Clinical trial NCT05398445: A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
Official title: A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
AMG 451
KHK4083
Rocatinlimab
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-06-01
Enrollment: 769
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
* History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]).
* EASI score ≥16
* vIGA-AD score ≥3
* ≥10% body surface area (BSA) of AD involvement
* Worst pruritus numerical rating scale ≥ 4

Exclusion Criteria:

* Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
* Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

  * Systemic corticosteroids
  * Systemic immunosuppressants
  * Phototherapy
  * Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

  * TCS of any potency
  * TCI
  * Topical phosphodiesterase type 4 inhibitors
  * Other topical immunosuppressive agents
  * Combination topical agents including TCS of any potency, TCI, PDE4 inhibitors, or other topical immunosuppressive agents

Primary outcomes:
measure: Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with ≥2 point reduction from baseline at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Achievement of ≥75% reduction from baseline in EASI score at Week 16
timeFrame: Baseline, Week 16
measure: Achievement of a vIGA-AD score of 0 or 1 from baseline at Week 16
timeFrame: Baseline, Week 16
measure: Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus numerical rating scale (NRS) score at Week 16 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4
timeFrame: Baseline, Week 16
measure: Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus NRS score at Week 24 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4
timeFrame: Baseline, Week 24
measure: Achievement of ≥90% reduction from baseline in EASI score at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of a ≥ 4-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 24 in subjects with baseline weekly average of AD skin pain NRS score ≥ 4
timeFrame: Baseline, Week 24
measure: Achievement of a vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response (revised Investigator's Global Assessment [rIGA™] 0/1) at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of Facial AD Severity Score (FASS) of clear at Week 24 for subjects with facial AD at baseline
timeFrame: Baseline, Week 24
measure: Achievement of Hand AD Severity Score (HASS) of clear at Week 24 for subjects with hand AD at baseline
timeFrame: Baseline, Week 24
measure: Change from baseline in weekly average of daily worst pruritus NRS score at week 16
timeFrame: Baseline, Week 16
measure: Change from baseline in weekly average of daily worst pruritus NRS score at Week 24
timeFrame: Baseline, Week 24
measure: Change from baseline in SCORing Atopic Dermatitis (SCORAD) itch visual analogue scale (VAS) score at Week 16
timeFrame: Baseline, Week 16
measure: Change from baseline in SCORAD itch VAS score at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of ≥ 4-point reduction from baseline in DLQI score at Week 24 in subjects with baseline DLQI score ≥ 4
timeFrame: Baseline, Week 24
measure: Change from baseline in DLQI score at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of ≥ 4-point reduction from baseline in POEM score at Week 24 in subjects with baseline POEM score ≥ 4
timeFrame: Baseline, Week 24
measure: Change from baseline in POEM score at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of a ≥ 4-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 16 in subjects with baseline weekly average of AD skin pain NRS score ≥ 4
timeFrame: Baseline, Week 16
measure: Change from baseline in weekly average of daily AD skin pain NRS score at Week 24
timeFrame: Baseline, Week 24
measure: Change from baseline in weekly average of daily AD skin pain NRS score at Week 16
timeFrame: Baseline, Week 16
measure: Achievement of a ≥ 3-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 24 in subjects with baseline weekly average of AD skin pain NRS score ≥ 3
timeFrame: Baseline, Week 24
measure: Achievement of a ≥ 3-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 16 in subjects with baseline weekly average of AD skin pain NRS score ≥ 3
timeFrame: Baseline, Week 16
measure: Change from baseline in weekly average of daily sleep disturbance NRS score at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety subscale score < 8 at Week 24 in subjects with baseline HADS-anxiety subscale score ≥ 8
timeFrame: Baseline, Week 24
measure: Change from baseline in HADS-anxiety subscale score at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of HADS-depression subscale score < 8 at week 24 in subjects with baseline HADS-depression subscale score ≥ 8
timeFrame: Baseline, Week 24
measure: Change from baseline in HADS-depression subscale score at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of a ≥ 8.7-point reduction from baseline in SCORAD score at Week 24 in participants with baseline SCORAD score ≥ 8.7
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology and Skin Health Center
state: Alabama
city: Phoenix
country: United States
facility: Alliance Dermatology and Mohs Center
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Fountain Valley
country: United States
facility: First OC Dermatology
state: California
city: Glendale
country: United States
facility: Kaiser Permanente - Glendale Medical Center
state: California
city: Long Beach
country: United States
facility: Long Beach Research Institute
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente Los Angeles Medical Center
state: California
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Sherman Oaks
country: United States
facility: Cura Clinical Research
state: California
city: Centennial
country: United States
facility: IMMUNOe Research Centers
state: Colorado
city: Boca Raton
country: United States
facility: Skin Care Research Incorporated
state: Florida
city: Delray Beach
country: United States
facility: Palm Beach Dermatology Group
state: Florida
city: Homestead
country: United States
facility: Global Research Associates
state: Florida
city: Miami Lakes
country: United States
facility: Savin Medical Group LLC
state: Florida
city: Miami
country: United States
facility: Healthy Life Research
state: Florida
city: Naples
country: United States
facility: Kirsch Dermatology LLC
state: Florida
city: Orlando
country: United States
facility: Pure Skin Dermatology and Aesthetics
state: Florida
city: Saint Petersburg
country: United States
facility: Industrial Medicine Associates Ima Clinical Research Inc
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research LLC
state: Florida
city: Boise
country: United States
facility: Treasure Valley Medical Research
state: Idaho
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: West Dundee
country: United States
facility: Dundee Dermatology
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center PC
state: Indiana
city: Chevy Chase
country: United States
facility: Institute for Asthma and Allergy
state: Maryland
city: Towson
country: United States
facility: Continental Clinical Solutions, LLC
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Flint
country: United States
facility: Onyx Clinical Research
state: Michigan
city: Lee's Summit
country: United States
facility: Dermatology and Skin Cancer Center of Lees Summit
state: Missouri
city: Las Vegas
country: United States
facility: Jubilee Clinical Research Inc
state: Nevada
city: Portsmouth
country: United States
facility: Allcutis Research, Llc - Portsmouth
state: New Hampshire
city: Cherry Hill
country: United States
facility: Continental Clinical Solutions - Cherry Hill
state: New Jersey
city: Hartsdale
country: United States
facility: Industrial Medicine Associates Ima Clinical Research Inc
state: New York
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Charlotte
country: United States
facility: Dermatology Specialists of Charlotte
state: North Carolina
city: Charlotte
country: United States
facility: Onsite Clinical Solutions
state: North Carolina
city: Wilmington
country: United States
facility: Wilmington Dermatology Center
state: North Carolina
city: Winston-Salem
country: United States
facility: The Skin Surgery Center for Clinical Research
state: North Carolina
city: Boardman
country: United States
facility: Optima Research
state: Ohio
city: Columbus
country: United States
facility: ClinOhio Research Services
state: Ohio
city: Oklahoma City
country: United States
facility: Unity Clinical Research
state: Oklahoma
city: Tulsa
country: United States
facility: Dermatology Research Center of Oklahoma, PLLC
state: Oklahoma
city: Tulsa
country: United States
facility: Essential Medical Research LLC
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Sugarloaf
country: United States
facility: DermDox Dermatology, LLC
state: Pennsylvania
city: Hermitage
country: United States
facility: Cumberland Skin Center
state: Tennessee
city: Dallas
country: United States
facility: Dermatology Treatment and Research Center PA
state: Texas
city: The Woodlands
country: United States
facility: The Woodlands Dermatology Associates
state: Texas
city: Lynchburg
country: United States
facility: Education and Research Foundation Inc
state: Virginia
city: Mill Creek
country: United States
facility: Frontier Derm Partners
state: Washington
city: Morgantown
country: United States
facility: West Virginia Research Institute
state: West Virginia
city: Caba
country: Argentina
facility: Cinme - Centro de Investigaciones Metabolicas
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion Respirar
state: Buenos Aires
city: Derqui, Pilar
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
city: San Miguel
country: Argentina
facility: Centro Dermatológico Schejtman
state: Buenos Aires
city: Caba
country: Argentina
facility: Conexa Investigacion Clinica SA
state: Distrito Federal
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: InAER - Investigaciones en Alergia y Enfermedades Respiratorias
state: Distrito Federal
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Instituto de Neumonologia y Dermatologia
state: Distrito Federal
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Diagnostico Abc American British Cowdray
state: Santa Fe
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Upeclin-Pesq Clin FacMed Botucatu
state: São Paulo
city: Santo Andre
country: Brazil
facility: Hosp e Maternidade Dr Christovao da Gama
state: São Paulo
city: Santo Andre
country: Brazil
facility: Fundacao Abc - Centro Univ Fmabc
state: São Paulo
city: Sorocaba
country: Brazil
facility: Consultoria Medica e Pesquisa Clinica Cmpc
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: IBPClin Instituto Brasil de Pesquisa Clinica
city: São Paulo
country: Brazil
facility: Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
city: Edmonton
country: Canada
facility: Alberta Derma Surgery Centre
state: Alberta
city: Edmonton
country: Canada
facility: Vida Clinical Research
state: Alberta
city: Ajax
country: Canada
facility: CCA Medical Research Corporation
state: Ontario
city: Barrie
country: Canada
facility: SimcoDerm Medical and Surgical Dermatology Centre
state: Ontario
city: Hamilton
country: Canada
facility: LEADER Research
state: Ontario
city: Mississauga
country: Canada
facility: DermEdge Research Incorporated
state: Ontario
city: North York
country: Canada
facility: Canadian Dermatology Centre
state: Ontario
city: North York
country: Canada
facility: Gordon Sussman Clinical Research Incorporated
state: Ontario
city: Richmond Hill
country: Canada
facility: Oak Ridges Aesthetics Centre
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
city: Saskatoon
country: Canada
facility: Skinsense Medical Research
state: Saskatchewan
city: Quebec
country: Canada
facility: Recherche Clinique Sigma Incorporated
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital ,Sun-Yat Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Dermatology Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital Sun Yat-sen University
state: Guangdong
city: Shijiazhuang
country: China
facility: The First Hospital Of Hebei Medical University
state: Hebei
city: Nanyang
country: China
facility: Nanyang First Peoples Hospital
state: Henan
city: Sanmenxia
country: China
facility: Sanmenxia Central Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Jiangyin
country: China
facility: Jiangyin Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Peoples Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Dermatology Hospital of Jiangxi Province
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Chengdu
country: China
facility: Chengdu Second Peoples Hospital
state: Sichuan
city: Hangzhou
country: China
facility: the First Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial Peoples Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Central Hospital
state: Zhejiang
city: Beijing
country: China
facility: Peking University Peoples Hospital
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
city: Ivanic-Grad
country: Croatia
facility: Special Hospital for Medical Rehabilitation Naftalan
city: Zagreb
country: Croatia
facility: Sestre milosrdnice University Hospital Center
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
city: Nachod
country: Czechia
facility: Dermamedica, sro
city: Ostrava
country: Czechia
facility: CCR Ostrava sro
city: Pardubice
country: Czechia
facility: Pratia Pardubice as
city: Praha 10
country: Czechia
facility: Clintrial sro
city: Praha 3
country: Czechia
facility: Pratia Prague sro
city: Praha 8
country: Czechia
facility: Fakultni nemocnice Bulovka
city: Usti nad Labem
country: Czechia
facility: Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
city: Berlin
country: Germany
facility: Charite - Universitaetsmedizin Berlin, Campus Mitte
city: Blankenfelde-Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis-Mahlow
city: Bochum
country: Germany
facility: Hautarztpraxis Dr Niesmann und Dr Othlinghaus
city: Darmstadt
country: Germany
facility: Rosenpark Research GmbH
city: Dresden
country: Germany
facility: Universitaetsklinikum Dresden
city: Duesseldorf
country: Germany
facility: Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
city: Essen
country: Germany
facility: Universitaetsklinikum Essen
city: Hamburg
country: Germany
facility: Institute for Health Services Research in Dermatology and Nursing
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Stuttgart
country: Germany
facility: Hautarztpraxis Dres Leitz und Kollegen
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Wuppertal
country: Germany
facility: CentroDerm GmbH
city: Athens
country: Greece
facility: Athens Naval Hospital
city: Athens
country: Greece
facility: Thoracic General Hospital Of Athens Sotiria
city: Athens
country: Greece
facility: University General Hospital Attikon
city: Athens
country: Greece
facility: Andreas Syngros Hospital Of Venereal And Dermatological Diseases
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Larissa
country: Greece
facility: General University Hospital of Larissa
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
city: Veszprem
country: Hungary
facility: Medmare Bt
city: Chieti
country: Italy
facility: Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
city: Roma
country: Italy
facility: Azienda Ospedaliera Policlinico Umberto I
city: Torino
country: Italy
facility: Azienda Ospedaliera Citta della Salute e della Scienza di Torino
city: Nagakute-shi
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Nagoya-shi
country: Japan
facility: Japan Community Healthcare Organization Chukyo Hospital
state: Aichi
city: Nagoya-shi
country: Japan
facility: Central Clinic
state: Aichi
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Matsuo Clinic
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital
state: Fukushima
city: Asahikawa-shi
country: Japan
facility: Asahikawa City Hospital
state: Hokkaido
city: Inashiki-gun
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center
state: Ibaraki
city: Nonoichi-shi
country: Japan
facility: Kaji Dermatology Clinic
state: Ishikawa
city: Morioka-shi
country: Japan
facility: Iwate Medical University Uchimaru Medical Center
state: Iwate
city: Marugame-shi
country: Japan
facility: Takeoka Dermatology Clinic
state: Kagawa
city: Kawasaki-shi
country: Japan
facility: Nippon Medical School Musashikosugi Hospital
state: Kanagawa
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
state: Kyoto
city: Kyoto-shi
country: Japan
facility: Rakuwakai Otowa Hospital
state: Kyoto
city: Izumiotsu-shi
country: Japan
facility: Mochida Dermatology Clinic
state: Osaka
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital
state: Tochigi
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Ansansi, Gyeonggido
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: National Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Riga
country: Latvia
facility: Outpatient clinic Veselibas Centrs 4
city: Riga
country: Latvia
facility: Outpatient clinic Veselibascentrs 4
city: Talsi
country: Latvia
facility: Smite Aija practice in dermatology and venerology
city: Born
country: Netherlands
facility: PreCare Trial and Recruitment
city: Gdansk
country: Poland
facility: AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
city: Katowice
country: Poland
facility: Centrum Medyczne Angelius Provita
city: Lublin
country: Poland
facility: Centrum Zdrowia i Urody Maxxmed
city: Malbork
country: Poland
facility: Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
city: Nowa Sol
country: Poland
facility: Twoja przychodnia Ncm
city: Poznan
country: Poland
facility: Twoja przychodnia Pcm
city: Szczecin
country: Poland
facility: Twoja Przychodnia Scm
city: Tarnow
country: Poland
facility: Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
city: Warszawa
country: Poland
facility: Royalderm Agnieszka Nawrocka
city: Wroclaw
country: Poland
facility: Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
city: Lisboa
country: Portugal
facility: Hospital Lusiadas Lisboa
city: Lisboa
country: Portugal
facility: Hospital Cuf Descobertas
city: Matosinhos
country: Portugal
facility: Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
city: Porto
country: Portugal
facility: Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
city: San Juan
country: Puerto Rico
facility: Clinical Research of Puerto Rico
city: Banska Bystrica
country: Slovakia
facility: Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
city: Bratislava
country: Slovakia
facility: Derma therapy, spol s ro
city: Svidnik
country: Slovakia
facility: Sanare spol sro
city: Topolcany
country: Slovakia
facility: Kaderma Majtan, sro
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
state: Andalucía
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Aragón
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Universitario de Gran Canaria Doctor Negrin
state: Canarias
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Cataluña
city: Hospitalet de LLobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Cataluña
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
state: Comunidad Valenciana
city: Pontevedra
country: Spain
facility: Hospital Clinico Universitario de Santiago
state: Galicia
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital Taipei Branch
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: