Clinical trial NCT06130566: 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
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-11-14
Enrollment: 601
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:

* 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

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 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: Percent change in weekly average of daily SP-NRS from baseline
timeFrame: Baseline to Week 24
measure: Proportion of participants with vIGA-AD 0
timeFrame: 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 SD-NRS
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 experienced Treatment-Emergent Adverse Events (TEAEs), experienced 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: Scottsdale Clinical Trials- Site Number : 8401149
state: Arizona
city: Fountain Valley
country: United States
facility: First OC Dermatology- Site Number : 8401025
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research- Site Number : 8401018
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research- Site Number : 8401022
state: California
city: North Hollywood
country: United States
facility: Carbon Health - North Hollywood - NoHo West- Site Number : 8401218
state: California
city: Northridge
country: United States
facility: Northridge Clinical Trials - Northridge- Site Number : 8401080
state: California
city: Doral
country: United States
facility: St Jude Clinical Research- Site Number : 8401287
state: Florida
city: Fort Myers
country: United States
facility: Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center- Site Number : 8401056
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research- Site Number : 8401030
state: Florida
city: Miami
country: United States
facility: Florida International Research Center- Site Number : 8401091
state: Florida
city: Miami
country: United States
facility: Miami Dermatology and Laser Research- Site Number : 8401086
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions - Orlando - South Delaney Avenue- Site Number : 8401035
state: Florida
city: Cumming
country: United States
facility: Cleaver Medical Group Dermatology- Site Number : 8401139
state: Georgia
city: Macon
country: United States
facility: Skin Care Physicians of Georgia - Macon- Site Number : 8401034
state: Georgia
city: Thomasville
country: United States
facility: Javara Research - Thomasville- Site Number : 8401189
state: Georgia
city: Union City
country: United States
facility: Rophe Adult & Pediatric Medicine- Site Number : 8401289
state: Georgia
city: Louisville
country: United States
facility: Skin Sciences- Site Number : 8401039
state: Kentucky
city: Covington
country: United States
facility: MedPharmics - Covington- Site Number : 8401137
state: Louisiana
city: Lafayette
country: United States
facility: MedPharmics - Lafeyette- Site Number : 8401152
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital- Site Number : 8401192
state: Massachusetts
city: Needham
country: United States
facility: Metro Boston Clinical Partners- Site Number : 8401128
state: Massachusetts
city: Dearborn
country: United States
facility: Revival Research - Doral- Site Number : 8401012
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital- Site Number : 8401044
state: Michigan
city: Ridgeland
country: United States
facility: SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058
state: Mississippi
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials- Site Number : 8401140
state: Missouri
city: Lincoln
country: United States
facility: Somnos Clinical Research- Site Number : 8401203
state: Nebraska
city: Bronx
country: United States
facility: CHEAR Center- Site Number : 8401123
state: New York
city: Fairport
country: United States
facility: Universal Dermatology- Site Number : 8401224
state: New York
city: New York
country: United States
facility: Sadick Research Group - New York - Park Avenue- Site Number : 8401050
state: New York
city: Charlotte
country: United States
facility: Onsite Clinical Solutions - Charlotte - Blakeney Park Drive- Site Number : 8401124
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center- Site Number : 8401017
state: Oregon
city: Camp Hill
country: United States
facility: Vial Health - DermDox Dermatology- Site Number : 8401031
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Testing Company- Site Number : 8401041
state: Pennsylvania
city: Philadelphia
country: United States
facility: Clinical Research of Philadelphia- Site Number : 8401193
state: Pennsylvania
city: Greenville
country: United States
facility: Tribe Clinical Research - 525 Verdae Boulevard- Site Number : 8401225
state: South Carolina
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center- Site Number : 8401164
state: Texas
city: Dallas
country: United States
facility: Skin Specialist of Addison- Site Number : 8401208
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists- Site Number : 8401131
state: Texas
city: Southlake
country: United States
facility: Stryde Research - Epiphany Dermatology- Site Number : 8401185
state: Texas
city: Springville
country: United States
facility: Springville Dermatology - Springville- Site Number : 8401106
state: Utah
city: Norfolk
country: United States
facility: Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
state: Virginia
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320023
state: Ciudad De Buenos Aires
city: SAN Miguel DE Tucumã¡n
country: Argentina
facility: Investigational Site Number : 0320024
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320022
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320010
city: Westmead
country: Australia
facility: Investigational Site Number : 0360010
state: New South Wales
city: Woolloongabba
country: Australia
facility: Investigational Site Number : 0360007
state: Queensland
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360008
state: Victoria
city: Melbourne
country: Australia
facility: Investigational Site Number : 0360006
state: Victoria
city: Traralgon
country: Australia
facility: Investigational Site Number : 0361006
state: Victoria
city: Salvador
country: Brazil
facility: Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
state: Bahia
city: Bequimão
country: Brazil
facility: Hospital São Domingos- Site Number : 0760028
state: Maranhão
city: Curitiba
country: Brazil
facility: Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022
state: Paraná
city: Curitiba
country: Brazil
facility: PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023
state: Paraná
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
state: Rio Grande Do Sul
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila- Site Number : 0760006
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC- Site Number : 0760001
city: São Paulo
country: Brazil
facility: Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240031
state: Alberta
city: Surrey
country: Canada
facility: Investigational Site Number : 1240040
state: British Columbia
city: Ajax
country: Canada
facility: Investigational Site Number : 1240033
state: Ontario
city: Hamilton
country: Canada
facility: Investigational Site Number : 1240055
state: Ontario
city: London
country: Canada
facility: Investigational Site Number : 1240029
state: Ontario
city: Niagara Falls
country: Canada
facility: Investigational Site Number : 1241108
state: Ontario
city: Ottawa
country: Canada
facility: Investigational Site Number : 1240034
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240013
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240035
state: Ontario
city: Saint-jérôme
country: Canada
facility: Investigational Site Number : 1240043
state: Quebec
city: Regina
country: Canada
facility: Investigational Site Number : 1240028
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Investigational Site Number : 1240036
state: Saskatchewan
city: Osorno
country: Chile
facility: Investigational Site Number : 1520009
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520008
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520002
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 : 1520010
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520011
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520005
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Viña Del Mar
country: Chile
facility: Investigational Site Number : 1520006
state: Valparaíso
city: Talcahuano
country: Chile
facility: Investigational Site Number : 1520012
city: Beijing
country: China
facility: Investigational Site Number : 1560042
city: Chengdu
country: China
facility: Investigational Site Number : 1560060
city: Chengdu
country: China
facility: Investigational Site Number : 1560068
city: Chongqing
country: China
facility: Investigational Site Number : 1560057
city: Chongqing
country: China
facility: Investigational Site Number : 1560065
city: Guangzhou
country: China
facility: Investigational Site Number : 1560058
city: Jinan
country: China
facility: Investigational Site Number : 1560059
city: Shenzhen
country: China
facility: Investigational Site Number : 1560064
city: Antony
country: France
facility: Investigational Site Number : 2500008
city: Nantes
country: France
facility: Investigational Site Number : 2500009
city: Paris
country: France
facility: Investigational Site Number : 2500003
city: Reims
country: France
facility: Investigational Site Number : 2500007
city: Romans-sur-isère
country: France
facility: Investigational Site Number : 2500010
city: Bad Bentheim
country: Germany
facility: Investigational Site Number : 2760009
city: Buxtehude
country: Germany
facility: Investigational Site Number : 2760014
city: Hamburg
country: Germany
facility: Investigational Site Number : 2760017
city: Kiel
country: Germany
facility: Investigational Site Number : 2762208
city: Magdeburg
country: Germany
facility: Investigational Site Number : 2760018
city: Mainz
country: Germany
facility: Investigational Site Number : 2760016
city: Münster
country: Germany
facility: Investigational Site Number : 2762201
city: Athens
country: Greece
facility: Investigational Site Number : 3000004
city: Athens
country: Greece
facility: Investigational Site Number : 3000001
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000002
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000003
city: Ahmedabad
country: India
facility: Investigational Site Number : 3560001
city: Belagavi
country: India
facility: Investigational Site Number : 3560005
city: Bengaluru
country: India
facility: Investigational Site Number : 3560008
city: Chandigarh
country: India
facility: Investigational Site Number : 3560004
city: Haryana
country: India
facility: Investigational Site Number : 3560006
city: Kolkata
country: India
facility: Investigational Site Number : 3560007
city: Nagpur
country: India
facility: Investigational Site Number : 3560002
city: Pune
country: India
facility: Investigational Site Number : 3560003
city: Afula
country: Israel
facility: Investigational Site Number : 3760004
city: Be'er Sheva
country: Israel
facility: Investigational Site Number : 3760005
city: Haifa
country: Israel
facility: Investigational Site Number : 3760001
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760003
city: Petah Tikva
country: Israel
facility: Investigational Site Number : 3760006
city: Petah Tikva
country: Israel
facility: Investigational Site Number : 3760002
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number : 4100008
state: Daegu-gwangyeoksi
city: Ansan-si
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Investigational Site Number : 4100014
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Investigational Site Number : 4100009
state: Gyeonggi-do
city: Yangsan-si
country: Korea, Republic of
facility: Investigational Site Number : 4100003
state: Gyeongsangnam-do
city: Bupyeong-gu
country: Korea, Republic of
facility: Investigational Site Number : 4100015
state: Incheon-gwangyeoksi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100010
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100013
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100007
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100006
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100011
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100017
state: Seoul-teukbyeolsi
city: Gwangju
country: Korea, Republic of
facility: Investigational Site Number : 4100012
city: Gdansk
country: Poland
facility: Investigational Site Number : 6160006
state: Pomorskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160003
state: Slaskie
city: Krakow
country: Poland
facility: Investigational Site Number : 6162406
city: Lodz
country: Poland
facility: Investigational Site Number : 6160002
city: Lublin
country: Poland
facility: Investigational Site Number : 6160004
city: Olsztyn
country: Poland
facility: Investigational Site Number : 6160011
city: Tarnow
country: Poland
facility: Investigational Site Number : 6160010
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160009
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160007
city: Kaohsiung City
country: Taiwan
facility: Investigational Site Number : 1583201
city: Taichung
country: Taiwan
facility: Investigational Site Number : 1583202
city: Taipei City
country: Taiwan
facility: Investigational Site Number : 1580001
city: Taipei
country: Taiwan
facility: Investigational Site Number : 1580003
city: Taoyuan City
country: Taiwan
facility: Investigational Site Number : 1583203
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: