A Study Evaluating Rocatinlimab in Moderate-to-severe Atopic Dermatitis (ROCKET-IGNITE)

NCT05398445 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: 202101422022-501540-15-00
• Study Type: interventional
• Target: 769
• Locations: 21 countries
• Sites: 202

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy treatment.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis; AMG 451; KHK4083; Rocatinlimab

Outcome Measures

Primary Outcomes (2)

• Achievement of a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 or 1 with ≥2 point reduction from baseline at Week 24

  Baseline, Week 24

• Achievement of ≥75% reduction from baseline in Eczema Area and Severity Index (EASI) score at Week 24

  Baseline, Week 24

Secondary Outcomes (28)

• Achievement of ≥75% reduction from baseline in EASI score at Week 16

  Baseline, Week 16

• Achievement of a vIGA-AD score of 0 or 1 from baseline at Week 16

  Baseline, Week 16

• Achievement of a ≥ 4-point reduction from baseline in weekly average of daily worst pruritus numerical rating scale (NRS) score at Week 16 in subjects 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 subjects with baseline weekly average of daily worst pruritus NRS score ≥ 4

  Baseline, Week 24

• Achievement of ≥90% reduction from baseline in EASI score at Week 24

  Baseline, Week 24

Study Arms (3)

Arm A

EXPERIMENTAL

Rocatinlimab Dose 1 every 4 weeks (Q4W) + loading dose at Week 2

Drug: Rocatinlimab

Arm B

EXPERIMENTAL

Rocatinlimab Dose 2 Q4W + loading dose at Week 2

Drug: Rocatinlimab

Arm C

PLACEBO COMPARATOR

Placebo Q4W+ loading dose at Week 2

Drug: Placebo

Interventions

Rocatinlimab DRUG

Participants will receive Rocatinlimab subcutaneously.

Also known as: AMG 451

Arm A; Arm B

Placebo DRUG

Participants will receive a placebo subcutaneously.

Arm C

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (202)

Cahaba Dermatology and Skin Health Center

Birmingham, Alabama, 35244, United States

Location

Alliance Dermatology and Mohs Center

Phoenix, Arizona, 85032, United States

Location

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

First OC Dermatology

Fountain Valley, California, 92708, United States

Location

Kaiser Permanente - Glendale Medical Center

Glendale, California, 91203, United States

Location

Long Beach Research Institute

Long Beach, California, 90805, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Cura Clinical Research

Sherman Oaks, California, 91403, United States

Location

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

Location

Skin Care Research Incorporated

Boca Raton, Florida, 33486, United States

Location

Palm Beach Dermatology Group

Delray Beach, Florida, 33484, United States

Location

Global Research Associates

Homestead, Florida, 33030, United States

Location

Healthy Life Research

Miami, Florida, 33175, United States

Location

Savin Medical Group LLC

Miami Lakes, Florida, 33014, United States

Location

Kirsch Dermatology LLC

Naples, Florida, 34102, United States

Location

Pure Skin Dermatology and Aesthetics

Orlando, Florida, 32819, United States

Location

Industrial Medicine Associates Ima Clinical Research Inc

St. Petersburg, Florida, 33709, United States

Location

Genesis Clinical Research LLC

Tampa, Florida, 33606, United States

Location

Treasure Valley Medical Research

Boise, Idaho, 83706, United States

Location

DeNova Research

Chicago, Illinois, 60611, United States

Location

Dundee Dermatology

West Dundee, Illinois, 60118, United States

Location

The Indiana Clinical Trials Center PC

Plainfield, Indiana, 46168, United States

Location

Institute for Asthma and Allergy

Chevy Chase, Maryland, 20815, United States

Location

Continental Clinical Solutions, LLC

Towson, Maryland, 21204, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Onyx Clinical Research

Flint, Michigan, 48532, United States

Location

Dermatology and Skin Cancer Center of Lees Summit

Lee's Summit, Missouri, 64064, United States

Location

Jubilee Clinical Research Inc

Las Vegas, Nevada, 89106, United States

Location

Allcutis Research, Llc - Portsmouth

Portsmouth, New Hampshire, 03801, United States

Location

Continental Clinical Solutions - Cherry Hill

Cherry Hill, New Jersey, 08034, United States

Location

Industrial Medicine Associates Ima Clinical Research Inc

Hartsdale, New York, 10530, United States

Location

Sadick Research Group

New York, New York, 10075, United States

Location

Dermatology Specialists of Charlotte

Charlotte, North Carolina, 28277, United States

Location

Onsite Clinical Solutions

Charlotte, North Carolina, 28277, United States

Location

Wilmington Dermatology Center

Wilmington, North Carolina, 28405, United States

Location

The Skin Surgery Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Optima Research

Boardman, Ohio, 44512, United States

Location

ClinOhio Research Services

Columbus, Ohio, 43213, United States

Location

Unity Clinical Research

Oklahoma City, Oklahoma, 73118, United States

Location

Dermatology Research Center of Oklahoma, PLLC

Tulsa, Oklahoma, 74132, United States

Location

Essential Medical Research LLC

Tulsa, Oklahoma, 74137, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

DermDox Dermatology, LLC

Sugarloaf, Pennsylvania, 18249, United States

Location

Cumberland Skin Center

Hermitage, Tennessee, 37076, United States

Location

Dermatology Treatment and Research Center PA

Dallas, Texas, 75230, United States

Location

The Woodlands Dermatology Associates

The Woodlands, Texas, 77380, United States

Location

Education and Research Foundation Inc

Lynchburg, Virginia, 24501, United States

Location

Frontier Derm Partners

Mill Creek, Washington, 98012, United States

Location

West Virginia Research Institute

Morgantown, West Virginia, 26505, United States

Location

Cinme - Centro de Investigaciones Metabolicas

CABA, Buenos Aires, C1027AAP, Argentina

Location

Fundacion Respirar

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina

Location

Hospital Universitario Austral

Derqui, Pilar, Buenos Aires, B1629ODT, Argentina

Location

Centro Dermatológico Schejtman

San Miguel, Buenos Aires, 1663, Argentina

Location

InAER - Investigaciones en Alergia y Enfermedades Respiratorias

Buenos Aires, Distrito Federal, 1425, Argentina

Location

Instituto de Neumonologia y Dermatologia

Buenos Aires, Distrito Federal, 1425, Argentina

Location

Conexa Investigacion Clinica SA

CABA, Distrito Federal, C1012AAY, Argentina

Location

Fundacion Estudios Clinicos

Rosario, Santa Fe Province, 2000, Argentina

Location

Instituto de Diagnostico Abc American British Cowdray

Rosario, Santa Fe Province, 2000, Argentina

Location

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

Location

Upeclin-Pesq Clin FacMed Botucatu

Botucatu, São Paulo, 18618-686, Brazil

Location

Hosp e Maternidade Dr Christovao da Gama

Santo André, São Paulo, 09030-010, Brazil

Location

Fundacao Abc - Centro Univ Fmabc

Santo André, São Paulo, 09060-870, Brazil

Location

Consultoria Medica e Pesquisa Clinica Cmpc

Sorocaba, São Paulo, 18040-425, Brazil

Location

IBPClin Instituto Brasil de Pesquisa Clinica

Rio de Janeiro, 20241-180, Brazil

Location

Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia

São Paulo, 06454-010, Brazil

Location

Alberta Derma Surgery Centre

Edmonton, Alberta, T6G 1C3, Canada

Location

Vida Clinical Research

Edmonton, Alberta, T6H 4J8, Canada

Location

CCA Medical Research Corporation

Ajax, Ontario, L1S 7K8, Canada

Location

SimcoDerm Medical and Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1, Canada

Location

LEADER Research

Hamilton, Ontario, L8L 3C3, Canada

Location

DermEdge Research Incorporated

Mississauga, Ontario, L4Y 4C5, Canada

Location

Canadian Dermatology Centre

North York, Ontario, M3B 0A7, Canada

Location

Gordon Sussman Clinical Research Incorporated

North York, Ontario, M3B 3S6, Canada

Location

Oak Ridges Aesthetics Centre

Richmond Hill, Ontario, L4E 4L6, Canada

Location

Innovaderm Research Inc

Montreal, Quebec, H2X 2V1, Canada

Location

Recherche Clinique Sigma Incorporated

Québec, Quebec, G1G 3Y8, Canada

Location

Skinsense Medical Research

Saskatoon, Saskatchewan, S7K 2C1, Canada

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China

Location

The First Affiliated Hospital ,Sun-Yat Sen University

Guangzhou, Guangdong, 510080, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, Guangdong, 510091, China

Location

Sun Yat-sen Memorial Hospital Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

The First Hospital Of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

Nanyang First Peoples Hospital

Nanyang, Henan, 473002, China

Location

Sanmenxia Central Hospital

Sanmenxia, Henan, 472099, China

Location

Union Hospital Tongji Medical College Huazhong University of science and Technology

Wuhan, Hubei, 430022, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Jiangyin Hospital of Traditional Chinese Medicine

Jiangyin, Jiangsu, 214400, China

Location

Wuxi Peoples Hospital

Wuxi, Jiangsu, 241023, China

Location

Dermatology Hospital of Jiangxi Province

Nanchang, Jiangxi, 330000, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Chengdu Second Peoples Hospital

Chengdu, Sichuan, 610021, China

Location

the First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Provincial Peoples Hospital

Hangzhou, Zhejiang, 310004, China

Location

Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310020, China

Location

Taizhou Central Hospital

Taizhou, Zhejiang, 318000, China

Location

Peking University Peoples Hospital

Beijing, 100044, China

Location

Shanghai Skin Disease Hospital

Shanghai, 200443, China

Location

Special Hospital for Medical Rehabilitation Naftalan

Ivanić-Grad, 10310, Croatia

Location

Sestre milosrdnice University Hospital Center

Zagreb, 10000, Croatia

Location

University Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Dermamedica, sro

Náchod, 547 01, Czechia

Location

CCR Ostrava sro

Ostrava, 702 00, Czechia

Location

Pratia Pardubice as

Pardubice, 530 02, Czechia

Location

Clintrial sro

Prague, 100 00, Czechia

Location

Pratia Prague sro

Prague, 130 00, Czechia

Location

Fakultni nemocnice Bulovka

Prague, 180 81, Czechia

Location

Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz

Ústí nad Labem, 401 13, Czechia

Location

Charite - Universitaetsmedizin Berlin, Campus Mitte

Berlin, 10117, Germany

Location

Dermatologische Gemeinschaftspraxis-Mahlow

Blankenfelde-Mahlow, 15831, Germany

Location

Hautarztpraxis Dr Niesmann und Dr Othlinghaus

Bochum, 44793, Germany

Location

Rosenpark Research GmbH

Darmstadt, 64283, Germany

Location

Universitaetsklinikum Dresden

Dresden, 01307, Germany

Location

Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

Universitaetsklinikum Essen

Essen, 45174, Germany

Location

Institute for Health Services Research in Dermatology and Nursing

Hamburg, 20246, Germany

Location

Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Hautarztpraxis Dres Leitz und Kollegen

Stuttgart, 70178, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, 72076, Germany

Location

CentroDerm GmbH

Wuppertal, 42287, Germany

Location

Athens Naval Hospital

Athens, 11521, Greece

Location

Thoracic General Hospital Of Athens Sotiria

Athens, 11527, Greece

Location

University General Hospital Attikon

Athens, 12462, Greece

Location

Andreas Syngros Hospital Of Venereal And Dermatological Diseases

Athens, 16121, Greece

Location

University General Hospital of Ioannina

Ioannina, 45500, Greece

Location

General University Hospital of Larissa

Larissa, 41110, Greece

Location

Papageorgiou General Hospital

Thessaloniki, 56403, Greece

Location

Medmare Bt

Veszprém, 8200, Hungary

Location

Universita degli Studi Gabriele D Annunzio di Chieti e Pescara

Chieti, 66100, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

Perugia, 06156, Italy

Location

Azienda Ospedaliera Policlinico Umberto I

Roma, 00161, Italy

Location

Azienda Ospedaliera Citta della Salute e della Scienza di Torino

Torino, 10126, Italy

Location

Aichi Medical University Hospital

Nagakute-shi, Aichi-ken, 480-1195, Japan

Location

Japan Community Healthcare Organization Chukyo Hospital

Nagoya, Aichi-ken, 457-8510, Japan

Location

Central Clinic

Nagoya, Aichi-ken, 464-0821, Japan

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Fukuoka University Hospital

Fukuoka, Fukuoka, 814-0180, Japan

Location

Matsuo Clinic

Fukuoka, Fukuoka, 819-0373, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Asahikawa City Hospital

Asahikawa-shi, Hokkaido, 070-8610, Japan

Location

Tokyo Medical University Ibaraki Medical Center

Inashiki-gun, Ibaraki, 300-0395, Japan

Location

Kaji Dermatology Clinic

Nonoichi-shi, Ishikawa-ken, 921-8801, Japan

Location

Iwate Medical University Uchimaru Medical Center

Morioka, Iwate, 020-8505, Japan

Location

Takeoka Dermatology Clinic

Marugame-shi, Kagawa-ken, 763-0074, Japan

Location

Nippon Medical School Musashikosugi Hospital

Kawasaki-shi, Kanagawa, 211-8533, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Kyoto, 602-8566, Japan

Location

Rakuwakai Otowa Hospital

Kyoto, Kyoto, 607-8062, Japan

Location

Mochida Dermatology Clinic

Izumiotsu-shi, Osaka, 595-0025, Japan

Location

Dokkyo Medical University Hospital

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

Teikyo University Hospital

Itabashi-ku, Tokyo, 173-8606, Japan

Location

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Outpatient clinic Veselibas Centrs 4

Riga, 1003, Latvia

Location

Outpatient clinic Veselibascentrs 4

Riga, LV-1013, Latvia

Location

Smite Aija practice in dermatology and venerology

Talsi, 3201, Latvia

Location

PreCare Trial and Recruitment

Born, 6121 XK, Netherlands

Location

AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy

Gdansk, 80-280, Poland

Location

Centrum Medyczne Angelius Provita

Katowice, 40-611, Poland

Location

Centrum Zdrowia i Urody Maxxmed

Lublin, 20-080, Poland

Location

Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo

Malbork, 82-200, Poland

Location

Twoja przychodnia Ncm

Nowa Sól, 67-100, Poland

Location

Twoja przychodnia Pcm

Poznan, 61-293, Poland

Location

Twoja Przychodnia Scm

Szczecin, 71-500, Poland

Location

Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo

Tarnów, 33-100, Poland

Location

Royalderm Agnieszka Nawrocka

Warsaw, 02-962, Poland

Location

Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych

Wroclaw, 50-450, Poland

Location

Hospital Lusiadas Lisboa

Lisbon, 1500-458, Portugal

Location

Hospital Cuf Descobertas

Lisbon, 1998-018, Portugal

Location

Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano

Matosinhos Municipality, 4464-513, Portugal

Location

Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio

Porto, 4099-001, Portugal

Location

Clinical Research of Puerto Rico

San Juan, 00909, Puerto Rico

Location

Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica

Banská Bystrica, 975 17, Slovakia

Location

Derma therapy, spol s ro

Bratislava, 851 01, Slovakia

Location

Sanare spol sro

Svidník, 089 01, Slovakia

Location

Kaderma Majtan, sro

Topoľčany, 955 01, Slovakia

Location

Fakultna nemocnica Trnava

Trnava, 917 75, Slovakia

Location

Korea University Ansan Hospital

Ansansi, Gyeonggido, 15355, South Korea

Location

The Catholic University of Korea Incheon St Marys Hospital

Incheon, 21431, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

National Medical Center

Seoul, 04564, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Korea University Guro Hospital

Seoul, 08308, South Korea

Location

Hospital Universitario Reina Sofia

Córdoba, Andalusia, 14004, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Aragon, 50009, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrin

Las Palmas de Gran Canaria, Canary Islands, 35010, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Catalonia, 08916, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Hospital Clinico Universitario de Santiago

Pontevedra, Galicia, 36001, Spain

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Mackay Memorial Hospital Taipei Branch

Taipei, 10449, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 40012373 BACKGROUND

• Guttman-Yassky E, Kabashima K, Worm M, Luna PC, Hong HC, Chovatiya R, Bernstein JA, Kern JS, Ehst BD, Magnolo N, Herranz-Pinto P, Stein Gold L, Sofen H, Pink AE, Esfandiari E, Arai T, Yang Y, Shi R, Barragan C, Kricorian G, Schwartz-Sagi L, Bissonnette R. Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials. Lancet. 2026 Jan 3;407(10523):53-66. doi: 10.1016/S0140-6736(25)01865-3. Epub 2025 Nov 25.

  PMID: 41314226 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2022
• First Posted: June 1, 2022
• Study Start: May 31, 2022
• Primary Completion: November 28, 2024
• Study Completion: January 13, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

CA (12); CN (23); CZ (7); ES (10); PT (4); DE (12); LA (3); JP (19); PR (1); KR (6); SL (5); TW (6); NL (1); PL (10); IT (5); US (50); BR (8); CR (3); HU (1); GR (7); AR (9)