A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
NCT ID: NCT05398445
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
769 participants
INTERVENTIONAL
2022-05-31
2025-01-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Assess Long-term Safety, Tolerability, and Efficacy of Rocatinlimab in Adult and Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
NCT05882877
A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
NCT05724199
A Study With Self-administered Rocatinlimab in Adolescent and Adult Participants With Moderate-to-severe Atopic Dermatitis
NCT06224192
A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
NCT05704738
A Study to Assess the Safety, Tolerability, and Efficacy of Rocatinlimab in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
NCT05633355
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A
Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2
Rocatinlimab
Participants will receive Rocatinlimab subcutaneously.
Arm B
Rocatinlimab Dose 2 Q4W + loading dose at Week 2
Rocatinlimab
Participants will receive Rocatinlimab subcutaneously.
Arm C
Placebo Q4W+ loading dose at Week 2
Placebo
Participants will receive a placebo subcutaneously.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rocatinlimab
Participants will receive Rocatinlimab subcutaneously.
Placebo
Participants will receive a placebo subcutaneously.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
100 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amgen
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
MD
Role: STUDY_DIRECTOR
Amgen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, United States
Alliance Dermatology and Mohs Center
Phoenix, Arizona, United States
Anaheim Clinical Trials
Anaheim, California, United States
First OC Dermatology
Fountain Valley, California, United States
Kaiser Permanente - Glendale Medical Center
Glendale, California, United States
Long Beach Research Institute
Long Beach, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Cura Clinical Research
Sherman Oaks, California, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
Skin Care Research Incorporated
Boca Raton, Florida, United States
Palm Beach Dermatology Group
Delray Beach, Florida, United States
Global Research Associates
Homestead, Florida, United States
Healthy Life Research
Miami, Florida, United States
Savin Medical Group LLC
Miami Lakes, Florida, United States
Kirsch Dermatology LLC
Naples, Florida, United States
Pure Skin Dermatology and Aesthetics
Orlando, Florida, United States
Industrial Medicine Associates Ima Clinical Research Inc
St. Petersburg, Florida, United States
Genesis Clinical Research LLC
Tampa, Florida, United States
Treasure Valley Medical Research
Boise, Idaho, United States
DeNova Research
Chicago, Illinois, United States
Dundee Dermatology
West Dundee, Illinois, United States
The Indiana Clinical Trials Center PC
Plainfield, Indiana, United States
Institute for Asthma and Allergy
Chevy Chase, Maryland, United States
Continental Clinical Solutions, LLC
Towson, Maryland, United States
Henry Ford Health System
Detroit, Michigan, United States
Onyx Clinical Research
Flint, Michigan, United States
Dermatology and Skin Cancer Center of Lees Summit
Lee's Summit, Missouri, United States
Jubilee Clinical Research Inc
Las Vegas, Nevada, United States
Allcutis Research, Llc - Portsmouth
Portsmouth, New Hampshire, United States
Continental Clinical Solutions - Cherry Hill
Cherry Hill, New Jersey, United States
Industrial Medicine Associates Ima Clinical Research Inc
Hartsdale, New York, United States
Sadick Research Group
New York, New York, United States
Dermatology Specialists of Charlotte
Charlotte, North Carolina, United States
Onsite Clinical Solutions
Charlotte, North Carolina, United States
Wilmington Dermatology Center
Wilmington, North Carolina, United States
The Skin Surgery Center for Clinical Research
Winston-Salem, North Carolina, United States
Optima Research
Boardman, Ohio, United States
ClinOhio Research Services
Columbus, Ohio, United States
Unity Clinical Research
Oklahoma City, Oklahoma, United States
Dermatology Research Center of Oklahoma, PLLC
Tulsa, Oklahoma, United States
Essential Medical Research LLC
Tulsa, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
DermDox Dermatology, LLC
Sugarloaf, Pennsylvania, United States
Cumberland Skin Center
Hermitage, Tennessee, United States
Dermatology Treatment and Research Center PA
Dallas, Texas, United States
The Woodlands Dermatology Associates
The Woodlands, Texas, United States
Education and Research Foundation Inc
Lynchburg, Virginia, United States
Frontier Derm Partners
Mill Creek, Washington, United States
West Virginia Research Institute
Morgantown, West Virginia, United States
Cinme - Centro de Investigaciones Metabolicas
CABA, Buenos Aires, Argentina
Fundacion Respirar
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital Universitario Austral
Derqui, Pilar, Buenos Aires, Argentina
Centro Dermatológico Schejtman
San Miguel, Buenos Aires, Argentina
InAER - Investigaciones en Alergia y Enfermedades Respiratorias
Buenos Aires, Distrito Federal, Argentina
Instituto de Neumonologia y Dermatologia
Buenos Aires, Distrito Federal, Argentina
Conexa Investigacion Clinica SA
CABA, Distrito Federal, Argentina
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, Argentina
Instituto de Diagnostico Abc American British Cowdray
Rosario, Santa Fe Province, Argentina
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, Brazil
Upeclin-Pesq Clin FacMed Botucatu
Botucatu, São Paulo, Brazil
Hosp e Maternidade Dr Christovao da Gama
Santo André, São Paulo, Brazil
Fundacao Abc - Centro Univ Fmabc
Santo André, São Paulo, Brazil
Consultoria Medica e Pesquisa Clinica Cmpc
Sorocaba, São Paulo, Brazil
IBPClin Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, , Brazil
Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
São Paulo, , Brazil
Alberta Derma Surgery Centre
Edmonton, Alberta, Canada
Vida Clinical Research
Edmonton, Alberta, Canada
CCA Medical Research Corporation
Ajax, Ontario, Canada
SimcoDerm Medical and Surgical Dermatology Centre
Barrie, Ontario, Canada
LEADER Research
Hamilton, Ontario, Canada
DermEdge Research Incorporated
Mississauga, Ontario, Canada
Canadian Dermatology Centre
North York, Ontario, Canada
Gordon Sussman Clinical Research Incorporated
North York, Ontario, Canada
Oak Ridges Aesthetics Centre
Richmond Hill, Ontario, Canada
Innovaderm Research Inc
Montreal, Quebec, Canada
Recherche Clinique Sigma Incorporated
Québec, Quebec, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, Canada
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital ,Sun-Yat Sen University
Guangzhou, Guangdong, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, China
The First Hospital Of Hebei Medical University
Shijiazhuang, Hebei, China
Nanyang First Peoples Hospital
Nanyang, Henan, China
Sanmenxia Central Hospital
Sanmenxia, Henan, China
Union Hospital Tongji Medical College Huazhong University of science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangyin Hospital of Traditional Chinese Medicine
Jiangyin, Jiangsu, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Chengdu Second Peoples Hospital
Chengdu, Sichuan, China
the First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial Peoples Hospital
Hangzhou, Zhejiang, China
Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
Peking University Peoples Hospital
Beijing, , China
Shanghai Skin Disease Hospital
Shanghai, , China
Special Hospital for Medical Rehabilitation Naftalan
Ivanić-Grad, , Croatia
Sestre milosrdnice University Hospital Center
Zagreb, , Croatia
University Hospital Centre Zagreb
Zagreb, , Croatia
Dermamedica, sro
Náchod, , Czechia
CCR Ostrava sro
Ostrava, , Czechia
Pratia Pardubice as
Pardubice, , Czechia
Clintrial sro
Prague, , Czechia
Pratia Prague sro
Prague, , Czechia
Fakultni nemocnice Bulovka
Prague, , Czechia
Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
Ústí nad Labem, , Czechia
Charite - Universitaetsmedizin Berlin, Campus Mitte
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
Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
Düsseldorf, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Institute for Health Services Research in Dermatology and Nursing
Hamburg, , Germany
Universitaetsklinikum Heidelberg
Heidelberg, , Germany
Hautarztpraxis Dres Leitz und Kollegen
Stuttgart, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
CentroDerm GmbH
Wuppertal, , Germany
Athens Naval Hospital
Athens, , Greece
Thoracic General Hospital Of Athens Sotiria
Athens, , Greece
University General Hospital Attikon
Athens, , Greece
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Athens, , Greece
University General Hospital of Ioannina
Ioannina, , Greece
General University Hospital of Larissa
Larissa, , Greece
Papageorgiou General Hospital
Thessaloniki, , Greece
Medmare Bt
Veszprém, , Hungary
Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
Chieti, , Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, , Italy
Azienda Ospedaliera Policlinico Umberto I
Roma, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, , Italy
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, Japan
Japan Community Healthcare Organization Chukyo Hospital
Nagoya, Aichi-ken, Japan
Central Clinic
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Fukuoka University Hospital
Fukuoka, Fukuoka, Japan
Matsuo Clinic
Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Asahikawa City Hospital
Asahikawa-shi, Hokkaido, Japan
Tokyo Medical University Ibaraki Medical Center
Inashiki-gun, Ibaraki, Japan
Kaji Dermatology Clinic
Nonoichi-shi, Ishikawa-ken, Japan
Iwate Medical University Uchimaru Medical Center
Morioka, Iwate, Japan
Takeoka Dermatology Clinic
Marugame-shi, Kagawa-ken, Japan
Nippon Medical School Musashikosugi Hospital
Kawasaki-shi, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, Japan
Rakuwakai Otowa Hospital
Kyoto, Kyoto, Japan
Mochida Dermatology Clinic
Izumiotsu-shi, Osaka, Japan
Dokkyo Medical University Hospital
Shimotsuga-gun, Tochigi, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
Nihon University Itabashi Hospital
Itabashi-ku, Tokyo, Japan
Outpatient clinic Veselibas Centrs 4
Riga, , Latvia
Outpatient clinic Veselibascentrs 4
Riga, , Latvia
Smite Aija practice in dermatology and venerology
Talsi, , Latvia
PreCare Trial and Recruitment
Born, , Netherlands
AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
Gdansk, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Centrum Zdrowia i Urody Maxxmed
Lublin, , Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
Malbork, , Poland
Twoja przychodnia Ncm
Nowa Sól, , Poland
Twoja przychodnia Pcm
Poznan, , Poland
Twoja Przychodnia Scm
Szczecin, , Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
Tarnów, , Poland
Royalderm Agnieszka Nawrocka
Warsaw, , Poland
Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
Wroclaw, , Poland
Hospital Lusiadas Lisboa
Lisbon, , Portugal
Hospital Cuf Descobertas
Lisbon, , Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
Matosinhos Municipality, , Portugal
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
Porto, , Portugal
Clinical Research of Puerto Rico
San Juan, , Puerto Rico
Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
Banská Bystrica, , Slovakia
Derma therapy, spol s ro
Bratislava, , Slovakia
Sanare spol sro
Svidník, , Slovakia
Kaderma Majtan, sro
Topoľčany, , Slovakia
Fakultna nemocnica Trnava
Trnava, , Slovakia
Korea University Ansan Hospital
Ansansi, Gyeonggido, , South Korea
The Catholic University of Korea Incheon St Marys Hospital
Incheon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
National Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hospital Universitario Reina Sofia
Córdoba, Andalusia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Universitari Germans Trias i Pujol
Badalona, Catalonia, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Catalonia, Spain
Hospital Clinico Universitario de Santiago
Pontevedra, Galicia, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Valencia, Spain
Hospital Universitario de La Princesa
Madrid, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Mackay Memorial Hospital Taipei Branch
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
Related Links
Access external resources that provide additional context or updates about the study.
AmgenTrials clinical trials website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-501540-15-00
Identifier Type: CTIS
Identifier Source: secondary_id
20210142
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.