A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids
- Conditions
- Dermatitis Atopic
- Interventions
- Registration Number
- NCT06224348
- Lead Sponsor
- Sanofi
- Brief Summary
This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe atopic dermatitis (AD) with a history of inadequate response of topical treatment, on background topical corticosteroid (TCS) and/or topical calcineurin inhibitor (TCI).
The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate to severe AD aged 12 years and older on background TCS and/or TCI.
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 643
- 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 inadequate response 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
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 potential participation in a clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amlitelimab dose 2 Topical corticosteroids Subcutaneous injection as per protocol Placebo Placebo Subcutaneous injection as per protocol Amlitelimab dose 1 Topical corticosteroids Subcutaneous injection as per protocol Placebo Topical calcineurin inhibitors Subcutaneous injection as per protocol Amlitelimab dose 1 Topical calcineurin inhibitors Subcutaneous injection as per protocol Amlitelimab dose 2 Topical calcineurin inhibitors Subcutaneous injection as per protocol Placebo Topical corticosteroids Subcutaneous injection as per protocol Amlitelimab dose 1 Amlitelimab Subcutaneous injection as per protocol Amlitelimab dose 2 Amlitelimab Subcutaneous injection as per protocol
- Primary Outcome Measures
Name Time Method 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 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).
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 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.
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 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).
- Secondary Outcome Measures
Name Time Method Incidence of antidrug antibodies (ADAs) of amlitelimab Baseline to Week 40 Proportion of participants reaching EASI-75 at Week 24 (for US and US reference countries only) Week 24 The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.
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 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).
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 The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Proportion of participants reaching EASI-75 Baseline to Week 20 The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score.
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 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).
Proportion of participants with vIGA-AD 0 (clear) 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).
Proportion of participants reaching EASI-90 Baseline to Week 24 The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-90 is 90% reduction from baseline in EASI score.
Proportion of participants reaching EASI-100 Baseline to Week 24 The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-100 is 100% reduction from baseline in EASI score.
Proportion of participants with PP-NRS 0 or 1 Baseline to Week 2 The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old Baseline to Week 24 The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4 Baseline to Week 24 The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old Baseline to Week 24 The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-\<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
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 Baseline to Week 24 The CDLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in children aged 4-\<16 years. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.
Change in Hospital Anxiety Depression Scale (HADS) from baseline Baseline to Week 24 The HADS is 14-item questionnaire with two subscales: anxiety \& depression. Each subscale (anxiety \& depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state.
Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8 Baseline to Week 24 HADS-A score ranges 0-21 with higher score indicating a poorer state.
Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline ≥8 Baseline to Week 24 HADS-D score ranges 0-21 with higher score indicating a poorer state.
Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline Baseline to Week 24 The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
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 Baseline to Week 24 The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline Baseline to Week 24 The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
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 Baseline to Week 24 The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
Percent change in weekly average of daily SP-NRS from baseline Baseline to Week 24 The SP-NRS is a single item 0-10 numeric rating scale assessing skin pain associated with AD with 0 = no pain and 10 = worst possible pain imaginable.
Percent change in weekly average of daily SD-NRS from baseline Baseline to Week 24 The SD-NRS is a single item 0-10 numeric rating scale assessing sleep disturbance associated with AD with 0 = no sleep loss and 10 = did not sleep at all.
Percent change in EASI score from baseline Baseline to Week 24 The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Percent change in weekly average of daily PP-NRS from baseline Baseline to Week 24 The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Absolute change in weekly average of daily PP-NRS from baseline Baseline to Week 24 The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.
Proportion of participants reaching EASI-50 Baseline to Week 24 The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-50 is 50% reduction from baseline in EASI score.
Proportion of participants with EASI ≤7 Baseline to Week 24 The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
Change in percent Body Surface Area (BSA) affected by AD from baseline Baseline to Week 24 Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline Baseline to Week 24 The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
Absolute change in SCORAD index from baseline Baseline to Week 24 The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
Proportion of participants with a reduction in SCORAD ≥ 8.7 points from baseline in participants with baseline SCORAD score ≥ 8.7 Baseline to Week 24 The SCORAD index is a clinical tool to evaluate the extent and severity of AD. Total score ranges from 0 (absent disease) to 103 (severe disease).
Change in Patient Oriented Eczema Measure (POEM) from baseline Baseline to Week 24 The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.
Proportion of participants with a reduction in POEM ≥4 from baseline in participants with POEM Baseline ≥4 Baseline to Week 24 The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.
Proportion of participants with rescue medication use Baseline to Week 24 Cumulative amount of topical corticosteroids (TCS) consumption Baseline to Week 24 Percentage of TCS/topical calcineurin inhibitors (TCI) free days Baseline to Week 24 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) Baseline to Week 40 Serum amlitelimab concentrations Baseline to Week 40
Trial Locations
- Locations (165)
Investigational Site Number : 1560047
🇨🇳Tianjin, China
Investigational Site Number : 1560049
🇨🇳Wuhan, China
Investigational Site Number : 1560003
🇨🇳Wuxi, China
Investigational Site Number : 7920002
🇹🇷Istanbul, Turkey
Investigational Site Number : 7920009
🇹🇷Istanbul, Turkey
Investigational Site Number : 7920004
🇹🇷Kayseri, Turkey
Investigational Site Number : 7920007
🇹🇷Samsun, Turkey
Investigational Site Number : 2760018
🇩🇪Magdeburg, Germany
Investigational Site Number : 2760016
🇩🇪Mainz, Germany
Investigational Site Number : 2762201
🇩🇪Münster, Germany
Investigational Site Number : 2760019
🇩🇪Witten, Germany
Investigational Site Number : 3800003
🇮🇹Milan, Lombardia, Italy
Investigational Site Number : 3800012
🇮🇹Bologna, Italy
Investigational Site Number : 3800011
🇮🇹L'aquila, Italy
Investigational Site Number : 3800008
🇮🇹Pisa, Italy
Investigational Site Number : 3800019
🇮🇹Torette, Italy
Investigational Site Number : 3920009
🇯🇵Chitose, Hokkaido, Japan
Investigational Site Number : 3923114
🇯🇵Obihiro, Hokkaido, Japan
Investigational Site Number : 3920008
🇯🇵Sapporo, Hokkaido, Japan
Investigational Site Number : 3920006
🇯🇵Kobe, Hyogo, Japan
Investigational Site Number : 3920005
🇯🇵Sagamihara, Kanagawa, Japan
Investigational Site Number : 3923113
🇯🇵Yokohama, Japan
Investigational Site Number : 3920010
🇯🇵Miyagi-gun, Miyagi, Japan
Investigational Site Number : 2500002
🇫🇷Toulouse, France
Investigational Site Number : 2760020
🇩🇪Augsburg, Germany
Investigational Site Number : 2760009
🇩🇪Bad Bentheim, Germany
Investigational Site Number : 2760014
🇩🇪Buxtehude, Germany
Investigational Site Number : 1560044
🇨🇳Hangzhou, China
Investigational Site Number : 2760017
🇩🇪Hamburg, Germany
Investigational Site Number : 1560006
🇨🇳Hangzhou, China
Investigational Site Number : 1560051
🇨🇳Nanchang, China
Investigational Site Number : 1560005
🇨🇳Shanghai, China
Investigational Site Number : 2760021
🇩🇪Hamburg, Germany
Investigational Site Number : 1560041
🇨🇳Shenyang, China
Investigational Site Number : 2762208
🇩🇪Kiel, Germany
Investigational Site Number : 0320004
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 2500016
🇫🇷Saint-pierre, France
Cahaba Dermatology & Skin Health Center- Site Number : 8401066
🇺🇸Birmingham, Alabama, United States
Johnson Dermatology- Site Number : 8401076
🇺🇸Fort Smith, Arkansas, United States
Encino Research Center- Site Number : 8401042
🇺🇸Encino, California, United States
Marvel Clinical Research- Site Number : 8401102
🇺🇸Huntington Beach, California, United States
LA Universal Research Center- Site Number : 8401064
🇺🇸Los Angeles, California, United States
Cura Clinical Research- Site Number : 8401141
🇺🇸Palmdale, California, United States
Integrative Skin Science and Research- Site Number : 8401275
🇺🇸Sacramento, California, United States
Southern California Dermatology- Site Number : 8401043
🇺🇸Santa Ana, California, United States
Skin Care Research - Hollywood- Site Number : 8401071
🇺🇸Hollywood, Florida, United States
Palm Springs Community Health Center- Site Number : 8401264
🇺🇸Miami Lakes, Florida, United States
Clever Medical Research- Site Number : 8401160
🇺🇸Miami, Florida, United States
Acevedo Clinical Research Associates- Site Number : 8401088
🇺🇸Miami, Florida, United States
Global Clinical Professionals (GCP)- Site Number : 8401045
🇺🇸Saint Petersburg, Florida, United States
University of South Florida- Site Number : 8401070
🇺🇸Tampa, Florida, United States
Avita Clinical Research- Site Number : 8401073
🇺🇸Tampa, Florida, United States
Cleaver Medical Group- Site Number : 8401138
🇺🇸Dawsonville, Georgia, United States
NorthShore University HealthSystem - Skokie Hospital- Site Number : 8401038
🇺🇸Skokie, Illinois, United States
Dawes Fretzin Clinical Research- Site Number : 8401015
🇺🇸Indianapolis, Indiana, United States
BRCR Global Gretna- Site Number : 8401243
🇺🇸Gretna, Louisiana, United States
Velocity Clinical Research - New Orleans- Site Number : 8401155
🇺🇸New Orleans, Louisiana, United States
Oakland Medical Center- Site Number : 8401116
🇺🇸Troy, Michigan, United States
Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078
🇺🇸Ypsilanti, Michigan, United States
Dermatology and Skin Cancer Lee's Summit- Site Number : 8401157
🇺🇸Lee's Summit, Missouri, United States
Skin Specialists- Site Number : 8401068
🇺🇸Omaha, Nebraska, United States
Jubilee Clinical Research- Site Number : 8401054
🇺🇸Las Vegas, Nevada, United States
Allcutis Research - Portsmouth- Site Number : 8401082
🇺🇸Portsmouth, New Hampshire, United States
Equity Medical- Site Number : 8401239
🇺🇸New York, New York, United States
Icahn School of Medicine at Mount Sinai- Site Number : 8401129
🇺🇸New York, New York, United States
OptiSkin- Site Number : 8401163
🇺🇸New York, New York, United States
Apex Clinical Research Center- Site Number : 8401237
🇺🇸Mayfield Heights, Ohio, United States
Essential Medical Research- Site Number : 8401183
🇺🇸Tulsa, Oklahoma, United States
Vial Health - DermDox Dermatology- Site Number : 8401031
🇺🇸Camp Hill, Pennsylvania, United States
Clinical Research Center of the Carolinas- Site Number : 8401067
🇺🇸Charleston, South Carolina, United States
SMS Clinical Research- Site Number : 8401182
🇺🇸Mesquite, Texas, United States
Sienna Dermatology- Site Number : 8401148
🇺🇸Missouri City, Texas, United States
Texas Dermatology and Laser Specialists- Site Number : 8401131
🇺🇸San Antonio, Texas, United States
Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026
🇺🇸San Antonio, Texas, United States
Complete Dermatology - Sugar Land- Site Number : 8401061
🇺🇸Sugar Land, Texas, United States
Cope Family Medicine - Ogden Clinic- Site Number : 8401114
🇺🇸Bountiful, Utah, United States
Tanner Clinic - Layton Antelope A- Site Number : 8401151
🇺🇸Layton, Utah, United States
Investigational Site Number : 0320005
🇦🇷Caba, Ciudad De Buenos Aires, Argentina
Investigational Site Number : 0320011
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320019
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320008
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320018
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320010
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320012
🇦🇷Corrientes, Argentina
Investigational Site Number : 0320013
🇦🇷Mendoza, Argentina
Investigational Site Number : 0320020
🇦🇷San Miguel de Tucumán, Argentina
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
🇧🇷Salvador, Bahia, Brazil
Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017
🇧🇷Vitoria, Espírito Santo, Brazil
PUC Trials- Nucleo de Pesquisa clinica da Escola de Medicina da PUCPR- Site Number : 0760023
🇧🇷Curitiba, Paraná, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760005
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015
🇧🇷Ribeirão Preto, São Paulo, Brazil
Faculdade de Medicina do ABC- Site Number : 0760001
🇧🇷Santo André, Brazil
Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010
🇧🇷São Paulo, Brazil
Hospital das Clinicas FMUSP- Site Number : 0760012
🇧🇷São Paulo, Brazil
Investigational Site Number : 1002007
🇧🇬Dupnitsa, Bulgaria
Investigational Site Number : 1002004
🇧🇬Pleven, Bulgaria
Investigational Site Number : 1002009
🇧🇬Sofia, Bulgaria
Investigational Site Number : 1002006
🇧🇬Sofia, Bulgaria
Investigational Site Number : 1240039
🇨🇦Calgary, Alberta, Canada
Investigational Site Number : 1240045
🇨🇦Red Deer, Alberta, Canada
Investigational Site Number : 1240046
🇨🇦Kamloops, British Columbia, Canada
Investigational Site Number : 1240030
🇨🇦Surrey, British Columbia, Canada
Investigational Site Number : 1240041
🇨🇦Winnipeg, Manitoba, Canada
Investigational Site Number : 1240057
🇨🇦Brampton, Ontario, Canada
Investigational Site Number : 1241106
🇨🇦Markham, Ontario, Canada
Investigational Site Number : 1240008
🇨🇦Mississauga, Ontario, Canada
Investigational Site Number : 1240004
🇨🇦Peterborough, Ontario, Canada
Investigational Site Number : 1240038
🇨🇦Richmond Hill, Ontario, Canada
Investigational Site Number : 1240012
🇨🇦Toronto, Ontario, Canada
Investigational Site Number : 1241107
🇨🇦Waterloo, Ontario, Canada
Investigational Site Number : 1240006
🇨🇦Québec City, Quebec, Canada
Investigational Site Number : 1520009
🇨🇱Osorno, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520008
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520002
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520003
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520011
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520005
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520001
🇨🇱Santiago, Reg Metropolitana De Santiago, Chile
Investigational Site Number : 1520006
🇨🇱Viña Del Mar, Valparaíso, Chile
Investigational Site Number : 1520010
🇨🇱Santiago, Chile
Investigational Site Number : 1520012
🇨🇱Talcahuano, Chile
Investigational Site Number : 1560050
🇨🇳Changsha, China
Investigational Site Number : 1560060
🇨🇳Chengdu, China
Investigational Site Number : 1560043
🇨🇳Fuzhou, China
Investigational Site Number : 1560021
🇨🇳Guangzhou, China
Investigational Site Number : 2032105
🇨🇿Nový Jičín, Czechia
Investigational Site Number : 2030010
🇨🇿Olomouc, Czechia
Investigational Site Number : 2032104
🇨🇿Ostrava, Czechia
Investigational Site Number : 2030009
🇨🇿Pilsen, Czechia
Investigational Site Number : 2030008
🇨🇿Praha 1, Czechia
Investigational Site Number : 2030011
🇨🇿Prague, Czechia
Investigational Site Number : 2500011
🇫🇷Bordeaux, France
Investigational Site Number : 2500009
🇫🇷Nantes, France
Investigational Site Number : 2500013
🇫🇷Nice, France
Investigational Site Number : 2500006
🇫🇷Pierre-bénite, France
Investigational Site Number : 2500010
🇫🇷Romans-sur-isère, France
Investigational Site Number : 2500012
🇫🇷Rouen, France
Investigational Site Number : 3920011
🇯🇵Sendai-shi, Miyagi, Japan
Investigational Site Number : 3923110
🇯🇵Sakai, Osaka, Japan
Investigational Site Number : 3920002
🇯🇵Iruma, Saitama, Japan
Investigational Site Number : 3923106
🇯🇵Mibu, Tochigi, Japan
Investigational Site Number : 3920004
🇯🇵Chuo, Tokyo, Japan
Investigational Site Number : 3923107
🇯🇵Minato, Tokyo, Japan
Investigational Site Number : 3920001
🇯🇵Tachikawa, Tokyo, Japan
Investigational Site Number : 3923109
🇯🇵Habikino, Japan
Investigational Site Number : 3923108
🇯🇵Kagoshima, Japan
Investigational Site Number : 3923102
🇯🇵Kyoto, Japan
Investigational Site Number : 3920003
🇯🇵Kyoto, Japan
Investigational Site Number : 7240019
🇪🇸Granada, Andalucia, Spain
Investigational Site Number : 7240020
🇪🇸Seville, Andalucia, Spain
Investigational Site Number : 7240008
🇪🇸Bilbao, Bizkaia, Spain
Investigational Site Number : 7240010
🇪🇸Esplugues de Llobregat, Catalunya [Cataluña], Spain
Investigational Site Number : 7240015
🇪🇸Pamplona, Navarra, Spain
Investigational Site Number : 7240023
🇪🇸Burjassot, Valenciana, Comunidad, Spain
Investigational Site Number : 7242502
🇪🇸Manises, Valencia, Spain
Investigational Site Number : 7242505
🇪🇸Alicante, Spain
Investigational Site Number : 7240013
🇪🇸Madrid, Spain
Investigational Site Number : 7240014
🇪🇸Vigo, Spain
Investigational Site Number : 7920010
🇹🇷Ankara, Turkey
Investigational Site Number : 7920001
🇹🇷Antalya, Turkey
Investigational Site Number : 7920008
🇹🇷Gaziantep, Turkey
Investigational Site Number : 7920003
🇹🇷Istanbul, Turkey
Investigational Site Number : 7920005
🇹🇷Istanbul, Turkey
Investigational Site Number : 7920006
🇹🇷Istanbul, Turkey