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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05882877
Other study ID # 20210146
Secondary ID 2022-501587-17
Status Recruiting
Phase Phase 3
First received
Last updated
Start date May 31, 2023
Est. completion date June 4, 2027

Study information

Verified date June 2024
Source Amgen
Contact Amgen Call Center
Phone 866-572-6436
Email medinfo@amgen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to describe the long-term safety and tolerability of rocatinlimab in participants with moderate-to-severe AD.


Recruitment information / eligibility

Status Recruiting
Enrollment 2200
Est. completion date June 4, 2027
Est. primary completion date June 4, 2027
Accepts healthy volunteers No
Gender All
Age group 12 Years to 100 Years
Eligibility Inclusion Criteria: - Completion of an end of treatment duration visit (Week 24 or Week 52 visit for adult or adolescent studies, respectively) in a rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER) within the past 28 days. Exclusion Criteria: - Permanent investigational product discontinuation due to safety-related reasons, protocol-defined stopping rules or conditions/reasons unrelated to efficacy during the rocatinlimab parent study (ROCKET-IGNITE, ROCKET-HORIZON, ROCKET-SHUTTLE, ROCKET-ASTRO, ROCKET-ORBIT, OR ROCKET-VOYAGER), or at the time of Screening or Day 1.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rocatinlimab
Subcutaneous (SC) injection
Other:
Placebo
SC injection

Locations

Country Name City State
Argentina Cinme - Centro de Investigaciones Metabolicas Caba Buenos Aires
Argentina Conexa Investigacion Clinica SA Caba Distrito Federal
Argentina Buenos Aires Skin SA Ciudad Autonoma de Buenos Aires Distrito Federal
Argentina Care- Centro de Alergia y Enfermedades Respiratorias Ciudad Autonoma de Buenos Aires Distrito Federal
Argentina Fundacion Cidea Ciudad Autonoma de Buenos Aires Distrito Federal
Argentina Fundacion Respirar Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina InAER - Investigaciones en Alergia y Enfermedades Respiratorias Ciudad Autonoma de Buenos Aires Distrito Federal
Argentina Instituto de Neumonologia y Dermatologia Ciudad Autonoma de Buenos Aires Distrito Federal
Argentina Psoriahue Medicina Interdisciplinaria SRL Ciudad Autonoma de Buenos Aires Distrito Federal
Argentina Hospital Universitario Austral Derqui, Pilar Buenos Aires
Argentina Framingham Centro Medico La Plata Buenos Aires
Argentina Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario Rosario Santa Fe
Argentina Fundacion Estudios Clinicos Rosario Santa Fe
Argentina Instituto de Diagnostico ABC Rosario Santa Fe
Australia The Skin Centre Benowa Queensland
Australia Box Hill Hospital Box Hill Victoria
Australia Emeritus Research Melbourne Camberwell Victoria
Australia Skin Health Institute Carlton Victoria
Australia Premier Specialists Kogarah New South Wales
Australia St George Dermatology and Skin Cancer Centre Kogarah New South Wales
Australia The Alfred Hospital Melbourne Victoria
Australia The Royal Melbourne Hospital Parkville Victoria
Australia Princess Alexandra Hospital South Brisbane Queensland
Australia Veracity Clinical Research Woolloongabba Queensland
Austria Medizinische Universitaet Graz Graz
Austria Landeskrankenhaus Salzburg Salzburg
Belgium Universitair Ziekenhuis Gent Gent
Belgium Clinique Andre Renard Herstal
Belgium Dermatologie Handelskaai Kortrijk
Belgium Grand Hopital de Charleroi Loverval
Belgium Dermatologie Maldegem Maldegem
Brazil Ceti Centro Est Terap Inovadoras Curitiba Paraná
Brazil Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande Do Sul
Brazil Hospital Ernesto Dornelles Porto Alegre Rio Grande Do Sul
Brazil IBPClin Instituto Brasil de Pesquisa Clinica Rio de Janeiro
Brazil Fundacao Abc - Centro Univ Fmabc Santo Andre São Paulo
Brazil Centro Multidisciplinar de Estudos Clinicos - Cemec Sao Bernardo do Campo São Paulo
Brazil Ispem-Instituto São José dos Campos em Pesquisas Médicas São José dos Campos São Paulo
Brazil Consultoria Medica e Pesquisa Clinica Cmpc Sorocaba São Paulo
Bulgaria Medical Center Asklepii OOD Dupnitsa
Bulgaria Medical Center Medconsult Pleven OOD Pleven
Bulgaria Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD Sofia
Bulgaria Medical Center Excelsior OOD Sofia
Canada CCA Medical Research Corporation Ajax Ontario
Canada SimcoDerm Medical and Surgical Dermatology Centre Barrie Ontario
Canada Beacon Dermatology Calgary Alberta
Canada Dermatology Research Institute Incorporated Calgary Alberta
Canada SKiN Health Coburg Ontario
Canada Alberta Derma Surgery Centre Edmonton Alberta
Canada Laser Rejuvenation Clinics Edmonton D T Incorporated Edmonton Alberta
Canada Skin Physicians Dermatology Edmonton Alberta
Canada Vida Clinical Research Edmonton Alberta
Canada Kingsway Clinical Research Etobicoke Ontario
Canada Guelph Dermatology Research Guelph Ontario
Canada LEADER Research Hamilton Ontario
Canada Interior Dermatology Centre Kelowna British Columbia
Canada Centricity Research London London Ontario
Canada Lynderm Research Inc Markham Ontario
Canada DermEdge Research Incorporated Mississauga Ontario
Canada Clinique de Dermatologie Rosemont Montreal Quebec
Canada Innovaderm Research Inc Montreal Quebec
Canada Dr SK Siddha Medicine Professional Corporation Newmarket Ontario
Canada Allergy Research Canada Incorporated Niagara Falls Ontario
Canada North Bay Dermatology Centre North Bay Ontario
Canada Canadian Dermatology Centre North York Ontario
Canada The Centre for Clinical Trials Inc Oakville Ontario
Canada Dermatology Ottawa Research Centre Ottawa Ontario
Canada JRB Research Incorporated Ottawa Ontario
Canada SKiN Centre for Dermatology Peterborough Ontario
Canada Centre de Recherche Dermatologique du Quebec Metropolitain Quebec
Canada Recherche Clinique Sigma Incorporated Quebec
Canada Clinique Medicale Saint Louis Quebec City Quebec
Canada Oak Ridges Aesthetics Centre Richmond Hill Ontario
Canada The Centre for Dermatology Richmond Hill Ontario
Canada York Dermatology Clinic and Research Centre Richmond Hill Ontario
Canada Saskatoon Dermatology Centre Saskatoon Saskatchewan
Canada Skinsense Medical Research Saskatoon Saskatchewan
Canada Doctor Chih-Ho Hong Medical Incorporated Surrey British Columbia
Canada Enverus Medical Research Surrey British Columbia
Canada FACET Dermatology Toronto Ontario
Canada North York Research Incorporated Toronto Ontario
Canada Research Toronto Toronto Ontario
Canada Toronto Research Centre Inc Toronto Ontario
Canada Alliance Clinical Trials Waterloo Ontario
Canada XLR8 Medical Research, Incorporated Windsor Ontario
Canada Wiseman Dermatology Research Incorporated Winnipeg Manitoba
China Beijing Friendship Hospital, Capital Medical University Beijing Beijing
China Peking University Peoples Hospital Beijing
China Peking University Third Hospital Beijing Beijing
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
China Affiliated Hangzhou First Peoples Hospital,Zhejiang University School of Medicine Hangzhou Zhejiang
China Zhejiang Provincial Peoples Hospital Hangzhou Zhejiang
China Dermatology Hospital of Jiangxi Province Nanchang Jiangxi
China Nanyang First Peoples Hospital Nanyang Henan
China The First Hospital Of Hebei Medical University Shijiazhuang Hebei
China Wuxi Peoples Hospital Wuxi Jiangsu
Croatia Special Hospital for Medical Rehabilitation Naftalan Ivanic-Grad
Croatia University Hospital Centre Zagreb Zagreb
Czechia Kozni ambulance Kutna Hora sro Kutna Hora
Czechia Dermamedica, sro Nachod
Czechia Nemocnice Novy Jicin as Novy Jicin
Czechia CCR Ostrava sro Ostrava
Czechia Pratia Pardubice as Pardubice
Czechia Fakultni nemocnice Plzen Plzen
Czechia Dermamedest sro Praha
Czechia Clintrial sro Praha 10
Czechia Pratia Prague sro Praha 3
Czechia Praglandia sro Praha 5
Czechia Kozni ambulance Fialova sro Praha 6
Czechia Fakultni nemocnice Bulovka Praha 8
Czechia Dermatologicka ambulance MUDr Petr Trestik Svitavy
Czechia Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz Usti nad Labem
Denmark Gentofte Hospital Hellerup
Estonia North Estonia Medical Centre Tallinn
Estonia Clinical Research Centre Tartu
Finland Clinical Research Services Helsinki Helsinki
Finland Oulun Yliopistollinen sairaala Oulu
Finland Terveystalo Tampere Tampere
France Hopital Prive d Antony Antony
France Polyclinique de Courlancy Bezannes
France Centre Hospitalier Regional Universitaire Brest Hopital Morvan Brest
France Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez Lille
France Centre Hospitalier de Bretagne Sud - Hopital du Scorff Lorient Cedex
France Cabinet du Docteur Ruer-Mulard Mireille Martigues
France Centre Hospitalier Universitaire Archet 2 Nice
France Hopital Saint Louis Paris Cedex 10
France Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle Rouen Cedex
Germany Fachklinik Bad Bentheim Bad Bentheim
Germany Charite - Universitaetsmedizin Berlin, Campus Mitte Berlin
Germany Clinical Research Services Berlin GmbH Berlin
Germany Dermatologische Gemeinschaftspraxis-Mahlow Blankenfelde-Mahlow
Germany Hautarztpraxis Dr Niesmann und Dr Othlinghaus Bochum
Germany Rosenpark Research GmbH Darmstadt
Germany Universitaetsklinikum Dresden Dresden
Germany Universitaetsmedizin Goettingen - Georg-August-Universitaet Goettingen
Germany Institute for Health Services Research in Dermatology and Nursing Hamburg
Germany Universitaetsklinikum Heidelberg Heidelberg
Germany Universitaetsklinikum Schleswig-Holstein Kiel
Germany Velocity Clinical Research Leipzig
Germany Universitaetsmedizin Mainz Mainz
Germany Beldio Research GmbH Memmingen
Germany Hautmedizin Saar Merzing
Germany Klinikum rechts der Isar der TUM Muenchen
Germany Universitaetsklinikum Muenster Muenster
Germany KliFOs Klinische Forschung Osnabrueck Osnabrueck
Germany Hautarztpraxis Mortazawi Remscheid
Germany Hautarztpraxis Dres Leitz und Kollegen Stuttgart
Germany Universitaetsklinikum Tuebingen Tuebingen
Germany CentroDerm GmbH Wuppertal
Germany Helios Klinikum Wuppertal Wuppertal
Greece Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens
Greece University General Hospital Attikon Athens
Greece University General Hospital of Ioannina Ioannina
Greece General University Hospital of Larissa Larissa
Greece General Hospital Of Nea Ionia Konstantopouleio Patision Nea Ionia
Greece Papageorgiou General Hospital Thessaloniki
Hungary Trial Pharma Kft Bekescsaba
Hungary Csalogany Orvosi Kozpont Budapest
Hungary Obudai Egeszsegugyi Centrum Kft Budapest
Hungary Debreceni Egyetem Klinikai Kozpont Debrecen
Hungary Gyongyosi Bugat Pal Korhaz Gyongyos
Hungary Somogy Varmegyei Kaposi Mor Oktato Korhaz Kaposvar
Hungary DermaMed Research Kft Oroshaza
Hungary Allergo-Derm Bakos Kft Szolnok
Hungary Medmare Bt Veszprem
Hungary Obudai Egeszsegugyi Centrum Kft Zalaegerszeg
Italy Universita degli Studi Gabriele D Annunzio di Chieti e Pescara Chieti
Italy Ospedale San Salvatore LAquila
Italy Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico Milano
Italy Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia Perugia
Italy Azienda Ospedaliera Policlinico Umberto I Roma
Italy IRCCS Istituto Clinico Humanitas Rozzano MI
Japan Mildix Skin Clinic Adachi-ku Tokyo
Japan Asahikawa City Hospital Asahikawa-shi Hokkaido
Japan Ekihigashi Dermatology Allergy Clinic Fukuoka-shi Fukuoka
Japan Fukuoka University Hospital Fukuoka-shi Fukuoka
Japan Matsuo Clinic Fukuoka-shi Fukuoka
Japan Fukushima Medical University Hospital Fukushima-shi Fukushima
Japan Osaka Habikino Medical Center Habikino-shi Osaka
Japan Hamamatsu University Hospital Hamamatsu-shi Shizuoka
Japan JA Shizuoka Kohseiren Enshu Hospital Hamamatsu-shi Shizuoka
Japan Tokyo Medical University Ibaraki Medical Center Inashiki-gun Ibaraki
Japan Nihon University Itabashi Hospital Itabashi-ku Tokyo
Japan Teikyo University Hospital Itabashi-ku Tokyo
Japan Mochida Dermatology Clinic Izumiotsu-shi Osaka
Japan Katahira Dermatology Urology Clinic Kagoshima-shi Kagoshima
Japan Kosugi Dermatology Clinic Kawasaki-shi Kanagawa
Japan Nippon Medical School Musashikosugi Hospital Kawasaki-shi Kanagawa
Japan St Marianna University Hospital Kawasaki-shi Kanagawa
Japan Kobe University Hospital Kobe-shi Hyogo
Japan Jouzan Hihuka Hinyoukika Clinic Kumamoto-shi Kumamoto
Japan Suizenji Dermatology Clinic Kumamoto-shi Kumamoto
Japan Rakuwakai Otowa Hospital Kyoto-shi Kyoto
Japan University Hospital Kyoto Prefectural University of Medicine Kyoto-shi Kyoto
Japan Takeoka Dermatology Clinic Marugame-shi Kagawa
Japan Miyata Dermatology Clinic Matsudo-shi Chiba
Japan Mita Dermatology Clinic Minato-ku Tokyo
Japan Iwate Medical University Uchimaru Medical Center Morioka-shi Iwate
Japan Aichi Medical University Hospital Nagakute-shi Aichi
Japan Nagasaki University Hospital Nagasaki-shi Nagasaki
Japan Central Clinic Nagoya-shi Aichi
Japan Fukui Dermatology Clinic Nagoya-shi Aichi
Japan Japan Community Healthcare Organization Chukyo Hospital Nagoya-shi Aichi
Japan Nagoya City University Hospital Nagoya-shi Aichi
Japan International University of Health and Welfare Narita Hospital Narita-shi Chiba
Japan Yoshioka Dermatology Clinic Neyagawa-shi Osaka
Japan Kaji Dermatology Clinic Nonoichi-shi Ishikawa
Japan Takagi Dermatological Clinic Obihiro-shi Hokkaido
Japan National Hospital Organization Sagamihara National Hospital Sagamihara-shi Kanagawa
Japan Dermatology and Ophthalmology Kume Clinic Sakai-shi Osaka
Japan Medical Corporation Kojinkai Sapporo Skin Clinic Sapporo-shi Hokkaido
Japan Naoko Dermatology Clinic Setagaya-ku Tokyo
Japan Dokkyo Medical University Hospital Shimotsuga-gun Tochigi
Japan NTT Medical Center Tokyo Shinagawa-ku Tokyo
Japan Showa University Hospital Shinagawa-ku Tokyo
Japan Seibo International Catholic Hospital Shinjuku-ku Tokyo
Japan Yamate Dermatology Clinic Shinjuku-ku Tokyo
Japan Shirasaki Dermatology Clinic Takaoka-shi Toyama
Japan Sugamo Kobayashi Derma Clinic Toshima-ku Tokyo
Japan Nomura Dermatology Clinic Yokohama-shi Kanagawa
Japan Showa University Northern Yokohama Hospital Yokohama-shi Kanagawa
Korea, Republic of Korea University Ansan Hospital Ansansi, Gyeonggido
Korea, Republic of Soon Chun Hyang University Bucheon Hospital Bucheon-si, Gyeonggi-do
Korea, Republic of Chosun University Hospital Gwangju
Korea, Republic of Inha University Hospital Incheon
Korea, Republic of The Catholic University of Korea Incheon St Marys Hospital Incheon
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Chung-Ang University Hospital Seoul
Korea, Republic of Ewha Womans University Seoul Hospital Seoul
Korea, Republic of Hallym University Kangnam Sacred Heart Hospital Seoul
Korea, Republic of Konkuk University Medical Center Seoul
Korea, Republic of Korea University Anam Hospital Seoul
Korea, Republic of Kyung Hee University Hospital at Gangdong Seoul
Korea, Republic of National Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of The Catholic University of Korea Seoul St Marys Hospital Seoul
Korea, Republic of Ajou University Hospital Suwon-si, Gyeonggi-do
Latvia Outpatient clinic Veselibas Centrs 4 Riga
Latvia Outpatient clinic Veselibascentrs 4 Riga
Latvia Smite Aija practice in dermatology and venerology Talsi
Malaysia Hospital Pulau Pinang Georgetown Pinang
Malaysia Hospital Raja Permaisuri Bainun Ipoh Perak
Malaysia Hospital Sultan Ismail Johor Bahru Johor
Malaysia University Malaya Medical Centre Kuala Lumpur Wilayah Persekutuan
Mexico Phylasis Clinical Research Cuautitlán Izcalli
Mexico Clínica de Enfermedades Crónicas y de Procedimientos Especiales Morelia Michoacán
Netherlands Bravis Ziekenhuis Bergen op Zoom
Netherlands Universitair Medisch Centrum Groningen Groningen
Netherlands Universitair Medisch Centrum Utrecht Utrecht
Poland ClinicMed Daniluk Nowak Spolka komandytowa Bialystok
Poland Dermapolis Medical Dermatology Center dr n med Edyta Gebska Chorzow
Poland AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy Gdansk
Poland Uniwersyteckie Centrum Kliniczne Gdansk
Poland Centrum Medyczne Angelius Provita Katowice
Poland GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero Katowice
Poland Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna Krakow
Poland Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne Lodz
Poland AppleTreeClinics Network Spzoo Lodz
Poland Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna Lodz
Poland Ip Clinic Sp zoo Lodz
Poland Centrum Zdrowia i Urody Maxxmed Lublin
Poland Clinical Best Solutions Sp zoo Spolka Komandytowa Lublin
Poland Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo Malbork
Poland Twoja przychodnia Ncm Nowa Sol
Poland Twoja przychodnia Pcm Poznan
Poland Twoja Przychodnia Scm Szczecin
Poland Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo Tarnow
Poland Evimed sp zoo centrum medyczne evimed Warszawa
Poland Klinika Osipowicz and Turkowski Sp zoo Warszawa
Poland Royalderm Agnieszka Nawrocka Warszawa
Poland Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych Wroclaw
Poland DermMedica Spzoo Centrum Columbus Wroclaw
Portugal Unidade de Saude Local de Almada-Seixal, EPE - Hospital Garcia de Orta Almada
Portugal Unidade Local de Saude de Coimbra, EPE Coimbra
Portugal Hospital Cuf Descobertas Lisboa
Portugal Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio Porto
Portugal Unidade Local de Saude de Sao Joao, EPE - Hospital de Sao Joao Porto
Singapore National Skin Centre Singapore
Singapore National University Hospital Singapore
Singapore Singapore General Hospital Singapore
Slovakia Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica Banska Bystrica
Slovakia Maxderm, sro Bardejov
Slovakia Derma therapy, spol s ro Bratislava
Slovakia Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto Bratislava
Slovakia Sanare spol sro Svidnik
Slovakia Kaderma Majtan, sro Topolcany
Slovenia Univerzitetni klinicni center Ljubljana Ljubljana
Slovenia Univerzitetni Klinicni Center Maribor Maribor
South Africa Hiway Medical Centre Westville, Durban KwaZulu-Natal
Spain Hospital General Universitario de Alicante Alicante Comunidad Valenciana
Spain Hospital Universitari Germans Trias i Pujol Badalona Cataluña
Spain Hospital Universitario Basurto Bilbao País Vasco
Spain Hospital Universitario Reina Sofia Cordoba Andalucía
Spain Hospital Universitari de Bellvitge Hospitalet de LLobregat Cataluña
Spain Hospital Universitario de Gran Canaria Doctor Negrin Las Palmas de Gran Canaria Canarias
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario de La Princesa Madrid
Spain Hospital Universitario Infanta Leonor Madrid
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital de Manises Manises Comunidad Valenciana
Spain Clinica Universidad de Navarra Pamplona Navarra
Spain Hospital Universitario Quironsalud Madrid Pozuelo de Alarcon Madrid
Spain Hospital Clinico Universitario de Santiago Santiago de Compostela Galicia
Spain Hospital Universitario Virgen Macarena Sevilla Andalucía
Spain Hospital Arnau de Vilanova de Valencia Valencia Comunidad Valenciana
Spain Hospital Universitario Miguel Servet Zaragoza
Switzerland Inselspital Bern Bern
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne
Switzerland Universitaetsspital Zuerich Zuerich
Taiwan National Cheng Kung University Hospital Tainan
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Turkey Ankara Bilkent Sehir Hastanesi Ankara
Turkey Gaziantep Universitesi Tip Fakultesi Hastanesi Gaziantep
Turkey Acibadem Altunizade Hastanesi Istanbul
Turkey Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi Istanbul
Turkey Marmara Universitesi Tip Fakultesi Hastanesi Istanbul
Turkey Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi Izmir
Turkey Erciyes Universitesi Tip Fakultesi Hastanesi Kayseri
Turkey Kocaeli Universitesi Tip Fakultesi Hastanesi Kocaeli
Turkey Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi Samsun
United Kingdom Guys Hospital London
United Kingdom Salford Care Organisation Salford
United Kingdom Accellacare Yorkshire Shipley
United States Albuquerque Clinical Trials Incorporated Albuquerque New Mexico
United States Atlanta Dermatology, Vein and Research Center, PC Alpharetta Georgia
United States University of Michigan Medical Center Ann Arbor Michigan
United States US Dermatology Partners Jollyville Austin Texas
United States Kern Research Inc Bakersfield California
United States Bellaire Dermatology Associates Bellaire Texas
United States Bexley Dermatology Research Bexley Ohio
United States Cahaba Dermatology and Skin Health Center Birmingham Alabama
United States Skin Care Research Incorporated Boca Raton Florida
United States Treasure Valley Medical Research Boise Idaho
United States MetroBoston Clinical Partners Brighton Massachusetts
United States Chear Center LLC Bronx New York
United States Ace Clinical Trials Brooklyn New York
United States Hope Clinical Research LLC Canoga Park California
United States Renaissance Research and Medical Group Cape Coral Florida
United States US Dermatology Partners Cedar Park Cedar Park Texas
United States IMMUNOe Research Centers Centennial Colorado
United States Dermatology Specialists of Charlotte Charlotte North Carolina
United States Institute for Asthma and Allergy Chevy Chase Maryland
United States DeNova Research Chicago Illinois
United States Bernstein Clinical Research Center LLC Cincinnati Ohio
United States DS Research Clarksville Indiana
United States Driven Research LLC Coral Gables Florida
United States Corazon United States of America, LLC doing business as Life Clinical Trials Coral Springs Florida
United States Alina Clinical Trials, LLC Dallas Texas
United States Dermatology Treatment and Research Center PA Dallas Texas
United States Zenos Clinical Research, LLC Dallas Texas
United States Henry Ford Health System Detroit Michigan
United States D and H Doral Research Centers Doral Florida
United States Saint Jude Clinical Research Doral Florida
United States West Coast Research LLC Dublin California
United States Newco 3A Research LLC El Paso Texas
United States California Dermatology and Clinical Research Institute Encinitas California
United States Onyx Clinical Research Flint Michigan
United States First OC Dermatology Fountain Valley California
United States The Ohio State University Dermatology East Gahanna Ohio
United States Cumberland Skin Center Hermitage Tennessee
United States Direct Helpers Research Center Hialeah Florida
United States Global Research Solutions Homestead Florida
United States Burke Pharmaceutical Research Hot Springs Arkansas
United States University of Texas Health Science Center at Houston Houston Texas
United States Dawes Fretzin Clinical Research Group, LLC Indianapolis Indiana
United States Sante Clinical Research Kerrville Texas
United States Antelope Valley Clinical Trials Lancaster California
United States Chemidox Clinical Trials Incorporated Lancaster California
United States Excel Clinical Research Las Vegas Nevada
United States Jubilee Clinical Research Inc Las Vegas Nevada
United States Dermatology and Skin Cancer Center Leawood Leawood Kansas
United States Dermatology and Skin Cancer Center of Lees Summit Lee's Summit Missouri
United States Somnos Clinical Research Lincoln Nebraska
United States Long Beach Research Institute Long Beach California
United States Dermatology Research Associates Los Angeles California
United States Wallace Medical Group Inc Los Angeles California
United States DS Research Louisville Kentucky
United States Education and Research Foundation Inc Lynchburg Virginia
United States Glick Skin Institute Margate Florida
United States Apex Clinical Research Center LLC Mayfield Heights Ohio
United States Velocity Clinical Research Inc Medford Oregon
United States Sms Clinical Research Limited Liability Company Mesquite Texas
United States Anchor Medical Research Miami Florida
United States Gold Coast Health Research Center Miami Florida
United States Healthy Life Research Miami Florida
United States Meridian International Research Miami Gardens Florida
United States Savin Medical Group LLC Miami Lakes Florida
United States Kentucky Advanced Medical Research LLC Murray Kentucky
United States Tanner Clinic Murray Utah
United States Icahn School of Medicine at Mount Sinai New York New York
United States OptiSkin Medical New York New York
United States Sadick Research Group New York New York
United States Eastern Virginia Medical School Norfolk Virginia
United States Virginia Dermatology and Skin Cancer Center Norfolk Virginia
United States Sneeze, Wheeze, and Itch Associates, LLC Normal Illinois
United States Las Vegas Clinical Trials North Las Vegas Nevada
United States Arkansas Research Trials, LLC North Little Rock Arkansas
United States Unity Clinical Research Oklahoma City Oklahoma
United States Skin Specialists PC Omaha Nebraska
United States Innovation Medical Research Center Inc Palmetto Bay Florida
United States Havana Research Institute Inc Pasadena California
United States Paddington Testing Company Inc Philadelphia Pennsylvania
United States Alliance Dermatology and Mohs Center Phoenix Arizona
United States Medical Dermatology Specialists Phoenix Arizona
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States The Indiana Clinical Trials Center PC Plainfield Indiana
United States Texas Dermatology Research Center Plano Texas
United States Oregon Medical Research Center Portland Oregon
United States Health Concepts Rapid City South Dakota
United States Skin Cancer and Dermatology Institute Reno Nevada
United States Integrative Skin Science and Research Sacramento California
United States University of California at Davis Medical Center Sacramento California
United States Dermatology Clinical Research Center of San Antonio San Antonio Texas
United States Texas Dermatology and Laser Specialists San Antonio Texas
United States Acclaim Clinical Research San Diego California
United States Kaiser Permanente Medical Center - Oakland San Francisco California
United States Advanced Medical Research PC Sandy Springs Georgia
United States Clinical Science Institute Santa Monica California
United States Affiliated Dermatology Scottsdale Arizona
United States NorthShore University HealthSystem Skokie Illinois
United States MultiCare Institute for Research and Innovation Spokane Washington
United States Dermatologist of Central States Clinical Research - Springfield Springfield Ohio
United States DermDox Dermatology, LLC Sugarloaf Pennsylvania
United States Olympian Clinical Research - Tampa Tampa Florida
United States The Woodlands Dermatology Associates The Woodlands Texas
United States Continental Clinical Solutions, LLC Towson Maryland
United States Revival Research Institute LLC Troy Michigan
United States Somerset Skin Centre Troy Michigan
United States Dermatology Research Center of Oklahoma, PLLC Tulsa Oklahoma
United States Essential Medical Research LLC Tulsa Oklahoma
United States Wolverine Clinical Trials Tustin California
United States Foxhall Research Center Washington District of Columbia
United States Dundee Dermatology West Dundee Illinois
United States Options Research Group LLC West Lafayette Indiana
United States Accellacare of Wilmington Wilmington North Carolina
United States Wilmington Dermatology Center Wilmington North Carolina
United States The Skin Surgery Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  China,  Croatia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Germany,  Greece,  Hungary,  Italy,  Japan,  Korea, Republic of,  Latvia,  Malaysia,  Mexico,  Netherlands,  Poland,  Portugal,  Singapore,  Slovakia,  Slovenia,  South Africa,  Spain,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Treatment-emergent Adverse Events Up to 116 weeks
Secondary Maintaining Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™) 0/1 Response Among Participants Achieving vIGA-AD™ 0/1 Response at Day 1 Up to 104 weeks
Secondary Maintaining vIGA-AD™ 1 Response with Presence of Only Barely Perceptible Erythema or vIGA-AD™ 0 Response Among Participants Achieving vIGA-AD™ 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD™ 0 Response at Day 1 Up to 104 weeks
Secondary Maintaining EASI 75 Response Among Participants Achieving EASI 75 Response at Day 1 Up to 104 weeks
Secondary Maintaining vIGA-AD™ 0/1 Response and EASI 75 Response Among Participants Achieving vIGA-AD™ 0/1 Response and EASI 75 Response at Day 1 Up to 104 weeks
Secondary Percent Change From Parent Study Baseline in EASI Score Among Participants Achieving EASI 75 Response at Day 1 Up to 104 weeks
Secondary Maintaining = 4-point Reduction From Parent Study Baseline in Weekly Average of Daily Worst Pruritus Numerical Rating Scale (NRS) Score Among Participants Achieving = 4-point Reduction From Parent Study Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Day 1 Up to 104 weeks
See also
  Status Clinical Trial Phase
Completed NCT05018806 - Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis Phase 2
Completed NCT04090229 - A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis Phase 1
Terminated NCT03847389 - Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis Phase 1/Phase 2
Active, not recruiting NCT05388760 - Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1) Phase 2
Completed NCT05530707 - Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer N/A
Completed NCT02595073 - Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis Phase 3
Recruiting NCT05509023 - Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD) Phase 2
Recruiting NCT05048056 - Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis Phase 2
Completed NCT04598269 - Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis Phase 2
Recruiting NCT03936335 - An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
Withdrawn NCT03089476 - Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy N/A
Recruiting NCT05029895 - A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Terminated NCT03654755 - Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis Phase 2
Completed NCT04556461 - Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function Phase 2
Recruiting NCT04818138 - BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort N/A
Completed NCT03719742 - A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer N/A
Completed NCT05375955 - A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis. Phase 2
Completed NCT03441568 - In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control N/A
Recruiting NCT06366932 - Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models Phase 4
Completed NCT03304470 - A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis Phase 2