A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)
- Registration Number
- NCT05398445
- Lead Sponsor
- Amgen
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 769
- Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months
- History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency (with or without topical calcineurin inhibitors [TCI]).
- EASI score ≥16
- vIGA-AD score ≥3
- ≥10% body surface area (BSA) of AD involvement
- Worst pruritus numerical rating scale ≥ 4
-
Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1
-
Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
- Systemic corticosteroids
- Systemic immunosuppressants
- Phototherapy
- Janus kinase inhibitors
-
Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
- TCS of any potency
- TCI
- Topical phosphodiesterase type 4 inhibitors
- Other topical immunosuppressive agents
- Combination topical agents including TCS of any potency, TCI, PDE4 inhibitors, or other topical immunosuppressive agents
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Rocatinlimab Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2 Arm C Placebo Placebo Q4W+ loading dose at Week 2 Arm B Rocatinlimab Rocatinlimab Dose 2 Q4W + loading dose at Week 2
- Primary Outcome Measures
Name Time Method Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with ≥2 point reduction from baseline at Week 24 Baseline, Week 24 Achievement of ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24 Baseline, Week 24
- Secondary Outcome Measures
Name Time Method Change from baseline in HADS-depression subscale score at Week 24 Baseline, Week 24 Achievement of ≥75% reduction from baseline in EASI score at Week 16 Baseline, Week 16 Achievement of a vIGA-AD score of 0 or 1 from baseline at Week 16 Baseline, Week 16 Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus numerical rating scale (NRS) score at Week 16 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4 Baseline, Week 16 Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus NRS score at Week 24 in subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4 Baseline, Week 24 Achievement of ≥90% reduction from baseline in EASI score at Week 24 Baseline, Week 24 Achievement of a ≥ 4-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 24 in subjects with baseline weekly average of AD skin pain NRS score ≥ 4 Baseline, Week 24 Achievement of a vIGA-AD 1 response with presence of only barely perceptible erythema or vIGA-AD 0 response (revised Investigator's Global Assessment [rIGA™] 0/1) at Week 24 Baseline, Week 24 Achievement of Facial AD Severity Score (FASS) of clear at Week 24 for subjects with facial AD at baseline Baseline, Week 24 Change from baseline in weekly average of daily worst pruritus NRS score at week 16 Baseline, Week 16 Change from baseline in weekly average of daily worst pruritus NRS score at Week 24 Baseline, Week 24 Achievement of Hand AD Severity Score (HASS) of clear at Week 24 for subjects with hand AD at baseline Baseline, Week 24 Change from baseline in SCORing Atopic Dermatitis (SCORAD) itch visual analogue scale (VAS) score at Week 16 Baseline, Week 16 Change from baseline in SCORAD itch VAS score at Week 24 Baseline, Week 24 Achievement of ≥ 4-point reduction from baseline in DLQI score at Week 24 in subjects with baseline DLQI score ≥ 4 Baseline, Week 24 Change from baseline in DLQI score at Week 24 Baseline, Week 24 Achievement of ≥ 4-point reduction from baseline in POEM score at Week 24 in subjects with baseline POEM score ≥ 4 Baseline, Week 24 Change from baseline in POEM score at Week 24 Baseline, Week 24 Change from baseline in HADS-anxiety subscale score at Week 24 Baseline, Week 24 Achievement of HADS-depression subscale score < 8 at week 24 in subjects with baseline HADS-depression subscale score ≥ 8 Baseline, Week 24 Achievement of a ≥ 4-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 16 in subjects with baseline weekly average of AD skin pain NRS score ≥ 4 Baseline, Week 16 Change from baseline in weekly average of daily AD skin pain NRS score at Week 24 Baseline, Week 24 Change from baseline in weekly average of daily AD skin pain NRS score at Week 16 Baseline, Week 16 Achievement of a ≥ 3-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 24 in subjects with baseline weekly average of AD skin pain NRS score ≥ 3 Baseline, Week 24 Achievement of a ≥ 3-point reduction from baseline in weekly average of daily AD skin pain NRS score at Week 16 in subjects with baseline weekly average of AD skin pain NRS score ≥ 3 Baseline, Week 16 Change from baseline in weekly average of daily sleep disturbance NRS score at Week 24 Baseline, Week 24 Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety subscale score < 8 at Week 24 in subjects with baseline HADS-anxiety subscale score ≥ 8 Baseline, Week 24 Achievement of a ≥ 8.7-point reduction from baseline in SCORAD score at Week 24 in participants with baseline SCORAD score ≥ 8.7 Baseline, Week 24
Trial Locations
- Locations (201)
Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
🇵🇱Wroclaw, Poland
Smite Aija practice in dermatology and venerology
🇱🇻Talsi, Latvia
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
DeNova Research
🇺🇸Chicago, Illinois, United States
ClinOhio Research Services
🇺🇸Columbus, Ohio, United States
Jubilee Clinical Research Inc
🇺🇸Las Vegas, Nevada, United States
Hospital Ernesto Dornelles
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Unity Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Sanmenxia Central Hospital
🇨🇳Sanmenxia, Henan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Union Hospital Tongji Medical College Huazhong University of science and Technology
🇨🇳Wuhan, Hubei, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Chengdu Second Peoples Hospital
🇨🇳Chengdu, Sichuan, China
Recherche Clinique Sigma Incorporated
🇨🇦Quebec, Canada
Alliance Dermatology and Mohs Center
🇺🇸Phoenix, Arizona, United States
West Virginia Research Institute
🇺🇸Morgantown, West Virginia, United States
Education and Research Foundation Inc
🇺🇸Lynchburg, Virginia, United States
Cinme - Centro de Investigaciones Metabolicas
🇦🇷Caba, Buenos Aires, Argentina
Dermatology Treatment and Research Center PA
🇺🇸Dallas, Texas, United States
Alberta Derma Surgery Centre
🇨🇦Edmonton, Alberta, Canada
IBPClin Instituto Brasil de Pesquisa Clinica
🇧🇷Rio de Janeiro, Brazil
The Woodlands Dermatology Associates
🇺🇸The Woodlands, Texas, United States
DermDox Dermatology, LLC
🇺🇸Sugarloaf, Pennsylvania, United States
Cumberland Skin Center
🇺🇸Hermitage, Tennessee, United States
Fundacion Respirar
🇦🇷Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto de Diagnostico Abc American British Cowdray
🇦🇷Rosario, Santa Fe, Argentina
Hospital de Clinicas de Porto Alegre
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
🇧🇷São Paulo, Brazil
Pratia Prague sro
🇨🇿Praha 3, Czechia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Papageorgiou General Hospital
🇬🇷Thessaloniki, Greece
Central Clinic
🇯🇵Nagoya-shi, Aichi, Japan
Azienda Ospedaliera Policlinico Umberto I
🇮🇹Roma, Italy
Fukushima Medical University Hospital
🇯🇵Fukushima-shi, Fukushima, Japan
Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
🇮🇹Chieti, Italy
Rakuwakai Otowa Hospital
🇯🇵Kyoto-shi, Kyoto, Japan
Matsuo Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
Korea University Ansan Hospital
🇰🇷Ansansi, Gyeonggido, Korea, Republic of
Dokkyo Medical University Hospital
🇯🇵Shimotsuga-gun, Tochigi, Japan
Tokyo Medical University Ibaraki Medical Center
🇯🇵Inashiki-gun, Ibaraki, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
PreCare Trial and Recruitment
🇳🇱Born, Netherlands
Twoja przychodnia Pcm
🇵🇱Poznan, Poland
Hospital Universitario Austral
🇦🇷Derqui, Pilar, Buenos Aires, Argentina
Conexa Investigacion Clinica SA
🇦🇷Caba, Distrito Federal, Argentina
Centro Dermatológico Schejtman
🇦🇷San Miguel, Buenos Aires, Argentina
Instituto de Neumonologia y Dermatologia
🇦🇷Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina
Frontier Derm Partners
🇺🇸Mill Creek, Washington, 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
IMMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
Cura Clinical Research
🇺🇸Sherman Oaks, California, United States
Skin Care Research Incorporated
🇺🇸Boca Raton, Florida, United States
Savin Medical Group LLC
🇺🇸Miami Lakes, Florida, United States
Global Research Associates
🇺🇸Homestead, Florida, United States
Palm Beach Dermatology Group
🇺🇸Delray Beach, Florida, United States
Kirsch Dermatology LLC
🇺🇸Naples, Florida, United States
Healthy Life Research
🇺🇸Miami, Florida, United States
Industrial Medicine Associates Ima Clinical Research Inc
🇺🇸Hartsdale, New York, United States
Genesis Clinical Research LLC
🇺🇸Tampa, Florida, United States
Dundee Dermatology
🇺🇸West Dundee, Illinois, United States
Treasure Valley Medical Research
🇺🇸Boise, Idaho, United States
The Indiana Clinical Trials Center PC
🇺🇸Plainfield, Indiana, United States
Continental Clinical Solutions, LLC
🇺🇸Towson, Maryland, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Institute for Asthma and Allergy
🇺🇸Chevy Chase, Maryland, United States
Dermatology and Skin Cancer Center of Lees Summit
🇺🇸Lee's Summit, Missouri, United States
Onyx Clinical Research
🇺🇸Flint, Michigan, United States
Allcutis Research, Llc - Portsmouth
🇺🇸Portsmouth, New Hampshire, United States
Continental Clinical Solutions - Cherry Hill
🇺🇸Cherry Hill, New Jersey, 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
Optima Research
🇺🇸Boardman, Ohio, United States
Dermatology Research Center of Oklahoma, PLLC
🇺🇸Tulsa, Oklahoma, United States
Essential Medical Research LLC
🇺🇸Tulsa, Oklahoma, United States
InAER - Investigaciones en Alergia y Enfermedades Respiratorias
🇦🇷Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina
Upeclin-Pesq Clin FacMed Botucatu
🇧🇷Botucatu, São Paulo, Brazil
Fundacao Abc - Centro Univ Fmabc
🇧🇷Santo Andre, São Paulo, Brazil
Consultoria Medica e Pesquisa Clinica Cmpc
🇧🇷Sorocaba, São Paulo, Brazil
CCA Medical Research Corporation
🇨🇦Ajax, Ontario, Canada
SimcoDerm Medical and Surgical Dermatology Centre
🇨🇦Barrie, Ontario, Canada
Gordon Sussman Clinical Research Incorporated
🇨🇦North York, Ontario, Canada
LEADER Research
🇨🇦Hamilton, Ontario, Canada
DermEdge Research Incorporated
🇨🇦Mississauga, Ontario, Canada
Canadian Dermatology Centre
🇨🇦North York, Ontario, Canada
Oak Ridges Aesthetics Centre
🇨🇦Richmond Hill, Ontario, Canada
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
Skinsense Medical Research
🇨🇦Saskatoon, Saskatchewan, Canada
Innovaderm Research Inc
🇨🇦Montreal, Quebec, Canada
The First Affiliated Hospital ,Sun-Yat Sen University
🇨🇳Guangzhou, Guangdong, China
Dermatology Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, 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
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 Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Provincial Peoples Hospital
🇨🇳Hangzhou, Zhejiang, China
Peking University Peoples Hospital
🇨🇳Beijing, China
Shanghai Skin Disease Hospital
🇨🇳Shanghai, China
Taizhou Central Hospital
🇨🇳Taizhou, Zhejiang, China
Pratia Pardubice as
🇨🇿Pardubice, Czechia
Dermamedica, sro
🇨🇿Nachod, Czechia
CCR Ostrava sro
🇨🇿Ostrava, Czechia
University Hospital Centre Zagreb
🇭🇷Zagreb, Croatia
Sestre milosrdnice University Hospital Center
🇭🇷Zagreb, Croatia
Clintrial sro
🇨🇿Praha 10, Czechia
Charite - Universitaetsmedizin Berlin, Campus Mitte
🇩🇪Berlin, Germany
Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
🇨🇿Usti nad Labem, Czechia
Fakultni nemocnice Bulovka
🇨🇿Praha 8, Czechia
Dermatologische Gemeinschaftspraxis-Mahlow
🇩🇪Blankenfelde-Mahlow, Germany
Hautarztpraxis Dr Niesmann und Dr Othlinghaus
🇩🇪Bochum, Germany
Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
🇩🇪Duesseldorf, Germany
Rosenpark Research GmbH
🇩🇪Darmstadt, Germany
Universitaetsklinikum Dresden
🇩🇪Dresden, Germany
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Institute for Health Services Research in Dermatology and Nursing
🇩🇪Hamburg, Germany
Universitaetsklinikum Heidelberg
🇩🇪Heidelberg, Germany
CentroDerm GmbH
🇩🇪Wuppertal, Germany
Hautarztpraxis Dres Leitz und Kollegen
🇩🇪Stuttgart, Germany
Universitaetsklinikum Tuebingen
🇩🇪Tuebingen, Germany
Athens Naval Hospital
🇬🇷Athens, Greece
University General Hospital Attikon
🇬🇷Athens, Greece
Thoracic General Hospital Of Athens Sotiria
🇬🇷Athens, Greece
Medmare Bt
🇭🇺Veszprem, Hungary
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
🇬🇷Athens, Greece
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
🇮🇹Perugia, Italy
University General Hospital of Ioannina
🇬🇷Ioannina, Greece
General University Hospital of Larissa
🇬🇷Larissa, Greece
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
🇮🇹Torino, Italy
Aichi Medical University Hospital
🇯🇵Nagakute-shi, Aichi, Japan
Japan Community Healthcare Organization Chukyo Hospital
🇯🇵Nagoya-shi, Aichi, Japan
Nagoya City University Hospital
🇯🇵Nagoya-shi, Aichi, Japan
Fukuoka University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Takeoka Dermatology Clinic
🇯🇵Marugame-shi, Kagawa, Japan
Kaji Dermatology Clinic
🇯🇵Nonoichi-shi, Ishikawa, Japan
Iwate Medical University Uchimaru Medical Center
🇯🇵Morioka-shi, Iwate, Japan
Asahikawa City Hospital
🇯🇵Asahikawa-shi, Hokkaido, Japan
Nippon Medical School Musashikosugi Hospital
🇯🇵Kawasaki-shi, Kanagawa, Japan
Mochida Dermatology Clinic
🇯🇵Izumiotsu-shi, Osaka, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto-shi, Kyoto, Japan
Teikyo University Hospital
🇯🇵Itabashi-ku, Tokyo, Japan
National Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Incheon St Marys Hospital
🇰🇷Incheon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Outpatient clinic Veselibas Centrs 4
🇱🇻Riga, Latvia
Centrum Medyczne Angelius Provita
🇵🇱Katowice, Poland
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
🇵🇱Malbork, Poland
Centrum Zdrowia i Urody Maxxmed
🇵🇱Lublin, Poland
Twoja przychodnia Ncm
🇵🇱Nowa Sol, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
🇵🇱Tarnow, Poland
Hospital Cuf Descobertas
🇵🇹Lisboa, Portugal
Derma therapy, spol s ro
🇸🇰Bratislava, Slovakia
Clinical Research of Puerto Rico
🇵🇷San Juan, Puerto Rico
Sanare spol sro
🇸🇰Svidnik, Slovakia
Hospital Universitari Germans Trias i Pujol
🇪🇸Badalona, Cataluña, Spain
Hospital Universitario Miguel Servet
🇪🇸Zaragoza, Aragón, Spain
Fakultna nemocnica Trnava
🇸🇰Trnava, Slovakia
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Andalucía, Spain
Hospital Universitario de Gran Canaria Doctor Negrin
🇪🇸Las Palmas de Gran Canaria, Canarias, Spain
Hospital Universitari de Bellvitge
🇪🇸Hospitalet de LLobregat, Cataluña, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Comunidad Valenciana, Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Spain
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Hospital Universitario Quironsalud Madrid
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital Clinico Universitario de Santiago
🇪🇸Pontevedra, Galicia, Spain
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, Taiwan
Cahaba Dermatology and Skin Health Center
🇺🇸Birmingham, Alabama, United States
Pure Skin Dermatology and Aesthetics
🇺🇸Orlando, Florida, United States
The Skin Surgery Center for Clinical Research
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Special Hospital for Medical Rehabilitation Naftalan
🇭🇷Ivanic-Grad, Croatia
Outpatient clinic Veselibascentrs 4
🇱🇻Riga, Latvia
Hosp e Maternidade Dr Christovao da Gama
🇧🇷Santo Andre, São Paulo, Brazil
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
🇵🇹Matosinhos, Portugal
Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
🇸🇰Banska Bystrica, Slovakia
Hospital Lusiadas Lisboa
🇵🇹Lisboa, Portugal
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
🇵🇹Porto, Portugal
Kaderma Majtan, sro
🇸🇰Topolcany, Slovakia
Twoja Przychodnia Scm
🇵🇱Szczecin, Poland
Royalderm Agnieszka Nawrocka
🇵🇱Warszawa, Poland
AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
🇵🇱Gdansk, Poland
Vida Clinical Research
🇨🇦Edmonton, Alberta, Canada
Fundacion Estudios Clinicos
🇦🇷Rosario, Santa Fe, Argentina
Nihon University Itabashi Hospital
🇯🇵Itabashi-ku, Tokyo, Japan