A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon) (ROCKET-Horizon)

A Phase 3, Randomized, 24-week, 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) (ROCKET-Horizon)

The co-primary objectives of the study are to:

• Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD).
• Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 726
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St George Dermatology and Skin Cancer Centre
    • Kogarah, New South Wales, Australia, 2217
      • Premier Specialists
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital
    • Carlton, Victoria, Australia, 3053
      • Skin Health Institute
    • East Melbourne, Victoria, Australia, 3002
      • Sinclair Dermatology
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
    • Parkville, Victoria, Australia, 3050
      • The Royal Melbourne Hospital
• Belgium
  • Bruxelles, Belgium, 1070
    • Hôpital Erasme
  • Herstal, Belgium, 4040
    • Clinique Andre Renard
  • Maldegem, Belgium, 9990
    • Dermatologie Maldegem
• Brazil
  • Paraná
    • Curitiba, Paraná, Brazil, 80030-110
      • CETI - Centro de Estudo em Terapias Inovadoras
  • São Paulo
    • Sao Bernardo do Campo, São Paulo, Brazil, 09715-090
      • Centro Multidisciplinar de Estudos Clínicos - CEMEC
    • São José dos Campos, São Paulo, Brazil, 12243-280
      • ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
• Canada
  • Quebec, Canada, G1V 4X7
    • Centre De Recherche Dermatologique Du Quebec Metropolitain
  • Alberta
    • Calgary, Alberta, Canada, T3E 0B2
      • Beacon Dermatology
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Doctor Chih-Ho Hong Medical Incorporated
  • Ontario
    • Etobicoke, Ontario, Canada, M8X 1Y9
      • Kingsway Clinical Research
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc
    • Oakville, Ontario, Canada, L6J 7W5
      • The Centre for Clinical Trials Inc
    • Peterborough, Ontario, Canada, K9J 5K2
      • SKiN Centre for Dermatology
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Centre for Dermatology
    • Toronto, Ontario, Canada, M4W 2N4
      • Research Toronto
    • Windsor, Ontario, Canada, N8T 1E6
      • XLR8 Medical Research, Incorporated
  • Quebec
    • Sherbrooke, Quebec, Canada, J1G 1X9
      • Clinique Dermatologique de Sherbrooke
• Czechia
  • Kutna Hora, Czechia, 284 01
    • Kozni ambulance Kutna Hora sro
  • Novy Jicin, Czechia, 741 01
    • Nemocnice Novy Jicin as
  • Pardubice, Czechia, 530 02
    • CCR Czech as
  • Plzen, Czechia, 305 99
    • Fakultni nemocnice Plzen
  • Praha, Czechia, 120 00
    • Dermamedest sro
  • Praha 3, Czechia, 130 00
    • CCR Prague sro
  • Praha 5, Czechia, 150 00
    • Praglandia sro
  • Praha 6, Czechia, 106 00
    • Kozni ambulance Fialova sro
  • Svitavy, Czechia, 568 02
    • Dermatologicka ambulance MUDr Petr Trestik
• Denmark
  • Hellerup, Denmark, 2900
    • Gentofte Hospital
  • Odense, Denmark, 5000
    • Odense University Hospital
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre
  • Tartu, Estonia, 50106
    • Clinical Research Centre
• Finland
  • Helsinki, Finland, 00180
    • CRST Helsinki
  • Helsinki, Finland, 00180
    • CRST Turku
  • Oulu, Finland, 90029
    • Oulun yliopistollinen sairaala (OYS)
  • Tampere, Finland, 33100
    • Terveystalo Tampere
• Germany
  • Bad Bentheim, Germany, 48455
    • Fachklinik Bad Bentheim
  • Berlin, Germany, 10247
    • Hautzentrum Friedrichshain - Dermatologie
  • Berlin, Germany, 13672
    • Clinical Research Services Berlin GmbH
  • Halle (Saale), Germany, 06120
    • Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
  • Hamburg, Germany, 20354
    • Dermatologikum Hamburg
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig-Holstein
  • Leipzig, Germany, 04103
    • Velocity Clinical Research
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Osnabrueck, Germany, 49074
    • KliFOs Klinische Forschung Osnabrueck
  • Remscheid, Germany, 42897
    • Hautarztpraxis Mortazawi
  • Wuppertal, Germany, 42283
    • Helios Klinikum Wuppertal
• Japan
  • Chiba
    • Matsudo-shi, Chiba, Japan, 271-0092
      • Miyata Dermatology Clinic
    • Narita-shi, Chiba, Japan, 286-8520
      • International University of Health and Welfare Narita Hospital
  • Hyogo
    • Kobe-shi, Hyogo, Japan, 650-0017
      • Kobe University Hospital
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 216-8511
      • St Marianna University Hospital
    • Sagamihara-shi, Kanagawa, Japan, 252-0392
      • National Hospital Organization Sagamihara National Hospital
    • Yokohama-shi, Kanagawa, Japan, 224-8503
      • Showa University Northern Yokohama Hospital
  • Nagasaki
    • Nagasaki-shi, Nagasaki, Japan, 852-8501
      • Nagasaki University Hospital
  • Osaka
    • Habikino-shi, Osaka, Japan, 583-8588
      • Osaka Habikino Medical Center
    • Sakai-shi, Osaka, Japan, 593-8324
      • Dermatology and Ophthalmology Kume Clinic
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
  • Tokyo
    • Minato-ku, Tokyo, Japan, 108-0014
      • Mita Dermatology Clinic
    • Shinagawa-ku, Tokyo, Japan, 142-8666
      • Showa University Hospital
    • Shinjuku-ku, Tokyo, Japan, 161-8521
      • Seibo International Catholic Hospital
    • Toshima-ku, Tokyo, Japan, 170-0002
      • Sugamo Kobayashi Derma Clinic
  • Toyama
    • Takaoka-shi, Toyama, Japan, 933-0871
      • Shirasaki Dermatology Clinic
• Korea, Republic of
  • Ansansi, Gyeonggido, Korea, Republic of, 15355
    • Korea University Ansan Hospital
  • Bucheon-si, Gyeonggi-do, Korea, Republic of, 14584
    • Soon Chun Hyang University Bucheon Hospital
  • Busan, Korea, Republic of, 49241
    • Pusan National University Hospital
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Gwangju, Korea, Republic of, 61453
    • Chosun university hospital
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Incheon, Korea, Republic of, 21431
    • The Catholic University of Korea Incheon St Marys Hospital
  • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06973
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of, 07441
    • Hallym University Kangnam Sacred Heart Hospital
  • Seoul, Korea, Republic of, 05278
    • Kyung Hee University Hospital at Gangdong
  • Seoul, Korea, Republic of, 04564
    • National Medical Center
  • Seoul, Korea, Republic of, 07804
    • Ewha Womans University Seoul Hospital
  • Seoul, Korea, Republic of, 06591
    • The Catholic Univ of Korea Seoul St Marys Hospital
  • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
    • Ajou University Hospital
• Mexico
  • Chihuahua, Mexico, 31203
    • SCIENTIA Investigacion Clinica SC
  • Cuautitlán Izcalli, Mexico, 54750
    • Phylasis Clínicas Research S. De R. L. De C. V.
  • Michoacán
    • Morelia, Michoacán, Mexico, 58249
      • Clinica de Enfermedades Cronicas y de Procedimientos Especiales
• Poland
  • Bialystok, Poland, 15-879
    • ClinicMed Daniluk Nowak Spolka Komandytowa
  • Chorzow, Poland, 41-500
    • Dermapolis Medical Dermatology Center dr n med Edyta Gebska
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Krakow, Poland, 31-530
    • Centermed Krakow Sp zoo
  • Lodz, Poland, 90-349
    • AppleTreeClinics Network Spzoo
  • Lodz, Poland, 90-338
    • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
  • Lodz, Poland, 91-495
    • Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
  • Lublin, Poland, 20-078
    • Clinical Best Solutions Sp zoo Spolka komandytowa
  • Poznan, Poland, 61-731
    • Clinical Research Center Spzoo Medic-R Spolka Komandytowa
  • Warszawa, Poland, 02-625
    • Evimed sp zoo centrum medyczne evimed
• Portugal
  • Almada, Portugal, 2801-951
    • Hospital Garcia de Orta, EPE
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar e Universitário de Coimbra, EPE
  • Lisboa, Portugal, 1998-018
    • Hospital CUF Descobertas
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
  • Porto, Portugal, 4200-319
    • Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
• Romania
  • Bucharest, Romania, 020125
    • Spitalul Clinic Colentina
• South Africa
  • Durban, South Africa, 3630
    • Hiway Medical Centre
  • Gauteng
    • Centurion, Gauteng, South Africa, 0157
      • Ryexo Clinical Research
    • Johannesburg, Gauteng, South Africa, 2057
      • About Allergy
• Spain
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Majadahonda, Spain, 28222
    • Hospital Universitario Puerta de Hierro Majadahonda
  • Andalucía
    • Sevilla, Andalucía, Spain, 41009
      • Hospital Universitario Virgen Macarena
  • Comunidad Valenciana
    • Alicante, Comunidad Valenciana, Spain, 03010
      • Hospital General Universitario de Alicante
    • Manises, Comunidad Valenciana, Spain, 46940
      • Hospital de Manises
    • Valencia, Comunidad Valenciana, Spain, 46015
      • Hospital Arnau de Vilanova de Valencia
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska Universitetssjukhuset Solna
• Turkey
  • Ankara, Turkey, 06230
    • Hacettepe Universitesi Tip Fakultesi Hastanesi
  • Gaziantep, Turkey, 27310
    • Gaziantep Universitesi Tip Fakultesi Hastanesi
  • Istanbul, Turkey, 34093
    • Bezmialem Vakif Universitesi Hastanesi
  • Izmir, Turkey, 35620
    • Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
  • Kayseri, Turkey, 38030
    • Erciyes Universitesi Tip Fakultesi Hastanesi
  • Kocaeli, Turkey, 41380
    • Kocaeli Universitesi Tip Fakultesi Hastanesi
  • Sakarya, Turkey, 54050
    • Sakarya Egitim ve Arastirma Hastanesi
• United Kingdom
  • Corby, United Kingdom, NN17 2UR
    • Lakeside Healthcare
  • London, United Kingdom, SE1 9RT
    • Guys Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Southampton General Hospital
• United States
  • Arizona
    • Litchfield Park, Arizona, United States, 85340
      • Research Solutions of Arizona, PC
    • Scottsdale, Arizona, United States, 85260
      • Center for Dermatology and Plastic Surgery
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Clinical Trials Institute of Northwest Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • Chula Vista, California, United States, 91911
      • Velocity Clinical Research Chula Vista
    • Dublin, California, United States, 94568
      • West Coast Research LLC
    • Encinitas, California, United States, 92024
      • California Dermatology and Clinical Research Institute
    • Fremont, California, United States, 94538
      • Center for Dermatology Clinical Research Inc
    • La Mesa, California, United States, 91942
      • Velocity Clinical Research - San Diego
    • North Hollywood, California, United States, 91606
      • Velocity Clinical Research - North Hollywood
    • Palmdale, California, United States, 93551
      • Cura Clinical Research
    • San Francisco, California, United States, 94115
      • University of California at San Francisco, Dermatology Clinic at Mount Zion
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Colorado
    • Castle Rock, Colorado, United States, 80109
      • Clarity Dermatology
    • Denver, Colorado, United States, 80209
      • Velocity Clinical Research - Denver
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Foxhall Research Center
  • Florida
    • Cape Coral, Florida, United States, 33991
      • Renaissance Research and Medical Group
    • Coral Gables, Florida, United States, 33134
      • Driven Research LLC
    • Doral, Florida, United States, 33172
      • Saint Jude Clinical Research
    • Hialeah, Florida, United States, 33012
      • Direct Helpers Research Center
    • Margate, Florida, United States, 33063
      • Glick Skin Institute
    • Miami, Florida, United States, 33176
      • Miami Dade Medical Research Institute, LLC
    • Palmetto Bay, Florida, United States, 33157
      • Innovation Medical Research Center Inc
    • Tampa, Florida, United States, 33612
      • University of South Florida Health Morsani Center for Advanced Healthcare
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research PC
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze, and Itch Associates, LLC
  • Indiana
    • South Bend, Indiana, United States, 46617
      • The South Bend Clinic LLP
    • West Lafayette, Indiana, United States, 47906
      • Options Research Group LLC
  • Kansas
    • Overland Park, Kansas, United States, 66223
      • Dermatology and Skin Cancer Center of Overland Park
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • DS Research
    • Murray, Kentucky, United States, 42071
      • Kentucky Advanced Medical Research LLC
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • MetroBoston Clinical Partners
  • Michigan
    • Farmington Hills, Michigan, United States, 48334
      • Wendy Sadoff MD Dermatology PC
    • Troy, Michigan, United States, 48084
      • Somerset Skin Centre
    • Troy, Michigan, United States, 48084
      • Revival Research Institute LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Advanced Dermatology of the Midlands
  • Nevada
    • Las Vegas, Nevada, United States, 89117
      • James Del Rosso Dermatology Research
    • Reno, Nevada, United States, 89509
      • Skin Cancer and Dermatology Institute
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth-Hitchcock Medical Center
  • New Jersey
    • Riverdale, New Jersey, United States, 07457
      • Weiss Medical
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • Horseheads, New York, United States, 14845
      • Corning Center for Clinical Research
    • Kew Gardens, New York, United States, 11415
      • Forest Hills Dermatology Group
    • Monroe, New York, United States, 10950
      • Crystal Run Healthcare
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10022
      • Ace Clinical Trials
    • New York, New York, United States, 10128
      • OptiSkin Medical
  • North Carolina
    • Durham, North Carolina, United States, 27713
      • Duke South Durham
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati
    • Cincinnati, Ohio, United States, 45236
      • Bernstein Clinical Research Center LLC
    • Gahanna, Ohio, United States, 43230
      • The Ohio State University Dermatology East
  • Oregon
    • Grants Pass, Oregon, United States, 97527
      • Velocity Clinical Research - Grants Pass
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
  • Texas
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates
    • Cedar Park, Texas, United States, 78613
      • US Dermatology Partners Cedar Park
    • Dallas, Texas, United States, 75225
      • Alina Clinical Trials, LLC
    • Dallas, Texas, United States, 75230
      • Zenos Clinical Research, LLC
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77037
      • MedCare Pharma - Houston
    • Lampasas, Texas, United States, 76550
      • FMCScience LLC
    • Lewisville, Texas, United States, 75057
      • Epic Clinical Research Incorporated
    • Missouri City, Texas, United States, 77459
      • Sienna Dermatology Research
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
    • San Antonio, Texas, United States, 78229
      • Andante Research
  • Utah
    • Murray, Utah, United States, 84107
      • University of Utah MidValley Dermatology
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Eastern Virginia Medical School
  • Washington
    • Spokane, Washington, United States, 99202
      • MultiCare Institute for Research and Innovation

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 (or ≥ legal adult age within the country if it is older than 18 years at signing of informed consent) 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 or higher potency (with or without topical calcineurin inhibitors [TCI]) as appropriate or for whom topical treatments are otherwise medically inadvisable (eg, because of important side effects or safety risks).
• 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
  • Oral or topical 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 (PDE4) inhibitors
  • Other topical immunosuppressive agents
  • Combination agents including TCS of any potency or TCI, PDE4 inhibitors, or other 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rocatinlimab; Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with a loading dose at Week 2.	Drug: Rocatinlimab; Rocatinlimab will be administered through a subcutaneous (SC) injection.; Other Names: AMG 451; KHK 4083
Placebo Comparator: Placebo; Placebo Q4W for 24 weeks with a loading dose at Week 2.	Other: Placebo; The matching placebo will be administered through a SC injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24	Baseline and Week 24
Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis Score of 0 (Clear) or 1 (Almost Clear) with a ≥ 2 Point Reduction From Baseline (vIGA-AD 0/1) at Week 24	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Achievement of EASI 75 at Week 16	Baseline and Week 16
Achievement of vIGA-AD 0/1 at Week 16	Baseline and Week 16
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4	Baseline and Week 16
Achievement of a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants with Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4	Baseline and Week 24
Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24	Baseline and Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24	Baseline to Week 24
Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline	Baseline and Week 24
Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline	Baseline and Week 24
Change from Baseline in SCORing Atopic Dermatitis (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16	Baseline and Week 16
Achievement of a ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants with Baseline POEM Score ≥ 4	Baseline and Week 24
Change from Baseline in POEM Score at Week 24	Baseline and Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16	Baseline and Week 16
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24	Baseline and Week 24
Change From Baseline in SCORAD Itch VAS Score at Week 24	Baseline and Week 24
Change From Baseline in HADS-anxiety Subscale Score at Week 24	Baseline and Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24	Baseline and 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 and Week 24
Achievement of ≥ 4-point Reduction From Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4	Baseline to Week 24
Achievement of 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 and Week 24
Achievement of a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants with Baseline DLQI ≥ 4	Baseline and Week 24
Change From Baseline in DLQI Score at Week 24	Baseline and Week 24
Achievement of ≥ 4-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4	Baseline to Week 16
Change from Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16	Baseline and Week 16
Achievement of ≥ 3-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 24 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 3	Baseline to Week 24
Achievement of ≥ 3-point Reduction from Baseline in Weekly Average of AD Skin Pain NRS Score at Week 16 in Participants with Baseline Weekly Average of AD Skin Pain NRS Score ≥ 3	Baseline to Week 16
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24	Baseline to Week 24
Achievement of Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score <8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8	Baseline and Week 24
Achievement of HADS-depression Subscale Score <8 at Week 24 in Participants with Baseline HADS-depression Subscale Score ≥ 8	Baseline and Week 24

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2022
• Primary Completion (Actual): June 5, 2024
• Study Completion (Actual): August 27, 2024

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Eczema; AMG 451; Rocatinlimab; KHK 4083
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis, Atopic; Dermatitis; Eczema; Dermatologic Agents; KHK4083
• Other Study ID Numbers: 20210143; 2022-501538-44 (Other Identifier: EU CT Number)

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