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)

NCT06181435 | Completed Phase 3 DMC FDA Drug

• 3 other identifiers: EFC175602023-506557-38U1111-1275-9665
• Study Type: interventional
• Target: 589
• Locations: 16 countries
• Sites: 142

Brief 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).

Conditions

Dermatitis Atopic

Outcome Measures

Primary Outcomes (3)

• EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24

  The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

  Week 24

• EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at Week 24

  The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

  Week 24

• US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24

  The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

  Week 24

Secondary Outcomes (37)

• Proportion of participants reaching EASI-75 at Week 24 (for US and US reference countries only)

  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

  Baseline to Week 24

• Proportion of participants with ≥4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS ≥4

  Baseline to Week 24

• Proportion of participants reaching EASI-75

  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

  Baseline to Week 20

Study Arms (3)

Amlitelimab dose 1

EXPERIMENTAL

Subcutaneous injection as per protocol

Drug: Amlitelimab

Amlitelimab dose 2

EXPERIMENTAL

Subcutaneous injection as per protocol

Drug: Amlitelimab

Placebo

PLACEBO COMPARATOR

Subcutaneous injection as per protocol

Drug: Placebo

Interventions

Placebo DRUG

Pharmaceutical form: Injection solution Route of administration: SC injection

Placebo

Amlitelimab DRUG

Pharmaceutical form: Injection solution Route of administration: SC injection

Also known as: SAR445229

Amlitelimab dose 1; Amlitelimab dose 2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (142)

Center for Dermatology and Plastic Surgery- Site Number : 8401119

Scottsdale, Arizona, 85260, United States

Location

Eclipse Clinical Research- Site Number : 8401158

Tucson, Arizona, 85745, United States

Location

Torrance Clinical Research- Site Number : 8401027

Lomita, California, 90717, United States

Location

Dermatology Research Associates - Los Angeles- Site Number : 8401092

Los Angeles, California, 90045, United States

Location

Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079

Mission Viejo, California, 92691, United States

Location

Cura Clinical Research - Oxnard- Site Number : 8401142

Oxnard, California, 93030, United States

Location

Clinical Science Institute- Site Number : 8401028

Santa Monica, California, 90404, United States

Location

University of Connecticut Health Center- Site Number : 8401115

Farmington, Connecticut, 06032, United States

Location

Pediatric Skin Research- Site Number : 8401198

Coral Gables, Florida, 33146, United States

Location

Skin Care Research - Hollywood- Site Number : 8401071

Hollywood, Florida, 33021, United States

Location

Savin Medical Group - Miami- Site Number : 8401085

Miami, Florida, 33126, United States

Location

Anchor Medical Research- Site Number : 8401300

Miami, Florida, 33176, United States

Location

Accel Research - Nona Pediatric Center- Site Number : 8401081

Orlando, Florida, 32829, United States

Location

Nuline Clinical Trial Center- Site Number : 8401161

Pompano Beach, Florida, 33060, United States

Location

Clinical Research Trials of Florida- Site Number : 8401023

Tampa, Florida, 33607, United States

Location

AllerVie Clinical Research - Columbus- Site Number : 8401104

Columbus, Georgia, 31904, United States

Location

First Georgia Physician Group- Site Number : 8401190

Fayetteville, Georgia, 30214, United States

Location

Access Dermatology- Site Number : 8401296

Bowling Green, Kentucky, 42104, United States

Location

MedPharmics - Covington- Site Number : 8401137

Covington, Louisiana, 70433, United States

Location

Care Access Research - Marriottsville- Site Number : 8401126

Marriottsville, Maryland, 21104, United States

Location

Tufts Medical Center Site Number : 8401201

Boston, Massachusetts, 02111, United States

Location

University Of Mississippi Medical Center- Site Number : 8401184

Jackson, Mississippi, 39216, United States

Location

Care Access - Hoboken- Site Number : 8401132

Hoboken, New Jersey, 07030, United States

Location

University of New Mexico Comprehensive Cancer Center- Site Number : 8401263

Albuquerque, New Mexico, 87102, United States

Location

OmeraNY- Site Number : 8401156

Brooklyn, New York, 11220, United States

Location

Equity Medical- Site Number : 8401239

New York, New York, 10023, United States

Location

Montefiore Medical Center - Moses Campus- Site Number : 8401150

The Bronx, New York, 10467, United States

Location

Red River Research Partners- Site Number : 8401196

Fargo, North Dakota, 58103, United States

Location

Bexley Dermatology Research- Site Number : 8401051

Bexley, Ohio, 43209, United States

Location

Velocity Clinical Research - Springdale- Site Number : 8401153

Cincinnati, Ohio, 45246, United States

Location

Dermatology Associates of Plymouth Meeting- Site Number : 8401147

Plymouth Meeting, Pennsylvania, 19462, United States

Location

PEAK Research- Site Number : 8401083

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Columbia Dermatology & Aesthetics- Site Number : 8401166

Columbia, South Carolina, 29212, United States

Location

Health Concepts- Site Number : 8401059

Rapid City, South Dakota, 57702, United States

Location

Arlington Research Center- Site Number : 8401248

Arlington, Texas, 76011, United States

Location

Derm Texas- Site Number : 8401217

Dallas, Texas, 75235, United States

Location

Center for Clinical Studies - Houston - Binz Street- Site Number : 8401063

Houston, Texas, 77004, United States

Location

Prolato Clinical Research Center- Site Number : 8401209

Houston, Texas, 77054, United States

Location

Sienna Dermatology- Site Number : 8401148

Missouri City, Texas, 77459, United States

Location

Progressive Clinical Research - San Antonio- Site Number : 8401016

San Antonio, Texas, 78229, United States

Location

Advanced Research Institute - Odgen- Site Number : 8401057

Ogden, Utah, 84405, United States

Location

Care Access - Arlington- Site Number : 8401134

Arlington, Virginia, 22206, United States

Location

Velocity Clinical Research - Hampton- Site Number : 8401154

Hampton, Virginia, 23666, United States

Location

Investigational Site Number : 0320021

Berazategui, Buenos Aires, 1886, Argentina

Location

Investigational Site Number : 0320017

Pilar, Buenos Aires, 1629, Argentina

Location

Investigational Site Number : 0320006

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320007

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320015

Rosario, Santa Fe Province, 2000, Argentina

Location

Investigational Site Number : 0320016

Buenos Aires, 1055, Argentina

Location

Investigational Site Number : 0320001

Buenos Aires, 1121, Argentina

Location

Investigational Site Number : 0320002

Buenos Aires, 1425, Argentina

Location

Investigational Site Number : 0320009

Buenos Aires, 1425, Argentina

Location

Investigational Site Number : 1002008

Gabrovo, 5300, Bulgaria

Location

Investigational Site Number : 1002004

Pleven, 5800, Bulgaria

Location

Investigational Site Number : 1002005

Sofia, 1431, Bulgaria

Location

Investigational Site Number : 1520004

Valdivia, Los Ríos Region, 5110683, Chile

Location

Investigational Site Number : 1520013

Santiago, Reg Metropolitana de Santiago, 7500505, Chile

Location

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, 7640881, Chile

Location

Investigational Site Number : 1520014

Santiago, Reg Metropolitana de Santiago, 7750495, Chile

Location

Investigational Site Number : 1520015

Quillota, Región de Valparaíso, 2260877, Chile

Location

Investigational Site Number : 1560004

Beijing, 100191, China

Location

Investigational Site Number : 1560030

Beijing, 100730, China

Location

Investigational Site Number : 1560022

Chengdu, 610041, China

Location

Investigational Site Number : 1560021

Guangzhou, 510018, China

Location

Investigational Site Number : 1560025

Guangzhou, 510080, China

Location

Investigational Site Number : 1560002

Hangzhou, 310006, China

Location

Investigational Site Number : 1560006

Hangzhou, 310009, China

Location

Investigational Site Number : 1560029

Hangzhou, 310014, China

Location

Investigational Site Number : 1560007

Jinan, 250013, China

Location

Investigational Site Number : 1560024

Ningbo, 315010, China

Location

Investigational Site Number : 1560001

Shanghai, 200040, China

Location

Investigational Site Number : 1560005

Shanghai, 200443, China

Location

Investigational Site Number : 1560026

Shenyang, 110179, China

Location

Investigational Site Number : 1560023

Wenzhou, 325035, China

Location

Investigational Site Number : 1560003

Wuxi, 214000, China

Location

Investigational Site Number : 1560028

Zhenjiang, 212000, China

Location

Investigational Site Number : 2032106

Kutná Hora, 284 01, Czechia

Location

Investigational Site Number : 2030010

Olomouc, 779 00, Czechia

Location

Investigational Site Number : 2032104

Ostrava, 702 00, Czechia

Location

Investigational Site Number : 2030011

Prague, 150 00, Czechia

Location

Investigational Site Number : 2030006

Prague, 160 00, Czechia

Location

Investigational Site Number : 2080002

Aalborg, 9000, Denmark

Location

Investigational Site Number : 2080001

Aarhus, 8200, Denmark

Location

Investigational Site Number : 2080003

Herlev, 2730, Denmark

Location

Investigational Site Number : 3800018

Rozzano, Milano, 20089, Italy

Location

Investigational Site Number : 3800013

Rome, Roma, 00133, Italy

Location

Investigational Site Number : 3800009

Catania, 95123, Italy

Location

Investigational Site Number : 3800008

Pisa, 56126, Italy

Location

Investigational Site Number : 3800022

Vicenza, 36100, Italy

Location

Investigational Site Number : 3920009

Chitose, Hokkaido, 066-0021, Japan

Location

Investigational Site Number : 3923114

Obihiro, Hokkaido, 080-0013, Japan

Location

Investigational Site Number : 3920008

Sapporo, Hokkaido, 064-0921, Japan

Location

Investigational Site Number : 3920006

Kobe, Hyōgo, 653-0836, Japan

Location

Investigational Site Number : 3920005

Sagamihara, Kanagawa, 252-0315, Japan

Location

Investigational Site Number : 3923113

Yokohama, Kanagawa, 221-0825, Japan

Location

Investigational Site Number : 3920010

Miyagi-gun, Miyagi, 981-0112, Japan

Location

Investigational Site Number : 3920011

Sendai, Miyagi, 981-3133, Japan

Location

Investigational Site Number : 3923109

Habikino, Osaka, 583-8588, Japan

Location

Investigational Site Number : 3923110

Sakai, Osaka, 593-8324, Japan

Location

Investigational Site Number : 3920002

Iruma, Saitama, 350-0495, Japan

Location

Investigational Site Number : 3923106

Mibu, Tochigi, 321-0293, Japan

Location

Investigational Site Number : 3920004

Chūō, Tokyo, 104-0031, Japan

Location

Investigational Site Number : 3923107

Minato, Tokyo, 108-0014, Japan

Location

Investigational Site Number : 3920001

Tachikawa, Tokyo, 190-0023, Japan

Location

Investigational Site Number : 3923108

Kagoshima, 890-0063, Japan

Location

Investigational Site Number : 3923102

Kyoto, 602-8566, Japan

Location

Investigational Site Number : 3920003

Kyoto, 606-8507, Japan

Location

Investigational Site Number : 4840011

Monterrey, Nuevo León, 64460, Mexico

Location

Investigational Site Number : 4840005

Monterrey, Nuevo León, 64718, Mexico

Location

Investigational Site Number : 4840012

Aguascalientes, 20127, Mexico

Location

Investigational Site Number : 4840009

Durango, 34000, Mexico

Location

Investigational Site Number : 4840003

Veracruz, 91900, Mexico

Location

Investigational Site Number : 6200005

Lisbon, 1169-050, Portugal

Location

Investigational Site Number : 6200004

Lisbon, 1649-035, Portugal

Location

Investigational Site Number : 6200001

Lisbon, 1998-018, Portugal

Location

Investigational Site Number : 6200003

Porto, 4099-001, Portugal

Location

Investigational Site Number : 7100004

Boksburg, 1459, South Africa

Location

Investigational Site Number : 7100010

Cape Town, 7533, South Africa

Location

Investigational Site Number : 7100009

Cape Town, 7708, South Africa

Location

Investigational Site Number : 7100012

Durban, 3630, South Africa

Location

Investigational Site Number : 7100001

Durban, 4058, South Africa

Location

Investigational Site Number : 7100015

Johannesburg, 1500, South Africa

Location

Investigational Site Number : 7100007

Johannesburg, 2196, South Africa

Location

Investigational Site Number : 7100003

Pretoria, 0009, South Africa

Location

Investigational Site Number : 7240012

Las Palmas de Gran Canaria, Las Palmas, 35010, Spain

Location

Investigational Site Number : 7240018

Granada, 18014, Spain

Location

Investigational Site Number : 7240029

Madrid, 28007, Spain

Location

Investigational Site Number : 7242503

Madrid, 28046, Spain

Location

Investigational Site Number : 7520006

Älvsjö, 125 44, Sweden

Location

Investigational Site Number : 7520001

Örebro, 701 85, Sweden

Location

Investigational Site Number : 7920001

Antalya, 07070, Turkey (Türkiye)

Location

Investigational Site Number : 7920005

Istanbul, 34093, Turkey (Türkiye)

Location

Investigational Site Number : 7920006

Istanbul, 34093, Turkey (Türkiye)

Location

Investigational Site Number : 7920002

Istanbul, 34098, Turkey (Türkiye)

Location

Investigational Site Number : 7920004

Kayseri, 38039, Turkey (Türkiye)

Location

Investigational Site Number : 7920011

Mersin, 33343, Turkey (Türkiye)

Location

Investigational Site Number : 7920007

Samsun, 55139, Turkey (Türkiye)

Location

Investigational Site Number : 8260003

Portsmouth, Hampshire, PO3 6DW, United Kingdom

Location

Investigational Site Number : 8262602

London, London, City of, SE1 7EH, United Kingdom

Location

Investigational Site Number : 8262601

London, London, City of, SE1 9RT, United Kingdom

Location

Investigational Site Number : 8260006

Glasgow, G3 8SJ, United Kingdom

Location

Investigational Site Number : 8260004

Leicester, LE2 0TA, United Kingdom

Location

Related Links

• EFC17560 Plain Language Results Summary

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 26, 2023
• Study Start: December 21, 2023
• Primary Completion: November 25, 2025
• Study Completion: March 12, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

PT (4); BU (3); US (43); ME (5); ES (4); AR (9); CZ (5); DK (3); IT (5); SE (2); CL (5); CN (16); JP (18); GB (5); ZA (8); TU (7)