A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE) (ROCKET-Ignite)

A Phase 3, 24-week, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety and Tolerability of Rocatinlimab (AMG 451) Monotherapy in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD)

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Rocatinlimab

• Study Type: Interventional
• Enrollment (Actual): 769
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • CABA, Buenos Aires, Argentina, C1027AAP
      • Cinme - Centro de Investigaciones Metabolicas
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
      • Fundación Respirar
    • Derqui, Pilar, Buenos Aires, Argentina, B1629ODT
      • Hospital Universitario Austral
    • San Miguel, Buenos Aires, Argentina, 1663
      • Centro Dermatologico Schejtman
  • Distrito Federal
    • Buenos Aires, Distrito Federal, Argentina, 1425
      • Instituto de Neumonologia Y Dermatologia
    • Buenos Aires, Distrito Federal, Argentina, 1425
      • InAER - Investigaciones en Alergia y Enfermedades Respiratorias
    • CABA, Distrito Federal, Argentina, C1012AAY
      • Conexa Investigacion Clinica SA
  • Santa Fe Province
    • Rosario, Santa Fe Province, Argentina, 2000
      • Fundacion Estudios Clinicos
    • Rosario, Santa Fe Province, Argentina, 2000
      • Instituto de Diagnostico Abc American British Cowdray
• Brazil
  • Rio de Janeiro, Brazil, 20241-180
    • IBPClin Instituto Brasil de Pesquisa Clinica
  • São Paulo, Brazil, 06454-010
    • Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 90160-093
      • Hospital Ernesto Dornelles
  • São Paulo
    • Botucatu, São Paulo, Brazil, 18618-686
      • Upeclin-Pesq Clin FacMed Botucatu
    • Santo André, São Paulo, Brazil, 09060-870
      • Fundacao Abc - Centro Univ Fmabc
    • Santo André, São Paulo, Brazil, 09030-010
      • Hosp e Maternidade Dr Christovao da Gama
    • Sorocaba, São Paulo, Brazil, 18040-425
      • Consultoria Medica e Pesquisa Clinica Cmpc
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1C3
      • Alberta Derma Surgery Centre
    • Edmonton, Alberta, Canada, T6H 4J8
      • Vida Clinical Research
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research Corporation
    • Barrie, Ontario, Canada, L4M 7G1
      • Simcoderm Medical and Surgical Dermatology Centre
    • Hamilton, Ontario, Canada, L8L 3C3
      • LEADER research
    • Mississauga, Ontario, Canada, L4Y 4C5
      • DermEdge Research Incorporated
    • North York, Ontario, Canada, M3B 3S6
      • Gordon Sussman Clinical Research Incorporated
    • North York, Ontario, Canada, M3B 0A7
      • Canadian Dermatology Centre
    • Richmond Hill, Ontario, Canada, L4E 4L6
      • Oak Ridges Aesthetics Centre
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc
    • Québec, Quebec, Canada, G1G 3Y8
      • Recherche Clinique Sigma Incorporated
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 2C1
      • Skinsense Medical Research
• China
  • Beijing, China, 100044
    • Peking University Peoples Hospital
  • Shanghai, China, 200443
    • Shanghai Skin Disease Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510091
      • Dermatology Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital Sun Yat-sen University
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital ,Sun-Yat Sen University
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The First Hospital of Hebei Medical University
  • Henan
    • Nanyang, Henan, China, 473002
      • Nanyang First Peoples Hospital
    • Sanmenxia, Henan, China, 472099
      • Sanmenxia Central Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital Of Central South University
  • Jiangsu
    • Jiangyin, Jiangsu, China, 214400
      • Jiangyin Hospital of Traditional Chinese Medicine
    • Wuxi, Jiangsu, China, 241023
      • Wuxi Peoples Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Dermatology Hospital of Jiangxi Province
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610021
      • Chengdu Second Peoples Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital Zhejiang University School Of Medicine
    • Hangzhou, Zhejiang, China, 310020
      • Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310004
      • Zhejiang Provincial Peoples Hospital
    • Taizhou, Zhejiang, China, 318000
      • Taizhou Central Hospital
• Croatia
  • Ivanić-Grad, Croatia, 10310
    • Special Hospital for Medical Rehabilitation Naftalan
  • Zagreb, Croatia, 10000
    • University Hospital Centre Zagreb
  • Zagreb, Croatia, 10000
    • Sestre milosrdnice University Hospital Center
• Czechia
  • Náchod, Czechia, 547 01
    • Dermamedica, sro
  • Ostrava, Czechia, 702 00
    • CCR Ostrava sro
  • Pardubice, Czechia, 530 02
    • Pratia Pardubice as
  • Prague, Czechia, 180 81
    • Fakultni Nemocnice Bulovka
  • Prague, Czechia, 100 00
    • Clintrial sro
  • Prague, Czechia, 130 00
    • Pratia Prague sro
  • Ústí nad Labem, Czechia, 401 13
    • Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
• Germany
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin, Campus Mitte
  • Blankenfelde-Mahlow, Germany, 15831
    • Dermatologische Gemeinschaftspraxis-Mahlow
  • Bochum, Germany, 44793
    • Hautarztpraxis Dr Niesmann und Dr Othlinghaus
  • Darmstadt, Germany, 64283
    • Rosenpark Research GmbH
  • Dresden, Germany, 01307
    • Universitaetsklinikum Dresden
  • Düsseldorf, Germany, 40225
    • Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
  • Essen, Germany, 45174
    • Universitaetsklinikum Essen
  • Hamburg, Germany, 20246
    • Institute for Health Services Research in Dermatology and Nursing
  • Heidelberg, Germany, 69120
    • Universitaetsklinikum Heidelberg
  • Stuttgart, Germany, 70178
    • Hautarztpraxis Dres Leitz und Kollegen
  • Tübingen, Germany, 72076
    • Universitaetsklinikum Tuebingen
  • Wuppertal, Germany, 42287
    • CentroDerm GmbH
• Greece
  • Athens, Greece, 12462
    • University General Hospital Attikon
  • Athens, Greece, 11521
    • Athens Naval Hospital
  • Athens, Greece, 16121
    • Andreas Syngros Hospital Of Venereal And Dermatological Diseases
  • Athens, Greece, 11527
    • Thoracic General Hospital Of Athens Sotiria
  • Ioannina, Greece, 45500
    • University General Hospital of Ioannina
  • Larissa, Greece, 41110
    • General University Hospital Of Larissa
  • Thessaloniki, Greece, 56403
    • Papageorgiou General Hospital
• Hungary
  • Veszprém, Hungary, 8200
    • Medmare Bt
• Italy
  • Chieti, Italy, 66100
    • Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
  • Milan, Italy, 20122
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
  • Perugia, Italy, 06156
    • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
  • Roma, Italy, 00161
    • Azienda Ospedaliera Policlinico Umberto I
  • Torino, Italy, 10126
    • Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Japan
  • Aichi-ken
    • Nagakute-shi, Aichi-ken, Japan, 480-1195
      • Aichi Medical University Hospital
    • Nagoya, Aichi-ken, Japan, 467-8602
      • Nagoya City University Hospital
    • Nagoya, Aichi-ken, Japan, 464-0821
      • Central Clinic
    • Nagoya, Aichi-ken, Japan, 457-8510
      • Japan Community Healthcare Organization Chukyo Hospital
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 819-0373
      • Matsuo Clinic
    • Fukuoka, Fukuoka, Japan, 814-0180
      • Fukuoka University Hospital
  • Fukushima
    • Fukushima, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital
  • Hokkaido
    • Asahikawa-shi, Hokkaido, Japan, 070-8610
      • Asahikawa City Hospital
  • Ibaraki
    • Inashiki-gun, Ibaraki, Japan, 300-0395
      • Tokyo Medical University Ibaraki Medical Center
  • Ishikawa-ken
    • Nonoichi-shi, Ishikawa-ken, Japan, 921-8801
      • Kaji Dermatology Clinic
  • Iwate
    • Morioka, Iwate, Japan, 020-8505
      • Iwate Medical University Uchimaru Medical Center
  • Kagawa-ken
    • Marugame-shi, Kagawa-ken, Japan, 763-0074
      • Takeoka Dermatology Clinic
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 211-8533
      • Nippon Medical School Musashikosugi Hospital
  • Kyoto
    • Kyoto, Kyoto, Japan, 607-8062
      • Rakuwakai Otowa Hospital
    • Kyoto, Kyoto, Japan, 602-8566
      • University Hospital Kyoto Prefectural University of Medicine
  • Osaka
    • Izumiotsu-shi, Osaka, Japan, 595-0025
      • Mochida Dermatology Clinic
  • Tochigi
    • Shimotsuga-gun, Tochigi, Japan, 321-0293
      • Dokkyo Medical University Hospital
  • Tokyo
    • Itabashi-ku, Tokyo, Japan, 173-8610
      • Nihon University Itabashi Hospital
    • Itabashi-ku, Tokyo, Japan, 173-8606
      • Teikyo University Hospital
• Latvia
  • Riga, Latvia, 1003
    • Outpatient clinic Veselibas Centrs 4
  • Riga, Latvia, LV-1013
    • Outpatient clinic Veselibascentrs 4
  • Talsi, Latvia, 3201
    • Smite Aija practice in dermatology and venerology
• Netherlands
  • Born, Netherlands, 6121 XK
    • PreCare Trial and Recruitment
• Poland
  • Gdansk, Poland, 80-280
    • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
  • Katowice, Poland, 40-611
    • Centrum Medyczne Angelius Provita
  • Lublin, Poland, 20-080
    • Centrum Zdrowia i Urody Maxxmed
  • Malbork, Poland, 82-200
    • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
  • Nowa Sól, Poland, 67-100
    • Twoja Przychodnia NCM
  • Poznan, Poland, 61-293
    • Twoja Przychodnia PCM
  • Szczecin, Poland, 71-500
    • Twoja Przychodnia SCM
  • Tarnów, Poland, 33-100
    • Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
  • Warsaw, Poland, 02-962
    • Royalderm Agnieszka Nawrocka
  • Wroclaw, Poland, 50-450
    • Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
• Portugal
  • Lisbon, Portugal, 1998-018
    • Hospital CUF Descobertas
  • Lisbon, Portugal, 1500-458
    • Hospital Lusíadas Lisboa
  • Matosinhos Municipality, Portugal, 4464-513
    • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
  • Porto, Portugal, 4099-001
    • Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
• Puerto Rico
  • San Juan, Puerto Rico, 00909
    • Clinical Research of Puerto Rico
• Slovakia
  • Banská Bystrica, Slovakia, 975 17
    • Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
  • Bratislava, Slovakia, 851 01
    • Derma therapy, spol s ro
  • Svidník, Slovakia, 089 01
    • Sanare spol sro
  • Topoľčany, Slovakia, 955 01
    • Kaderma Majtan, sro
  • Trnava, Slovakia, 917 75
    • Fakultna Nemocnica Trnava
• South Korea
  • Ansansi, Gyeonggido, South Korea, 15355
    • Korea University Ansan Hospital
  • Incheon, South Korea, 21431
    • The Catholic University of Korea Incheon St Marys Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 08308
    • Korea University Guro Hospital
  • Seoul, South Korea, 04564
    • National medical center
• Spain
  • Madrid, Spain, 28006
    • Hospital Universitario de La Princesa
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Andalusia
    • Córdoba, Andalusia, Spain, 14004
      • Hospital Universitario Reina Sofía
  • Aragon
    • Zaragoza, Aragon, Spain, 50009
      • Hospital Universitario Miguel Servet
  • Canary Islands
    • Las Palmas de Gran Canaria, Canary Islands, Spain, 35010
      • Hospital Universitario de Gran Canaria Doctor Negrin
  • Catalonia
    • Badalona, Catalonia, Spain, 08916
      • Hospital Universitari Germans Trias i Pujol
    • L'Hospitalet de Llobregat, Catalonia, Spain, 08907
      • Hospital Universitari de Bellvitge
  • Galicia
    • Pontevedra, Galicia, Spain, 36001
      • Hospital Clínico Universitario de Santiago
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Universitario Quironsalud Madrid
  • Valencia
    • Valencia, Valencia, Spain, 46026
      • Hospital Universitari i Politecnic La Fe
• Taiwan
  • Kaohsiung City, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital
  • Tainan, Taiwan, 70403
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital Taipei Branch
  • Taoyuan District, Taiwan, 33305
    • Linkou Chang Gung Memorial Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Cahaba Dermatology and Skin Health Center
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Alliance Dermatology and Mohs Center
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Glendale, California, United States, 91203
      • Kaiser Permanente - Glendale Medical Center
    • Long Beach, California, United States, 90805
      • Long Beach Research Institute
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Sherman Oaks, California, United States, 91403
      • Cura Clinical Research
  • Colorado
    • Centennial, Colorado, United States, 80112
      • IMMUNOe Research Centers
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research Incorporated
    • Delray Beach, Florida, United States, 33484
      • Palm Beach Dermatology Group
    • Homestead, Florida, United States, 33030
      • Global Research Associates
    • Miami, Florida, United States, 33175
      • Healthy Life Research
    • Miami Lakes, Florida, United States, 33014
      • Savin Medical Group LLC
    • Naples, Florida, United States, 34102
      • Kirsch Dermatology LLC
    • Orlando, Florida, United States, 32819
      • Pure Skin Dermatology and Aesthetics
    • St. Petersburg, Florida, United States, 33709
      • Industrial Medicine Associates Ima Clinical Research Inc
    • Tampa, Florida, United States, 33606
      • Genesis Clinical Research LLC
  • Idaho
    • Boise, Idaho, United States, 83706
      • Treasure Valley Medical Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research
    • West Dundee, Illinois, United States, 60118
      • Dundee Dermatology
  • Indiana
    • Plainfield, Indiana, United States, 46168
      • The Indiana Clinical Trials Center PC
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Institute for Asthma and Allergy
    • Towson, Maryland, United States, 21204
      • Continental Clinical Solutions, LLC
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Flint, Michigan, United States, 48532
      • Onyx Clinical Research
  • Missouri
    • Lee's Summit, Missouri, United States, 64064
      • Dermatology and Skin Cancer Center of Lees Summit
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Jubilee Clinical Research Inc
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Allcutis Research, Llc - Portsmouth
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • Continental Clinical Solutions - Cherry Hill
  • New York
    • Hartsdale, New York, United States, 10530
      • Industrial Medicine Associates Ima Clinical Research Inc
    • New York, New York, United States, 10075
      • Sadick Research Group
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • Dermatology Specialists of Charlotte
    • Charlotte, North Carolina, United States, 28277
      • Onsite Clinical Solutions
    • Wilmington, North Carolina, United States, 28405
      • Wilmington Dermatology Center
    • Winston-Salem, North Carolina, United States, 27103
      • The Skin Surgery Center for Clinical Research
  • Ohio
    • Boardman, Ohio, United States, 44512
      • Optima Research
    • Columbus, Ohio, United States, 43213
      • ClinOhio Research Services
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Unity Clinical Research
    • Tulsa, Oklahoma, United States, 74132
      • Dermatology Research Center of Oklahoma, PLLC
    • Tulsa, Oklahoma, United States, 74137
      • Essential Medical Research LLC
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Sugarloaf, Pennsylvania, United States, 18249
      • DermDox Dermatology, LLC
  • Tennessee
    • Hermitage, Tennessee, United States, 37076
      • Cumberland Skin Center
  • Texas
    • Dallas, Texas, United States, 75230
      • Dermatology Treatment and Research Center PA
    • The Woodlands, Texas, United States, 77380
      • The Woodlands Dermatology Associates
  • Virginia
    • Lynchburg, Virginia, United States, 24501
      • Education and Research Foundation Inc
  • Washington
    • Mill Creek, Washington, United States, 98012
      • Frontier Derm Partners
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • West Virginia Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1

• Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:

  • Systemic corticosteroids
  • Systemic immunosuppressants
  • Phototherapy
  • 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2	Drug: Rocatinlimab; Participants will receive Rocatinlimab subcutaneously.; Other Names: AMG 451
Experimental: Arm B; Rocatinlimab Dose 2 Q4W + loading dose at Week 2	Drug: Rocatinlimab; Participants will receive Rocatinlimab subcutaneously.; Other Names: AMG 451
Placebo Comparator: Arm C; Placebo Q4W+ loading dose at Week 2	Drug: Placebo; Participants will receive a placebo subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Achievement of ≥75% reduction from baseline in EASI score at Week 16	Baseline, Week 16
Achievement of ≥90% reduction from baseline in EASI 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
Change from baseline in weekly average of daily worst pruritus NRS 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 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
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 weekly average of daily worst pruritus NRS score at Week 24	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
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
Change from baseline in HADS-anxiety subscale score at Week 24	Baseline, Week 24
Change from baseline in HADS-depression subscale score at Week 24	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

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

General Publications

• 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.

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): November 28, 2024
• Study Completion (Actual): January 13, 2025

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; AMG 451; KHK4083; Rocatinlimab
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic
• Other Study ID Numbers: 20210142; 2022-501540-15-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No