Clinical trial NCT06181435: 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)
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-12-26
Enrollment: 547
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Week 24
measure: 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
timeFrame: Week 24
measure: 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
timeFrame: Week 24
Secondary outcomes:
measure: Proportion of participants reaching EASI-75 at Week 24 (for US and US reference countries only)
timeFrame: Week 24
measure: 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
timeFrame: Baseline to Week 24
measure: 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
timeFrame: Baseline to Week 24
measure: Proportion of participants reaching EASI-75
timeFrame: Baseline to Week 20
measure: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points
timeFrame: Baseline to Week 20
measure: Proportion of participants with vIGA-AD 0 (clear)
timeFrame: Week 24
measure: Proportion of participants reaching EASI-90
timeFrame: Baseline to Week 24
measure: Proportion of participants reaching EASI-100
timeFrame: Baseline to Week 24
measure: Proportion of participants with PP-NRS 0 or 1
timeFrame: Baseline to Week 24
measure: Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old
timeFrame: Baseline to Week 24
measure: Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4
timeFrame: Baseline to Week 24
measure: Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old
timeFrame: Baseline to Week 24
measure: 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
timeFrame: Baseline to Week 24
measure: Change in Hospital Anxiety Depression Scale (HADS) from baseline
timeFrame: Baseline to Week 24
measure: Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8
timeFrame: Baseline to Week 24
measure: Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline ≥8
timeFrame: Baseline to Week 24
measure: Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline
timeFrame: Baseline to Week 24
measure: 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
timeFrame: Baseline to Week 24
measure: Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline
timeFrame: Baseline to Week 24
measure: 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
timeFrame: Baseline to Week 24
measure: Percent change in weekly average of daily SP-NRS from baseline
timeFrame: Baseline to Week 24
measure: Percent change in weekly average of daily SD-NRS from baseline
timeFrame: Baseline to Week 24
measure: Percent change in EASI score from baseline
timeFrame: Baseline to Week 24
measure: Percent change in weekly average of daily PP-NRS from baseline
timeFrame: Baseline to Week 24
measure: Absolute change in weekly average of daily PP-NRS from baseline
timeFrame: Baseline to Week 24
measure: Proportion of participants reaching EASI-50
timeFrame: Baseline to Week 24
measure: Proportion of participants with EASI ≤7
timeFrame: Baseline to Week 24
measure: Change in percent Body Surface Area (BSA) affected by AD from baseline
timeFrame: Baseline to Week 24
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline
timeFrame: Baseline to Week 24
measure: Absolute change in SCORAD index from baseline
timeFrame: Baseline to Week 24
measure: Proportion of participants with a reduction in SCORAD ≥ 8.7 points from baseline in participants with baseline SCORAD score ≥ 8.7
timeFrame: Baseline to Week 24
measure: Change in Patient Oriented Eczema Measure (POEM) from baseline
timeFrame: Baseline to Week 24
measure: Proportion of participants with a reduction in POEM ≥4 from baseline in participants with POEM Baseline ≥4
timeFrame: Baseline to Week 24
measure: Proportion of participants with rescue medication use
timeFrame: Baseline to Week 24
measure: 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)
timeFrame: Baseline to Week 40
measure: Serum amlitelimab concentrations
timeFrame: Baseline to Week 40
measure: Incidence of antidrug antibodies (ADAs) of amlitelimab
timeFrame: Baseline to Week 40
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery- Site Number : 8401119
state: Arizona
city: Tucson
country: United States
facility: Eclipse Clinical Research- Site Number : 8401158
state: Arizona
city: Lomita
country: United States
facility: Torrance Clinical Research- Site Number : 8401027
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates - Los Angeles- Site Number : 8401092
state: California
city: Mission Viejo
country: United States
facility: Allergy & Asthma Associates of Southern California - Mission Viejo- Site Number : 8401079
state: California
city: Oxnard
country: United States
facility: Cura Clinical Research - Oxnard- Site Number : 8401142
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute- Site Number : 8401028
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center- Site Number : 8401115
state: Connecticut
city: Coral Gables
country: United States
facility: Pediatric Skin Research- Site Number : 8401198
state: Florida
city: Hollywood
country: United States
facility: Skin Care Research - Hollywood- Site Number : 8401071
state: Florida
city: Miami
country: United States
facility: Savin Medical Group - Miami- Site Number : 8401085
state: Florida
city: Miami
country: United States
facility: Anchor Medical Research- Site Number : 8401300
state: Florida
city: Orlando
country: United States
facility: Nona Pediatric Center- Site Number : 8401081
state: Florida
city: Pompano Beach
country: United States
facility: Nuline Clinical Trial Center- Site Number : 8401161
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida- Site Number : 8401023
state: Florida
city: Columbus
country: United States
facility: AllerVie Clinical Research - Columbus- Site Number : 8401104
state: Georgia
city: Fayetteville
country: United States
facility: First Georgia Physician Group- Site Number : 8401190
state: Georgia
city: Bowling Green
country: United States
facility: Access Dermatology- Site Number : 8401296
state: Kentucky
city: Covington
country: United States
facility: MedPharmics - Covington- Site Number : 8401137
state: Louisiana
city: Marriottsville
country: United States
facility: Care Access Research - Marriottsville- Site Number : 8401126
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center Site Number : 8401201
state: Massachusetts
city: Jackson
country: United States
facility: University Of Mississippi Medical Center- Site Number : 8401184
state: Mississippi
city: Hoboken
country: United States
facility: Care Access - Hoboken- Site Number : 8401132
state: New Jersey
city: Albuquerque
country: United States
facility: The University of New Mexico- Site Number : 8401263
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center - Moses Campus- Site Number : 8401150
state: New York
city: Brooklyn
country: United States
facility: OmeraNY- Site Number : 8401156
state: New York
city: New York
country: United States
facility: Equity Medical- Site Number : 8401239
state: New York
city: Fargo
country: United States
facility: Red River Research Partners- Site Number : 8401196
state: North Dakota
city: Bexley
country: United States
facility: Bexley Dermatology Research- Site Number : 8401051
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research - Springdale- Site Number : 8401153
state: Ohio
city: Plymouth Meeting
country: United States
facility: Dermatology Associates of Plymouth Meeting- Site Number : 8401147
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: PEAK Research- Site Number : 8401083
state: Pennsylvania
city: Columbia
country: United States
facility: Columbia Dermatology & Aesthetics- Site Number : 8401166
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts- Site Number : 8401059
state: South Dakota
city: Arlington
country: United States
facility: Arlington Research Center- Site Number : 8401248
state: Texas
city: Dallas
country: United States
facility: Derm Texas- Site Number : 8401217
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies - Houston - Binz Street- Site Number : 8401063
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center- Site Number : 8401209
state: Texas
city: Missouri City
country: United States
facility: Sienna Dermatology- Site Number : 8401148
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research - San Antonio- Site Number : 8401016
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute - Odgen- Site Number : 8401057
state: Utah
city: Arlington
country: United States
facility: Care Access - Arlington 2- Site Number : 8401134
state: Virginia
city: Hampton
country: United States
facility: Velocity Clinical Research - Hampton- Site Number : 8401154
state: Virginia
city: Berazategui
country: Argentina
facility: Investigational Site Number : 0320021
state: Buenos Aires
city: Pilar
country: Argentina
facility: Investigational Site Number : 0320017
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320006
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320007
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320015
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320016
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320002
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320009
city: Gabrovo
country: Bulgaria
facility: Investigational Site Number : 1002008
city: Pleven
country: Bulgaria
facility: Investigational Site Number : 1002004
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1002005
city: Valdivia
country: Chile
facility: Investigational Site Number : 1520004
state: Los Ríos
city: Santiago
country: Chile
facility: Investigational Site Number : 1520013
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520003
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520014
state: Reg Metropolitana De Santiago
city: Quillota
country: Chile
facility: Investigational Site Number : 1520015
state: Valparaíso
city: Beijing
country: China
facility: Investigational Site Number : 1560004
city: Beijing
country: China
facility: Investigational Site Number : 1560030
city: Chengdu
country: China
facility: Investigational Site Number : 1560022
city: Guangzhou
country: China
facility: Investigational Site Number : 1560021
city: Guangzhou
country: China
facility: Investigational Site Number : 1560025
city: Hangzhou
country: China
facility: Investigational Site Number : 1560002
city: Hangzhou
country: China
facility: Investigational Site Number : 1560006
city: Hangzhou
country: China
facility: Investigational Site Number : 1560029
city: Jinan
country: China
facility: Investigational Site Number : 1560007
city: Ningbo
country: China
facility: Investigational Site Number : 1560024
city: Shanghai
country: China
facility: Investigational Site Number : 1560001
city: Shanghai
country: China
facility: Investigational Site Number : 1560005
city: Shenyang
country: China
facility: Investigational Site Number : 1560026
city: Wenzhou
country: China
facility: Investigational Site Number : 1560023
city: Wuxi
country: China
facility: Investigational Site Number : 1560003
city: Zhenjiang
country: China
facility: Investigational Site Number : 1560028
city: Kutná Hora
country: Czechia
facility: Investigational Site Number : 2032106
city: Olomouc
country: Czechia
facility: Investigational Site Number : 2030010
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2032104
city: Prague
country: Czechia
facility: Investigational Site Number : 2030011
city: Prague
country: Czechia
facility: Investigational Site Number : 2030006
city: Aalborg
country: Denmark
facility: Investigational Site Number : 2080002
city: Aarhus
country: Denmark
facility: Investigational Site Number : 2080001
city: Herlev
country: Denmark
facility: Investigational Site Number : 2080003
city: Rozzano
country: Italy
facility: Investigational Site Number : 3800018
state: Milano
city: Rome
country: Italy
facility: Investigational Site Number : 3800013
state: Roma
city: Catania
country: Italy
facility: Investigational Site Number : 3800009
city: Pisa
country: Italy
facility: Investigational Site Number : 3800008
city: Vicenza
country: Italy
facility: Investigational Site Number : 3800022
city: Chitose
country: Japan
facility: Investigational Site Number : 3920009
state: Hokkaido
city: Obihiro
country: Japan
facility: Investigational Site Number : 3923114
state: Hokkaido
city: Sapporo
country: Japan
facility: Investigational Site Number : 3920008
state: Hokkaido
city: Kobe
country: Japan
facility: Investigational Site Number : 3920006
state: Hyogo
city: Sagamihara
country: Japan
facility: Investigational Site Number : 3920005
state: Kanagawa
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number : 3923113
state: Kanagawa
city: Miyagi-gun
country: Japan
facility: Investigational Site Number : 3920010
state: Miyagi
city: Sendai
country: Japan
facility: Investigational Site Number : 3920011
state: Miyagi
city: Habikino
country: Japan
facility: Investigational Site Number : 3923109
state: Osaka
city: Sakai
country: Japan
facility: Investigational Site Number : 3923110
state: Osaka
city: Iruma
country: Japan
facility: Investigational Site Number : 3920002
state: Saitama
city: Mibu
country: Japan
facility: Investigational Site Number : 3923106
state: Tochigi
city: Chuo
country: Japan
facility: Investigational Site Number : 3920004
state: Tokyo
city: Minato
country: Japan
facility: Investigational Site Number : 3923107
state: Tokyo
city: Tachikawa
country: Japan
facility: Investigational Site Number : 3920001
state: Tokyo
city: Kagoshima
country: Japan
facility: Investigational Site Number : 3923108
city: Kyoto
country: Japan
facility: Investigational Site Number : 3923102
city: Kyoto
country: Japan
facility: Investigational Site Number : 3920003
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840011
state: Nuevo León
city: Monterrey
country: Mexico
facility: Investigational Site Number : 4840005
state: Nuevo León
city: Aguascalientes
country: Mexico
facility: Investigational Site Number : 4840012
city: Durango
country: Mexico
facility: Investigational Site Number : 4840009
city: Veracruz
country: Mexico
facility: Investigational Site Number : 4840003
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6200005
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6200004
city: Lisbon
country: Portugal
facility: Investigational Site Number : 6200001
city: Porto
country: Portugal
facility: Investigational Site Number : 6200003
city: Boksburg
country: South Africa
facility: Investigational Site Number : 7100004
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100010
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100009
city: Durban
country: South Africa
facility: Investigational Site Number : 7100012
city: Durban
country: South Africa
facility: Investigational Site Number : 7100001
city: Johannesburg
country: South Africa
facility: Investigational Site Number : 7100015
city: Johannesburg
country: South Africa
facility: Investigational Site Number : 7100007
city: Pretoria
country: South Africa
facility: Investigational Site Number : 7100003
city: Las Palmas de Gran Canaria
country: Spain
facility: Investigational Site Number : 7240012
state: Las Palmas
city: Granada
country: Spain
facility: Investigational Site Number : 7240018
city: Madrid
country: Spain
facility: Investigational Site Number : 7240029
city: Madrid
country: Spain
facility: Investigational Site Number : 7242503
city: Alvsjo
country: Sweden
facility: Investigational Site Number : 7520006
city: Örebro
country: Sweden
facility: Investigational Site Number : 7520001
city: Antalya
country: Turkey
facility: Investigational Site Number : 7920001
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920005
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920006
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920002
city: Kayseri
country: Turkey
facility: Investigational Site Number : 7920004
city: Mersin
country: Turkey
facility: Investigational Site Number : 7920011
city: Samsun
country: Turkey
facility: Investigational Site Number : 7920007
city: Portsmouth
country: United Kingdom
facility: Investigational Site Number : 8260003
state: Hampshire
city: London
country: United Kingdom
facility: Investigational Site Number : 8262602
state: London, City Of
city: London
country: United Kingdom
facility: Investigational Site Number : 8262601
state: London, City Of
city: Glasgow
country: United Kingdom
facility: Investigational Site Number : 8260006
city: Leicester
country: United Kingdom
facility: Investigational Site Number : 8260004
Study officials:
References: