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
- Registration Number
- NCT06130566
- Lead Sponsor
- Sanofi
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 601
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Amlitelimab dose 1 Amlitelimab Subcutaneous injection as per protocol Placebo Placebo 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).
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).
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.
- Secondary Outcome Measures
Name Time Method 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 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 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.
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.
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.
Proportion of participants with vIGA-AD 0 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).
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 SD-NRS 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 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 Incidence of antidrug antibodies (ADAs) of amlitelimab Baseline to Week 40
Trial Locations
- Locations (148)
Investigational Site Number : 3000002
🇬🇷Thessaloniki, Greece
Investigational Site Number : 3000003
🇬🇷Thessaloniki, Greece
Investigational Site Number : 3560001
🇮🇳Ahmedabad, India
Investigational Site Number : 3560005
🇮🇳Belagavi, India
Investigational Site Number : 3560008
🇮🇳Bengaluru, India
Investigational Site Number : 3560004
🇮🇳Chandigarh, India
Investigational Site Number : 3560006
🇮🇳Haryana, India
Investigational Site Number : 3560007
🇮🇳Kolkata, India
Investigational Site Number : 3560002
🇮🇳Nagpur, India
Investigational Site Number : 3560003
🇮🇳Pune, India
Investigational Site Number : 3760004
🇮🇱Afula, Israel
Investigational Site Number : 3760005
🇮🇱Be'er Sheva, Israel
Investigational Site Number : 3760001
🇮🇱Haifa, Israel
Investigational Site Number : 3760003
🇮🇱Jerusalem, Israel
Investigational Site Number : 3760006
🇮🇱Petah Tikva, Israel
Investigational Site Number : 3760002
🇮🇱Petah Tikva, Israel
Investigational Site Number : 6162406
🇵🇱Krakow, Poland
Investigational Site Number : 6160002
🇵🇱Lodz, Poland
Investigational Site Number : 6160004
🇵🇱Lublin, Poland
Investigational Site Number : 6160011
🇵🇱Olsztyn, Poland
Investigational Site Number : 6160010
🇵🇱Tarnow, Poland
Investigational Site Number : 6160009
🇵🇱Warsaw, Poland
Investigational Site Number : 6160007
🇵🇱Warsaw, Poland
Investigational Site Number : 2762201
🇩🇪Münster, Germany
Investigational Site Number : 3000004
🇬🇷Athens, Greece
Investigational Site Number : 3000001
🇬🇷Athens, Greece
Investigational Site Number : 2760018
🇩🇪Magdeburg, Germany
Investigational Site Number : 2760016
🇩🇪Mainz, Germany
Investigational Site Number : 2760014
🇩🇪Buxtehude, Germany
Investigational Site Number : 2760017
🇩🇪Hamburg, Germany
Investigational Site Number : 2762208
🇩🇪Kiel, Germany
Investigational Site Number : 1240029
🇨🇦London, Ontario, Canada
Investigational Site Number : 1241108
🇨🇦Niagara Falls, Ontario, Canada
Investigational Site Number : 2500010
🇫🇷Romans-sur-isère, France
Investigational Site Number : 6160003
🇵🇱Katowice, Slaskie, Poland
Investigational Site Number : 2760009
🇩🇪Bad Bentheim, Germany
Investigational Site Number : 1240055
🇨🇦Hamilton, Ontario, Canada
Scottsdale Clinical Trials- Site Number : 8401149
🇺🇸Scottsdale, Arizona, United States
First OC Dermatology- Site Number : 8401025
🇺🇸Fountain Valley, California, United States
Center for Dermatology Clinical Research- Site Number : 8401018
🇺🇸Fremont, California, United States
Investigational Site Number : 6160006
🇵🇱Gdansk, Pomorskie, Poland
Sunwise Clinical Research- Site Number : 8401022
🇺🇸Lafayette, California, United States
Carbon Health - North Hollywood - NoHo West- Site Number : 8401218
🇺🇸North Hollywood, California, United States
Northridge Clinical Trials - Northridge- Site Number : 8401080
🇺🇸Northridge, California, United States
St Jude Clinical Research- Site Number : 8401287
🇺🇸Doral, Florida, United States
Beth Israel Deaconess Medical Center - Fort Myers- Site Number : 8401286
🇺🇸Fort Myers, Florida, United States
Direct Helpers Research Center- Site Number : 8401056
🇺🇸Hialeah, Florida, United States
Encore Medical Research- Site Number : 8401030
🇺🇸Hollywood, Florida, United States
Florida International Research Center- Site Number : 8401091
🇺🇸Miami, Florida, United States
Miami Dermatology and Laser Research- Site Number : 8401086
🇺🇸Miami, Florida, United States
Clinical Neuroscience Solutions - Orlando - South Delaney Avenue- Site Number : 8401035
🇺🇸Orlando, Florida, United States
Cleaver Medical Group Dermatology- Site Number : 8401139
🇺🇸Cumming, Georgia, United States
Skin Care Physicians of Georgia - Macon- Site Number : 8401034
🇺🇸Macon, Georgia, United States
Javara Research - Thomasville- Site Number : 8401189
🇺🇸Thomasville, Georgia, United States
Rophe Adult & Pediatric Medicine- Site Number : 8401289
🇺🇸Union City, Georgia, United States
Skin Sciences- Site Number : 8401039
🇺🇸Louisville, Kentucky, United States
MedPharmics - Covington- Site Number : 8401137
🇺🇸Covington, Louisiana, United States
MedPharmics - Lafeyette- Site Number : 8401152
🇺🇸Lafayette, Louisiana, United States
Massachusetts General Hospital- Site Number : 8401192
🇺🇸Boston, Massachusetts, United States
Metro Boston Clinical Partners- Site Number : 8401128
🇺🇸Needham, Massachusetts, United States
Revival Research - Doral- Site Number : 8401012
🇺🇸Dearborn, Michigan, United States
Henry Ford Hospital- Site Number : 8401044
🇺🇸Detroit, Michigan, United States
SKY Integrative Medical Center/SKYCRNG - Ridgeland- Site Number : 8401058
🇺🇸Ridgeland, Mississippi, United States
MediSearch Clinical Trials- Site Number : 8401140
🇺🇸Saint Joseph, Missouri, United States
Somnos Clinical Research- Site Number : 8401203
🇺🇸Lincoln, Nebraska, United States
CHEAR Center- Site Number : 8401123
🇺🇸Bronx, New York, United States
Universal Dermatology- Site Number : 8401224
🇺🇸Fairport, New York, United States
Sadick Research Group - New York - Park Avenue- Site Number : 8401050
🇺🇸New York, New York, United States
Onsite Clinical Solutions - Charlotte - Blakeney Park Drive- Site Number : 8401124
🇺🇸Charlotte, North Carolina, United States
Oregon Medical Research Center- Site Number : 8401017
🇺🇸Portland, Oregon, United States
Vial Health - DermDox Dermatology- Site Number : 8401031
🇺🇸Camp Hill, Pennsylvania, United States
Paddington Testing Company- Site Number : 8401041
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research of Philadelphia- Site Number : 8401193
🇺🇸Philadelphia, Pennsylvania, United States
Tribe Clinical Research - 525 Verdae Boulevard- Site Number : 8401225
🇺🇸Greenville, South Carolina, United States
Dermatology Treatment and Research Center- Site Number : 8401164
🇺🇸Dallas, Texas, United States
Skin Specialist of Addison- Site Number : 8401208
🇺🇸Dallas, Texas, United States
Texas Dermatology and Laser Specialists- Site Number : 8401131
🇺🇸San Antonio, Texas, United States
Stryde Research - Epiphany Dermatology- Site Number : 8401185
🇺🇸Southlake, Texas, United States
Springville Dermatology - Springville- Site Number : 8401106
🇺🇸Springville, Utah, United States
Virginia Dermatology & Skin Cancer Center- Site Number : 8401047
🇺🇸Norfolk, Virginia, United States
Investigational Site Number : 0320023
🇦🇷Buenos Aires, Ciudad De Buenos Aires, Argentina
Investigational Site Number : 0320024
🇦🇷SAN Miguel DE Tucumã¡n, Tucumán, Argentina
Investigational Site Number : 0320022
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0320010
🇦🇷Buenos Aires, Argentina
Investigational Site Number : 0360010
🇦🇺Westmead, New South Wales, Australia
Investigational Site Number : 0360007
🇦🇺Woolloongabba, Queensland, Australia
Investigational Site Number : 0360008
🇦🇺Melbourne, Victoria, Australia
Investigational Site Number : 0360006
🇦🇺Melbourne, Victoria, Australia
Investigational Site Number : 0361006
🇦🇺Traralgon, Victoria, Australia
Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
🇧🇷Salvador, Bahia, Brazil
Hospital São Domingos- Site Number : 0760028
🇧🇷Bequimão, Maranhão, Brazil
Hospital de Clinicas da Universidade Federal do Parana- Site Number : 0760022
🇧🇷Curitiba, Paraná, 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
Clinica de Alergia Martti Antila- Site Number : 0760006
🇧🇷Sorocaba, São Paulo, Brazil
CCBR / IBPClin - Instituto Brasil de Pesquisa Clínica- Site Number : 0760018
🇧🇷Rio de Janeiro, Brazil
Faculdade de Medicina do ABC- Site Number : 0760001
🇧🇷Santo André, Brazil
Centro de Desenvolvimento em Estudos ClÌnicos Brasil- Site Number : 0760014
🇧🇷São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760012
🇧🇷São Paulo, Brazil
Investigational Site Number : 1240031
🇨🇦Edmonton, Alberta, Canada
Investigational Site Number : 1240040
🇨🇦Surrey, British Columbia, Canada
Investigational Site Number : 1240033
🇨🇦Ajax, Ontario, Canada
Investigational Site Number : 1240034
🇨🇦Ottawa, Ontario, Canada
Investigational Site Number : 1240013
🇨🇦Toronto, Ontario, Canada
Investigational Site Number : 1240035
🇨🇦Toronto, Ontario, Canada
Investigational Site Number : 1240043
🇨🇦Saint-jérôme, Quebec, Canada
Investigational Site Number : 1240028
🇨🇦Regina, Saskatchewan, Canada
Investigational Site Number : 1240036
🇨🇦Saskatoon, Saskatchewan, 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 : 1520010
🇨🇱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 : 1520012
🇨🇱Talcahuano, Chile
Investigational Site Number : 1560042
🇨🇳Beijing, China
Investigational Site Number : 1560060
🇨🇳Chengdu, China
Investigational Site Number : 1560068
🇨🇳Chengdu, China
Investigational Site Number : 1560057
🇨🇳Chongqing, China
Investigational Site Number : 1560065
🇨🇳Chongqing, China
Investigational Site Number : 1560058
🇨🇳Guangzhou, China
Investigational Site Number : 1560059
🇨🇳Jinan, China
Investigational Site Number : 1560064
🇨🇳Shenzhen, China
Investigational Site Number : 2500008
🇫🇷Antony, France
Investigational Site Number : 2500009
🇫🇷Nantes, France
Investigational Site Number : 2500003
🇫🇷Paris, France
Investigational Site Number : 2500007
🇫🇷Reims, France
Investigational Site Number : 4100008
🇰🇷Daegu, Daegu-gwangyeoksi, Korea, Republic of
Investigational Site Number : 4100002
🇰🇷Ansan-si, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100014
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100009
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Investigational Site Number : 4100003
🇰🇷Yangsan-si, Gyeongsangnam-do, Korea, Republic of
Investigational Site Number : 4100015
🇰🇷Bupyeong-gu, Incheon-gwangyeoksi, Korea, Republic of
Investigational Site Number : 4100010
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100013
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100007
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100006
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100011
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100017
🇰🇷Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100012
🇰🇷Gwangju, Korea, Republic of
Investigational Site Number : 1583201
🇨🇳Kaohsiung City, Taiwan
Investigational Site Number : 1583202
🇨🇳Taichung, Taiwan
Investigational Site Number : 1580001
🇨🇳Taipei City, Taiwan
Investigational Site Number : 1580003
🇨🇳Taipei, Taiwan
Investigational Site Number : 1583203
🇨🇳Taoyuan City, Taiwan