Clinical trial NCT06208306: A Study to Investigate Long-term Safety and Tolerability of Itepekimab in Participants With COPD
Official title: A Double-blinded Extension Study to Evaluate the Long-term Safety and Tolerability of Itepekimab in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Participated in Either EFC16750 or EFC16819 Clinical Studies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2024-01-17
Enrollment: 700
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a parallel, double blind, Phase 3, 2-arm study that is designed to provide additional safety information, assess the durability of treatment response, and provide additional PK and immunogenicity assessments.

The primary purpose of this study is to evaluate safety and tolerability of both itepekimab SC Q2W or itepekimab SC Q4W in participants with COPD having completed the treatment period of the clinical studies EFC16750 or EFC16819. A secondary purpose of this study is to provide efficacy outcomes beyond the treatment period of the parent trials EFC16750 and EFC16819.

Study details include:

* The study duration will be up to 72 weeks
* The treatment duration will be up to 52 weeks
* A follow-up period of 20 weeks will be conducted
* The number of on-site visits will be 7 and the number of phone contacts will be 5


Eligibility criteria: Inclusion Criteria:

- Patients with COPD who completed the treatment period in a previous itepekimab COPD Phase 3 clinical study (ie, EFC16750 or EFC16819) and for which an end-of-treatment (EOT) visit occurred no later than 3 days before the enrolment visit of this study.

Exclusion Criteria:

* Diagnosis of a malignancy during parent study, except a squamous or basal cell carcinoma of the skin
* Any opportunistic infection during the parent study, such as tuberculosis (TB) or other infections whose nature or course may suggest an immunocompromised status
* Anaphylactic reactions or systemic allergic reactions that are related to IMP and require treatment during the parent study
* Any situation that led to a permanent premature IMP discontinuation in parent trials

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

Primary outcomes:
measure: Incidence of treatment-emergent AEs, AESIs, SAEs, and AEs leading to permanent treatment discontinuation
timeFrame: Baseline up to Week 72
Secondary outcomes:
measure: Functional itepekimab concentrations in serum
timeFrame: Baseline up to Week 52
measure: Incidence of treatment-emergent (TE) anti-drug antibody responses
timeFrame: Baseline up to Week 72
measure: Annualized rate of moderate-to-severe acute exacerbation of COPD (AECOPD)
timeFrame: Baseline up to Week 52
measure: Annualized rate of severe AECOPD
timeFrame: Baseline up to Week 52
measure: Time to first moderate-to-severe AECOPD
timeFrame: Baseline up to Week 52
measure: Time to first severe AECOPD
timeFrame: Baseline up to Week 52
measure: Change from baseline of the parent studies (EFC16750, EFC16819): Pre-BD and post-BD FEV1
timeFrame: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
measure: Change from baseline of the parent studies (EFC16750, EFC16819): SGRQ total score and domain scores
timeFrame: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
measure: Change from baseline of the parent studies (EFC16750, EFC16819): EQ-5D-5L single index score
timeFrame: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
measure: Change from baseline of the parent studies (EFC16750, EFC16819): EQ-VAS
timeFrame: Baseline of the parent studies (EFC16750,EFC16819) up to Week 52
measure: Change from Week 0 for CASA-Q
timeFrame: Baseline up to Week 52
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Chandler Clinical Research Trials- Site Number : 8401034
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research Site Number : 8401182
state: Arizona
city: Tucson
country: United States
facility: Tucson Clinical Research Institute- Site Number : 8401431
state: Arizona
city: La Palma
country: United States
facility: IMAX Clinical Trials- Site Number : 8401419
state: California
city: Lancaster
country: United States
facility: Antelope Valley Clinical Trials Site Number : 8401003
state: California
city: Los Angeles
country: United States
facility: Downtown L.A. Research Center- Site Number : 8401027
state: California
city: Aurora
country: United States
facility: Allianz Research Institute CO Site Number : 8402061
state: Colorado
city: Boulder
country: United States
facility: Alpine Clinical Research Center - Boulder - 47th Street- Site Number : 8401180
state: Colorado
city: Boynton Beach
country: United States
facility: Helix Biomedics- Site Number : 8402049
state: Florida
city: Cutler Bay
country: United States
facility: Beautiful Minds Clinical Research Center Site Number : 8401201
state: Florida
city: DeBary
country: United States
facility: Omega Research Consultants - Debary - North Charles Richard Beall Boulevard- Site Number : 8402031
state: Florida
city: Doral
country: United States
facility: Science Connections, LLC Site Number : 8402045
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center- Site Number : 8402065
state: Florida
city: Lady Lake
country: United States
facility: Premier Medical Associates Site Number : 8401388
state: Florida
city: Loxahatchee Groves
country: United States
facility: Advanced Pulmonary Research Institute Site Number : 8402018
state: Florida
city: Miami Lakes
country: United States
facility: Deluxe Health Center Site Number : 8401188
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research- Site Number : 8402007
state: Florida
city: Miami
country: United States
facility: Elite Clinical Research - Miami- Site Number : 8402009
state: Florida
city: Miami
country: United States
facility: DL Research Solutions- Site Number : 8401033
state: Florida
city: Miami
country: United States
facility: My Community Research Center Site Number : 8402060
state: Florida
city: Miami
country: United States
facility: Phoenix Medical Research - Miami - 24th Street- Site Number : 8402019
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida- Site Number : 8401006
state: Florida
city: Miami
country: United States
facility: Reed Medical Research Site Number : 8401032
state: Florida
city: Miami
country: United States
facility: High Quality Research Site Number : 8401406
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research - Ocala - Northeast 1st Avenue- Site Number : 8402015
state: Florida
city: Orlando
country: United States
facility: Heuer M.D. Research- Site Number : 8402016
state: Florida
city: Orlando
country: United States
facility: Florida Institute for Clinical Research Site Number : 8401013
state: Florida
city: Oviedo
country: United States
facility: Oviedo Medical Research Site Number : 8402026
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center - Palmetto Bay- Site Number : 8402067
state: Florida
city: Pembroke Pines
country: United States
facility: Pines Care Research Center- Site Number : 8402056
state: Florida
city: Pembroke Pines
country: United States
facility: Tellabio International Research Services Site Number : 8401411
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida - Tampa - North Howard Avenue- Site Number : 8402008
state: Florida
city: Calhoun
country: United States
facility: Appalachian Clinical Research Site Number : 8400024
state: Georgia
city: Cordele
country: United States
facility: Private Practice - Dr. David Kavtaradze- Site Number : 8401029
state: Georgia
city: Dunwoody
country: United States
facility: Alpha Clinical Research Group - Dunwoody- Site Number : 8401190
state: Georgia
city: East Point
country: United States
facility: Covenant Pulmonary Critical Care Site Number : 8401183
state: Georgia
city: Peoria
country: United States
facility: OSF Saint Fracis Medical Center- Site Number : 8402024
state: Illinois
city: Covington
country: United States
facility: Benchmark Research - Covington- Site Number : 8401193
state: Louisiana
city: Shreveport
country: United States
facility: Care Access - Shreveport- Site Number : 8402047
state: Louisiana
city: Bangor
country: United States
facility: Private Practice - Dr. Paul Shapero- Site Number : 8401016
state: Maine
city: Boston
country: United States
facility: Care Access - Boston- Site Number : 8402276
state: Massachusetts
city: Lathrup Village
country: United States
facility: Revive Research Institute - Lathrup Village- Site Number : 8402186
state: Michigan
city: Warren
country: United States
facility: Pulmonary and Medicine Associates- Site Number : 8401403
state: Michigan
city: Hannibal
country: United States
facility: Hannibal Regional Healthcare System-HRMG-Hannibal Site Number : 8401383
state: Missouri
city: Saint Charles
country: United States
facility: Midwest Chest Consultants- Site Number : 8401002
state: Missouri
city: Saint Louis
country: United States
facility: Washington University- Site Number : 8402035
state: Missouri
city: Henderson
country: United States
facility: Henderson Clinical Trials Site Number : 8401365
state: Nevada
city: Buffalo
country: United States
facility: VA Western New York Healthcare System Site Number : 8402050
state: New York
city: Schenectady
country: United States
facility: Schenectady Pulmonary and Critical Care Associates - Schenectady Main Office- Site Number : 8402029
state: New York
city: Greenville
country: United States
facility: East Carolina University- Site Number : 8401022
state: North Carolina
city: Huntersville
country: United States
facility: Advanced Respiratory and Sleep Medicine - Huntersville- Site Number : 8400022
state: North Carolina
city: Edmond
country: United States
facility: OK Clinical Research- Site Number : 8402001
state: Oklahoma
city: DuBois
country: United States
facility: Clinical Research Associates of Central PA - Dubois- Site Number : 8401023
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital- Site Number : 8402058
state: Pennsylvania
city: Columbia
country: United States
facility: MedTrial- Site Number : 8402048
state: South Carolina
city: Rock Hill
country: United States
facility: Clinical Research of Rock Hill Site Number : 8401008
state: South Carolina
city: Beaumont
country: United States
facility: REX Clinical Trials - Beaumont- Site Number : 8401371
state: Texas
city: Boerne
country: United States
facility: South Texas Medical Research Institute - TTS Research- Site Number : 8402012
state: Texas
city: Carrollton
country: United States
facility: ClinRx Research - Carrollton- Site Number : 8401021
state: Texas
city: Corsicana
country: United States
facility: Corsicana Medical Research- Site Number : 8401018
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital Research Institute Site Number : 8401194
state: Texas
city: McKinney
country: United States
facility: Metroplex Pulmonary and Sleep Center Site Number : 8401015
state: Texas
city: Webster
country: United States
facility: Clear Lake Specialties Research Center, PLLC Site Number : 8401025
state: Texas
city: Beckley
country: United States
facility: Rheumatology & Pulmonary Clinic- Site Number : 8402053
state: West Virginia
city: Berazategui
country: Argentina
facility: Investigational Site Number : 0320012
state: Buenos Aires
city: La Plata
country: Argentina
facility: Investigational Site Number : 0320013
state: Buenos Aires
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320003
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320007
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320008
state: Santa Fe
city: Rosario
country: Argentina
facility: Investigational Site Number : 0320011
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320010
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320005
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320002
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320006
city: Buenos Aires
country: Argentina
facility: Investigational Site Number : 0320009
city: Mendoza
country: Argentina
facility: Investigational Site Number : 0320004
city: Salvador
country: Brazil
facility: Serviços Especializados em Reumatologia- Site Number : 0760020
state: Bahia
city: Brasília
country: Brazil
facility: Centro De Cardiologia Clinica E Pesquisa- Site Number : 0760018
state: Distrito Federal
city: Vitoria
country: Brazil
facility: Centro de Diagnostico e Pesquisa da Osteoporose do Espirito Santo- Site Number : 0760009
state: Espírito Santo
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericordia de Belo Horizonte- Site Number : 0760014
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Centro de Estudos em Terapias Inovadoras- Site Number : 0760012
state: Paraná
city: Porto Alegre
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760001
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Instituto Ceos Site Number : 0760021
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da PUCRS - Porto Alegre - Avenida Ipiranga- Site Number : 0760007
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: WM Pesquisas Clínicas em Doenças Respiratórias- Site Number : 0760006
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Universidade Estadual Paulista - Faculdade de Medicina de Botucatu- Site Number : 0760005
state: São Paulo
city: Campinas
country: Brazil
facility: Hospital e Maternidade Celso Pierro - PUC-Campinas- Site Number : 0760010
state: São Paulo
city: São Bernardo Do Campo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clínicos- Site Number : 0760015
state: São Paulo
city: São Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo- Site Number : 0760013
city: Gabrovo
country: Bulgaria
facility: Investigational Site Number : 1000004
city: Haskovo
country: Bulgaria
facility: Investigational Site Number : 1000007
city: Ruse
country: Bulgaria
facility: Investigational Site Number : 1000018
city: Ruse
country: Bulgaria
facility: Investigational Site Number : 1000010
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000016
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000001
city: Sofia
country: Bulgaria
facility: Investigational Site Number : 1000009
city: Stara Zagora
country: Bulgaria
facility: Investigational Site Number : 1000017
city: Stara Zagora
country: Bulgaria
facility: Investigational Site Number : 1000003
city: Veliko Tarnovo
country: Bulgaria
facility: Investigational Site Number : 1000013
city: Vidin
country: Bulgaria
facility: Investigational Site Number : 1000006
city: Sherwood Park
country: Canada
facility: Investigational Site Number : 1240006
state: Alberta
city: Ajax
country: Canada
facility: Investigational Site Number : 1240021
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site Number : 1240009
state: Ontario
city: Windsor
country: Canada
facility: Investigational Site Number : 1240022
state: Ontario
city: Windsor
country: Canada
facility: Investigational Site Number : 1240018
state: Ontario
city: Sherbrooke
country: Canada
facility: Investigational Site Number : 1240004
state: Quebec
city: Trois-rivières
country: Canada
facility: Investigational Site Number : 1240001
state: Quebec
city: Victoriaville
country: Canada
facility: Investigational Site Number : 1240002
state: Quebec
city: Valdivia
country: Chile
facility: Investigational Site Number : 1520008
state: Los Ríos
city: Talca
country: Chile
facility: Investigational Site Number : 1520006
state: Maule
city: Santiago
country: Chile
facility: Investigational Site Number : 1520007
state: Reg Metropolitana De Santiago
city: Santiago
country: Chile
facility: Investigational Site Number : 1520001
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 : 1520002
state: Reg Metropolitana De Santiago
city: Quillota
country: Chile
facility: Investigational Site Number : 1520005
state: Valparaíso
city: Beijing
country: China
facility: Investigational Site Number : 1560012
city: Changchun
country: China
facility: Investigational Site Number : 1560004
city: Chengdu
country: China
facility: Investigational Site Number : 1560001
city: Haikou
country: China
facility: Investigational Site Number : 1560018
city: Hefei
country: China
facility: Investigational Site Number : 1560016
city: Hohhot
country: China
facility: Investigational Site Number : 1560017
city: Jinan
country: China
facility: Investigational Site Number : 1560002
city: Nanchang
country: China
facility: Investigational Site Number : 1560014
city: Pingxiang
country: China
facility: Investigational Site Number : 1560019
city: Shanghai
country: China
facility: Investigational Site Number : 1560020
city: Shanghai
country: China
facility: Investigational Site Number : 1560006
city: Shenyang
country: China
facility: Investigational Site Number : 1560008
city: Wuhan
country: China
facility: Investigational Site Number : 1560005
city: Xiangtan
country: China
facility: Investigational Site Number : 1560011
city: Xuzhou
country: China
facility: Investigational Site Number : 1560007
city: Yangzhou
country: China
facility: Investigational Site Number : 1560015
city: Havlíčkův Brod
country: Czechia
facility: Investigational Site Number : 2030003
city: Jindřichův Hradec
country: Czechia
facility: Investigational Site Number : 2030001
city: Tartu
country: Estonia
facility: Investigational Site Number : 2330001
city: Lyon
country: France
facility: Investigational Site Number : 2500001
city: Reims
country: France
facility: Investigational Site Number : 2500004
city: Batumi
country: Georgia
facility: Investigational Site Number : 2680006
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680002
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680003
city: Tbilisi
country: Georgia
facility: Investigational Site Number : 2680001
city: Bendorf
country: Germany
facility: Investigational Site Number : 2760006
city: Berlin
country: Germany
facility: Investigational Site Number : 2760010
city: Frankfurt
country: Germany
facility: Investigational Site Number : 2760005
city: Leipzig
country: Germany
facility: Investigational Site Number : 2760008
city: Leipzig
country: Germany
facility: Investigational Site Number : 2760007
city: Lübeck
country: Germany
facility: Investigational Site Number : 2760003
city: Mainz
country: Germany
facility: Investigational Site Number : 2760001
city: Rosenheim
country: Germany
facility: Investigational Site Number : 2760011
city: Palaio Faliro
country: Greece
facility: Investigational Site Number : 3000008
city: Thessaloniki
country: Greece
facility: Investigational Site Number : 3000002
city: Budapest
country: Hungary
facility: Investigational Site Number : 3480009
city: Gödöllő
country: Hungary
facility: Investigational Site Number : 3480001
city: Hajdunanas
country: Hungary
facility: Investigational Site Number : 3480004
city: Mosonmagyaróvár
country: Hungary
facility: Investigational Site Number : 3480002
city: Püspökladány
country: Hungary
facility: Investigational Site Number : 3480003
city: Calicut
country: India
facility: Investigational Site Number : 3560001
city: Chandigarh
country: India
facility: Investigational Site Number : 3560006
city: Hyderabad
country: India
facility: Investigational Site Number : 3560005
city: Jaipur
country: India
facility: Investigational Site Number : 3560009
city: Jaipur
country: India
facility: Investigational Site Number : 3560004
city: Kanpur
country: India
facility: Investigational Site Number : 3560012
city: Nagpur
country: India
facility: Investigational Site Number : 3560010
city: Nagpur
country: India
facility: Investigational Site Number : 3560011
city: Nagpur
country: India
facility: Investigational Site Number : 3560007
city: Nagpur
country: India
facility: Investigational Site Number : 3560003
city: Pune
country: India
facility: Investigational Site Number : 3560013
city: Haifa
country: Israel
facility: Investigational Site Number : 3760008
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760003
city: Jerusalem
country: Israel
facility: Investigational Site Number : 3760002
city: Kefar Sava
country: Israel
facility: Investigational Site Number : 3760006
city: Petah Tikva
country: Israel
facility: Investigational Site Number : 3760001
city: Ramat Gan
country: Israel
facility: Investigational Site Number : 3760009
city: Rehovot
country: Israel
facility: Investigational Site Number : 3760004
city: Tel Aviv
country: Israel
facility: Investigational Site Number : 3760007
city: Ferrara
country: Italy
facility: Investigational Site Number : 3800001
city: Nagoya
country: Japan
facility: Investigational Site Number : 3920008
state: Aichi
city: Kurume
country: Japan
facility: Investigational Site Number : 3920002
state: Fukuoka
city: Kure
country: Japan
facility: Investigational Site Number : 3920007
state: Hiroshima
city: Himeji
country: Japan
facility: Investigational Site Number : 3920006
state: Hyogo
city: Yokohama
country: Japan
facility: Investigational Site Number : 3920009
state: Kanagawa
city: Matsusaka
country: Japan
facility: Investigational Site Number : 3920001
state: Mie
city: Kiyose
country: Japan
facility: Investigational Site Number : 3920005
state: Tokyo
city: Fukuoka
country: Japan
facility: Investigational Site Number : 3920003
city: Tokyo
country: Japan
facility: Investigational Site Number : 3920004
city: Wonju-si
country: Korea, Republic of
facility: Investigational Site Number : 4100002
state: Gangwon-do
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number : 4100001
state: Seoul-teukbyeolsi
city: Kaunas
country: Lithuania
facility: Investigational Site Number : 4400002
city: Durango
country: Mexico
facility: Investigational Site Number : 4840007
city: Breda
country: Netherlands
facility: Investigational Site Number : 5280001
city: Lørenskog
country: Norway
facility: Investigational Site Number : 5780001
city: Bialystok
country: Poland
facility: Investigational Site Number : 6160001
state: Podlaskie
city: Ostrowiec Swietokrzyski
country: Poland
facility: Investigational Site Number : 6160002
state: Swietokrzyskie
city: Porto
country: Portugal
facility: Investigational Site Number : 6200006
city: Cluj Napoca
country: Romania
facility: Investigational Site Number : 6420002
city: Humenné
country: Slovakia
facility: Investigational Site Number : 7030002
city: Prešov
country: Slovakia
facility: Investigational Site Number : 7030004
city: Spišská Nová Ves
country: Slovakia
facility: Investigational Site Number : 7030003
city: Benoni
country: South Africa
facility: Investigational Site Number : 7100004
city: Durban
country: South Africa
facility: Investigational Site Number : 7100001
city: Durban
country: South Africa
facility: Investigational Site Number : 7100006
city: Durban
country: South Africa
facility: Investigational Site Number : 7100005
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240014
state: Barcelona [Barcelona]
city: Sant Boi de Llobregat
country: Spain
facility: Investigational Site Number : 7240006
state: Catalunya [Cataluña]
city: Pozuelo de Alarcón
country: Spain
facility: Investigational Site Number : 7240008
state: Madrid
city: Madrid
country: Spain
facility: Investigational Site Number : 7240003
city: Madrid
country: Spain
facility: Investigational Site Number : 7240007
city: Málaga
country: Spain
facility: Investigational Site Number : 7240001
city: Palma
country: Spain
facility: Investigational Site Number : 7240004
city: Zaragoza
country: Spain
facility: Investigational Site Number : 7240012
city: Kaohsiung City
country: Taiwan
facility: Investigational Site Number : 1580005
city: Taichung
country: Taiwan
facility: Investigational Site Number : 1580006
city: Taipei City
country: Taiwan
facility: Investigational Site Number : 1580003
city: Akdeniz
country: Turkey
facility: Investigational Site Number : 7920002
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920007
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920001
city: Kirikkale
country: Turkey
facility: Investigational Site Number : 7920006
city: Portsmouth
country: United Kingdom
facility: Investigational Site Number : 8260004
state: Hampshire
city: Chertsey
country: United Kingdom
facility: Investigational Site Number : 8260002
state: Surrey
city: Bradford
country: United Kingdom
facility: Investigational Site Number : 8260003
city: Hounslow
country: United Kingdom
facility: Investigational Site Number : 8260014
city: Liverpool
country: United Kingdom
facility: Investigational Site Number : 8260005
city: London
country: United Kingdom
facility: Investigational Site Number : 8260010
city: Milton Keynes
country: United Kingdom
facility: Investigational Site Number : 8260008
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: