Clinical trial NCT05651711: A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)
Official title: A Phase 3, Randomized, 24-week, 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) (ROCKET-Horizon)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
AMG 451
KHK 4083
Eczema
Rocatinlimab
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-12-15
Enrollment: 726
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 co-primary objectives of the study are to:

* Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
* Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) 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 or higher potency (with or without topical calcineurin inhibitors \[TCI\]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
* 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
  * Oral or topical 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 (PDE4) inhibitors
  * Other topical immunosuppressive agents
  * Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other immunosuppressive agents

Primary outcomes:
measure: Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a ≥ 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
timeFrame: Baseline and Week 24
measure: Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Achievement of EASI 75 at Week 16
timeFrame: Baseline and Week 16
measure: Achievement of vIGA-AD 0/1 at Week 16
timeFrame: Baseline and Week 16
measure: Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
timeFrame: Baseline and Week 16
measure: Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
timeFrame: Baseline and Week 24
measure: Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
timeFrame: Baseline and Week 24
measure: Achievement of ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
timeFrame: Baseline to Week 24
measure: Achievement of 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 and Week 24
measure: Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline
timeFrame: Baseline and Week 24
measure: Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline
timeFrame: Baseline and Week 24
measure: Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
timeFrame: Baseline and Week 24
measure: Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
timeFrame: Baseline and Week 16
measure: Change From Baseline in SCORAD Itch VAS Score at Week 24
timeFrame: Baseline and Week 24
measure: Achievement of a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI ≥ 4
timeFrame: Baseline and Week 24
measure: Change From Baseline in DLQI Score at Week 24
timeFrame: Baseline and Week 24
measure: Achievement of a ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants with Baseline POEM Score ≥ 4
timeFrame: Baseline and Week 24
measure: Change from Baseline in POEM Score at Week 24
timeFrame: Baseline and Week 24
measure: Achievement of ≥ 4-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
timeFrame: Baseline to Week 16
measure: Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
timeFrame: Baseline to Week 24
measure: Change from Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
timeFrame: Baseline and Week 16
measure: Achievement of ≥ 3-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 3
timeFrame: Baseline to Week 24
measure: Achievement of ≥ 3-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 3
timeFrame: Baseline to Week 16
measure: Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
timeFrame: Baseline to Week 24
measure: Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score <8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8
timeFrame: Baseline and Week 24
measure: Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8
timeFrame: Baseline and Week 24
measure: Change From Baseline in HADS-anxiety Subscale Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in HADS-depression Subscale Score at Week 24
timeFrame: Baseline and 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 and Week 24
Other outcomes:
Locations:
city: Litchfield Park
country: United States
facility: Research Solutions of Arizona, PC
state: Arizona
city: Scottsdale
country: United States
facility: Center for Dermatology and Plastic Surgery
state: Arizona
city: Fayetteville
country: United States
facility: Clinical Trials Institute of Northwest Arkansas
state: Arkansas
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Chula Vista
country: United States
facility: Velocity Clinical Research Chula Vista
state: California
city: Dublin
country: United States
facility: West Coast Research LLC
state: California
city: Encinitas
country: United States
facility: California Dermatology and Clinical Research Institute
state: California
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research Inc
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research - San Diego
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research - North Hollywood
state: California
city: Palmdale
country: United States
facility: Cura Clinical Research
state: California
city: San Francisco
country: United States
facility: University of California at San Francisco, Dermatology Clinic at Mount Zion
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Castle Rock
country: United States
facility: Clarity Dermatology
state: Colorado
city: Denver
country: United States
facility: Velocity Clinical Research - Denver
state: Colorado
city: Washington
country: United States
facility: Foxhall Research Center
state: District of Columbia
city: Cape Coral
country: United States
facility: Renaissance Research and Medical Group
state: Florida
city: Coral Gables
country: United States
facility: Driven Research LLC
state: Florida
city: Doral
country: United States
facility: Saint Jude Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center
state: Florida
city: Margate
country: United States
facility: Glick Skin Institute
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute, LLC
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center Inc
state: Florida
city: Tampa
country: United States
facility: University of South Florida Health Morsani Center for Advanced Healthcare
state: Florida
city: Sandy Springs
country: United States
facility: Advanced Medical Research PC
state: Georgia
city: Normal
country: United States
facility: Sneeze, Wheeze, and Itch Associates, LLC
state: Illinois
city: South Bend
country: United States
facility: The South Bend Clinic LLP
state: Indiana
city: West Lafayette
country: United States
facility: Options Research Group LLC
state: Indiana
city: Overland Park
country: United States
facility: Dermatology and Skin Cancer Center of Overland Park
state: Kansas
city: Louisville
country: United States
facility: DS Research
state: Kentucky
city: Murray
country: United States
facility: Kentucky Advanced Medical Research LLC
state: Kentucky
city: Brighton
country: United States
facility: MetroBoston Clinical Partners
state: Massachusetts
city: Farmington Hills
country: United States
facility: Wendy Sadoff MD Dermatology PC
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute LLC
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Omaha
country: United States
facility: Advanced Dermatology of the Midlands
state: Nebraska
city: Las Vegas
country: United States
facility: James Del Rosso Dermatology Research
state: Nevada
city: Reno
country: United States
facility: Skin Cancer and Dermatology Institute
state: Nevada
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Riverdale
country: United States
facility: Weiss Medical
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Horseheads
country: United States
facility: Corning Center For Clinical Research
state: New York
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: Monroe
country: United States
facility: Crystal Run Healthcare
state: New York
city: New York
country: United States
facility: Ace Clinical Trials
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: New York
country: United States
facility: OptiSkin Medical
state: New York
city: Durham
country: United States
facility: Duke South Durham
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center LLC
state: Ohio
city: Gahanna
country: United States
facility: The Ohio State University Dermatology East
state: Ohio
city: Grants Pass
country: United States
facility: Velocity Clinical Research - Grants Pass
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Warwick
country: United States
facility: Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
state: Rhode Island
city: Bellaire
country: United States
facility: Bellaire Dermatology Associates
state: Texas
city: Cedar Park
country: United States
facility: US Dermatology Partners Cedar Park
state: Texas
city: Dallas
country: United States
facility: Alina Clinical Trials, LLC
state: Texas
city: Dallas
country: United States
facility: Zenos Clinical Research, LLC
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: MedCare Pharma - Houston
state: Texas
city: Lampasas
country: United States
facility: FMCScience LLC
state: Texas
city: Lewisville
country: United States
facility: Epic Clinical Research Incorporated
state: Texas
city: Missouri City
country: United States
facility: Sienna Dermatology Research
state: Texas
city: San Antonio
country: United States
facility: Texas Dermatology and Laser Specialists
state: Texas
city: San Antonio
country: United States
facility: Andante Research
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Murray
country: United States
facility: University of Utah MidValley Dermatology
state: Utah
city: Norfolk
country: United States
facility: Eastern Virginia Medical School
state: Virginia
city: Spokane
country: United States
facility: MultiCare Institute for Research and Innovation
state: Washington
city: Darlinghurst
country: Australia
facility: St George Dermatology and Skin Cancer Centre
state: New South Wales
city: Kogarah
country: Australia
facility: Premier Specialists
state: New South Wales
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Carlton
country: Australia
facility: Skin Health Institute
state: Victoria
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Parkville
country: Australia
facility: The Royal Melbourne Hospital
state: Victoria
city: Bruxelles
country: Belgium
facility: Hopital Erasme
city: Herstal
country: Belgium
facility: Clinique Andre Renard
city: Maldegem
country: Belgium
facility: Dermatologie Maldegem
city: Curitiba
country: Brazil
facility: CETI - Centro de Estudo em Terapias Inovadoras
state: Paraná
city: Sao Bernardo do Campo
country: Brazil
facility: Centro Multidisciplinar de Estudos Clinicos - CEMEC
state: São Paulo
city: São José dos Campos
country: Brazil
facility: ISPEM - Instituto São José dos Campos em Pesquisas Médicas
state: São Paulo
city: Calgary
country: Canada
facility: Beacon Dermatology
state: Alberta
city: Surrey
country: Canada
facility: Doctor Chih-Ho Hong Medical Incorporated
state: British Columbia
city: Etobicoke
country: Canada
facility: Kingsway Clinical Research
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Oakville
country: Canada
facility: The Centre for Clinical Trials Inc
state: Ontario
city: Peterborough
country: Canada
facility: SKiN Centre for Dermatology
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: Research Toronto
state: Ontario
city: Windsor
country: Canada
facility: XLR8 Medical Research, Incorporated
state: Ontario
city: Sherbrooke
country: Canada
facility: Clinique Dermatologique de Sherbrooke
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec Metropolitain
city: Kutna Hora
country: Czechia
facility: Kozni ambulance Kutna Hora sro
city: Novy Jicin
country: Czechia
facility: Nemocnice Novy Jicin as
city: Pardubice
country: Czechia
facility: CCR Czech as
city: Plzen
country: Czechia
facility: Fakultni nemocnice Plzen
city: Praha 3
country: Czechia
facility: CCR Prague sro
city: Praha 5
country: Czechia
facility: Praglandia sro
city: Praha 6
country: Czechia
facility: Kozni ambulance Fialova sro
city: Praha
country: Czechia
facility: Dermamedest sro
city: Svitavy
country: Czechia
facility: Dermatologicka ambulance MUDr Petr Trestik
city: Hellerup
country: Denmark
facility: Gentofte Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Tallinn
country: Estonia
facility: North Estonia Medical Centre
city: Tartu
country: Estonia
facility: Clinical Research Centre
city: Helsinki
country: Finland
facility: CRST Helsinki
city: Helsinki
country: Finland
facility: CRST Turku
city: Oulu
country: Finland
facility: Oulun Yliopistollinen sairaala (OYS)
city: Tampere
country: Finland
facility: Terveystalo Tampere
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim
city: Berlin
country: Germany
facility: Hautzentrum Friedrichshain - Dermatologie
city: Berlin
country: Germany
facility: Clinical Research Services Berlin GmbH
city: Halle (Saale)
country: Germany
facility: Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
city: Hamburg
country: Germany
facility: Dermatologikum Hamburg
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Leipzig
country: Germany
facility: Velocity Clinical Research
city: Muenster
country: Germany
facility: Universitaetsklinikum Muenster
city: Osnabrueck
country: Germany
facility: KliFOs Klinische Forschung Osnabrueck
city: Remscheid
country: Germany
facility: Hautarztpraxis Mortazawi
city: Wuppertal
country: Germany
facility: Helios Klinikum Wuppertal
city: Matsudo-shi
country: Japan
facility: Miyata Dermatology Clinic
state: Chiba
city: Narita-shi
country: Japan
facility: International University of Health and Welfare Narita Hospital
state: Chiba
city: Kobe-shi
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Kawasaki-shi
country: Japan
facility: St Marianna University Hospital
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: National Hospital Organization Sagamihara National Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Showa University Northern Yokohama Hospital
state: Kanagawa
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
state: Nagasaki
city: Habikino-shi
country: Japan
facility: Osaka Habikino Medical Center
state: Osaka
city: Sakai-shi
country: Japan
facility: Dermatology and Ophthalmology Kume Clinic
state: Osaka
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Minato-ku
country: Japan
facility: Mita Dermatology Clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Seibo International Catholic Hospital
state: Tokyo
city: Toshima-ku
country: Japan
facility: Sugamo Kobayashi Derma Clinic
state: Tokyo
city: Takaoka-shi
country: Japan
facility: Shirasaki Dermatology Clinic
state: Toyama
city: Ansansi, Gyeonggido
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Bucheon-si, Gyeonggi-do
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Incheon
country: Korea, Republic of
facility: The Catholic University of Korea Incheon St Marys Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: National Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic Univ of Korea Seoul St Marys Hospital
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Seoul Hospital
city: Suwon-si, Gyeonggi-do
country: Korea, Republic of
facility: Ajou University Hospital
city: Morelia
country: Mexico
facility: Clínica de Enfermedades Crónicas y de Procedimientos Especiales
state: Michoacán
city: Chihuahua
country: Mexico
facility: Scientia Investigacion Clinica Sc
city: Cuautitlán Izcalli
country: Mexico
facility: Phylasis Clínicas Research S. De R. L. De C. V.
city: Bialystok
country: Poland
facility: ClinicMed Daniluk Nowak Spolka komandytowa
city: Chorzow
country: Poland
facility: Dermapolis Medical Dermatology Center dr n med Edyta Gebska
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Centermed krakow sp zoo
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
city: Lodz
country: Poland
facility: AppleTreeClinics Network Spzoo
city: Lodz
country: Poland
facility: Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
city: Lublin
country: Poland
facility: Clinical Best Solutions Sp zoo Spolka Komandytowa
city: Poznan
country: Poland
facility: Clinical Research Center Spzoo Medic-R Spolka Komandytowa
city: Warszawa
country: Poland
facility: Evimed sp zoo centrum medyczne evimed
city: Almada
country: Portugal
facility: Hospital Garcia de Orta, EPE
city: Coimbra
country: Portugal
facility: Centro Hospitalar e Universitario de Coimbra, EPE
city: Lisboa
country: Portugal
facility: Hospital Cuf Descobertas
city: Porto
country: Portugal
facility: Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
city: Bucharest
country: Romania
facility: Spitalul Clinic Colentina
city: Centurion
country: South Africa
facility: Ryexo Clinical Research
state: Gauteng
city: Johannesburg
country: South Africa
facility: About Allergy
state: Gauteng
city: Durban
country: South Africa
facility: Hiway Medical Centre
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
state: Andalucía
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
state: Comunidad Valenciana
city: Manises
country: Spain
facility: Hospital de Manises
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova de Valencia
state: Comunidad Valenciana
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi
city: Gaziantep
country: Turkey
facility: Gaziantep Universitesi Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Bezmialem Vakif Universitesi Hastanesi
city: Izmir
country: Turkey
facility: Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tip Fakultesi Hastanesi
city: Kocaeli
country: Turkey
facility: Kocaeli Universitesi Tip Fakultesi Hastanesi
city: Sakarya
country: Turkey
facility: Sakarya Egitim ve Arastirma Hastanesi
city: Corby
country: United Kingdom
facility: Lakeside Healthcare
city: London
country: United Kingdom
facility: Guys Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: