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

June 2, 2026 updated by: Amgen

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

726

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • Brussels, 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
      • São 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
    • 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
      • Québec, Quebec, Canada, G1V 4X7
        • Centre De Recherche Dermatologique Du Quebec Metropolitain
      • Sherbrooke, Quebec, Canada, J1G 1X9
        • Clinique Dermatologique de Sherbrooke
  • Czechia
      • Kutná Hora, Czechia, 284 01
        • Kozni ambulance Kutna Hora sro
      • Nový Jičín, Czechia, 741 01
        • Nemocnice Novy Jicin as
      • Pardubice, Czechia, 530 02
        • CCR Czech as
      • Pilsen, Czechia, 305 99
        • Fakultni nemocnice Plzen
      • Prague, Czechia, 130 00
        • CCR Prague sro
      • Prague, Czechia, 120 00
        • Dermamedest sro
      • Prague, Czechia, 106 00
        • Kozni ambulance Fialova sro
      • Prague, Czechia, 150 00
        • Praglandia 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, 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
      • Münster, Germany, 48149
        • Universitaetsklinikum Muenster
      • Osnabrück, 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
    • Hyōgo
      • Kobe, Hyōgo, 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, Kanagawa, Japan, 224-8503
        • Showa University Northern Yokohama Hospital
    • Nagasaki
      • Nagasaki, 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, 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
  • Mexico
      • Chihuahua City, 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 Crónicas y de Procedimientos Especiales
  • Poland
      • Bialystok, Poland, 15-879
        • ClinicMed Daniluk Nowak Spolka Komandytowa
      • Chorzów, 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
      • Warsaw, 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
      • Lisbon, 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
  • South Korea
      • Ansansi, Gyeonggido, South Korea, 15355
        • Korea University Ansan Hospital
      • Bucheon-si, Gyeonggi-do, South Korea, 14584
        • Soon Chun Hyang University Bucheon Hospital
      • Busan, South Korea, 49241
        • Pusan National University Hospital
      • Daegu, South Korea, 41944
        • Kyungpook National University Hospital
      • Gwangju, South Korea, 61453
        • Chosun University Hospital
      • Incheon, South Korea, 22332
        • Inha University Hospital
      • Incheon, South Korea, 21431
        • The Catholic University of Korea Incheon St Marys Hospital
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, South Korea, 05278
        • Kyung Hee University Hospital at Gangdong
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 05030
        • Konkuk University Medical Center
      • Seoul, South Korea, 06973
        • Chung-Ang University Hospital
      • Seoul, South Korea, 07441
        • Hallym University Kangnam Sacred Heart Hospital
      • Seoul, South Korea, 04564
        • National Medical Center
      • Seoul, South Korea, 07804
        • Ewha Womans University Seoul Hospital
      • Seoul, South Korea, 06591
        • The Catholic Univ of Korea Seoul St Marys Hospital
      • Suwon-si, Gyeonggi-do, South Korea, 16499
        • Ajou University Hospital
  • 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
    • Andalusia
      • Seville, Andalusia, Spain, 41009
        • Hospital Universitario Virgen Macarena
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Clinica Universidad de Navarra
    • Valencia
      • Alicante, Valencia, Spain, 03010
        • Hospital General Universitario de Alicante
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises
      • Valencia, Valencia, Spain, 46015
        • Hospital Arnau de Vilanova de Valencia
  • Sweden
      • Stockholm, Sweden, 171 76
        • Karolinska Universitetssjukhuset Solna
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universitesi Tip Fakultesi Hastanesi
      • Gaziantep, Turkey (Türkiye), 27310
        • Gaziantep Universitesi Tip Fakultesi Hastanesi
      • Istanbul, Turkey (Türkiye), 34093
        • Bezmialem Vakif Universitesi Hastanesi
      • Izmir, Turkey (Türkiye), 35620
        • Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
      • Kayseri, Turkey (Türkiye), 38030
        • Erciyes Universitesi Tip Fakultesi Hastanesi
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli Universitesi Tip Fakultesi Hastanesi
      • Sakarya, Turkey (Türkiye), 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 D.C., 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
      • 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
      • The Bronx, New York, United States, 10467
        • Montefiore Medical Center
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Measure Description
Time Frame
Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (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
Time Frame: Baseline and Week 24
vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," the participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, the participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Time Frame: Baseline and Week 24
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Achieved EASI 75 at Week 16
Time Frame: Baseline and Week 16
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (vIGA-AD 0/1) at Week 16
Time Frame: Baseline and Week 16
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Number of Participants Who Achieved 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
Time Frame: Baseline and Week 16
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Number of Participants Who Achieved 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
Time Frame: Baseline and Week 24
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Time Frame: Baseline and Week 24
The EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved ≥ 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
Time Frame: Baseline and Week 24
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) With a ≥ 2-Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
Time Frame: Baseline and Week 24
The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
Time Frame: Baseline and Week 24
The severity of facial AD was assessed using the Facial AD Severity Scale (FASS). The FASS was an instrument used to rate the overall severity of facial AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline
Time Frame: Baseline and Week 24
The severity of hand AD was assessed using the Hand Atopic Dermatitis Severity Scale (HASS). The HASS was an instrument used to rate the overall severity of hand AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Time Frame: Baseline and Week 16
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward [WOCF]) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Baseline and Week 16
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Time Frame: Baseline and Week 24
The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.
Baseline and Week 24
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Time Frame: Baseline and Week 16
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Baseline and Week 16
Change From Baseline in SCORAD Itch VAS Score at Week 24
Time Frame: Baseline and Week 24
The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Baseline and Week 24
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
Time Frame: Baseline and Week 24
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adult patients suffering from skin disease. The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in DLQI Score at Week 24
Time Frame: Baseline and Week 24
The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adult patients suffering from skin disease. The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
Baseline and Week 24
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
Time Frame: Baseline and Week 24
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in POEM Score at Week 24
Time Frame: Baseline and Week 24
The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
Baseline and Week 24
Number of Participants Who Achieved ≥ 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
Time Frame: Baseline and Week 16
AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Time Frame: Baseline and Week 24
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Baseline and Week 24
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Time Frame: Baseline and Week 16
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.
Baseline and Week 16
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Time Frame: Baseline and Week 24
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Time Frame: Baseline and Week 16
AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Time Frame: Baseline and Week 24
Weekly average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours. Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance. Participants were asked to rate the intensity of their sleep disturbance using this scale each day. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in level of sleep disturbance.
Baseline and Week 24
Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
Time Frame: Baseline and Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
Time Frame: Baseline and Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Change From Baseline in HADS-anxiety Subscale Score at Week 24
Time Frame: Baseline and Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
Baseline and Week 24
Change From Baseline in HADS-depression Subscale Score at Week 24
Time Frame: Baseline and Week 24
HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.
Baseline and Week 24
Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
Time Frame: Baseline and Week 24
The SCORAD total score used to assess the severity of AD using both physician and patient-reported data. SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

June 26, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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