AzTrials
AzTrials

Atopic DermatitisPhase 3ROCKET-ASTRONCT05704738

A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)

A Phase 3 study testing Rocatinlimab in people with Atopic Dermatitis, run by Amgen at 246 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of rocatinlimab in monotherapy and combination therapy treatment in adolescent participants. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Rocatinlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
532 participants
Where
246 sitesin 22 countries
Study dates
20 Apr 2023to 25 Nov 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age ≥ 12 to < 18 years at Day 1.
  • Diagnosis of AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield et al, 2014]) that has been present for at least 12 months before signing of informed consent.
  • Body weight ≥ 40 kg at screening.
  • History of inadequate response to TCS of medium to higher potency (with or without TCI).
  • EASI score ≥ 12 at initial screening.
  • EASI score ≥ 16 at Day 1.
Show all 9Show fewer
  • vIGA-AD score ≥ 3.
  • ≥10% body surface area of AD involvement.
  • Worst pruritus NRS ≥ 4.

Who cannot join

  • 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
  • Non-biologic, non-targeted systemic immunosuppressants
  • Phototherapy
  • Oral or Topical Janus kinase inhibitors
Show all 11Show fewer
  • Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
  • TCS of any potency
  • TCI
  • Topical phosphodiesterase 4 inhibitors
  • Other topical immunosuppressive agents

Trial locations and contacts

246 sites in 22 countries.

246 sites in 22 countries

United States98 sites
  • University of New Mexico

    Albuquerque, New Mexico, 87102

  • Oakland Hills Dermatology

    Auburn Hills, Michigan, 48326

  • The University of Texas Health Science Center at Houston

    Bellaire, Texas, 77401

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Cahaba Dermatology and Skin Health Center

    Birmingham, Alabama, 35244

  • Optima Research

    Boardman, Ohio, 44512

  • Treasure Valley Medical Research

    Boise, Idaho, 83706-1345

  • Equity Medical

    Bowling Green, Kentucky, 42104

  • Clinical Research of Brandon

    Brandon, Florida, 33511

  • The Dermatology Center of New Jersey

    Bridgewater, New Jersey, 08807

  • Ace Clinical Trials

    Brooklyn, New York, 11211

  • US Dermatology Partners Cedar Park

    Cedar Park, Texas, 78613

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Epic Medical Research - Oklahoma

    Chickasha, Oklahoma, 73018

  • Academic Alliance in Dermatology - Saint Petersburg Office

    Clearwater, Florida, 33761

  • Centricity Research Columbus

    Columbus, Georgia, 31904

  • Corazon United States of America, LLC doing business as Life Clinical Trials

    Coral Springs, Florida, 33071

  • AllerVie Clinical Research- Cullman

    Cullman, Alabama, 35058

  • Studies in Dermatology LLC

    Cypress, Texas, 77429

  • Palm Beach Dermatology Group

    Delray Beach, Florida, 33484

  • Velocity Clinical Research - Denver

    Denver, Colorado, 80209

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke South Durham

    Durham, North Carolina, 27713

  • Empire Dermatology

    East Syracuse, New York, 13057

  • Onyx Clinical Research

    Flint, Michigan, 48532

  • Maria M Ona MD PC

    Franklin, Virginia, 23851

  • Center for Dermatology Clinical Research Inc

    Fremont, California, 94538

  • Doc1 Healthcare Systems Incorporated

    Fullerton, California, 92831

  • Velocity Clinical Research - Grants Pass

    Grants Pass, Oregon, 97527

  • Direct Helpers Research Center

    Hialeah, Florida, 33012

  • MedCare Pharma - Houston

    Houston, Texas, 77037

  • Tranquil Clinical Research

    Houston, Texas, 77098

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250

  • Axon Clinical Research

    Inglewood, California, 90301

  • Smart Medical Research Inc

    Jackson Heights, New York, 11372

  • Sante Clinical Research

    Kerrville, Texas, 78028

  • Forest Hills Dermatology Group

    Kew Gardens, New York, 11415

  • Avance Clinical Trials

    Laguna Niguel, California, 92677

  • Somnos Clinical Research

    Lincoln, Nebraska, 68505

  • Long and Harris Dermatology

    Lubbock, Texas, 79424

  • Glick Skin Institute

    Margate, Florida, 33063

  • Apex Clinical Research Center LLC

    Mayfield Heights, Ohio, 44124

  • Velocity Clinical Research - Boise

    Meridian, Idaho, 83642

  • Sms Clinical Research Limited Liability Company

    Mesquite, Texas, 75149

  • Miami Clinical Research

    Miami, Florida, 33155

  • ara Professionals Limited Liability Corporation

    Miami, Florida, 33176

  • Deluxe Health Care LLC

    Miami Lakes, Florida, 33014

  • Savin Medical Group LLC

    Miami Lakes, Florida, 33014

  • Angels Clinical Research Institute

    Miami Lakes, Florida, 33016

  • Sienna Dermatology Research

    Missouri City, Texas, 77459

  • Industrial Medicine Associates Clinical Research Advanced Dermatology Care

    Monroe, Louisiana, 71201

  • HealthStar Physicians Dermatology

    Morristown, Tennessee, 37813

  • Kentucky Advanced Medical Research LLC

    Murray, Kentucky, 42071

  • Tanner Clinic

    Murray, Utah, 84107

  • Southern Indiana Clinical Trials

    New Albany, Indiana, 47150

  • Pioneer Clinical Research New York

    New York, New York, 10016

  • Cornell University - Weill Cornell Medicine

    New York, New York, 10075

  • National Allergy and Asthma Research, LLC

    North Charleston, South Carolina, 29420

  • Arkansas Research Trials, LLC

    North Little Rock, Arkansas, 72117

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Dermatology and Aesthetics of Oklahoma

    Oklahoma City, Oklahoma, 73120

  • Optimal Research Sites, LLC

    Orange City, Florida, 32763

  • Clinical Associates of Orlando Limited Liability Company

    Orlando, Florida, 32819

  • Clinical Research Investments

    Orlando, Florida, 32819

  • Cura Clinical Research

    Palmdale, California, 93551

  • Paddington Testing Company Inc

    Philadelphia, Pennsylvania, 19103

  • The Indiana Clinical Trials Center PC

    Plainfield, Indiana, 46168

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Allcutis Research

    Portsmouth, New Hampshire, 03801

  • Rhode Island Hospital, Lifespan

    Providence, Rhode Island, 02903

  • Dermatology Research of Utah, dba Providence Dermatology

    Providence, Utah, 84332

  • Skin Cancer and Dermatology Institute

    Reno, Nevada, 89509

  • Rochester Clinical Research

    Rochester, New York, 14609

  • Aesthetic and Dermatology Center

    Rockville, Maryland, 20850

  • Derm Associates, PC

    Rockville, Maryland, 20850

  • Integrative Skin Science and Research

    Sacramento, California, 95815

  • University of California at Davis Medical Center

    Sacramento, California, 95816

  • MediSearch Clinical Trials

    Saint Joseph, Missouri, 64506

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • Allergy and Asthma Medical Group and Research Center

    San Diego, California, 92123

  • University of California at San Diego Rady Childrens Hospital San Diego

    San Diego, California, 92123

  • Advanced Medical Research PC

    Sandy Springs, Georgia, 30328

  • Clinical Science Institute

    Santa Monica, California, 90404

  • Divine Dermatology and Aesthetics

    Savannah, Georgia, 31419

  • Cura Clinical Research Sherman Oaks

    Sherman Oaks, California, 91403

  • NorthShore University HealthSystem Clinical Trials Center

    Skokie, Illinois, 60077

  • Jordan Valley Dermatology Center

    South Jordan, Utah, 84095

  • Epiphany Dermatology

    Southlake, Texas, 76092

  • Saint Louis University

    St Louis, Missouri, 63110

  • Pioneer Research Solutions

    Sugar Land, Texas, 77479

  • Coastal Pediatric Research

    Summerville, South Carolina, 29486

  • University of South Florida

    Tampa, Florida, 33612

  • Yeshiva University - Montefiore Medical Center

    The Bronx, New York, 10467

  • McIntosh Clinic PC

    Thomasville, Georgia, 31792

  • Eclipse Clinical Research

    Tucson, Arizona, 85745

  • Dermatology Research Center of Oklahoma, PLLC

    Tulsa, Oklahoma, 74132

  • Essential Medical Research LLC

    Tulsa, Oklahoma, 74137

  • Childrens National Medical Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

China24 sites
  • Childrens Hospital Capital Institute of Pediatrics

    Beijing, Beijing Municipality, 100020

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Childrens Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Childrens Hospital

    Changsha, 410007

  • Chengdu Second Peoples Hospital

    Chengdu, Sichuan, 610021

  • Childrens Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400014

  • Dalian Women and Childrens Medical Group

    Dalian, Liaoning, 116011

  • The First Affiliated Hospital Sun-Yat Sen University

    Guangzhou, Guangdong, 510080

  • Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong, 510091

  • Sun Yat-sen Memorial Hospital Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University

    Hangzhou, Zhejiang, 310020

  • Jiangyin Hospital of Traditional Chinese Medicine

    Jiangyin, Jiangsu, 214400

  • Kunming Childrens Hospital

    Kunming, Yunnan, 650103

  • Nanyang First Peoples Hospital

    Nanyang, Henan, 473002

  • Ningbo NO 2 Hospital

    Ningbo, Zhejiang, 315010

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai Municipality, 200443

  • Shenzhen Childrens Hospital

    Shenzhen, 518038

  • Suining Central Hospital

    Suining, Sichuan, 629099

  • Taizhou Central Hospital

    Taizhou, Zhejiang, 318000

  • The Central Hospital of Wuhan

    Wuhan, Hubei, 430014

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750003

Other trials in China

Japan16 sites
  • Yoshimura Child Clinic

    Akashi-shi, Hyōgo, 674-0068

  • Asahikawa City Hospital

    Asahikawa-shi, Hokkaido, 070-8610

  • Matsuo Clinic

    Fukuoka, Fukuoka, 819-0373

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Katahira Dermatology Urology Clinic

    Kagoshima, Kagoshima-ken, 890-0063

  • Jouzan Hihuka Hinyoukika Clinic

    Kumamoto, Kumamoto, 860-0066

  • Suizenji Dermatology Clinic

    Kumamoto, Kumamoto, 862-0950

  • Miyata Dermatology Clinic

    Matsudo-shi, Chiba, 271-0092

  • Central Clinic

    Nagoya, Aichi-ken, 464-0821

  • Yoshioka Dermatology Clinic

    Neyagawa, Osaka, 572-0838

  • Takagi Dermatological Clinic

    Obihiro-shi, Hokkaido, 080-0013

  • Dermatology and Ophthalmology Kume Clinic

    Sakai-shi, Osaka, 593-8324

  • Naoko Dermatology Clinic

    Setagaya-ku, Tokyo, 158-0097

  • NTT Medical Center Tokyo

    Shinagawa-ku, Tokyo, 141-8625

  • Nomura Dermatology Clinic

    Yokohama, Kanagawa, 221-0825

  • Yokohama City Minato Red Cross Hospital

    Yokohama, Kanagawa, 231-8682

Other trials in Japan

Poland16 sites
  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy

    Gdansk, 80-280

  • GynCentrum Sp zoo NZOZ Holsamed

    Katowice, 40-600

  • Centrum Medyczne Angelius Provita

    Katowice, 40-611

  • Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna

    Krakow, 30-002

  • Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center

    Krakow, 31-559

  • AppleTreeClinics Network Spzoo

    Lodz, 90-349

  • Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne

    Lodz, 91-495

  • Clinical Best Solutions Sp zoo Spolka Komandytowa

    Lublin, 20-011

  • Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych

    Sosnowiec, 41-200

  • Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo

    Tarnów, 33-100

  • Klinika Osipowicz and Turkowski Sp zoo

    Warsaw, 00-716

  • High Med Przychodnia Specjalistyczna

    Warsaw, 01-817

  • Klinika Ambroziak Dermatologia

    Warsaw, 02-953

  • Royalderm Agnieszka Nawrocka

    Warsaw, 02-962

  • Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych

    Wroclaw, 50-450

Other trials in Poland

Brazil11 sites
  • Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh

    Belo Horizonte, Minas Gerais, 30575-180

  • Cecip Centro Est Clin Int Paulista

    Jaú, São Paulo, 17201-130

  • Irmandade da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli

    Ribeirão Preto, São Paulo, 14026-020

  • IBPClin Instituto Brasil de Pesquisa Clinica

    Rio de Janeiro, 20241-180

  • Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda

    Salvador, Estado de Bahia, 41820-020

  • Hospital de Base de Sao Jose do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Instituto Pesquisa e Ensino em Saúde Infantil

    São Paulo, São Paulo, 01228-200

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, São Paulo, 05403-002

  • Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

South Korea11 sites
  • Korea University Ansan Hospital

    Ansansi, Gyeonggido, 15355

  • Nowon Eulji Medical Center, Eulji University

    Seoul, 01830

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • National Medical Center

    Seoul, 04564

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

  • The Catholic University of Korea Seoul St Marys Hospital

    Seoul, 06591

  • Chung-Ang University Hospital

    Seoul, 06973

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, 07441

  • Ewha Womans University Seoul Hospital

    Seoul, 07804

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Germany8 sites
  • Fachklinik Bad Bentheim

    Bad Bentheim, 48455

  • Universitaetsklinikum Bonn

    Bonn, 53127

  • Rosenpark Research GmbH

    Darmstadt, 64283

  • Universitaetsklinikum Dresden

    Dresden, 01307

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main

    Frankfurt am Main, 60590

  • Velocity Clinical Research

    Leipzig, 04103

  • Johannes Gutenberg Universitaet Mainz

    Mainz, 55101

Other trials in Germany

France7 sites
  • Hopital Prive d Antony

    Antony, 92160

  • Centre Hospitalier Regional Universitaire Brest Hopital Morvan

    Brest, 29200

  • Hôpital Saint-Joseph

    Marseille, 13285

  • Centre Hospitalier Universitaire de Nantes Hôtel Dieu

    Nantes, 44093

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033

  • Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle

    Rouen, 76031

  • Centre Hospitalier Universitaire de Toulouse, Hopital Larrey

    Toulouse, 31059

Other trials in France

Canada6 sites
  • Rejuvenation Dermatology Laser Calgary North

    Calgary, Alberta, T3K 6B8

  • Lynderm Research Inc

    Markham, Ontario, L3P 1X3

  • Dr SK Siddha Medicine Professional Corporation

    Newmarket, Ontario, L3Y 5G8

  • Allergy Research Canada Incorporated

    Niagara Falls, Ontario, L2H 1H5

  • Skinsense Medical Research

    Saskatoon, Saskatchewan, S7K 2C1

  • XLR8 Medical Research, Incorporated

    Windsor, Ontario, N8T 1E6

Other trials in Canada

Belgium5 sites
  • Hopital Erasme

    Brussels, 1070

  • Universite Catholique de Louvain Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Centre Hospitalier Universitaire de Liege - Sart Tilman

    Liège, 4000

  • Dermatologie Maldegem

    Maldegem, 9990

Other trials in Belgium

Chile5 sites
  • Centro Dermatologico Dermisur

    Osorno, 5310644

  • Centro Medico Skinmed Spa

    Santiago, 7580206

  • Clinica Dermacross SA

    Santiago, 7640881

  • Fundacion Innovacion Cardiovascular

    Santiago, 8380465

  • Centro Internacional de Estudios Clinicos

    Santiago, 8420383

Other trials in Chile

Croatia5 sites
  • Special Hospital for Medical Rehabilitation Naftalan

    Ivanić-Grad, 10310

  • University Hospital Centre Osijek

    Osijek, 31000

  • Children s Hospital Zagreb

    Zagreb, 10000

  • Sestre milosrdnice University Hospital Center

    Zagreb, 10000

  • University Hospital Centre Zagreb

    Zagreb, 10000

Other trials in Croatia

Spain5 sites
  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041

  • Hospital Sant Joan de Deu

    Esplugues de Llobregat, Catalonia, 08950

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Universitario La Paz

    Madrid, 28046

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

Other trials in Spain

Greece4 sites
  • Athens Naval Hospital

    Athens, 11521

  • Athens General Childrens Hospital Panagioti And Aglaia Kyriakou

    Athens, 11527

  • Thoracic General Hospital Of Athens Sotiria

    Athens, 11527

  • Ippokratio General Hospital of Thessaloniki

    Thessaloniki, 54643

Other trials in Greece

Hungary4 sites
  • Clinexpert Kft

    Budapest, 1033

  • Derma-B Egeszsegugyi es Szolgaltato Kft

    Debrecen, 4031

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Somogy Varmegyei Kaposi Mor Oktato Korhaz

    Kaposvár, 7400

Other trials in Hungary

Italy4 sites
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    Naples, 80131

  • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

    Perugia, 06129

  • Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino

    Torino, 10126

Other trials in Italy

Taiwan4 sites
  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 83301

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Linkou Chang Gung Memorial Hospital

    Taoyuan, 33305

Other trials in Taiwan

Thailand4 sites
  • King Chulalongkorn Memorial Hospital

    Bangkok, 10330

  • Siriraj Hospital

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

  • Thammasat University Hospital

    Pathum Thani, 12120

Other trials in Thailand

Israel3 sites
  • Soroka Medical Center

    Bear Sheva, 8410101

  • Sheba Medical Center

    Ramat Gan, 5262000

  • Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Romania3 sites
  • Dr Leventer Centre Clinica Dermatologie Bucuresti

    Bucharest, 011216

  • Derma Cluj

    Cluj-Napoca, 400105

  • Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor

    Cluj-Napoca, 400431

Other trials in Romania

Puerto Rico2 sites
  • Clinical Research of Puerto Rico

    San Juan, 00909

  • Gcm Medical Group, Psc

    San Juan, 00917

Other trials in Puerto Rico

Mexico1 site
  • Phylasis Clinicas Research Toluca

    Toluca, 50090

Other trials in Mexico

About this study

Official title: A Phase 3, Randomized, 52-week, Placebo-controlled, Double-blind Study With Re-randomization to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab (AMG 451) in Adolescent Subjects With Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-ASTRO)

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

Being tested
Rocatinlimab, Placebo
Keywords
Atopic Dermatitis, AMG 451, KHK4083, Rocatinlimab
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RocatinlimabDrug

    Also called AMG 451

    Subcutaneous (SC) injection

  • PlaceboDrug

    SC injection

Study groups in NCT05704738
Study groupRoleWhat they receive
Arm A: Dose 1ExperimentalPart 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 1 every 4 weeks (Q4W) for 24 weeks with loading dose at Week 2 (+ topical corticosteroids (TCS)/ topical calcineurin inhibitor (TCI) if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 1 Q4W or every 8 weeks (Q8W) for 28 weeks (+ TCS/TCI if within combination therapy cohort).
Receives: Drug: Rocatinlimab
Arm B: Dose 2ExperimentalPart 1 (Initial Period); Week 0 to Week 24: Rocatinlimab Dose 2 Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be rerandomised at Week 24 to Rocatinlimab Dose 2 Q4W or Q8W for 28 weeks (with TCS/TCI if within combination therapy cohort).
Receives: Drug: Rocatinlimab
Arm C: PlaceboExperimentalPart 1 (Initial Period); Week 0 to Week 24: Placebo Q4W for 24 weeks with loading dose at Week 2 (+TCS/TCI if within combination therapy cohort). Part 2 (Maintenance Period); Week 24 to Week 52: Part 1 Responders will be reassigned at Week 24 with Placebo Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort).
Receives: Drug: Placebo
Arm D: Open-Label Dose 1ExperimentalPart 2; Week 24 to Week 52: Part 1 Non-Responders will be reassigned at Week 24 with Rocatinlimab Open-label Dose 1 Q4W for 28 weeks (with TCS/TCI if within combination therapy cohort). Participants in Arms A, B or C Maintenance Period will be reassigned with Rocatinlimab Open-label Dose 1 Q4W (with TCS/TCI if within combination therapy cohort) upon relapse after Week 24.
Receives: Drug: Rocatinlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24

    vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity. Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'. For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?" If "Yes," participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 24

  2. Number of Participants Who Achieved EASI 75 at Week 24

    EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 24

Secondary outcomes (29)
  1. Number of Participants Who Achieved EASI 75 at Week 16

    EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 16

  2. Number of Participants Who Achieved vIGA-AD 0/1 at Week 16

    The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 16

  3. Number of Participants Who Achieved 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

    The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 16

  4. Number of Participants Who Achieved vIGA-AD 0/1 at Week 24

    The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe. Higher scores indicated greater disease severity. Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 24

  5. Number of Participants Who Achieved 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

    The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 24

  6. Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24

    The EASI was designed by modifying the Psoriasis Area and Severity Index, widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 24

  7. Number of Participants Who Achieved ≥ 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

    AD skin pain was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 24

  8. Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 16

    Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.

    Measured: Up to Week 16

  9. Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 24

    Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.

    Measured: Up to Week 24

  10. Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16

    The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward [WOCF]) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.

    Measured: Baseline and Week 16

  11. Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24

    The Worst Pruritus was assessed using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch. Participants were asked to rate the intensity of their worst itch using this scale. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in itch intensity.

    Measured: Baseline and Week 24

  12. Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16

    The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.

    Measured: Baseline and Week 16

  13. Change From Baseline in SCORAD Itch VAS Score at Week 24

    The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data. Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.

    Measured: Baseline and Week 24

  14. Number of Participants ≥ 16 Years Old at Enrollment Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4

    The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease. The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 24

  15. Change From Baseline in DLQI Score at Week 24 For Participants ≥ 16 Years Old at Enrollment

    The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of adolescent patients suffering from skin disease. The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.

    Measured: Baseline and Week 24

  16. Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 24 For Participants < 16 Years Old at Enrollment

    The CDLQI was a 10-item questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD. It was designed to measure the health-related quality of life of child patients suffering from skin disease. The CDLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.

    Measured: Baseline and Week 24

  17. Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4

    The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 24

  18. Change From Baseline in POEM Score at Week 24

    The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD. It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the impact of AD.

    Measured: Baseline and Week 24

  19. Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4

    AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 16

  20. Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24

    AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.

    Measured: Baseline and Week 24

  21. Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16

    AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD skin pain intensity.

    Measured: Baseline and Week 16

  22. Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3

    AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 24

  23. Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3

    AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 16

  24. Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24

    Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours. Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance. Participants were asked to rate the intensity of their sleep disturbance using this scale each day. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in level of sleep disturbance.

    Measured: Baseline and Week 24

  25. Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8

    HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 24

  26. Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8

    HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 24

  27. Change From Baseline in HADS-anxiety Subscale Score at Week 24

    HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing worse anxiety. Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the anxiety.

    Measured: Baseline and Week 24

  28. Change From Baseline in HADS-depression Subscale Score at Week 24

    HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings. The HADS-depression subscale score ranged from 0 to 21, with higher scores representing worse depression. Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe). Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in the depression.

    Measured: Baseline and Week 24

  29. Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7

    The SCORAD total score used to assess the severity of AD using both physician and patient-reported data. SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.

    Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study start20 Apr 2023
  3. Primary completion27 Feb 2025
  4. Study completion25 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
532 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05704738
Sponsor's protocol ID
20210145
Other IDs
2022-501586-50
Acronym
ROCKET-ASTRO
Status last verified
Jul 2026
First submitted
20 Jan 2023
Last updated
28 Aug 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Publications

  • 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.

    PubMed 40012373
  • Blauvelt A, Deininger KM, Porter J, Sohn A, Qin S, McLeod L, Rylands AJ, Nelson L. Psychometric Evaluation of Skin Pain and Sleep Disturbance Numeric Rating Scales in Moderate-to-Severe Atopic Dermatitis. Dermatol Ther (Heidelb). 2026 Jan 9. doi: 10.1007/s13555-025-01634-5. Online ahead of print.

    PubMed 41513913

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rocatinlimab in people with Atopic Dermatitis, run by Amgen at 246 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 246 sites in United States, China, Japan, Poland, Brazil and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Achieved vIGA-AD 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24 (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05704738, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.

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ROCKET-ASTRO Clinical Trial NCT05704738 | AzTrials