New eczema drug shows promise in large trial

NCT ID NCT05398445

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tested a new medication called rocatinlimab for adults with moderate-to-severe eczema (atopic dermatitis). About 769 people took part to see if the drug can clear skin and reduce itching better than a placebo. The goal is to provide a new treatment option for those who haven't had success with standard creams.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

769 people

The number who actually took part.

Started

May 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years with a diagnosis of AD according to the AAD Consensus Criteria (2014) present for at least 12 months * History of inadequate response to TCS (Topical Corticosteroid) of medium to higher potency (with or without topical calcineurin inhibitors \[TCI\]). * EASI score ≥16 * vIGA-AD score ≥3 * ≥10% body surface area (BSA) of AD involvement * Worst pruritus numerical rating scale ≥ 4 Exclusion Criteria: * Treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to Day 1 * Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1: * Systemic corticosteroids * Systemic immunosuppressants * Phototherapy * Janus kinase inhibitors * Treatment with any of the following medications or therapies within 1 week, prior to Day 1: * TCS of any potency * TCI * Topical phosphodiesterase type 4 inhibitors * Other topical immunosuppressive agents * Combination topical agents including TCS of any potency, TCI, PDE4 inhibitors, or other topical immunosuppressive agents

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy

Gdansk, 80-280, Poland
Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310020, China
Aichi Medical University Hospital

Nagakute-shi, Aichi-ken, 480-1195, Japan
Alberta Derma Surgery Centre

Edmonton, Alberta, T6G 1C3, Canada
Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo

Tarnów, 33-100, Poland
Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia

São Paulo, 06454-010, Brazil
Allcutis Research, Llc - Portsmouth

Portsmouth, New Hampshire, 03801, United States
Alliance Dermatology and Mohs Center

Phoenix, Arizona, 85032, United States
Anaheim Clinical Trials

Anaheim, California, 92801, United States
Andreas Syngros Hospital Of Venereal And Dermatological Diseases

Athens, 16121, Greece
Asahikawa City Hospital

Asahikawa-shi, Hokkaido, 070-8610, Japan
Asan Medical Center

Seoul, 05505, South Korea
Athens Naval Hospital

Athens, 11521, Greece
Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Torino, 10126, Italy
Azienda Ospedaliera Policlinico Umberto I

Roma, 00161, Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

Perugia, 06156, Italy
Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China
CCA Medical Research Corporation

Ajax, Ontario, L1S 7K8, Canada
CCR Ostrava sro

Ostrava, 702 00, Czechia
Cahaba Dermatology and Skin Health Center

Birmingham, Alabama, 35244, United States
Canadian Dermatology Centre

North York, Ontario, M3B 0A7, Canada
Central Clinic

Nagoya, Aichi-ken, 464-0821, Japan
Centro Dermatológico Schejtman

San Miguel, Buenos Aires, 1663, Argentina
CentroDerm GmbH

Wuppertal, 42287, Germany
Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo

Malbork, 82-200, Poland
Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland
Centrum Zdrowia i Urody Maxxmed

Lublin, 20-080, Poland
Charite - Universitaetsmedizin Berlin, Campus Mitte

Berlin, 10117, Germany
Chengdu Second Peoples Hospital

Chengdu, Sichuan, 610021, China
Cinme - Centro de Investigaciones Metabolicas

CABA, Buenos Aires, C1027AAP, Argentina
ClinOhio Research Services

Columbus, Ohio, 43213, United States
Clinical Research of Puerto Rico

San Juan, 00909, Puerto Rico
Clintrial sro

Prague, 100 00, Czechia
Conexa Investigacion Clinica SA

CABA, Distrito Federal, C1012AAY, Argentina
Consultoria Medica e Pesquisa Clinica Cmpc

Sorocaba, São Paulo, 18040-425, Brazil
Continental Clinical Solutions - Cherry Hill

Cherry Hill, New Jersey, 08034, United States
Continental Clinical Solutions, LLC

Towson, Maryland, 21204, United States
Cumberland Skin Center

Hermitage, Tennessee, 37076, United States
Cura Clinical Research

Sherman Oaks, California, 91403, United States
DeNova Research

Chicago, Illinois, 60611, United States
DermDox Dermatology, LLC

Sugarloaf, Pennsylvania, 18249, United States
DermEdge Research Incorporated

Mississauga, Ontario, L4Y 4C5, Canada
Derma therapy, spol s ro

Bratislava, 851 01, Slovakia
Dermamedica, sro

Náchod, 547 01, Czechia
Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych

Wroclaw, 50-450, Poland
Dermatologische Gemeinschaftspraxis-Mahlow

Blankenfelde-Mahlow, 15831, Germany
Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, 330000, China
Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China
Dermatology Research Associates

Los Angeles, California, 90045, United States
Dermatology Research Center of Oklahoma, PLLC

Tulsa, Oklahoma, 74132, United States
Dermatology Specialists of Charlotte

Charlotte, North Carolina, 28277, United States
Dermatology Treatment and Research Center PA

Dallas, Texas, 75230, United States
Dermatology and Skin Cancer Center of Lees Summit

Lee's Summit, Missouri, 64064, United States
Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi, 321-0293, Japan
Dundee Dermatology

West Dundee, Illinois, 60118, United States
Education and Research Foundation Inc

Lynchburg, Virginia, 24501, United States
Essential Medical Research LLC

Tulsa, Oklahoma, 74137, United States
Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica

Banská Bystrica, 975 17, Slovakia
Fakultna nemocnica Trnava

Trnava, 917 75, Slovakia
Fakultni nemocnice Bulovka

Prague, 180 81, Czechia
First OC Dermatology

Fountain Valley, California, 92708, United States
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy
Frontier Derm Partners

Mill Creek, Washington, 98012, United States
Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan
Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan
Fundacao Abc - Centro Univ Fmabc

Santo André, São Paulo, 09060-870, Brazil
Fundacion Estudios Clinicos

Rosario, Santa Fe Province, 2000, Argentina
Fundacion Respirar

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina
General University Hospital of Larissa

Larissa, 41110, Greece
Genesis Clinical Research LLC

Tampa, Florida, 33606, United States
Global Research Associates

Homestead, Florida, 33030, United States
Gordon Sussman Clinical Research Incorporated

North York, Ontario, M3B 3S6, Canada
Hautarztpraxis Dr Niesmann und Dr Othlinghaus

Bochum, 44793, Germany
Hautarztpraxis Dres Leitz und Kollegen

Stuttgart, 70178, Germany
Healthy Life Research

Miami, Florida, 33175, United States
Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany
Henry Ford Health System

Detroit, Michigan, 48202, United States
Hosp e Maternidade Dr Christovao da Gama

Santo André, São Paulo, 09030-010, Brazil
Hospital Clinico Universitario de Santiago

Pontevedra, Galicia, 36001, Spain
Hospital Cuf Descobertas

Lisbon, 1998-018, Portugal
Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, 90160-093, Brazil
Hospital Lusiadas Lisboa

Lisbon, 1500-458, Portugal
Hospital Universitari Germans Trias i Pujol

Badalona, Catalonia, 08916, Spain
Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Catalonia, 08907, Spain
Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain
Hospital Universitario Austral

Derqui, Pilar, Buenos Aires, B1629ODT, Argentina
Hospital Universitario Infanta Leonor

Madrid, 28031, Spain
Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain
Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Universitario Reina Sofia

Córdoba, Andalusia, 14004, Spain
Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Canary Islands, 35010, Spain
Hospital Universitario de La Princesa

Madrid, 28006, Spain
Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
IBPClin Instituto Brasil de Pesquisa Clinica

Rio de Janeiro, 20241-180, Brazil
IMMUNOe Research Centers

Centennial, Colorado, 80112, United States
InAER - Investigaciones en Alergia y Enfermedades Respiratorias

Buenos Aires, Distrito Federal, 1425, Argentina
Industrial Medicine Associates Ima Clinical Research Inc

St. Petersburg, Florida, 33709, United States
Industrial Medicine Associates Ima Clinical Research Inc

Hartsdale, New York, 10530, United States
Innovaderm Research Inc

Montreal, Quebec, H2X 2V1, Canada
Institute for Asthma and Allergy

Chevy Chase, Maryland, 20815, United States
Institute for Health Services Research in Dermatology and Nursing

Hamburg, 20246, Germany
Instituto de Diagnostico Abc American British Cowdray

Rosario, Santa Fe Province, 2000, Argentina
Instituto de Neumonologia y Dermatologia

Buenos Aires, Distrito Federal, 1425, Argentina
Iwate Medical University Uchimaru Medical Center

Morioka, Iwate, 020-8505, Japan
Japan Community Healthcare Organization Chukyo Hospital

Nagoya, Aichi-ken, 457-8510, Japan
Jiangyin Hospital of Traditional Chinese Medicine

Jiangyin, Jiangsu, 214400, China
Jubilee Clinical Research Inc

Las Vegas, Nevada, 89106, United States
Kaderma Majtan, sro

Topoľčany, 955 01, Slovakia
Kaiser Permanente - Glendale Medical Center

Glendale, California, 91203, United States
Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States
Kaji Dermatology Clinic

Nonoichi-shi, Ishikawa-ken, 921-8801, Japan
Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan
Kirsch Dermatology LLC

Naples, Florida, 34102, United States
Korea University Ansan Hospital

Ansansi, Gyeonggido, 15355, South Korea
Korea University Guro Hospital

Seoul, 08308, South Korea
Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz

Ústí nad Labem, 401 13, Czechia
LEADER Research

Hamilton, Ontario, L8L 3C3, Canada
Linkou Chang Gung Memorial Hospital

Taoyuan, 33305, Taiwan
Long Beach Research Institute

Long Beach, California, 90805, United States
Mackay Memorial Hospital Taipei Branch

Taipei, 10449, Taiwan
Matsuo Clinic

Fukuoka, Fukuoka, 819-0373, Japan
Medmare Bt

Veszprém, 8200, Hungary
Mochida Dermatology Clinic

Izumiotsu-shi, Osaka, 595-0025, Japan
Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan
Nanyang First Peoples Hospital

Nanyang, Henan, 473002, China
National Cheng Kung University Hospital

Tainan, 70403, Taiwan
National Medical Center

Seoul, 04564, South Korea
National Taiwan University Hospital

Taipei, 10002, Taiwan
Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, 173-8610, Japan
Nippon Medical School Musashikosugi Hospital

Kawasaki-shi, Kanagawa, 211-8533, Japan
Oak Ridges Aesthetics Centre

Richmond Hill, Ontario, L4E 4L6, Canada
Onsite Clinical Solutions

Charlotte, North Carolina, 28277, United States
Onyx Clinical Research

Flint, Michigan, 48532, United States
Optima Research

Boardman, Ohio, 44512, United States
Oregon Health and Science University

Portland, Oregon, 97239, United States
Outpatient clinic Veselibas Centrs 4

Riga, 1003, Latvia
Outpatient clinic Veselibascentrs 4

Riga, LV-1013, Latvia
Palm Beach Dermatology Group

Delray Beach, Florida, 33484, United States
Papageorgiou General Hospital

Thessaloniki, 56403, Greece
Peking University Peoples Hospital

Beijing, 100044, China
Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China
Pratia Pardubice as

Pardubice, 530 02, Czechia
Pratia Prague sro

Prague, 130 00, Czechia
PreCare Trial and Recruitment

Born, 6121 XK, Netherlands
Pure Skin Dermatology and Aesthetics

Orlando, Florida, 32819, United States
Rakuwakai Otowa Hospital

Kyoto, Kyoto, 607-8062, Japan
Recherche Clinique Sigma Incorporated

Québec, Quebec, G1G 3Y8, Canada
Rosenpark Research GmbH

Darmstadt, 64283, Germany
Royalderm Agnieszka Nawrocka

Warsaw, 02-962, Poland
Sadick Research Group

New York, New York, 10075, United States
Sanare spol sro

Svidník, 089 01, Slovakia
Sanmenxia Central Hospital

Sanmenxia, Henan, 472099, China
Savin Medical Group LLC

Miami Lakes, Florida, 33014, United States
Seoul National University Hospital

Seoul, 03080, South Korea
Sestre milosrdnice University Hospital Center

Zagreb, 10000, Croatia
Shanghai Skin Disease Hospital

Shanghai, 200443, China
SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, Canada
Skin Care Research Incorporated

Boca Raton, Florida, 33486, United States
Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada
Smite Aija practice in dermatology and venerology

Talsi, 3201, Latvia
Special Hospital for Medical Rehabilitation Naftalan

Ivanić-Grad, 10310, Croatia
Sun Yat-sen Memorial Hospital Sun Yat-sen University

Guangzhou, Guangdong, 510120, China
Taipei Veterans General Hospital

Taipei, 11217, Taiwan
Taizhou Central Hospital

Taizhou, Zhejiang, 318000, China
Takeoka Dermatology Clinic

Marugame-shi, Kagawa-ken, 763-0074, Japan
Teikyo University Hospital

Itabashi-ku, Tokyo, 173-8606, Japan
The Catholic University of Korea Incheon St Marys Hospital

Incheon, 21431, South Korea
The First Affiliated Hospital ,Sun-Yat Sen University

Guangzhou, Guangdong, 510080, China
The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China
The First Hospital Of Hebei Medical University

Shijiazhuang, Hebei, 050000, China
The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China
The First Hospital of Jilin University

Changchun, Jilin, 130021, China
The Indiana Clinical Trials Center PC

Plainfield, Indiana, 46168, United States
The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China
The Skin Surgery Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States
The Woodlands Dermatology Associates

The Woodlands, Texas, 77380, United States
Thoracic General Hospital Of Athens Sotiria

Athens, 11527, Greece
Tokyo Medical University Ibaraki Medical Center

Inashiki-gun, Ibaraki, 300-0395, Japan
Treasure Valley Medical Research

Boise, Idaho, 83706, United States
Twoja Przychodnia Scm

Szczecin, 71-500, Poland
Twoja przychodnia Ncm

Nowa Sól, 67-100, Poland
Twoja przychodnia Pcm

Poznan, 61-293, Poland
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

Matosinhos Municipality, 4464-513, Portugal
Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio

Porto, 4099-001, Portugal
Union Hospital Tongji Medical College Huazhong University of science and Technology

Wuhan, Hubei, 430022, China
Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States
Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

Chieti, 66100, Italy
Universitaetsklinikum Dresden

Dresden, 01307, Germany
Universitaetsklinikum Essen

Essen, 45174, Germany
Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany
Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany
University General Hospital Attikon

Athens, 12462, Greece
University General Hospital of Ioannina

Ioannina, 45500, Greece
University Hospital Centre Zagreb

Zagreb, 10000, Croatia
University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan
Upeclin-Pesq Clin FacMed Botucatu

Botucatu, São Paulo, 18618-686, Brazil
Vida Clinical Research

Edmonton, Alberta, T6H 4J8, Canada
West Virginia Research Institute

Morgantown, West Virginia, 26505, United States
Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States
Wuxi Peoples Hospital

Wuxi, Jiangsu, 241023, China
Zhejiang Provincial Peoples Hospital

Hangzhou, Zhejiang, 310004, China
the First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

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