1560025
  - Hangzhou, China, 310006
    - Investigational Site Number : 1560002
  - Hangzhou, China, 310009
    - Investigational Site Number : 1560006
  - Hangzhou, China, 310014
    - Investigational Site Number : 1560029
  - Jinan, China, 250013
    - Investigational Site Number : 1560007
  - Ningbo, China, 315010
    - Investigational Site Number : 1560024
  - Shanghai, China, 200040
    - Investigational Site Number : 1560001
  - Shanghai, China, 200443
    - Investigational Site Number : 1560005
  - Shenyang, China, 110179
    - Investigational Site Number : 1560026
  - Wenzhou, China, 325035
    - Investigational Site Number : 1560023
  - Wuxi, China, 214000
    - Investigational Site Number : 1560003
  - Zhenjiang, China, 212000
    - Investigational Site Number : 1560028
Czechia
- - Kutná Hora, Czechia, 284 01
    - Investigational Site Number : 2032106
  - Olomouc, Czechia, 779 00
    - Investigational Site Number : 2030010
  - Ostrava, Czechia, 702 00
    - Investigational Site Number : 2032104
  - Prague, Czechia, 150 00
    - Investigational Site Number : 2030011
  - Prague, Czechia, 160 00
    - Investigational Site Number : 2030006
Denmark
- - Aalborg, Denmark, 9000
    - Investigational Site Number : 2080002
  - Aarhus, Denmark, 8200
    - Investigational Site Number : 2080001
  - Herlev, Denmark, 2730
    - Investigational Site Number : 2080003
Italy
- - Catania, Italy, 95123
    - Investigational Site Number : 3800009
  - Pisa, Italy, 56126
    - Investigational Site Number : 3800008
  - Vicenza, Italy, 36100
    - Investigational Site Number : 3800022
- Milano
  - Rozzano, Milano, Italy, 20089
    - Investigational Site Number : 3800018
- Roma
  - Rome, Roma, Italy, 00133
    - Investigational Site Number : 3800013
Japan
- - Kagoshima, Japan, 890-0063
    - Investigational Site Number : 3923108
  - Kyoto, Japan, 606-8507
    - Investigational Site Number : 3920003
  - Kyoto, Japan, 602-8566
    - Investigational Site Number : 3923102
- Hokkaido
  - Chitose, Hokkaido, Japan, 066-0021
    - Investigational Site Number : 3920009
  - Obihiro, Hokkaido, Japan, 080-0013
    - Investigational Site Number : 3923114
  - Sapporo, Hokkaido, Japan, 064-0921
    - Investigational Site Number : 3920008
- Hyōgo
  - Kobe, Hyōgo, Japan, 653-0836
    - Investigational Site Number : 3920006
- Kanagawa
  - Sagamihara, Kanagawa, Japan, 252-0315
    - Investigational Site Number : 3920005
  - Yokohama, Kanagawa, Japan, 221-0825
    - Investigational Site Number : 3923113
- Miyagi
  - Miyagi-gun, Miyagi, Japan, 981-0112
    - Investigational Site Number : 3920010
  - Sendai, Miyagi, Japan, 981-3133
    - Investigational Site Number : 3920011
- Osaka
  - Habikino, Osaka, Japan, 583-8588
    - Investigational Site Number : 3923109
  - Sakai, Osaka, Japan, 593-8324
    - Investigational Site Number : 3923110
- Saitama
  - Iruma, Saitama, Japan, 350-0495
    - Investigational Site Number : 3920002
- Tochigi
  - Mibu, Tochigi, Japan, 321-0293
    - Investigational Site Number : 3923106
- Tokyo
  - Chūō, Tokyo, Japan, 104-0031
    - Investigational Site Number : 3920004
  - Minato, Tokyo, Japan, 108-0014
    - Investigational Site Number : 3923107
  - Tachikawa, Tokyo, Japan, 190-0023
    - Investigational Site Number : 3920001
Mexico
- - Aguascalientes, Mexico, 20127
    - Investigational Site Number : 4840012
  - Durango, Mexico, 34000
    - Investigational Site Number : 4840009
  - Veracruz, Mexico, 91900
    - Investigational Site Number : 4840003
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64460
    - Investigational Site Number : 4840011
  - Monterrey, Nuevo León, Mexico, 64718
    - Investigational Site Number : 4840005
Portugal
- - Lisbon, Portugal, 1169-050
    - Investigational Site Number : 6200005
  - Lisbon, Portugal, 1649-035
    - Investigational Site Number : 6200004
  - Lisbon, Portugal, 1998-018
    - Investigational Site Number : 6200001
  - Porto, Portugal, 4099-001
    - Investigational Site Number : 6200003
South Africa
- - Boksburg, South Africa, 1459
    - Investigational Site Number : 7100004
  - Cape Town, South Africa, 7533
    - Investigational Site Number : 7100010
  - Cape Town, South Africa, 7708
    - Investigational Site Number : 7100009
  - Durban, South Africa, 3630
    - Investigational Site Number : 7100012
  - Durban, South Africa, 4058
    - Investigational Site Number : 7100001
  - Johannesburg, South Africa, 1500
    - Investigational Site Number : 7100015
  - Johannesburg, South Africa, 2196
    - Investigational Site Number : 7100007
  - Pretoria, South Africa, 0009
    - Investigational Site Number : 7100003
Spain
- - Granada, Spain, 18014
    - Investigational Site Number : 7240018
  - Madrid, Spain, 28007
    - Investigational Site Number : 7240029
  - Madrid, Spain, 28046
    - Investigational Site Number : 7242503
- Las Palmas
  - Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
    - Investigational Site Number : 7240012
Sweden
- - Älvsjö, Sweden, 125 44
    - Investigational Site Number : 7520006
  - Örebro, Sweden, 701 85
    - Investigational Site Number : 7520001
Turkey (Türkiye)
- - Antalya, Turkey (Türkiye), 07070
    - Investigational Site Number : 7920001
  - Istanbul, Turkey (Türkiye), 34093
    - Investigational Site Number : 7920005
  - Istanbul, Turkey (Türkiye), 34093
    - Investigational Site Number : 7920006
  - Istanbul, Turkey (Türkiye), 34098
    - Investigational Site Number : 7920002
  - Kayseri, Turkey (Türkiye), 38039
    - Investigational Site Number : 7920004
  - Mersin, Turkey (Türkiye), 33343
    - Investigational Site Number : 7920011
  - Samsun, Turkey (Türkiye), 55139
    - Investigational Site Number : 7920007
United Kingdom
- - Glasgow, United Kingdom, G3 8SJ
    - Investigational Site Number : 8260006
  - Leicester, United Kingdom, LE2 0TA
    - Investigational Site Number : 8260004
- Hampshire
  - Portsmouth, Hampshire, United Kingdom, PO3 6DW
    - Investigational Site Number : 8260003
- London, City of
  - London, London, City of, United Kingdom, SE1 7EH
    - Investigational Site Number : 8262602
  - London, London, City of, United Kingdom, SE1 9RT
    - Investigational Site Number : 8262601
United States
- Arizona
  - Scottsdale, Arizona, United States, 85260
    - Center for Dermatology and Plastic Surgery- Site Number : 8401119
  - Tucson, Arizona, United States, 85745
    - Eclipse Clinical Research- Site Number : 8401158
- California
  - Lomita, California, United States, 90717
    - Torrance Clinical Research- Site Number : 8401027
  - Los Angeles, California, United States, 90045
    - Dermatology Research Associates - Los Angeles- Site Number : 8401092
  - Mission Viejo, California, United States, 92691
    - Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079
  - Oxnard, California, United States, 93030
    - Cura Clinical Research - Oxnard- Site Number : 8401142
  - Santa Monica, California, United States, 90404
    - Clinical Science Institute- Site Number : 8401028
- Connecticut
  - Farmington, Connecticut, United States, 06032
    - University of Connecticut Health Center- Site Number : 8401115
- Florida
  - Coral Gables, Florida, United States, 33146
    - Pediatric Skin Research- Site Number : 8401198
  - Hollywood, Florida, United States, 33021
    - Skin Care Research - Hollywood- Site Number : 8401071
  - Miami, Florida, United States, 33126
    - Savin Medical Group - Miami- Site Number : 8401085
  - Miami, Florida, United States, 33176
    - Anchor Medical Research- Site Number : 8401300
  - Orlando, Florida, United States, 32829
    - Accel Research - Nona Pediatric Center- Site Number : 8401081
  - Pompano Beach, Florida, United States, 33060
    - Nuline Clinical Trial Center- Site Number : 8401161
  - Tampa, Florida, United States, 33607
    - Clinical Research Trials of Florida- Site Number : 8401023
- Georgia
  - Columbus, Georgia, United States, 31904
    - AllerVie Clinical Research - Columbus- Site Number : 8401104
  - Fayetteville, Georgia, United States, 30214
    - First Georgia Physician Group- Site Number : 8401190
- Kentucky
  - Bowling Green, Kentucky, United States, 42104
    - Access Dermatology- Site Number : 8401296
- Louisiana
  - Covington, Louisiana, United States, 70433
    - MedPharmics - Covington- Site Number : 8401137
- Maryland
  - Marriottsville, Maryland, United States, 21104
    - Care Access Research - Marriottsville- Site Number : 8401126
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center Site Number : 8401201
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - University Of Mississippi Medical Center- Site Number : 8401184
- New Jersey
  - Hoboken, New Jersey, United States, 07030
    - Care Access - Hoboken- Site Number : 8401132
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - University of New Mexico Comprehensive Cancer Center- Site Number : 8401263
- New York
  - Brooklyn, New York, United States, 11220
    - OmeraNY- Site Number : 8401156
  - New York, New York, United States, 10023
    - Equity Medical- Site Number : 8401239
  - The Bronx, New York, United States, 10467
    - Montefiore Medical Center - Moses Campus- Site Number : 8401150
- North Dakota
  - Fargo, North Dakota, United States, 58103
    - Red River Research Partners- Site Number : 8401196
- Ohio
  - Bexley, Ohio, United States, 43209
    - Bexley Dermatology Research- Site Number : 8401051
  - Cincinnati, Ohio, United States, 45246
    - Velocity Clinical Research - Springdale- Site Number : 8401153
- Pennsylvania
  - Plymouth Meeting, Pennsylvania, United States, 19462
    - Dermatology Associates of Plymouth Meeting- Site Number : 8401147
  - Upper Saint Clair, Pennsylvania, United States, 15241
    - PEAK Research- Site Number : 8401083
- South Carolina
  - Columbia, South Carolina, United States, 29212
    - Columbia Dermatology & Aesthetics- Site Number : 8401166
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Health Concepts- Site Number : 8401059
- Texas
  - Arlington, Texas, United States, 76011
    - Arlington Research Center- Site Number : 8401248
  - Dallas, Texas, United States, 75235
    - Derm Texas- Site Number : 8401217
  - Houston, Texas, United States, 77004
    - Center for Clinical Studies - Houston - Binz Street- Site Number : 8401063
  - Houston, Texas, United States, 77054
    - Prolato Clinical Research Center- Site Number : 8401209
  - Missouri City, Texas, United States, 77459
    - Sienna Dermatology- Site Number : 8401148
  - San Antonio, Texas, United States, 78229
    - Progressive Clinical Research - San Antonio- Site Number : 8401016
- Utah
  - Ogden, Utah, United States, 84405
    - Advanced Research Institute - Odgen- Site Number : 8401057
- Virginia
  - Arlington, Virginia, United States, 22206
    - Care Access - Arlington- Site Number : 8401134
  - Hampton, Virginia, United States, 23666
    - Velocity Clinical Research - Hampton- Site Number : 8401154

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

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 either inadequate response or inadvisability to topical treatments, and/or inadequate response to systemic therapies (within 12 months before screening)
v-IGA-AD of 3 or 4 at baseline visit
EASI score of 16 or higher at baseline
AD involvement of 10% or more of BSA at baseline
Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
Able and willing to comply with requested study visits and procedures
Body weight ≥ 25 kg

Exclusion Criteria:

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

Skin co-morbidity that would adversely affect the ability to undertake AD assessments
Known history of or suspected significant current immunosuppression
Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline)
History of solid organ or stem cell transplant
Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Number of Arms

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
Experimental: Amlitelimab dose 2 Subcutaneous injection as per protocol	Drug: Amlitelimab Pharmaceutical form: Injection solution Route of administration: SC injection Other Names: SAR445229
Placebo Comparator: Placebo Subcutaneous injection as per protocol	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 Time Frame: 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 Time Frame: 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 Time Frame: 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) Time Frame: Week 24	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.	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 Time Frame: Baseline to Week 24	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Baseline to Week 24
Proportion of participants reaching EASI-75 Time Frame: Baseline to Week 20	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.	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 Time Frame: Baseline to Week 20	The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).	Baseline to Week 20
Proportion of participants reaching EASI-90 Time Frame: Baseline to Week 24	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.	Baseline to Week 24
Proportion of participants reaching EASI-100 Time Frame: Baseline to Week 24	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.	Baseline to Week 24
Change in Hospital Anxiety Depression Scale (HADS) from baseline Time Frame: Baseline to Week 24	The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.	Baseline to Week 24
Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8 Time Frame: Baseline to Week 24	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 Time Frame: Baseline to Week 24	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 Time Frame: Baseline to Week 24	The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.	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 Time Frame: Baseline to Week 24	The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.	Baseline to Week 24
Percent change in EASI score from baseline Time Frame: Baseline to Week 24	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.	Baseline to Week 24
Percent change in weekly average of daily PP-NRS from baseline Time Frame: Baseline to Week 24	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Baseline to Week 24
Proportion of participants reaching EASI-50 Time Frame: Baseline to Week 24	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.	Baseline to Week 24
Proportion of participants with EASI ≤7 Time Frame: Baseline to Week 24	The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.	Baseline to Week 24
Change in percent Body Surface Area (BSA) affected by AD from baseline Time Frame: Baseline to Week 24		Baseline to Week 24
Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline Time Frame: Baseline to Week 24	The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).	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 Time Frame: Baseline to Week 24	The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).	Baseline to Week 24
Proportion of participants with rescue medication use Time Frame: Baseline to Week 24		Baseline to Week 24
Serum amlitelimab concentrations Time Frame: Baseline to Week 40		Baseline to Week 40
Incidence of antidrug antibodies (ADAs) of amlitelimab Time Frame: Baseline to Week 40		Baseline to Week 40
Proportion of participants with PP-NRS 0 or 1 Time Frame: Baseline to Week 24	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	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 Time Frame: Baseline to Week 24	The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.	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 Time Frame: Baseline to Week 24	The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL	Baseline to Week 24
Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline Time Frame: Baseline to Week 24	The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.	Baseline to Week 24
Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline Time Frame: Baseline to Week 24	The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.	Baseline to Week 24
Percent change in weekly average of daily SP-NRS from baseline Time Frame: Baseline to Week 24	The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.	Baseline to Week 24
Percent change in weekly average of daily SD-NRS from baseline Time Frame: Baseline to Week 24	The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.	Baseline to Week 24
Absolute change in weekly average of daily PP-NRS from baseline Time Frame: Baseline to Week 24	The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.	Baseline to Week 24
Absolute change in SCORAD index from baseline Time Frame: Baseline to Week 24	The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).	Baseline to Week 24
Change in Patient Oriented Eczema Measure (POEM) from baseline Time Frame: Baseline to Week 24	The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.	Baseline to Week 24
Proportion of participants with a reduction in POEM ≥4 from baseline in participants with POEM Baseline ≥4 Time Frame: Baseline to Week 24	The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.	Baseline to Week 24
Percentage of participants who experience Treatment-Emergent Adverse Events (TEAEs), experience Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment- Emergent Adverse Events of Special Interest (AESI) Time Frame: Baseline to Week 40		Baseline to Week 40
Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old Time Frame: Baseline to Week 24	The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.	Baseline to Week 24
Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old Time Frame: Baseline to Week 24	The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.	Baseline to 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) and a reduction from baseline of ≥2 points Time Frame: Baseline to Week 24	The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).	Baseline to Week 24
Proportion of participants with vIGA-AD 0 (clear) Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

EFC17560 Plain Language Results Summary

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2023

Primary Completion (Actual)

November 25, 2025

Study Completion (Actual)

March 12, 2026

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 13, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

EFC17560
2023-506557-38 (Registry Identifier: CTIS)
U1111-1275-9665 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Amlitelimab

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