A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD)
NCT ID: NCT05724199
Last Updated: 2025-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
746 participants
INTERVENTIONAL
2023-02-21
2024-12-04
Brief Summary
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* 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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Rocatinlimab Dose 1 + TCS/TCI
Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks + TCS/TCI + loading dose at Week 2.
Rocatinlimab
Subcutaneous (SC) injection
Rocatinlimab Dose 2 + TCS/TCI
Rocatinlimab Dose 2 Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.
Rocatinlimab
Subcutaneous (SC) injection
Placebo + TCS/TCI
Placebo Q4W for 24 weeks + TCS/TCI + loading dose at Week 2.
Placebo
SC injection
Interventions
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Rocatinlimab
Subcutaneous (SC) injection
Placebo
SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
100 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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The University of Alabama at Birmingham
Birmingham, Alabama, United States
Medical Dermatology Specialists
Phoenix, Arizona, United States
Southwest Skin Specialists
Phoenix, Arizona, United States
US Dermatology Partners Sun City West
Sun City West, Arizona, United States
Arkansas Research Trials, LLC
North Little Rock, Arkansas, United States
Kern Research Inc
Bakersfield, California, United States
Keck Medicine of University of Southern California
Los Angeles, California, United States
Wallace Medical Group Inc
Los Angeles, California, United States
Antelope Valley Clinical Trials
Palmdale, California, United States
University of California at Davis Medical Center
Sacramento, California, United States
Kaiser Permanente South Sacramento Medical Center
Sacramento, California, United States
Acclaim Clinical Research
San Diego, California, United States
Kaiser Permanente Medical Center - Oakland
San Francisco, California, United States
Kaiser Permanente Medical Center - San Francisco
San Francisco, California, United States
Synergy Dermatology
San Francisco, California, United States
TrueBlue Clinical Research
Tampa, Florida, United States
Olympian Clinical Research - Tampa
Tampa, Florida, United States
Atlanta Dermatology, Vein and Research Center, PC
Alpharetta, Georgia, United States
Divine Dermatology and Aesthetics
Atlanta, Georgia, United States
NorthShore University HealthSystem
Skokie, Illinois, United States
DS Research
Clarksville, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Dermatology and Skin Cancer Center Leawood
Leawood, Kansas, United States
Industrial Medicine Associates Clinical Research Advanced Dermatology Care
Monroe, Louisiana, United States
Aesthetic and Dermatology Center
Rockville, Maryland, United States
University of Michigan Medical Center
Ann Arbor, Michigan, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
Somnos Clinical Research
Lincoln, Nebraska, United States
Skin Specialists PC
Omaha, Nebraska, United States
Vivida Dermatology
Las Vegas, Nevada, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
Schweiger Dermatology Group, PC Research Division
Hackensack, New Jersey, United States
Albuquerque Clinical Trials Incorporated
Albuquerque, New Mexico, United States
Chear Center LLC
The Bronx, New York, United States
Accellacare of Wilmington
Wilmington, North Carolina, United States
Bexley Dermatology Research
Bexley, Ohio, United States
Velocity Clinical Research Inc
Medford, Oregon, United States
Paddington Testing Company Inc
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Health Concepts
Rapid City, South Dakota, United States
US Dermatology Partners Jollyville
Austin, Texas, United States
Newco 3A Research LLC
El Paso, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
Texas Dermatology Research Center
Plano, Texas, United States
Virginia Dermatology and Skin Cancer Center
Norfolk, Virginia, United States
Cinme - Centro de Investigaciones Metabolicas
CABA, Buenos Aires, Argentina
Framingham Centro Medico
La Plata, Buenos Aires, Argentina
Dim Clinica Privada
Ramos Mejía, Buenos Aires, Argentina
Buenos Aires Skin SA
Buenos Aires, Distrito Federal, Argentina
Fundacion Cidea
Buenos Aires, Distrito Federal, Argentina
Care- Centro de Alergia y Enfermedades Respiratorias
Buenos Aires, Distrito Federal, Argentina
Psoriahue Medicina Interdisciplinaria SRL
Buenos Aires, Distrito Federal, Argentina
Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
Rosario, Santa Fe Province, Argentina
Emeritus Research Sydney
Botany, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Princess Alexandra Hospital
South Brisbane, Queensland, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
Emeritus Research Melbourne
Camberwell, Victoria, Australia
Medizinische Universitaet Graz
Graz, , Austria
Medizinische Universitaet Innsbruck
Innsbruck, , Austria
Landeskrankenhaus Salzburg
Salzburg, , Austria
Klinik Landstrasse
Vienna, , Austria
Klinik Hietzing
Vienna, , Austria
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
Bruges, , Belgium
Centre Hospitalier Universitaire Brugmann
Brussels, , Belgium
Universitair Ziekenhuis Brussel
Brussels, , Belgium
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Clinique Andre Renard
Herstal, , Belgium
Dermatologie Handelskaai
Kortrijk, , Belgium
Universitaire Ziekenhuizen Leuven Gasthuisberg
Leuven, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, , Belgium
Grand Hopital de Charleroi
Loverval, , Belgium
Medical Center Asklepii OOD
Dupnitsa, , Bulgaria
Medical Center Medconsult Pleven OOD
Pleven, , Bulgaria
Medical Center Excelsior OOD
Sofia, , Bulgaria
Diagnostic-Consultative Center Alexandrovska EOOD
Sofia, , Bulgaria
Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
Sofia, , Bulgaria
Dermatology Research Institute Incorporated
Calgary, Alberta, Canada
Laser Rejuvenation Clinics Edmonton D T Incorporated
Edmonton, Alberta, Canada
Alberta Derma Surgery Centre
Edmonton, Alberta, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
Wiseman Dermatology Research Incorporated
Winnipeg, Manitoba, Canada
SKiN Health
Coburg, Ontario, Canada
Centricity Research London
London, Ontario, Canada
Dr SK Siddha Medicine Professional Corporation
Newmarket, Ontario, Canada
Allergy Research Canada Incorporated
Niagara Falls, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
Dermatology Ottawa Research Centre
Ottawa, Ontario, Canada
JRB Research Incorporated
Ottawa, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
North York Research Incorporated
Toronto, Ontario, Canada
Toronto Research Centre Inc
Toronto, Ontario, Canada
Alliance Clinical Trials
Waterloo, Ontario, Canada
Clinique de Dermatologie Rosemont
Montreal, Quebec, Canada
Innovaderm Research Inc
Montreal, Quebec, Canada
DIEX Recherche Quebec
Québec, Quebec, Canada
Centre de Recherche Saint-Louis
Québec, Quebec, Canada
Saskatoon Dermatology Centre
Saskatoon, Saskatchewan, Canada
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First Affiliated Hospital ,Sun-Yat Sen University
Guangzhou, Guangdong, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, China
The Fist Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Shenzhen Qianhai Shekou Free Trade Zone Hospital
Shenzhen, Guangdong, China
Nanyang First Peoples Hospital
Nanyang, Henan, China
Union Hospital Tongji Medical College Huazhong University of science and Technology
Wuhan, Hubei, China
Wuxi Second Peoples Hospital
Wuxi, Jiangsu, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Chengdu Second Peoples Hospital
Chengdu, Sichuan, China
the First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliation Hospital Of Ningbo University
Ningbo, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
Peking University Peoples Hospital
Beijing, , China
Shanghai Skin Disease Hospital
Shanghai, , China
Hopital Prive d Antony
Antony, , France
Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André
Bordeaux, , France
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
Brest, , France
Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez
Lille, , France
Centre Hospitalier de Bretagne Sud - Hopital du Scorff
Lorient, , France
Hôpital La Timone
Marseille, , France
Cabinet du Docteur Ruer-Mulard Mireille
Martigues, , France
Centre Hospitalier Universitaire de Nantes Hôtel Dieu
Nantes, , France
Centre Hospitalier Universitaire Archet 2
Nice, , France
Hopital Bichat Claude Bernard
Paris, , France
Hopital Tenon
Paris, , France
Hopital Saint Louis
Paris, , France
Polyclinique de Courlancy
Reims, , France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, , France
Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
Rouen, , France
Centre Hospitalier Universitaire Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, , France
Hopital d instruction des armees sainte anne
Toulon, , France
Universitaetsklinikum Frankfurt
Frankfurt am Main, , Germany
Universitaetsmedizin Goettingen - Georg-August-Universitaet
Göttingen, , Germany
TFS Trial Form Support GmbH
Hamburg, , Germany
MensingDerma research GmbH
Hamburg, , Germany
Hautaerzte Zentrum Hannover
Hanover, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaetsmedizin Mainz
Mainz, , Germany
Beldio Research GmbH
Memmingen, , Germany
Hautmedizin Saar
Merzing, , Germany
Klinikum rechts der Isar der TUM
München, , Germany
401 General Military Hospital Of Athens
Athens, , Greece
Andreas Syngros Hospital Of Venereal And Dermatological Diseases
Athens, , Greece
University General Hospital of Heraklion
Heraklion, , Greece
General Hospital Of Nea Ionia Konstantopouleio Patision
Nea Ionia, , Greece
Geniko Nosokomeio Peiraia Tzaneio
Piraeus, , Greece
Ippokratio General Hospital of Thessaloniki
Thessaloniki, , Greece
Trial Pharma Kft
Békéscsaba, , Hungary
Csalogany Orvosi Kozpont
Budapest, , Hungary
Clinexpert Kft
Budapest, , Hungary
Obudai Egeszsegugyi Centrum Kft
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Gyongyosi Bugat Pal Korhaz
Gyöngyös, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
DermaMed Research Kft
Orosháza, , Hungary
Allergo-Derm Bakos Kft
Szolnok, , Hungary
Obudai Egeszsegugyi Centrum Kft
Zalaegerszeg, , Hungary
Ospedale Policlinico San Martino IRCCS
Genova, , Italy
Ospedale San Salvatore
LAquila, , Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, , Italy
IRCCS Istituto Clinico Humanitas
Rozzano MI, , Italy
Fukui Dermatology Clinic
Nagoya, Aichi-ken, Japan
Ekihigashi Dermatology Allergy Clinic
Fukuoka, Fukuoka, Japan
Takagi Dermatological Clinic Branch
Obihiro-shi, Hokkaido, Japan
Medical Corporation Kojinkai Sapporo Skin Clinic
Sapporo, Hokkaido, Japan
Katahira Dermatology Urology Clinic
Kagoshima, Kagoshima-ken, Japan
Kosugi Dermatology Clinic
Kawasaki-shi, Kanagawa, Japan
Nomura Dermatology Clinic
Yokohama, Kanagawa, Japan
Jouzan Hihuka Hinyoukika Clinic
Kumamoto, Kumamoto, Japan
Suizenji Dermatology Clinic
Kumamoto, Kumamoto, Japan
Yoshioka Dermatology Clinic
Neyagawa, Osaka, Japan
JA Shizuoka Kohseiren Enshu Hospital
Hamamatsu, Shizuoka, Japan
Mildix Skin Clinic
Adachi-ku, Tokyo, Japan
Naoko Dermatology Clinic
Setagaya-ku, Tokyo, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, Japan
Yamate Dermatology Clinic
Shinjuku-ku, Tokyo, Japan
Hospital Sultan Ismail
Johor Bahru, Johor, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
Pusat Perubatan Universiti Kebangsaan Malaysia
Kuala Lumpur, Kuala Lumpur, Malaysia
University Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, Perak, Malaysia
Hospital Pulau Pinang
George Town, Pulau Pinang, Malaysia
Queen Elizabeth Hospital
Kota Kinabalu, Sabah, Malaysia
Bravis Ziekenhuis
Bergen op Zoom, , Netherlands
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Dermapolis Medical Dermatology Center dr n med Edyta Gebska
Chorzów, , Poland
GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
Katowice, , Poland
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
Krakow, , Poland
AppleTreeClinics Network Spzoo
Lodz, , Poland
Ip Clinic Sp zoo
Lodz, , Poland
Twoja Przychodnia Scm
Szczecin, , Poland
DermMedica Spzoo Centrum Columbus
Wroclaw, , Poland
Doctor Samuel Sanchez PSC
Caguas, , Puerto Rico
Theramed Healthcare SRL
Brasov, , Romania
Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
Cluj-Napoca, , Romania
Spitalul Clinic Judetean Mures
Târgu Mureş, , Romania
National University Hospital
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
National Skin Centre
Singapore, , Singapore
Maxderm, sro
Bardejov, , Slovakia
Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
Bratislava, , Slovakia
Fakultna nemocnica s poliklinikou JA Reimana Presov
Prešov, , Slovakia
Sanare spol sro
Svidník, , Slovakia
Univerzitetni klinicni center Ljubljana
Ljubljana, , Slovenia
Univerzitetni Klinicni Center Maribor
Maribor, , Slovenia
Hospital Universitario Basurto
Bilbao, Basque Country, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Catalonia, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Complexo Hospitalario Universitario de Pontevedra
Pontevedra, , Spain
Inselspital Bern
Bern, , Switzerland
Hopitaux Universitaires de Geneve
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Kantonsspital Sankt Gallen
Sankt Gallen, , Switzerland
Universitaetsspital Zuerich
Zurich, , Switzerland
Ankara Bilkent Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
Istanbul, , Turkey (Türkiye)
Acibadem Altunizade Hastanesi
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Tip Fakultesi Hastanesi
Istanbul, , Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
Samsun, , Turkey (Türkiye)
Royal United Hospitals Bath NHS Foundation Trust
Bath, , United Kingdom
Russells Hall Hospital
Dudley, , United Kingdom
West Middlesex University Hospital
Isleworth, , United Kingdom
The Royal Free Hospital
London, , United Kingdom
Salford Care Organisation
Salford, , United Kingdom
Accellacare Yorkshire
Shipley, , United Kingdom
Countries
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References
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Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2022-501585-22-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
20210144
Identifier Type: -
Identifier Source: org_study_id
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