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

PHASE3CompletedINTERVENTIONAL
Enrollment

746

Participants

Timeline

Start Date

February 21, 2023

Primary Completion Date

September 15, 2024

Study Completion Date

December 4, 2024

Conditions
Atopic Dermatitis
Interventions
DRUG

Rocatinlimab

Subcutaneous (SC) injection

OTHER

Placebo

SC injection

Trial Locations (234)

1000

Univerzitetni klinicni center Ljubljana, Ljubljana

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

1020

Centre Hospitalier Universitaire Brugmann, Brussels

1027

Csalogany Orvosi Kozpont, Budapest

1030

Klinik Landstrasse, Vienna

1033

Clinexpert Kft, Budapest

1036

Obudai Egeszsegugyi Centrum Kft, Budapest

1054

Buenos Aires Skin SA, Buenos Aires

1090

Universitair Ziekenhuis Brussel, Brussels

1121

Fundacion Cidea, Buenos Aires

1130

Klinik Hietzing, Vienna

1200

Universite Catholique de Louvain Cliniques Universitaires Saint Luc, Brussels

1211

Hopitaux Universitaires de Geneve, Geneva

1407

Medical Center Excelsior OOD, Sofia

1414

Care- Centro de Alergia y Enfermedades Respiratorias, Buenos Aires

1425

Psoriahue Medicina Interdisciplinaria SRL, Buenos Aires

1431

Diagnostic-Consultative Center Alexandrovska EOOD, Sofia

1463

Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD, Sofia

1704

Dim Clinica Privada, Ramos Mejía

2000

Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario, Rosario

Univerzitetni Klinicni Center Maribor, Maribor

2019

Emeritus Research Sydney, Botany

2145

Westmead Hospital, Westmead

2600

Medical Center Asklepii OOD, Dupnitsa

3000

Universitaire Ziekenhuizen Leuven Gasthuisberg, Leuven

3010

Inselspital Bern, Bern

3124

Emeritus Research Melbourne, Camberwell

3200

Gyongyosi Bugat Pal Korhaz, Gyöngyös

4000

Centre Hospitalier Universitaire de Liege - Sart Tilman, Liège

4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

4040

Clinique Andre Renard, Herstal

4101

Princess Alexandra Hospital, South Brisbane

4102

Veracity Clinical Research, Woolloongabba

4217

The Skin Centre, Benowa

5000

Allergo-Derm Bakos Kft, Szolnok

5020

Landeskrankenhaus Salzburg, Salzburg

5600

Trial Pharma Kft, Békéscsaba

5800

Medical Center Medconsult Pleven OOD, Pleven

5900

DermaMed Research Kft, Orosháza

6020

Medizinische Universitaet Innsbruck, Innsbruck

6280

Grand Hopital de Charleroi, Loverval

7400

Somogy Varmegyei Kaposi Mor Oktato Korhaz, Kaposvár

8000

Algemeen Ziekenhuis Sint-Jan Brugge-Oostende, Bruges

8036

Medizinische Universitaet Graz, Graz

8091

Universitaetsspital Zuerich, Zurich

8500

Dermatologie Handelskaai, Kortrijk

8900

Obudai Egeszsegugyi Centrum Kft, Zalaegerszeg

9000

Universitair Ziekenhuis Gent, Ghent

9007

Kantonsspital Sankt Gallen, Sankt Gallen

10455

Chear Center LLC, The Bronx

10990

Hospital Pulau Pinang, George Town

11525

401 General Military Hospital Of Athens, Athens

13385

Hôpital La Timone, Marseille

13500

Cabinet du Docteur Ruer-Mulard Mireille, Martigues

14233

General Hospital Of Nea Ionia Konstantopouleio Patision, Nea Ionia

15213

University of Pittsburgh Medical Center, Pittsburgh

16121

Andreas Syngros Hospital Of Venereal And Dermatological Diseases, Athens

16132

Ospedale Policlinico San Martino IRCCS, Genova

18536

Geniko Nosokomeio Peiraia Tzaneio, Piraeus

19103

Paddington Testing Company Inc, Philadelphia

20089

IRCCS Istituto Clinico Humanitas, Rozzano MI

20537

TFS Trial Form Support GmbH, Hamburg

20850

Aesthetic and Dermatology Center, Rockville

22391

MensingDerma research GmbH, Hamburg

23502

Virginia Dermatology and Skin Cancer Center, Norfolk

28041

Hospital Universitario 12 de Octubre, Madrid

28401

Accellacare of Wilmington, Wilmington

29200

Centre Hospitalier Regional Universitaire Brest Hopital Morvan, Brest

30022

Atlanta Dermatology, Vein and Research Center, PC, Alpharetta

30159

Hautaerzte Zentrum Hannover, Hanover

30315

Divine Dermatology and Aesthetics, Atlanta

30450

Hospital Raja Permaisuri Bainun, Ipoh

30625

Medizinische Hochschule Hannover, Hanover

33609

TrueBlue Clinical Research, Tampa

33615

Olympian Clinical Research - Tampa, Tampa

34390

Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi, Istanbul

34662

Acibadem Altunizade Hastanesi, Istanbul

34899

Marmara Universitesi Tip Fakultesi Hastanesi, Istanbul

35033

Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou, Rennes

35233

The University of Alabama at Birmingham, Birmingham

36001

Complexo Hospitalario Universitario de Pontevedra, Pontevedra

37075

Universitaetsmedizin Goettingen - Georg-August-Universitaet, Göttingen

42270

Centre Hospitalier Universitaire Saint Etienne Hopital Nord, Saint-Priest-en-Jarez

43209

Bexley Dermatology Research, Bexley

44093

Centre Hospitalier Universitaire de Nantes Hôtel Dieu, Nantes

46014

Hospital General Universitario de Valencia, Valencia

46250

Dawes Fretzin Clinical Research Group, LLC, Indianapolis

47129

DS Research, Clarksville

48013

Hospital Universitario Basurto, Bilbao

48109

University of Michigan Medical Center, Ann Arbor

48326

Oakland Hills Dermatology, Auburn Hills

50586

Hospital Kuala Lumpur, Kuala Lumpur

51100

Polyclinique de Courlancy, Reims

54642

Ippokratio General Hospital of Thessaloniki, Thessaloniki

55101

Universitaetsmedizin Mainz, Mainz

55200

Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi, Samsun

56000

Pusat Perubatan Universiti Kebangsaan Malaysia, Kuala Lumpur

56322

Centre Hospitalier de Bretagne Sud - Hopital du Scorff, Lorient

57702

Health Concepts, Rapid City

59037

Centre Hospitalier Régional Universitaire de Lille - Hôpital Claude Huriez, Lille

59100

University Malaya Medical Centre, Kuala Lumpur

60077

NorthShore University HealthSystem, Skokie

60590

Universitaetsklinikum Frankfurt, Frankfurt am Main

66211

Dermatology and Skin Cancer Center Leawood, Leawood

66663

Hautmedizin Saar, Merzing

67100

Ospedale San Salvatore, LAquila

68144

Skin Specialists PC, Omaha

68505

Somnos Clinical Research, Lincoln

71201

Industrial Medicine Associates Clinical Research Advanced Dermatology Care, Monroe

71500

University General Hospital of Heraklion, Heraklion

72117

Arkansas Research Trials, LLC, North Little Rock

75018

Hopital Bichat Claude Bernard, Paris

75020

Hopital Tenon, Paris

75025

Texas Dermatology Research Center, Plano

75475

Hopital Saint Louis, Paris

76031

Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle, Rouen

78028

Sante Clinical Research, Kerrville

78759

US Dermatology Partners Jollyville, Austin

79925

Newco 3A Research LLC, El Paso

80802

Klinikum rechts der Isar der TUM, München

81100

Hospital Sultan Ismail, Johor Bahru

83800

Hopital d instruction des armees sainte anne, Toulon

85006

Medical Dermatology Specialists, Phoenix

85018

Southwest Skin Specialists, Phoenix

85375

US Dermatology Partners Sun City West, Sun City West

87102

Albuquerque Clinical Trials Incorporated, Albuquerque

87700

Beldio Research GmbH, Memmingen

88586

Queen Elizabeth Hospital, Kota Kinabalu

89030

Las Vegas Clinical Trials, North Las Vegas

89119

Vivida Dermatology, Las Vegas

90033

Keck Medicine of University of Southern California, Los Angeles

90056

Wallace Medical Group Inc, Los Angeles

92120

Acclaim Clinical Research, San Diego

92160

Hopital Prive d Antony, Antony

93301

Kern Research Inc, Bakersfield

93551

Antelope Valley Clinical Trials, Palmdale

94118

Kaiser Permanente Medical Center - Oakland, San Francisco

Kaiser Permanente Medical Center - San Francisco, San Francisco

94132

Synergy Dermatology, San Francisco

95816

University of California at Davis Medical Center, Sacramento

95823

Kaiser Permanente South Sacramento Medical Center, Sacramento

97504

Velocity Clinical Research Inc, Medford

100044

Peking University Peoples Hospital, Beijing

100050

Beijing Friendship Hospital, Capital Medical University, Beijing

100191

Peking University Third Hospital, Beijing

117599

National University Hospital, Singapore

130021

The First Hospital of Jilin University, Changchun

168753

Singapore General Hospital, Singapore

200443

Shanghai Skin Disease Hospital, Shanghai

214001

Wuxi Second Peoples Hospital, Wuxi

308205

National Skin Centre, Singapore

310003

the First Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

310016

Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, Hangzhou

310020

Affiliated Hangzhou First Peoples Hospital,Zhejiang University School of Medicine, Hangzhou

315010

The First Affiliation Hospital Of Ningbo University, Ningbo

318000

Taizhou Central Hospital, Taizhou

330000

Dermatology Hospital of Jiangxi Province, Nanchang

350000

The First Affiliated Hospital of Fujian Medical University, Fuzhou

400431

Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor, Cluj-Napoca

430022

Union Hospital Tongji Medical College Huazhong University of science and Technology, Wuhan

473002

Nanyang First Peoples Hospital, Nanyang

500112

Theramed Healthcare SRL, Brasov

510080

The First Affiliated Hospital ,Sun-Yat Sen University, Guangzhou

510091

Dermatology Hospital of Southern Medical University, Guangzhou

510120

Sun Yat-sen Memorial Hospital Sun Yat-sen University, Guangzhou

515041

The Fist Affiliated Hospital of Shantou University Medical College, Shantou

518101

Shenzhen Qianhai Shekou Free Trade Zone Hospital, Shenzhen

540613

Spitalul Clinic Judetean Mures, Târgu Mureş

610017

Chengdu Second Peoples Hospital, Chengdu

07601

Schweiger Dermatology Group, PC Research Division, Hackensack

C1027AAP

Cinme - Centro de Investigaciones Metabolicas, CABA

B1902COS

Framingham Centro Medico, La Plata

T2J 7E1

Dermatology Research Institute Incorporated, Calgary

T5J 3S9

Laser Rejuvenation Clinics Edmonton D T Incorporated, Edmonton

T6G 1C3

Alberta Derma Surgery Centre, Edmonton

V3V 0C6

Enverus Medical Research, Surrey

R3M 3Z4

Wiseman Dermatology Research Incorporated, Winnipeg

K9A 4J9

SKiN Health, Coburg

N6A 2C2

Centricity Research London, London

L3Y 5G8

Dr SK Siddha Medicine Professional Corporation, Newmarket

L2H 1H5

Allergy Research Canada Incorporated, Niagara Falls

P1B 3Z7

North Bay Dermatology Centre, North Bay

K2C 3N2

Dermatology Ottawa Research Centre, Ottawa

JRB Research Incorporated, Ottawa

L4B 1A5

The Centre for Dermatology, Richmond Hill

M2N 3A6

North York Research Incorporated, Toronto

M3H 5Y8

Toronto Research Centre Inc, Toronto

N2J 1C4

Alliance Clinical Trials, Waterloo

H1Y 3L1

Clinique de Dermatologie Rosemont, Montreal

H2X 2V1

Innovaderm Research Inc, Montreal

G1V 4T3

DIEX Recherche Quebec, Québec

G1W 4R4

Centre de Recherche Saint-Louis, Québec

S7T 0G3

Saskatoon Dermatology Centre, Saskatoon

Cedex

Centre Hospitalier Universitaire de Bordeaux - Hôpital Saint André, Bordeaux

06202

Centre Hospitalier Universitaire Archet 2, Nice

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma

454-0803

Fukui Dermatology Clinic, Nagoya

812-0013

Ekihigashi Dermatology Allergy Clinic, Fukuoka

080-0013

Takagi Dermatological Clinic Branch, Obihiro-shi

060-0063

Medical Corporation Kojinkai Sapporo Skin Clinic, Sapporo

890-0063

Katahira Dermatology Urology Clinic, Kagoshima

211-0063

Kosugi Dermatology Clinic, Kawasaki-shi

221-0825

Nomura Dermatology Clinic, Yokohama

860-0066

Jouzan Hihuka Hinyoukika Clinic, Kumamoto

862-0950

Suizenji Dermatology Clinic, Kumamoto

572-0838

Yoshioka Dermatology Clinic, Neyagawa

430-0929

JA Shizuoka Kohseiren Enshu Hospital, Hamamatsu

120-0034

Mildix Skin Clinic, Adachi-ku

158-0097

Naoko Dermatology Clinic, Setagaya-ku

141-8625

NTT Medical Center Tokyo, Shinagawa-ku

169-0075

Yamate Dermatology Clinic, Shinjuku-ku

4624 VT

Bravis Ziekenhuis, Bergen op Zoom

9700 RB

Universitair Medisch Centrum Groningen, Groningen

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

41-500

Dermapolis Medical Dermatology Center dr n med Edyta Gebska, Chorzów

40-600

GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero, Katowice

30-002

Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna, Krakow

90-349

AppleTreeClinics Network Spzoo, Lodz

90-752

Ip Clinic Sp zoo, Lodz

71-500

Twoja Przychodnia Scm, Szczecin

51-503

DermMedica Spzoo Centrum Columbus, Wroclaw

00727-9507

Doctor Samuel Sanchez PSC, Caguas

085 01

Maxderm, sro, Bardejov

813 69

Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto, Bratislava

081 81

Fakultna nemocnica s poliklinikou JA Reimana Presov, Prešov

089 01

Sanare spol sro, Svidník

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

06800

Ankara Bilkent Sehir Hastanesi, Ankara

BA1 3NG

Royal United Hospitals Bath NHS Foundation Trust, Bath

DY1 2HQ

Russells Hall Hospital, Dudley

TW7 6AF

West Middlesex University Hospital, Isleworth

NW3 2PF

The Royal Free Hospital, London

M6 8HD

Salford Care Organisation, Salford

BD18 3SA

Accellacare Yorkshire, Shipley

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT05724199 - A Study Assessing Rocatinlimab in Combination With Topical Corticosteroid and/or Topical Calcineurin Inhibitors in Adult Participants With Moderate-to-severe Atopic Dermatitis (AD) | Biotech Hunter | Biotech Hunter