Clinical trial NCT06224348: 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
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 by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis on Background Topical Corticosteroids
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Dermatitis Atopic
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2024-01-25
Enrollment: 643
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 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).


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 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

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

* Skin co-morbidity that would adversely affect the ability to undertake AD assessments
* Known history of or suspected significant current immunosuppression
* Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured \>5 years prior to baseline)
* History of solid organ or stem cell transplant
* Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
* Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
* Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
* Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
* In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
* History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)

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

Primary outcomes:
measure: EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24
timeFrame: Week 24
measure: EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at Week 24
timeFrame: Week 24
measure: US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Proportion of participants reaching EASI-75 at Week 24 (for US and US reference countries only)
timeFrame: Week 24
measure: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) and a reduction from baseline of ≥2 points
timeFrame: Baseline to Week 24
measure: Proportion of participants with ≥4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS ≥4
timeFrame: Baseline to Week 24
measure: Proportion of participants reaching EASI-75
timeFrame: Baseline to Week 20
measure: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points
timeFrame: Baseline to Week 20
measure: Proportion of participants with vIGA-AD 0 (clear)
timeFrame: Week 24
measure: Proportion of participants reaching EASI-90
timeFrame: Baseline to Week 24
measure: Proportion of participants reaching EASI-100
timeFrame: Baseline to Week 24
measure: Proportion of participants with PP-NRS 0 or 1
timeFrame: Baseline to Week 2
measure: Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old
timeFrame: Baseline to Week 24
measure: Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4
timeFrame: Baseline to Week 24
measure: Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years old
timeFrame: Baseline to Week 24
measure: Proportion of participants with a reduction in CDLQI ≥6 from baseline in participants with age ≥12 to <16 years old and with CDLQI baseline ≥6
timeFrame: Baseline to Week 24
measure: Change in Hospital Anxiety Depression Scale (HADS) from baseline
timeFrame: Baseline to Week 24
measure: Proportion of participants with HADS subscale Anxiety (HADS-A) <8 in participants with baseline HADS-A ≥8
timeFrame: Baseline to Week 24
measure: Proportion of participants with HADS subscale Depression (HADS-D) <8 in participants with HADS-D baseline ≥8
timeFrame: Baseline to Week 24
measure: Absolute change in weekly average of daily Skin Pain-Numerical Rating Scale (SP-NRS) from baseline
timeFrame: Baseline to Week 24
measure: Proportion of participants with a reduction in weekly average of daily SP-NRS ≥4 from baseline in participants with baseline weekly average of daily SP-NRS ≥4
timeFrame: Baseline to Week 24
measure: Absolute change in weekly average of daily Sleep Disturbance-Numerical Rating Scale (SD-NRS) from baseline
timeFrame: Baseline to Week 24
measure: Proportion of participants with a reduction in weekly average of daily SD-NRS ≥3 from baseline in participants with Baseline weekly average of daily SD-NRS ≥3
timeFrame: Baseline to Week 24
measure: Percent change in weekly average of daily SP-NRS from baseline
timeFrame: Baseline to Week 24
measure: Percent change in weekly average of daily SD-NRS from baseline
timeFrame: Baseline to Week 24
measure: Percent change in EASI score from baseline
timeFrame: Baseline to Week 24
measure: Percent change in weekly average of daily PP-NRS from baseline
timeFrame: Baseline to Week 24
measure: Absolute change in weekly average of daily PP-NRS from baseline
timeFrame: Baseline to Week 24
measure: Proportion of participants reaching EASI-50
timeFrame: Baseline to Week 24
measure: Proportion of participants with EASI ≤7
timeFrame: Baseline to Week 24
measure: Change in percent Body Surface Area (BSA) affected by AD from baseline
timeFrame: Baseline to Week 24
measure: Percent change in Scoring Atopic Dermatitis (SCORAD) index from baseline
timeFrame: Baseline to Week 24
measure: Absolute change in SCORAD index from baseline
timeFrame: Baseline to Week 24
measure: Proportion of participants with a reduction in SCORAD ≥ 8.7 points from baseline in participants with baseline SCORAD score ≥ 8.7
timeFrame: Baseline to Week 24
measure: Change in Patient Oriented Eczema Measure (POEM) from baseline
timeFrame: Baseline to Week 24
measure: Proportion of participants with a reduction in POEM ≥4 from baseline in participants with POEM Baseline ≥4
timeFrame: Baseline to Week 24
measure: Proportion of participants with rescue medication use
timeFrame: Baseline to Week 24
measure: Cumulative amount of topical corticosteroids (TCS) consumption
timeFrame: Baseline to Week 24
measure: Percentage of TCS/topical calcineurin inhibitors (TCI) free days
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: Birmingham
country: United States
facility: Cahaba Dermatology & Skin Health Center- Site Number : 8401066
state: Alabama
city: Fort Smith
country: United States
facility: Johnson Dermatology- Site Number : 8401076
state: Arkansas
city: Encino
country: United States
facility: Encino Research Center- Site Number : 8401042
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research- Site Number : 8401102
state: California
city: Los Angeles
country: United States
facility: LA Universal Research Center- Site Number : 8401064
state: California
city: Palmdale
country: United States
facility: Cura Clinical Research- Site Number : 8401141
state: California
city: Sacramento
country: United States
facility: Integrative Skin Science and Research- Site Number : 8401275
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology- Site Number : 8401043
state: California
city: Hollywood
country: United States
facility: Skin Care Research - Hollywood- Site Number : 8401071
state: Florida
city: Miami Lakes
country: United States
facility: Palm Springs Community Health Center- Site Number : 8401264
state: Florida
city: Miami
country: United States
facility: Clever Medical Research- Site Number : 8401160
state: Florida
city: Miami
country: United States
facility: Acevedo Clinical Research Associates- Site Number : 8401088
state: Florida
city: Saint Petersburg
country: United States
facility: Global Clinical Professionals (GCP)- Site Number : 8401045
state: Florida
city: Tampa
country: United States
facility: University of South Florida- Site Number : 8401070
state: Florida
city: Tampa
country: United States
facility: Avita Clinical Research- Site Number : 8401073
state: Florida
city: Dawsonville
country: United States
facility: Cleaver Medical Group- Site Number : 8401138
state: Georgia
city: Skokie
country: United States
facility: NorthShore University HealthSystem - Skokie Hospital- Site Number : 8401038
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research- Site Number : 8401015
state: Indiana
city: Gretna
country: United States
facility: BRCR Global Gretna- Site Number : 8401243
state: Louisiana
city: New Orleans
country: United States
facility: Velocity Clinical Research - New Orleans- Site Number : 8401155
state: Louisiana
city: Troy
country: United States
facility: Oakland Medical Center- Site Number : 8401116
state: Michigan
city: Ypsilanti
country: United States
facility: Allergy & Immunology Associates of Ann Arbor- Site Number : 8401078
state: Michigan
city: Lee's Summit
country: United States
facility: Dermatology and Skin Cancer Lee's Summit- Site Number : 8401157
state: Missouri
city: Omaha
country: United States
facility: Skin Specialists- Site Number : 8401068
state: Nebraska
city: Las Vegas
country: United States
facility: Jubilee Clinical Research- Site Number : 8401054
state: Nevada
city: Portsmouth
country: United States
facility: Allcutis Research - Portsmouth- Site Number : 8401082
state: New Hampshire
city: New York
country: United States
facility: Equity Medical- Site Number : 8401239
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai- Site Number : 8401129
state: New York
city: New York
country: United States
facility: OptiSkin- Site Number : 8401163
state: New York
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center- Site Number : 8401237
state: Ohio
city: Tulsa
country: United States
facility: Essential Medical Research- Site Number : 8401183
state: Oklahoma
city: Camp Hill
country: United States
facility: Vial Health - DermDox Dermatology- Site Number : 8401031
state: Pennsylvania
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas- Site Number : 8401067
state: South Carolina
city: Mesquite
country: United States
facility: SMS Clinical Research- Site Number : 8401182
state: Texas
city: Missouri City
country: United States
facility: Sienna Dermatology- Site Number : 8401148
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists- Site Number : 8401131
state: Texas
city: San Antonio
country: United States
facility: Discovery Clinical Trials - San Antonio - Stone Oak Parkway- Site Number : 8401026
state: Texas
city: Sugar Land
country: United States
facility: Complete Dermatology - Sugar Land- Site Number : 8401061
state: Texas
city: Bountiful
country: United States
facility: Cope Family Medicine - Ogden Clinic- Site Number : 8401114
state: Utah
city: Layton
country: United States
facility: Tanner Clinic - Layton Antelope A- Site Number : 8401151
state: Utah
city: Caba
country: Argentina
facility: Investigational Site Number : 0320005
state: Ciudad De Buenos Aires
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320011
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320019
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320008
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320018
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320010
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320004
city: Corrientes
country: Argentina
facility: Investigational Site Number : 0320012
city: Mendoza
country: Argentina
facility: Investigational Site Number : 0320013
city: San Miguel de Tucuman
country: Argentina
facility: Investigational Site Number : 0320020
city: San Miguel de Tucumán
country: Argentina
facility: Investigational Site Number : 0320020
city: Salvador
country: Brazil
facility: Centro de Pesquisas da Clínica IBIS- Site Number : 0760002
state: Bahia
city: Vitoria
country: Brazil
facility: Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760017
state: Espírito Santo
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: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760024
state: Rio Grande Do Sul
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760015
state: São Paulo
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC- Site Number : 0760001
city: São Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz - São Paulo- Site Number : 0760010
city: São Paulo
country: Brazil
facility: Hospital das Clinicas FMUSP- Site Number : 0760012
city: Dupnitsa
country: Bulgaria
facility: Investigational Site Number : 1002007
city: Pleven
country: Bulgaria
facility: Investigational Site Number : 1002004
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1002009
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1002006
city: Calgary
country: Canada
facility: Investigational Site Number : 1240039
state: Alberta
city: Red Deer
country: Canada
facility: Investigational Site Number : 1240045
state: Alberta
city: Kamloops
country: Canada
facility: Investigational Site Number : 1240046
state: British Columbia
city: Surrey
country: Canada
facility: Investigational Site Number : 1240030
state: British Columbia
city: Winnipeg
country: Canada
facility: Investigational Site Number : 1240041
state: Manitoba
city: Brampton
country: Canada
facility: Investigational Site Number : 1240057
state: Ontario
city: Markham
country: Canada
facility: Investigational Site Number : 1241106
state: Ontario
city: Mississauga
country: Canada
facility: Investigational Site Number : 1240008
state: Ontario
city: Peterborough
country: Canada
facility: Investigational Site Number : 1240004
state: Ontario
city: Richmond Hill
country: Canada
facility: Investigational Site Number : 1240038
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240012
state: Ontario
city: Waterloo
country: Canada
facility: Investigational Site Number : 1241107
state: Ontario
city: Québec City
country: Canada
facility: Investigational Site Number : 1240006
state: Quebec
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 : 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: Santiago
country: Chile
facility: Investigational Site Number : 1520010
city: Talcahuano
country: Chile
facility: Investigational Site Number : 1520012
city: Changsha
country: China
facility: Investigational Site Number : 1560050
city: Chengdu
country: China
facility: Investigational Site Number : 1560060
city: Fuzhou
country: China
facility: Investigational Site Number : 1560043
city: Guangzhou
country: China
facility: Investigational Site Number : 1560021
city: Hangzhou
country: China
facility: Investigational Site Number : 1560044
city: Hangzhou
country: China
facility: Investigational Site Number : 1560006
city: Nanchang
country: China
facility: Investigational Site Number : 1560051
city: Shanghai
country: China
facility: Investigational Site Number : 1560005
city: Shenyang
country: China
facility: Investigational Site Number : 1560041
city: Tianjin
country: China
facility: Investigational Site Number : 1560047
city: Wuhan
country: China
facility: Investigational Site Number : 1560049
city: Wuxi
country: China
facility: Investigational Site Number : 1560003
city: Nový Jičín
country: Czechia
facility: Investigational Site Number : 2032105
city: Olomouc
country: Czechia
facility: Investigational Site Number : 2030010
city: Ostrava
country: Czechia
facility: Investigational Site Number : 2032104
city: Pilsen
country: Czechia
facility: Investigational Site Number : 2030009
city: Prague
country: Czechia
facility: Investigational Site Number : 2030008
city: Prague
country: Czechia
facility: Investigational Site Number : 2030011
city: Praha 1
country: Czechia
facility: Investigational Site Number : 2030008
city: Bordeaux
country: France
facility: Investigational Site Number : 2500011
city: Nantes
country: France
facility: Investigational Site Number : 2500009
city: Nice
country: France
facility: Investigational Site Number : 2500013
city: Pierre-bénite
country: France
facility: Investigational Site Number : 2500006
city: Romans-sur-isère
country: France
facility: Investigational Site Number : 2500010
city: Rouen
country: France
facility: Investigational Site Number : 2500012
city: Saint-pierre
country: France
facility: Investigational Site Number : 2500016
city: Toulouse
country: France
facility: Investigational Site Number : 2500002
city: Augsburg
country: Germany
facility: Investigational Site Number : 2760020
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: Hamburg
country: Germany
facility: Investigational Site Number : 2760021
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: Witten
country: Germany
facility: Investigational Site Number : 2760019
city: Milan
country: Italy
facility: Investigational Site Number : 3800003
state: Lombardia
city: Bologna
country: Italy
facility: Investigational Site Number : 3800012
city: L'aquila
country: Italy
facility: Investigational Site Number : 3800011
city: Pisa
country: Italy
facility: Investigational Site Number : 3800008
city: Torette
country: Italy
facility: Investigational Site Number : 3800019
city: Chitose
country: Japan
facility: Investigational Site Number : 3920009
state: Hokkaido
city: Obihiro
country: Japan
facility: Investigational Site Number : 3923114
state: Hokkaido
city: Sapporo
country: Japan
facility: Investigational Site Number : 3920008
state: Hokkaido
city: Kobe
country: Japan
facility: Investigational Site Number : 3920006
state: Hyogo
city: Sagamihara
country: Japan
facility: Investigational Site Number : 3920005
state: Kanagawa
city: Yokohama-Shi
country: Japan
facility: Investigational Site Number : 3923113
state: Kanagawa
city: Miyagi-gun
country: Japan
facility: Investigational Site Number : 3920010
state: Miyagi
city: Sendai-shi
country: Japan
facility: Investigational Site Number : 3920011
state: Miyagi
city: Sakai
country: Japan
facility: Investigational Site Number : 3923110
state: Osaka
city: Iruma
country: Japan
facility: Investigational Site Number : 3920002
state: Saitama
city: Mibu
country: Japan
facility: Investigational Site Number : 3923106
state: Tochigi
city: Chuo
country: Japan
facility: Investigational Site Number : 3920004
state: Tokyo
city: Minato
country: Japan
facility: Investigational Site Number : 3923107
state: Tokyo
city: Tachikawa
country: Japan
facility: Investigational Site Number : 3920001
state: Tokyo
city: Habikino
country: Japan
facility: Investigational Site Number : 3923109
city: Kagoshima
country: Japan
facility: Investigational Site Number : 3923108
city: Kyoto
country: Japan
facility: Investigational Site Number : 3923102
city: Kyoto
country: Japan
facility: Investigational Site Number : 3920003
city: Yokohama
country: Japan
facility: Investigational Site Number : 3923113
city: Granada
country: Spain
facility: Investigational Site Number : 7240019
state: Andalucia
city: Seville
country: Spain
facility: Investigational Site Number : 7240020
state: Andalucia
city: Bilbao
country: Spain
facility: Investigational Site Number : 7240008
state: Bizkaia
city: Esplugues de Llobregat
country: Spain
facility: Investigational Site Number : 7240010
state: Catalunya [Cataluña]
city: Pamplona
country: Spain
facility: Investigational Site Number : 7240015
state: Navarra
city: Burjassot
country: Spain
facility: Investigational Site Number : 7240023
state: Valenciana, Comunidad
city: Manises
country: Spain
facility: Investigational Site Number : 7242502
state: Valencia
city: Alicante
country: Spain
facility: Investigational Site Number : 7242505
city: Madrid
country: Spain
facility: Investigational Site Number : 7240013
city: Vigo
country: Spain
facility: Investigational Site Number : 7240014
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920010
city: Antalya
country: Turkey
facility: Investigational Site Number : 7920001
city: Gaziantep
country: Turkey
facility: Investigational Site Number : 7920008
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920003
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920005
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920006
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920002
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920009
city: Kayseri
country: Turkey
facility: Investigational Site Number : 7920004
city: Samsun
country: Turkey
facility: Investigational Site Number : 7920007
Study officials:
References: