A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)

A Phase 3, Randomized, 24-week, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Combination With Topical Corticosteroids and/or Topical Calcineurin Inhibitors in Adult Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-SHUTTLE)

The coprimary objectives of the study are to:

• evaluate the efficacy of rocatinlimab in combination with topical corticosteroid and/or topical calcineurin inhibitor (TCS/TCI), compared with placebo in combination with TCS/TCI at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD™).
• evaluate the efficacy of rocatinlimab, in combination with TCS/TCI, compared with placebo in combination with TCS/TCI at Week 24, assessed using Eczema Area and Severity Index (EASI).

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Other: Placebo; Drug: Rocatinlimab

• Study Type: Interventional
• Enrollment (Actual): 746
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Amgen Call Center; Phone Number: 866-572-6436; Email: medinfo@amgen.com

Study Locations

• Argentina
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, C1027AAP
      • Cinme - Centro de Investigaciones Metabolicas
    • La Plata, Buenos Aires, Argentina, B1902COS
      • Framingham Centro Médico
    • Ramos Mejia, Buenos Aires, Argentina, 1704
      • DIM Clinica Privada
  • Distrito Federal
    • Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina, 1054
      • Buenos Aires Skin SA
    • Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina, 1121
      • Fundacion Cidea
    • Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina, 1414
      • Care- Centro de Alergia y Enfermedades Respiratorias
    • Ciudad Autonoma de Buenos Aires, Distrito Federal, Argentina, 1425
      • Psoriahue Medicina Interdisciplinaria SRL
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
• Australia
  • New South Wales
    • Botany, New South Wales, Australia, 2019
      • Emeritus Research Sydney
    • Westmead, New South Wales, Australia, 2145
      • Westmead Hospital
  • Queensland
    • Benowa, Queensland, Australia, 4217
      • The Skin Centre
    • South Brisbane, Queensland, Australia, 4101
      • Princess Alexandra Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Veracity Clinical Research
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research Melbourne
• Austria
  • Graz, Austria, 8036
    • Medizinische Universitaet Graz
  • Innsbruck, Austria, 6020
    • Medizinische Universitaet Innsbruck
  • Salzburg, Austria, 5020
    • Landeskrankenhaus Salzburg
  • Wien, Austria, 1030
    • Klinik Landstraße
  • Wien, Austria, 1130
    • Klinik Hietzing
• Belgium
  • Brugge, Belgium, 8000
    • Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
  • Brussel, Belgium, 1090
    • Universitair Ziekenhuis Brussel
  • Brussels, Belgium, 1020
    • Centre Hospitalier Universitaire Brugmann
  • Bruxelles, Belgium, 1200
    • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
  • Gent, Belgium, 9000
    • Universitair Ziekenhuis Gent
  • Herstal, Belgium, 4040
    • Clinique Andre Renard
  • Kortrijk, Belgium, 8500
    • Dermatologie Handelskaai
  • Leuven, Belgium, 3000
    • Universitaire Ziekenhuizen Leuven Gasthuisberg
  • Liege, Belgium, 4000
    • Centre Hospitalier Universitaire de Liege - Sart Tilman
  • Loverval, Belgium, 6280
    • Grand Hopital de Charleroi
• Bulgaria
  • Dupnitsa, Bulgaria, 2600
    • Medical Center Asklepii Ood
  • Pleven, Bulgaria, 5800
    • Medical Center Medconsult Pleven OOD
  • Sofia, Bulgaria, 1407
    • Medical Center Excelsior OOD
  • Sofia, Bulgaria, 1431
    • Diagnostic-Consultative Center Alexandrovska EOOD
  • Sofia, Bulgaria, 1463
    • Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
• Canada
  • Quebec, Canada, G1W 4R4
    • Centre de Recherche Saint-Louis
  • Quebec, Canada, G1V 4T3
    • DIEX Recherche Quebec
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Incorporated
    • Edmonton, Alberta, Canada, T5J 3S9
      • Laser Rejuvenation Clinics Edmonton D T Incorporated
    • Edmonton, Alberta, Canada, T6G 1C3
      • Alberta Derma Surgery Centre
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Enverus Medical Research
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Incorporated
  • Ontario
    • Coburg, Ontario, Canada, K9A 4J9
      • Skin Health
    • London, Ontario, Canada, N6A 2C2
      • Centricity Research London
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Dr SK Siddha Medicine Professional Corporation
    • Niagara Falls, Ontario, Canada, L2H 1H5
      • Allergy Research Canada Incorporated
    • North Bay, Ontario, Canada, P1B 3Z7
      • North Bay Dermatology Centre
    • Ottawa, Ontario, Canada, K2C 3N2
      • Dermatology Ottawa Research Centre
    • Ottawa, Ontario, Canada, K2C 3N2
      • JRB Research Incorporated
    • Richmond Hill, Ontario, Canada, L4B 1A5
      • The Centre for Dermatology
    • Toronto, Ontario, Canada, M2N 3A6
      • North York Research Incorporated
    • Toronto, Ontario, Canada, M3H 5Y8
      • Toronto Research Centre Inc
    • Waterloo, Ontario, Canada, N2J 1C4
      • Alliance Clinical Trials
  • Quebec
    • Montreal, Quebec, Canada, H2X 2V1
      • Innovaderm Research Inc
    • Montreal, Quebec, Canada, H1Y 3L1
      • Clinique de Dermatologie Rosemont
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7T 0G3
      • Saskatoon Dermatology Centre
• China
  • Beijing, China, 100044
    • Peking University Peoples Hospital
  • Shanghai, China, 200443
    • Shanghai skin disease hospital
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijing, Beijing, 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
    • Shantou, Guangdong, China, 515041
      • The Fist Affiliated Hospital of Shantou University Medical College
    • Shenzhen, Guangdong, China, 518101
      • Shenzhen Qianhai Shekou Free Trade Zone Hospital
  • Henan
    • Nanyang, Henan, China, 473002
      • Nanyang First Peoples Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Jiangsu
    • Wuxi, Jiangsu, China, 214001
      • Wuxi Second Peoples Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330000
      • Dermatology Hospital of Jiangxi Province
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Sichuan
    • Chengdu, Sichuan, China, 610017
      • Chengdu Second Peoples Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310020
      • Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
    • Ningbo, Zhejiang, China, 315010
      • The First Affiliation Hospital Of Ningbo University
    • Taizhou, Zhejiang, China, 318000
      • Taizhou Central Hospital
• France
  • Antony, France, 92160
    • Hopital Prive d Antony
  • Bordeaux, France, Cedex
    • Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André
  • Brest, France, 29200
    • Centre Hospitalier Regional Universitaire Brest Hopital Morvan
  • Lille, France, 59037
    • Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
  • Lorient Cedex, France, 56322
    • Centre Hospitalier de Bretagne Sud - Hopital du Scorff
  • Marseille cedex 05, France, 13385
    • Hôpital La Timone
  • Martigues, France, 13500
    • Cabinet du Docteur Ruer-Mulard Mireille
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes Hôtel Dieu
  • Nice, France, 06202
    • Centre Hospitalier Universitaire Archet 2
  • Paris, France, 75020
    • Hopital Tenon
  • Paris, France, 75018
    • Hopital Bichat Claude Bernard
  • Paris Cedex 10, France, 75475
    • Hôpital Saint Louis
  • Reims, France, 51100
    • Polyclinique de Courlancy
  • Rennes Cedex 9, France, 35033
    • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
  • Rouen Cedex, France, 76031
    • Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
  • Saint Priest en Jarez, France, 42270
    • Centre Hospitalier Universitaire Saint Etienne Hopital Nord
  • Toulon, France, 83800
    • Hopital d instruction des armees sainte anne
• Germany
  • Frankfurt am Main, Germany, 60590
    • Universitaetsklinikum Frankfurt
  • Goettingen, Germany, 37075
    • Universitaetsmedizin Goettingen - Georg-August-Universitaet
  • Hamburg, Germany, 22391
    • Mensingderma Research Gmbh
  • Hamburg, Germany, 20537
    • TFS Trial Form Support GmbH
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Hannover, Germany, 30159
    • Hautaerzte Zentrum Hannover
  • Mainz, Germany, 55101
    • Universitaetsmedizin Mainz
  • Memmingen, Germany, 87700
    • Beldio Research GmbH
  • Merzing, Germany, 66663
    • Hautmedizin Saar
  • Muenchen, Germany, 80802
    • Klinikum rechts der Isar der TUM
• Greece
  • Athens, Greece, 11525
    • 401 General Military Hospital of Athens
  • Athens, Greece, 16121
    • Andreas Syngros Hospital Of Venereal And Dermatological Diseases
  • Heraklion, Greece, 71500
    • University General Hospital of Heraklion
  • Nea Ionia, Greece, 14233
    • General Hospital Of Nea Ionia Konstantopouleio Patision
  • Piraeus, Greece, 18536
    • Geniko Nosokomeio Peiraia Tzaneio
  • Thessaloniki, Greece, 54642
    • Ippokratio General Hospital of Thessaloniki
• Hungary
  • Bekescsaba, Hungary, 5600
    • Trial Pharma Kft
  • Budapest, Hungary, 1036
    • Óbudai Egészségügyi Centrum Kft
  • Budapest, Hungary, 1027
    • Csalogany Orvosi Kozpont
  • Budapest, Hungary, 1033
    • Clinexpert Kft
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont
  • Gyongyos, Hungary, 3200
    • Gyongyosi Bugat Pal Korhaz
  • Kaposvar, Hungary, 7400
    • Somogy Varmegyei Kaposi Mor Oktato Korhaz
  • Oroshaza, Hungary, 5900
    • DermaMed Research Kft
  • Szolnok, Hungary, 5000
    • Allergo-Derm Bakos Kft
  • Zalaegerszeg, Hungary, 8900
    • Óbudai Egészségügyi Centrum Kft
• Italy
  • Genova, Italy, 16132
    • Ospedale Policlinico San Martino IRCCS
  • LAquila, Italy, 67100
    • Ospedale San Salvatore
  • Roma, Italy, 00168
    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • Rozzano MI, Italy, 20089
    • Irccs Istituto Clinico Humanitas
• Japan
  • Aichi
    • Nagoya-shi, Aichi, Japan, 454-0803
      • Fukui Dermatology Clinic
  • Fukuoka
    • Fukuoka-shi, Fukuoka, Japan, 812-0013
      • Ekihigashi Dermatology Allergy Clinic
  • Hokkaido
    • Obihiro-shi, Hokkaido, Japan, 080-0013
      • Takagi Dermatological Clinic Branch
    • Sapporo-shi, Hokkaido, Japan, 060-0063
      • Medical Corporation Kojinkai Sapporo Skin Clinic
  • Kagoshima
    • Kagoshima-shi, Kagoshima, Japan, 890-0063
      • Katahira Dermatology Urology Clinic
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan, 211-0063
      • Kosugi Dermatology Clinic
    • Yokohama-shi, Kanagawa, Japan, 221-0825
      • Nomura Dermatology Clinic
  • Kumamoto
    • Kumamoto-shi, Kumamoto, Japan, 860-0066
      • Jouzan Hihuka Hinyoukika Clinic
    • Kumamoto-shi, Kumamoto, Japan, 862-0950
      • Suizenji Dermatology Clinic
  • Osaka
    • Neyagawa-shi, Osaka, Japan, 572-0838
      • Yoshioka Dermatology Clinic
  • Shizuoka
    • Hamamatsu-shi, Shizuoka, Japan, 430-0929
      • JA Shizuoka Kohseiren Enshu Hospital
  • Tokyo
    • Adachi-ku, Tokyo, Japan, 120-0034
      • Mildix Skin Clinic
    • Setagaya-ku, Tokyo, Japan, 158-0097
      • Naoko Dermatology Clinic
    • Shinagawa-ku, Tokyo, Japan, 141-8625
      • Ntt Medical Center Tokyo
    • Shinjuku-ku, Tokyo, Japan, 169-0075
      • Yamate Dermatology Clinic
• Malaysia
  • Johor
    • Johor Bahru, Johor, Malaysia, 81100
      • Hospital Sultan Ismail
  • Perak
    • Ipoh, Perak, Malaysia, 30450
      • Hospital Raja Permaisuri Bainun
  • Pinang
    • Georgetown, Pinang, Malaysia, 10990
      • Hospital Pulau Pinang
  • Sabah
    • Kota Kinabalu, Sabah, Malaysia, 88586
      • Queen Elizabeth Hospital
  • Wilayah Persekutuan
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
      • University Malaya Medical Centre
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
      • Hospital Kuala Lumpur
    • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
      • Pusat Perubatan Universiti Kebangsaan Malaysia
• Netherlands
  • Bergen op Zoom, Netherlands, 4624 VT
    • Bravis Ziekenhuis
  • Groningen, Netherlands, 9700 RB
    • Universitair Medisch Centrum Groningen
  • Utrecht, Netherlands, 3584 CX
    • Universitair Medisch Centrum Utrecht
• Poland
  • Chorzow, Poland, 41-500
    • Dermapolis Medical Dermatology Center dr n med Edyta Gebska
  • Katowice, Poland, 40-600
    • GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
  • Krakow, Poland, 30-002
    • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
  • Lodz, Poland, 90-349
    • AppleTreeClinics Network Spzoo
  • Lodz, Poland, 90-752
    • Ip Clinic Sp zoo
  • Szczecin, Poland, 71-500
    • Twoja Przychodnia Scm
  • Wroclaw, Poland, 51-503
    • DermMedica Spzoo Centrum Columbus
• Puerto Rico
  • Caguas, Puerto Rico, 00727-9507
    • Doctor Samuel Sanchez PSC
• Romania
  • Brasov, Romania, 500112
    • Theramed Healthcare SRL
  • Cluj-Napoca, Romania, 400431
    • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
  • Targu Mures, Romania, 540613
    • Spitalul Clinic Judetean Mures
• Singapore
  • Singapore, Singapore, 308205
    • National Skin Centre
  • Singapore, Singapore, 168753
    • Singapore General Hospital
  • Singapore, Singapore, 117599
    • National University Hospital
• Slovakia
  • Bardejov, Slovakia, 085 01
    • Maxderm, sro
  • Bratislava, Slovakia, 813 69
    • Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
  • Presov, Slovakia, 081 81
    • Fakultna nemocnica s poliklinikou JA Reimana Presov
  • Svidnik, Slovakia, 089 01
    • Sanare spol sro
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Univerzitetni klinicni center Ljubljana
  • Maribor, Slovenia, 2000
    • Univerzitetni Klinicni Center Maribor
• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 De Octubre
  • Pontevedra, Spain, 36001
    • Complexo Hospitalario Universitario de Pontevedra
  • Cataluña
    • Barcelona, Cataluña, Spain, 08036
      • Hospital Clinic i Provincial de Barcelona
  • Comunidad Valenciana
    • Valencia, Comunidad Valenciana, Spain, 46014
      • Hospital General Universitario de Valencia
  • País Vasco
    • Bilbao, País Vasco, Spain, 48013
      • Hospital Universitario Basurto
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital Bern
  • Geneve 14, Switzerland, 1211
    • Hôpitaux universitaires de Genève
  • Lausanne, Switzerland, 1011
    • Centre Hospitalier Universitaire Vaudois
  • Sankt Gallen, Switzerland, 9007
    • Kantonsspital Sankt Gallen
  • Zuerich, Switzerland, 8091
    • Universitaetsspital Zuerich
• Turkey
  • Ankara, Turkey, 06800
    • Ankara Bilkent Sehir Hastanesi
  • Istanbul, Turkey, 34662
    • Acibadem Altunizade Hastanesi
  • Istanbul, Turkey, 34390
    • Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
  • Istanbul, Turkey, 34899
    • Marmara Universitesi Tip Fakultesi Hastanesi
  • Samsun, Turkey, 55200
    • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • Royal United Hospitals Bath NHS Foundation Trust
  • Dudley, United Kingdom, DY1 2HQ
    • Russells Hall Hospital
  • Isleworth, United Kingdom, TW7 6AF
    • West Middlesex University Hospital
  • London, United Kingdom, NW3 2PF
    • The Royal Free Hospital
  • Salford, United Kingdom, M6 8HD
    • Salford Royal Hospital
  • Shipley, United Kingdom, BD18 3SA
    • Accellacare Yorkshire
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • The University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists
    • Phoenix, Arizona, United States, 85018
      • Southwest Skin Specialists
    • Sun City West, Arizona, United States, 85375
      • US Dermatology Partners Sun City West
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Research Trials, LLC
  • California
    • Bakersfield, California, United States, 93301
      • Kern Research Inc
    • Los Angeles, California, United States, 90056
      • Wallace Medical Group Inc
    • Los Angeles, California, United States, 90033
      • Keck Medicine of University of Southern California
    • Palmdale, California, United States, 93551
      • Antelope Valley Clinical Trials
    • Sacramento, California, United States, 95816
      • University of California at Davis Medical Center
    • Sacramento, California, United States, 95823
      • Kaiser Permanente South Sacramento Medical Center
    • San Diego, California, United States, 92120
      • Acclaim Clinical Research
    • San Francisco, California, United States, 94132
      • Synergy Dermatology
    • San Francisco, California, United States, 94118
      • Kaiser Permanente Medical Center - Oakland
    • San Francisco, California, United States, 94118
      • Kaiser Permanente Medical Center - San Francisco
  • Florida
    • Tampa, Florida, United States, 33609
      • TrueBlue Clinical Research
    • Tampa, Florida, United States, 33615
      • Olympian Clinical Research - Tampa
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Atlanta Dermatology, Vein and Research Center, PC
    • Atlanta, Georgia, United States, 30315
      • Divine Dermatology and Aesthetics
  • Illinois
    • Skokie, Illinois, United States, 60077
      • NorthShore University Healthsystem
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • DS Research
    • Indianapolis, Indiana, United States, 46250
      • Dawes Fretzin Clinical Research Group, LLC
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Dermatology and Skin Cancer Center Leawood
  • Louisiana
    • Monroe, Louisiana, United States, 71201
      • Industrial Medicine Associates Clinical Research Advanced Dermatology Care
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Aesthetic and Dermatology Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Medical Center
    • Auburn Hills, Michigan, United States, 48326
      • Oakland Hills Dermatology
  • Nebraska
    • Lincoln, Nebraska, United States, 68505
      • Somnos Clinical Research
    • Omaha, Nebraska, United States, 68144
      • Skin Specialists PC
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Vivida Dermatology
    • North Las Vegas, Nevada, United States, 89030
      • Las Vegas Clinical Trials
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Schweiger Dermatology Group, PC Research Division
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials Incorporated
  • New York
    • Bronx, New York, United States, 10455
      • Chear Center LLC
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Accellacare of Wilmington
  • Ohio
    • Bexley, Ohio, United States, 43209
      • Bexley dermatology research
  • Oregon
    • Medford, Oregon, United States, 97504
      • Velocity Clinical Research Inc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Company Inc
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Dakota
    • Rapid City, South Dakota, United States, 57702
      • Health Concepts
  • Texas
    • Austin, Texas, United States, 78759
      • US Dermatology Partners Jollyville
    • El Paso, Texas, United States, 79925
      • Newco 3A Research LLC
    • Kerrville, Texas, United States, 78028
      • Sante Clinical Research
    • Plano, Texas, United States, 75025
      • Texas Dermatology Research Center
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Virginia Dermatology and Skin Cancer Center

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 (American Academy of Dermatology) Consensus Criteria (2014) present for at least 12 months
• History of inadequate response to TCS of medium or higher potency (with or without 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
  • Nonbiologic, non-targeted Systemic immunosuppressants
  • Phototherapy
  • Janus kinase inhibitors

• Treatment with any of the following medications or therapies within 1 week, prior to Day 1:

  • TCS
  • TCI
  • Topical phosphodiesterase type 4 inhibitors
  • Other topical immunosuppressive agents
  • Combination topical agents including TCS of any potency or TCI, PDE4 inhibitors, or other topical immunosuppressive agents

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rocatinlimab Dose 1 + TCS/TCI; Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2.	Drug: Rocatinlimab; Subcutaneous (SC) injection; Other Names: AMG 451
Experimental: Rocatinlimab Dose 2 + TCS/TCI; Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.	Drug: Rocatinlimab; Subcutaneous (SC) injection; Other Names: AMG 451
Placebo Comparator: Placebo + TCS/TCI; Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.	Other: Placebo; SC injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Achievement of a vIGA-AD Score of 0 or 1 with a ≥2 Point Reduction From Baseline at Week 24	Baseline, Week 24
Achievement of ≥ 75% Reduction From Baseline in EASI Score (EASI 75) at Week 24	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Achievement of EASI 75 at Week 16	Baseline, Week 16
Achievement of vIGA-AD 0/1 at Week 16	Baseline, 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, 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, Week 24
Achievement of ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24	Baseline, Week 24
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 Worst Pruritus NRS Score at Week 16	Baseline, Week 16
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24	Baseline, Week 24
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 Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI Score ≥ 4	Baseline, Week 24
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, Week 24
Change From Baseline in POEM 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
Change From Baseline in Weekly Average of Sleep Disturbance NRS Score at Week 24	Baseline, Week 24
Achievement of a Hospital Anxiety and Depression Scale (HADS)-anxiety Subscale Score < 8 at Week 24 in Participants with Baseline HADS-anxiety Subscale Score ≥ 8	Baseline, Week 24
Achievement of a HADS-depression Subscale Score < 8 at Week 24 in Participants with Baseline HADS-depression 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
Achievement of a Facial AD Severity Score of Clear at Week 24 for Participants with Facial AD at Baseline	Baseline, Week 24
Achievement of a Hand AD Severity Score of Clear at Week 24 for Participants with Hand AD at Baseline	Baseline, Week 24
Achievement of a ≥ 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, Week 24
Achievement of vIGA-AD 1 Response with a Presence of Only Barely Perceptible Erythema or vlGA-AD 0 Response (Revised IGA [rIGA™] 0/1) at Week 24	Baseline, Week 24
Change from Baseline in DLQI Score at Week 24	Baseline, Week 24
Achievement of a ≥ 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, Week 16
Achievement of a ≥ 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, Week 24
Achievement of a ≥ 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, Week 16

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): February 21, 2023
• Primary Completion (Estimated): September 16, 2024
• Study Completion (Estimated): January 6, 2025

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Eczema; AMG 451; KHK4083; Rocatinlimab
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 20210144; 2022-501585-22 (Registry Identifier: CTIS (EU))

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