Clinical trial NCT05769777: Open Label, Long-term Study Evaluating Safety and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
Official title: An Open-Label Multinational, Multicenter Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate to Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2023-03-15
Enrollment: 901
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single group, 1-arm, long-term safety study for treatment of participants with moderate to severe atopic dermatitis (AD).

The purpose of this study is to characterize the long-term safety and efficacy of amlitelimab in treated participants with age ≥12 years old with moderate to severe AD.

The study duration per participant will be up to 180 weeks, including:

* A screening period of up to 2 to 4 weeks
* An open label treatment period of up to 160 weeks (approximately 3 years)
* A post-treatment safety follow-up period of at least 20 weeks after the last dose administration

The planned number of visits will be 26 visits.


Eligibility criteria: Inclusion Criteria:

* Participant must be at least 12 years of age inclusive, at the time of signing the informed consent.
* Participants must have AD as defined by the American Academy of Dermatology Consensus Criteria for 1 year or longer at baseline.
* Participant must have documented history (within 6 months prior to screening visit), of inadequate response (including inadequate efficacy or medical inadvisability) to topical treatments and/or inadequate response to systemic therapies (within 12 months prior to screening visit).
* Eczema Area Severity Index (EASI) of 16 or higher at baseline visit/Visit 2.
* Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit/Visit 2.
* AD involvement of 10% or more of body surface area (BSA) at baseline visit/Visit 2.
* Weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) of ≥ 4 at baseline visit/Visit 2.
* Able and willing to comply with requested study visits and procedures.
* Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants must not be pregnant or breastfeeding.

Exclusion Criteria:

* Skin co-morbidity that would adversely affect the ability to undertake AD assessments as per investigator's judgement
* Known history of or suspected significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration.
* Any malignancies or history of malignancies prior to baseline (except for non-melanoma skin cancer that has been excised and completely cured for more than 5 years prior to baseline).
* History of solid organ or stem cell transplant.
* Any pre-planned major elective surgery known about at baseline that in the opinion of the investigator would necessitate that IMP be permanently discontinued or require more than three doses to be missed.
* Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study.
* Any medical or psychiatric condition which, in the opinion of the Investigator may present an unreasonable risk to the study participants as a result of his/her participation in this clinical study, may make participant's participation unreliable, or may interfere with study assessments.
* 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); and any infection which as per Investigator's opinion precludes the participant's participation in the study.
* Treatment with live (attenuated) vaccines within 12 weeks prior to baseline; failure to complete non-live immunizations required by local regulation (eg, vaccination for COVID-19) at least 14 days prior to baseline.
* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.
* Positive for human immunodeficiency virus (HIV), hepatitis B or hepatitis C at the screening visit.
* Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, non-TB mycobacterial infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening.
* In the Investigator's opinion, any clinically significant laboratory results from the clinical chemistry, hematology, coagulation, or urinalysis tests at the screening visit.
* In the Investigator's opinion, any significant abnormality on 12-lead electrocardiogram (ECG) at the screening visit that could be suggestive of an unstable or underlying cardio-vascular condition that could preclude the participant's participation in the study.
* History of hypersensitivity or allergy to any of the excipients or IMP or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.

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

Primary outcomes:
measure: Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to end of study (EOS) (Week 176)
measure: Percentage of participants who experienced Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: Baseline up to EOS (Week 176)
Secondary outcomes:
measure: Percentage of participants who experienced Treatment-Emergent Adverse Events of Special Interest (AESI)
timeFrame: Baseline up to EOS (Week 176)
measure: Percentage of participants with Potentially Clinically Significant Abnormalities (PCSA) for vital signs and clinical laboratory assessments, and electrocardiogram (ECG)
timeFrame: Baseline up to EOS (Week 176)
measure: Percentage of participants discontinued from study treatment due to Adverse Events (AEs)
timeFrame: Baseline up to EOS (Week 176)
measure: Percent change from baseline in Eczema Area and Severity Index (EASI) score
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of participants with at least a ≥75% reduction in EASI score (EASI-75) from baseline
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of participants with EASI-50 /EASI-90 /EASI-100
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction of ≥2 points from baseline
timeFrame: Baseline to EOS (Week 176)
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 EOS (Week 176)
measure: Proportion of participants with vIGA-AD of 0
timeFrame: Baseline to EOS (Week 176)
measure: Change in percent Body Surface Area (BSA) affected by AD from baseline
timeFrame: Baseline to EOS (Week 176)
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of participants requiring rescue treatment at each visit
timeFrame: Baseline to EOS (Week 176)
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 EOS (Week 176)
measure: Proportion of participants with PP-NRS 0 or 1
timeFrame: Baseline to EOS (Week 176)
measure: Percent change in weekly average of daily PP-NRS from baseline
timeFrame: Baseline to EOS (Week 176)
measure: Change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline
timeFrame: Baseline to EOS (Week 176)
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 EOS (Week 176)
measure: Change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline
timeFrame: Baseline to EOS (Week 176)
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 EOS (Week 176)
measure: Change in Patient Oriented Eczema Measure (POEM) from baseline
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of participants with a reduction in POEM ≥4 from Baseline in participants with POEM baseline ≥4
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of adolescent participants with a reduction in POEM ≥6 from Baseline in adolescents with POEM baseline ≥6
timeFrame: Baseline to EOS (Week 176)
measure: Change in Atopic Dermatitis Control Test (ADCT) from baseline
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of participants with a reduction in ADCT ≥5 from baseline in participants with baseline ADCT≥7
timeFrame: Baseline to EOS (Week 176)
measure: Change in Dermatology Quality of Life Index (DLQI) from baseline in participants with age ≥16 years old
timeFrame: Baseline to EOS (Week 176)
measure: Change in Children's Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of participants with age ≥12 to <16 with a reduction in CDLQI ≥4 from Baseline in participants with age ≥12 to <16 years old with CDLQI at baseline ≥6
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of participants with age ≥12 to <16 with a reduction in CDLQI ≥6 from Baseline in participants with age ≥12 to <16 years old with CDLQI at baseline ≥6
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of participants with a reduction in DLQI ≥4 from Baseline in participants with age ≥16 years old and with DLQI at baseline ≥4
timeFrame: Baseline to EOS (Week 176)
measure: Change in Patient Global Impression of Severity (PGIS) from baseline
timeFrame: Baseline to EOS (Week 176)
measure: Proportions of participants who report symptoms to be "No" on the PGIS score
timeFrame: Baseline to EOS (Week 176)
measure: Proportions of participants who report symptoms to be "No" or "Mild" on the PGIS score
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of participants who respond "Much better" on the Patient Global Impression of (PGIC) scale
timeFrame: Week 16 to EOS (Week 176)
measure: Proportion of participants who respond "Much better" or "A little better" on the PGIC scale
timeFrame: Week 16 to EOS (Week 176)
measure: Proportion of participants by PGIC responses
timeFrame: Week 16 to EOS (Week 176)
measure: Change in Hospital Anxiety Depression Scale (HADS) from baseline
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8
timeFrame: Baseline to EOS (Week 176)
measure: Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D Baseline ≥8
timeFrame: Baseline to EOS (Week 176)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Allergy & Asthma Center - Birmingham - Brookwood Boulevard- Site Number : 8400050
state: Alabama
city: Litchfield Park
country: United States
facility: Research Solutions of Arizona- Site Number : 8400020
state: Arizona
city: Phoenix
country: United States
facility: Medical Dermatology Specialists- Site Number : 8400016
state: Arizona
city: Bryant
country: United States
facility: Dermatology Trial Associates- Site Number : 8400027
state: Arkansas
city: Newport Beach
country: United States
facility: University Dermatology Trials, INC.- Site Number : 8400052
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado - Aurora- Site Number : 8400041
state: Colorado
city: Centennial
country: United States
facility: IMMUNOe International Research Centers - Centennial- Site Number : 8400024
state: Colorado
city: Cape Coral
country: United States
facility: Renaissance Research and Medical Group- Site Number : 8400006
state: Florida
city: Coral Springs
country: United States
facility: Life Clinical Trials - Coral Springs- Site Number : 8400040
state: Florida
city: Miami
country: United States
facility: Florida Pharmaceutical Research and Associates- Site Number : 8400018
state: Florida
city: Miami
country: United States
facility: Bio-Medical Research- Site Number : 8400037
state: Florida
city: Miami
country: United States
facility: Miami Clinical Research Tower- Site Number : 8400036
state: Florida
city: Miami
country: United States
facility: Florida Research Center, Inc.- Site Number : 8400011
state: Florida
city: Tampa
country: United States
facility: Clinical Research Trials of Florida- Site Number : 8400054
state: Florida
city: Atlanta
country: United States
facility: Advanced Medical Research - Atlanta- Site Number : 8400044
state: Georgia
city: Savannah
country: United States
facility: Georgia Skin & Cancer Clinic- Site Number : 8400048
state: Georgia
city: Normal
country: United States
facility: Sneeze Wheeze And Itch Assoc- Site Number : 8400002
state: Illinois
city: Sioux City
country: United States
facility: Velocity Clinical Research - Sioux City- Site Number : 8400046
state: Iowa
city: Murray
country: United States
facility: Kentucky Advanced Medical Research- Site Number : 8400014
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical Research - Baton Rouge- Site Number : 8400005
state: Louisiana
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology- Site Number : 8400021
state: Michigan
city: Caledonia
country: United States
facility: The Derm Institute of West Michigan- Site Number : 8400043
state: Michigan
city: Livonia
country: United States
facility: Michigan Dermatology Institute- Site Number : 8401010
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre- Site Number : 8400038
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute - Warren- Site Number : 8400042
state: Michigan
city: Waterford
country: United States
facility: Michigan Dermatology Institute- Site Number : 8400010
state: Michigan
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group @ Union Turnpike- Site Number : 8400007
state: New York
city: Woodbury
country: United States
facility: Aesthetic Dermatology- Site Number : 8400031
state: New York
city: Oklahoma City
country: United States
facility: Unity Clinical Research- Site Number : 8400001
state: Oklahoma
city: Tulsa
country: United States
facility: Dermatology Research Center of Oklahoma, PLLC - Site Number : 8400035
state: Oklahoma
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia- Site Number : 8400009
state: Pennsylvania
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists- Site Number : 8400053
state: Texas
city: Sugar Land
country: United States
facility: Pioneer Research Solutions- Site Number : 8400026
state: Texas
city: Burlington
country: United States
facility: Private Practice - Dr. Marthe N. Dika- Site Number : 8400022
state: Wisconsin
city: General Pico
country: Argentina
facility: Investigational Site Number : 0320022
state: La Pampa
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: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320008
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320001
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320003
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320002
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320009
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320005
city: Kogarah
country: Australia
facility: Investigational Site Number : 0360002
state: New South Wales
city: Sydney
country: Australia
facility: Investigational Site Number : 0360001
state: New South Wales
city: Salvador
country: Brazil
facility: Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
state: Bahia
city: Curitiba
country: Brazil
facility: HC - UFPR - Hospital de Clínicas da Universidade Federal do Paraná- Site Number : 0760022
state: Paraná
city: Curitiba
country: Brazil
facility: Pontifica Universidade Catolica do Parana- 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: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760008
state: São Paulo
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC- Site Number : 0760001
state: São Paulo
city: Sorocaba
country: Brazil
facility: Clinica de Alergia Martti Antila- Site Number : 0760006
state: São Paulo
city: São José Do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto- Site Number : 0760003
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: IDERJ - Instituto de Dermatologia e Estética do Brasil- Site Number : 0760004
city: Calgary
country: Canada
facility: Investigational Site Number : 1240001
state: Alberta
city: Edmonton
country: Canada
facility: Investigational Site Number : 1240052
state: Alberta
city: Vancouver
country: Canada
facility: Investigational Site Number : 1240051
state: British Columbia
city: Etobicoke
country: Canada
facility: Investigational Site Number : 1240009
state: Ontario
city: Mississauga
country: Canada
facility: Investigational Site Number : 1240008
state: Ontario
city: Oakville
country: Canada
facility: Investigational Site Number : 1240011
state: Ontario
city: Peterborough
country: Canada
facility: Investigational Site Number : 1240004
state: Ontario
city: Richmond Hill
country: Canada
facility: Investigational Site Number : 1240003
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240012
state: Ontario
city: Montreal
country: Canada
facility: Investigational Site Number : 1240002
state: Quebec
city: Québec City
country: Canada
facility: Investigational Site Number : 1240010
state: Quebec
city: Québec City
country: Canada
facility: Investigational Site Number : 1240006
state: Quebec
city: Saskatoon
country: Canada
facility: Investigational Site Number : 1240044
state: Saskatchewan
city: Osorno
country: Chile
facility: Investigational Site Number : 1520009
state: Los Lagos
city: Valdivia
country: Chile
facility: Investigational Site Number : 1520004
state: Los Ríos
city: Santiago
country: Chile
facility: Investigational Site Number : 1520011
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 : 1520013
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 : 1520005
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
state: Reg Metropolitana De Santiago
city: Chillán
country: Chile
facility: Investigational Site Number : 1520014
city: Beijing
country: China
facility: Investigational Site Number : 1560015
city: Changchun
country: China
facility: Investigational Site Number : 1560008
city: Changsha
country: China
facility: Investigational Site Number : 1560016
city: Chengdu
country: China
facility: Investigational Site Number : 1560014
city: Fuzhou
country: China
facility: Investigational Site Number : 1560072
city: Guangzhou
country: China
facility: Investigational Site Number : 1560074
city: Hangzhou
country: China
facility: Investigational Site Number : 1560044
city: Hangzhou
country: China
facility: Investigational Site Number : 1560011
city: Jingzhou
country: China
facility: Investigational Site Number : 1560013
city: Shanghai
country: China
facility: Investigational Site Number : 1560001
city: Suzhou
country: China
facility: Investigational Site Number : 1560018
city: Taiyuan
country: China
facility: Investigational Site Number : 1560010
city: Taizhou
country: China
facility: Investigational Site Number : 1560073
city: Xinxiang
country: China
facility: Investigational Site Number : 1560019
city: Yinchuan
country: China
facility: Investigational Site Number : 1560012
city: Zhenjiang
country: China
facility: Investigational Site Number : 1560028
city: Nový Jičín
country: Czechia
facility: Investigational Site Number : 2032105
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2032104
city: Prague
country: Czechia
facility: Investigational Site Number : 2032102
city: Prague
country: Czechia
facility: Investigational Site Number : 2030003
city: Prague
country: Czechia
facility: Investigational Site Number : 2030006
city: Prague
country: Czechia
facility: Investigational Site Number : 2030007
city: Aarhus
country: Denmark
facility: Investigational Site Number : 2080001
city: Créteil
country: France
facility: Investigational Site Number : 2500004
city: Lille
country: France
facility: Investigational Site Number : 2500001
city: Marseille
country: France
facility: Investigational Site Number : 2500005
city: Nantes
country: France
facility: Investigational Site Number : 2500009
city: Paris
country: France
facility: Investigational Site Number : 2500003
city: Pierre-bénite
country: France
facility: Investigational Site Number : 2500006
city: Toulouse
country: France
facility: Investigational Site Number : 2500002
city: Bad Bentheim
country: Germany
facility: Investigational Site Number : 2760009
city: Berlin
country: Germany
facility: Investigational Site Number : 2762203
city: Münster
country: Germany
facility: Investigational Site Number : 2762201
city: Osnabrück
country: Germany
facility: Investigational Site Number : 2760010
city: Bangalore
country: India
facility: Investigational Site Number : 3560006
city: Bikaner
country: India
facility: Investigational Site Number : 3560007
city: Gurugram
country: India
facility: Investigational Site Number : 3560003
city: Kolkata
country: India
facility: Investigational Site Number : 3560005
city: Mangaluru
country: India
facility: Investigational Site Number : 3560004
city: Nashik
country: India
facility: Investigational Site Number : 3560002
city: Surat
country: India
facility: Investigational Site Number : 3560008
city: Milan
country: Italy
facility: Investigational Site Number : 3800003
state: Milano
city: Naples
country: Italy
facility: Investigational Site Number : 3800004
state: Napoli
city: Rome
country: Italy
facility: Investigational Site Number : 3800007
state: Roma
city: Rome
country: Italy
facility: Investigational Site Number : 3800006
state: Roma
city: Brescia
country: Italy
facility: Investigational Site Number : 3800005
city: Caserta
country: Italy
facility: Investigational Site Number : 3800002
city: Vicenza
country: Italy
facility: Investigational Site Number : 3800008
city: Obihiro
country: Japan
facility: Investigational Site Number : 3923114
state: Hokkaido
city: Yokohama
country: Japan
facility: Investigational Site Number : 3923113
state: Kanagawa
city: Sakai
country: Japan
facility: Investigational Site Number : 3923110
state: Osaka
city: Mibu
country: Japan
facility: Investigational Site Number : 3923106
state: Tochigi
city: Tachikawa
country: Japan
facility: Investigational Site Number : 3920001
state: Tokyo
city: Ansan-si
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Gyeonggi-do
city: Bucheon-si
country: Korea, Republic of
facility: Investigational Site Number : 4100016
state: Gyeonggi-do
city: Yangsan-si
country: Korea, Republic of
facility: Investigational Site Number : 4100003
state: Gyeongsangnam-do
city: Incheon
country: Korea, Republic of
facility: Investigational Site Number : 4100018
state: Incheon-gwangyeoksi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100006
state: Seoul-teukbyeolsi
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100001
state: Seoul-teukbyeolsi
city: Chihuahua
country: Mexico
facility: Investigational Site Number : 4840001
city: Durango
country: Mexico
facility: Investigational Site Number : 4840008
city: Breda
country: Netherlands
facility: Investigational Site Number : 5280002
city: Rotterdam
country: Netherlands
facility: Investigational Site Number : 5280004
city: Utrecht
country: Netherlands
facility: Investigational Site Number : 5280001
city: Lodz
country: Poland
facility: Investigational Site Number : 6160014
state: Lódzkie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6162411
state: Mazowieckie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160009
state: Mazowieckie
city: Warsaw
country: Poland
facility: Investigational Site Number : 6160007
state: Mazowieckie
city: Gdansk
country: Poland
facility: Investigational Site Number : 6160006
state: Pomorskie
city: Chorzow
country: Poland
facility: Investigational Site Number : 6160001
state: Slaskie
city: Katowice
country: Poland
facility: Investigational Site Number : 6160003
state: Slaskie
city: Lublin
country: Poland
facility: Investigational Site Number : 6160012
city: Caguas
country: Puerto Rico
facility: Dr. Samuels Sanchez P.S.C.- Site Number : 8400045
city: San Juan
country: Puerto Rico
facility: GCM Medical Group - San Juan - Calle Jose Marti- Site Number : 8400049
city: San Juan
country: Puerto Rico
facility: Caribbean Medical Research Center- Site Number : 8400028
city: Boksburg
country: South Africa
facility: Investigational Site Number : 7100004
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100011
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100010
city: Cape Town
country: South Africa
facility: Investigational Site Number : 7100002
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 : 7100015
city: Johannesburg
country: South Africa
facility: Investigational Site Number : 7100006
city: Johannesburg
country: South Africa
facility: Investigational Site Number : 7100007
city: Middelburg
country: South Africa
facility: Investigational Site Number : 7100005
city: Pretoria
country: South Africa
facility: Investigational Site Number : 7100003
city: Pretoria
country: South Africa
facility: Investigational Site Number : 7100014
city: Badalona
country: Spain
facility: Investigational Site Number : 7240002
state: Barcelona [Barcelona]
city: Sabadell
country: Spain
facility: Investigational Site Number : 7240022
state: Castilla Y León
city: Alicante
country: Spain
facility: Investigational Site Number : 7242505
city: Córdoba
country: Spain
facility: Investigational Site Number : 7242501
city: Madrid
country: Spain
facility: Investigational Site Number : 7240021
city: Madrid
country: Spain
facility: Investigational Site Number : 7242503
city: Valencia
country: Spain
facility: Investigational Site Number : 7240006
city: Buochs
country: Switzerland
facility: Investigational Site Number : 7560002
city: Hsinchu
country: Taiwan
facility: Investigational Site Number : 1580006
city: Kaohsiung City
country: Taiwan
facility: Investigational Site Number : 1583201
city: New Taipei City
country: Taiwan
facility: Investigational Site Number : 1580002
city: Taichung
country: Taiwan
facility: Investigational Site Number : 1583202
city: Taichung
country: Taiwan
facility: Investigational Site Number : 1580007
city: Taipei City
country: Taiwan
facility: Investigational Site Number : 1580001
city: Taoyuan City
country: Taiwan
facility: Investigational Site Number : 1583203
city: Aydin
country: Turkey
facility: Investigational Site Number : 7920002
city: Izmit
country: Turkey
facility: Investigational Site Number : 7920003
city: Manisa
country: Turkey
facility: Investigational Site Number : 7920005
city: Trabzon
country: Turkey
facility: Investigational Site Number : 7920004
city: London
country: United Kingdom
facility: Investigational Site Number : 8260001
state: England
city: London
country: United Kingdom
facility: Investigational Site Number : 8262601
state: London, City Of
city: Edinburgh
country: United Kingdom
facility: Investigational Site Number : 8260002
city: Sheffield
country: United Kingdom
facility: Investigational Site Number : 8260004
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: