Clinical trial NCT05724199: A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
Official title: A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
AMG 451
Eczema
Rocatinlimab
KHK4083
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2023-02-13
Enrollment: 746
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The coprimary objectives of the study are to:

* evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™).
* evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years with a diagnosis of AD according to the AAD (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months
* History of inadequate response to TCS of medium or higher potency (with or without 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
  * Nonbiologic, non-targeted Systemic immunosuppressants
  * Phototherapy
  * Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

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

Primary outcomes:
measure: Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Achievement of EASI 75 at Week 16
timeFrame: Baseline, Week 16
measure: Achievement of vIGA-AD 0/1 at Week 16
timeFrame: Baseline, 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, 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, Week 24
measure: Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of a ≥ 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, Week 24
measure: Achievement of vIGA-AD 1 Response with a Presence of Only Barely Perceptible Erythema or vlGA-AD 0 Response (Revised IGA [rIGA™] 0/1) at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline
timeFrame: Baseline, Week 24
measure: Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants 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 Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants 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 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, 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 AD Skin Pain NRS Score at Week 16 in Participants 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 AD Skin Pain NRS Score at Week 24 in Participants 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 AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 3
timeFrame: Baseline, Week 16
measure: Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24
timeFrame: Baseline, Week 24
measure: Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8
timeFrame: Baseline, Week 24
measure: Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8
timeFrame: Baseline, Week 24
measure: Change From Baseline in HADS-anxiety Subscale Score at Week 24
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: The University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Medical Dermatology Specialists
state: Arizona
city: Phoenix
country: United States
facility: Southwest Skin Specialists
state: Arizona
city: Sun City West
country: United States
facility: US Dermatology Partners Sun City West
state: Arizona
city: North Little Rock
country: United States
facility: Arkansas Research Trials, LLC
state: Arkansas
city: Bakersfield
country: United States
facility: Kern Research Inc
state: California
city: Los Angeles
country: United States
facility: Keck Medicine of University of Southern California
state: California
city: Los Angeles
country: United States
facility: Wallace Medical Group Inc
state: California
city: Palmdale
country: United States
facility: Antelope Valley Clinical Trials
state: California
city: Sacramento
country: United States
facility: University of California at Davis Medical Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente South Sacramento Medical Center
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center - Oakland
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente Medical Center - San Francisco
state: California
city: San Francisco
country: United States
facility: Synergy Dermatology
state: California
city: Tampa
country: United States
facility: TrueBlue Clinical Research
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research - Tampa
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein and Research Center, PC
state: Georgia
city: Atlanta
country: United States
facility: Divine Dermatology and Aesthetics
state: Georgia
city: Skokie
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Clarksville
country: United States
facility: DS Research
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group, LLC
state: Indiana
city: Leawood
country: United States
facility: Dermatology and Skin Cancer Center Leawood
state: Kansas
city: Monroe
country: United States
facility: Industrial Medicine Associates Clinical Research Advanced Dermatology Care
state: Louisiana
city: Rockville
country: United States
facility: Aesthetic and Dermatology Center
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Medical Center
state: Michigan
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology
state: Michigan
city: Lincoln
country: United States
facility: Somnos Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Skin Specialists PC
state: Nebraska
city: Las Vegas
country: United States
facility: Vivida Dermatology
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Hackensack
country: United States
facility: Schweiger Dermatology Group, PC Research Division
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials Incorporated
state: New Mexico
city: Bronx
country: United States
facility: Chear Center LLC
state: New York
city: Wilmington
country: United States
facility: Accellacare of Wilmington
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology Research
state: Ohio
city: Medford
country: United States
facility: Velocity Clinical Research Inc
state: Oregon
city: Philadelphia
country: United States
facility: Paddington Testing Company Inc
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Austin
country: United States
facility: US Dermatology Partners Jollyville
state: Texas
city: El Paso
country: United States
facility: Newco 3A Research LLC
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research
state: Texas
city: Plano
country: United States
facility: Texas Dermatology Research Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Dermatology and Skin Cancer Center
state: Virginia
city: Caba
country: Argentina
facility: Cinme - Centro de Investigaciones Metabolicas
state: Buenos Aires
city: La Plata
country: Argentina
facility: Framingham Centro Medico
state: Buenos Aires
city: Ramos Mejia
country: Argentina
facility: Dim Clinica Privada
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Buenos Aires Skin SA
state: Distrito Federal
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion Cidea
state: Distrito Federal
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Care- Centro de Alergia y Enfermedades Respiratorias
state: Distrito Federal
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Psoriahue Medicina Interdisciplinaria SRL
state: Distrito Federal
city: Rosario
country: Argentina
facility: Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
state: Santa Fe
city: Botany
country: Australia
facility: Emeritus Research Sydney
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Benowa
country: Australia
facility: The Skin Centre
state: Queensland
city: South Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Veracity Clinical Research
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research Melbourne
state: Victoria
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Innsbruck
country: Austria
facility: Medizinische Universitaet Innsbruck
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Wien
country: Austria
facility: Klinik Landstrasse
city: Wien
country: Austria
facility: Klinik Hietzing
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitaire Brugmann
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
city: Bruxelles
country: Belgium
facility: Universite Catholique de Louvain Cliniques Universitaires Saint Luc
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Herstal
country: Belgium
facility: Clinique Andre Renard
city: Kortrijk
country: Belgium
facility: Dermatologie Handelskaai
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven Gasthuisberg
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege - Sart Tilman
city: Loverval
country: Belgium
facility: Grand Hopital de Charleroi
city: Dupnitsa
country: Bulgaria
facility: Medical Center Asklepii OOD
city: Pleven
country: Bulgaria
facility: Medical Center Medconsult Pleven OOD
city: Sofia
country: Bulgaria
facility: Medical Center Excelsior OOD
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center Alexandrovska EOOD
city: Sofia
country: Bulgaria
facility: Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
city: Calgary
country: Canada
facility: Dermatology Research Institute Incorporated
state: Alberta
city: Edmonton
country: Canada
facility: Laser Rejuvenation Clinics Edmonton D T Incorporated
state: Alberta
city: Edmonton
country: Canada
facility: Alberta Derma Surgery Centre
state: Alberta
city: Surrey
country: Canada
facility: Enverus Medical Research
state: British Columbia
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Incorporated
state: Manitoba
city: Coburg
country: Canada
facility: SKiN Health
state: Ontario
city: London
country: Canada
facility: Centricity Research London
state: Ontario
city: Newmarket
country: Canada
facility: Dr SK Siddha Medicine Professional Corporation
state: Ontario
city: Niagara Falls
country: Canada
facility: Allergy Research Canada Incorporated
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
city: Ottawa
country: Canada
facility: Dermatology Ottawa Research Centre
state: Ontario
city: Ottawa
country: Canada
facility: JRB Research Incorporated
state: Ontario
city: Richmond Hill
country: Canada
facility: The Centre for Dermatology
state: Ontario
city: Toronto
country: Canada
facility: North York Research Incorporated
state: Ontario
city: Toronto
country: Canada
facility: Toronto Research Centre Inc
state: Ontario
city: Waterloo
country: Canada
facility: Alliance Clinical Trials
state: Ontario
city: Montreal
country: Canada
facility: Clinique de Dermatologie Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Dermatology Centre
state: Saskatchewan
city: Quebec
country: Canada
facility: DIEX Recherche Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Saint-Louis
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: Shantou
country: China
facility: The Fist Affiliated Hospital of Shantou University Medical College
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Qianhai Shekou Free Trade Zone Hospital
state: Guangdong
city: Nanyang
country: China
facility: Nanyang First Peoples Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of science and Technology
state: Hubei
city: Wuxi
country: China
facility: Wuxi Second 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: 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: Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: The First Affiliation Hospital Of Ningbo University
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: Antony
country: France
facility: Hopital Prive d Antony
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André
city: Brest
country: France
facility: Centre Hospitalier Regional Universitaire Brest Hopital Morvan
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
city: Lorient Cedex
country: France
facility: Centre Hospitalier de Bretagne Sud - Hopital du Scorff
city: Marseille cedex 05
country: France
facility: Hôpital La Timone
city: Martigues
country: France
facility: Cabinet du Docteur Ruer-Mulard Mireille
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes Hôtel Dieu
city: Nice
country: France
facility: Centre Hospitalier Universitaire Archet 2
city: Paris Cedex 10
country: France
facility: Hopital Saint Louis
city: Paris
country: France
facility: Hopital Bichat Claude Bernard
city: Paris
country: France
facility: Hopital Tenon
city: Reims
country: France
facility: Polyclinique de Courlancy
city: Rennes Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
city: Rouen Cedex
country: France
facility: Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
city: Saint Priest en Jarez
country: France
facility: Centre Hospitalier Universitaire Saint Etienne Hopital Nord
city: Toulon
country: France
facility: Hopital d instruction des armees sainte anne
city: Frankfurt am Main
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Goettingen
country: Germany
facility: Universitaetsmedizin Goettingen - Georg-August-Universitaet
city: Hamburg
country: Germany
facility: TFS Trial Form Support GmbH
city: Hamburg
country: Germany
facility: MensingDerma research GmbH
city: Hannover
country: Germany
facility: Hautaerzte Zentrum Hannover
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Mainz
country: Germany
facility: Universitaetsmedizin Mainz
city: Memmingen
country: Germany
facility: Beldio Research GmbH
city: Merzing
country: Germany
facility: Hautmedizin Saar
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der TUM
city: Athens
country: Greece
facility: 401 General Military Hospital Of Athens
city: Athens
country: Greece
facility: Andreas Syngros Hospital Of Venereal And Dermatological Diseases
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Nea Ionia
country: Greece
facility: General Hospital Of Nea Ionia Konstantopouleio Patision
city: Piraeus
country: Greece
facility: Geniko Nosokomeio Peiraia Tzaneio
city: Thessaloniki
country: Greece
facility: Ippokratio General Hospital of Thessaloniki
city: Bekescsaba
country: Hungary
facility: Trial Pharma Kft
city: Budapest
country: Hungary
facility: Csalogany Orvosi Kozpont
city: Budapest
country: Hungary
facility: Clinexpert Kft
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyongyos
country: Hungary
facility: Gyongyosi Bugat Pal Korhaz
city: Kaposvar
country: Hungary
facility: Somogy Varmegyei Kaposi Mor Oktato Korhaz
city: Oroshaza
country: Hungary
facility: DermaMed Research Kft
city: Szolnok
country: Hungary
facility: Allergo-Derm Bakos Kft
city: Zalaegerszeg
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: LAquila
country: Italy
facility: Ospedale San Salvatore
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
city: Rozzano MI
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Nagoya-shi
country: Japan
facility: Fukui Dermatology Clinic
state: Aichi
city: Fukuoka-shi
country: Japan
facility: Ekihigashi Dermatology Allergy Clinic
state: Fukuoka
city: Obihiro-shi
country: Japan
facility: Takagi Dermatological Clinic Branch
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Medical Corporation Kojinkai Sapporo Skin Clinic
state: Hokkaido
city: Kagoshima-shi
country: Japan
facility: Katahira Dermatology Urology Clinic
state: Kagoshima
city: Kawasaki-shi
country: Japan
facility: Kosugi Dermatology Clinic
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Nomura Dermatology Clinic
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Jouzan Hihuka Hinyoukika Clinic
state: Kumamoto
city: Kumamoto-shi
country: Japan
facility: Suizenji Dermatology Clinic
state: Kumamoto
city: Neyagawa-shi
country: Japan
facility: Yoshioka Dermatology Clinic
state: Osaka
city: Hamamatsu-shi
country: Japan
facility: JA Shizuoka Kohseiren Enshu Hospital
state: Shizuoka
city: Adachi-ku
country: Japan
facility: Mildix Skin Clinic
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Naoko Dermatology Clinic
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: NTT Medical Center Tokyo
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Yamate Dermatology Clinic
state: Tokyo
city: Johor Bahru
country: Malaysia
facility: Hospital Sultan Ismail
state: Johor
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun
state: Perak
city: Georgetown
country: Malaysia
facility: Hospital Pulau Pinang
state: Pinang
city: Kota Kinabalu
country: Malaysia
facility: Queen Elizabeth Hospital
state: Sabah
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: Pusat Perubatan Universiti Kebangsaan Malaysia
state: Wilayah Persekutuan
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan
city: Bergen op Zoom
country: Netherlands
facility: Bravis Ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: Chorzow
country: Poland
facility: Dermapolis Medical Dermatology Center dr n med Edyta Gebska
city: Katowice
country: Poland
facility: GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
city: Krakow
country: Poland
facility: Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
city: Lodz
country: Poland
facility: AppleTreeClinics Network Spzoo
city: Lodz
country: Poland
facility: Ip Clinic Sp zoo
city: Szczecin
country: Poland
facility: Twoja Przychodnia Scm
city: Wroclaw
country: Poland
facility: DermMedica Spzoo Centrum Columbus
city: Caguas
country: Puerto Rico
facility: Doctor Samuel Sanchez PSC
city: Brasov
country: Romania
facility: Theramed Healthcare SRL
city: Cluj-Napoca
country: Romania
facility: Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
city: Targu Mures
country: Romania
facility: Spitalul Clinic Judetean Mures
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Skin Centre
city: Bardejov
country: Slovakia
facility: Maxderm, sro
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
city: Presov
country: Slovakia
facility: Fakultna nemocnica s poliklinikou JA Reimana Presov
city: Svidnik
country: Slovakia
facility: Sanare spol sro
city: Ljubljana
country: Slovenia
facility: Univerzitetni klinicni center Ljubljana
city: Maribor
country: Slovenia
facility: Univerzitetni Klinicni Center Maribor
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
state: Cataluña
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
state: Comunidad Valenciana
city: Bilbao
country: Spain
facility: Hospital Universitario Basurto
state: País Vasco
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Pontevedra
country: Spain
facility: Complexo Hospitalario Universitario de Pontevedra
city: Bern
country: Switzerland
facility: Inselspital Bern
city: Geneve 14
country: Switzerland
facility: Hopitaux Universitaires de Geneve
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Sankt Gallen
country: Switzerland
facility: Kantonsspital Sankt Gallen
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zuerich
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
city: Istanbul
country: Turkey
facility: Acibadem Altunizade Hastanesi
city: Istanbul
country: Turkey
facility: Marmara Universitesi Tip Fakultesi Hastanesi
city: Samsun
country: Turkey
facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
city: Bath
country: United Kingdom
facility: Royal United Hospitals Bath NHS Foundation Trust
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
city: Isleworth
country: United Kingdom
facility: West Middlesex University Hospital
city: London
country: United Kingdom
facility: The Royal Free Hospital
city: Salford
country: United Kingdom
facility: Salford Care Organisation
city: Shipley
country: United Kingdom
facility: Accellacare Yorkshire
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: