A Study to Evaluate Rocatinlimab (AMG 451) in Adolescent Participants With Moderate-to-severe Atopic Dermatitis (AD)
NCT ID: NCT05704738
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
532 participants
INTERVENTIONAL
2023-04-20
2025-11-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Arm A: Dose 1
Part 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).
Rocatinlimab
Subcutaneous (SC) injection
Arm B: Dose 2
Part 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).
Rocatinlimab
Subcutaneous (SC) injection
Arm C: Placebo
Part 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).
Placebo
SC injection
Arm D: Open-Label Dose 1
Part 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.
Rocatinlimab
Subcutaneous (SC) injection
Interventions
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Rocatinlimab
Subcutaneous (SC) injection
Placebo
SC injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
* vIGA-AD score ≥ 3.
* ≥10% body surface area of AD involvement.
* Worst pruritus NRS ≥ 4.
Exclusion Criteria
* Treatment with any of the following medications or therapies within 4 weeks or 5 half-lives, whichever is longer, prior to Day 1:
1. Systemic corticosteroids
2. Non-biologic, non-targeted systemic immunosuppressants
3. Phototherapy
4. Oral or Topical Janus kinase inhibitors
* Treatment with any of the following medications or therapies within 1 week, prior to Day 1:
1. TCS of any potency
2. TCI
3. Topical phosphodiesterase 4 inhibitors
4. Other topical immunosuppressive agents
12 Years
17 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Cahaba Dermatology and Skin Health Center
Birmingham, Alabama, United States
AllerVie Clinical Research- Cullman
Cullman, Alabama, United States
Eclipse Clinical Research
Tucson, Arizona, United States
Arkansas Research Trials, LLC
North Little Rock, Arkansas, United States
Center for Dermatology Clinical Research Inc
Fremont, California, United States
Doc1 Healthcare Systems Incorporated
Fullerton, California, United States
Axon Clinical Research
Inglewood, California, United States
Avance Clinical Trials
Laguna Niguel, California, United States
Cura Clinical Research
Palmdale, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
University of California at Davis Medical Center
Sacramento, California, United States
Allergy and Asthma Medical Group and Research Center
San Diego, California, United States
University of California at San Diego Rady Childrens Hospital San Diego
San Diego, California, United States
Clinical Science Institute
Santa Monica, California, United States
Cura Clinical Research Sherman Oaks
Sherman Oaks, California, United States
Velocity Clinical Research - Denver
Denver, Colorado, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
Clinical Research of Brandon
Brandon, Florida, United States
Academic Alliance in Dermatology - Saint Petersburg Office
Clearwater, Florida, United States
Corazon United States of America, LLC doing business as Life Clinical Trials
Coral Springs, Florida, United States
Palm Beach Dermatology Group
Delray Beach, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
Glick Skin Institute
Margate, Florida, United States
Miami Clinical Research
Miami, Florida, United States
ara Professionals Limited Liability Corporation
Miami, Florida, United States
Deluxe Health Care LLC
Miami Lakes, Florida, United States
Savin Medical Group LLC
Miami Lakes, Florida, United States
Angels Clinical Research Institute
Miami Lakes, Florida, United States
Optimal Research Sites, LLC
Orange City, Florida, United States
Clinical Associates of Orlando Limited Liability Company
Orlando, Florida, United States
Clinical Research Investments
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Centricity Research Columbus
Columbus, Georgia, United States
Advanced Medical Research PC
Sandy Springs, Georgia, United States
Divine Dermatology and Aesthetics
Savannah, Georgia, United States
McIntosh Clinic PC
Thomasville, Georgia, United States
Treasure Valley Medical Research
Boise, Idaho, United States
Velocity Clinical Research - Boise
Meridian, Idaho, United States
NorthShore University HealthSystem Clinical Trials Center
Skokie, Illinois, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
Southern Indiana Clinical Trials
New Albany, Indiana, United States
The Indiana Clinical Trials Center PC
Plainfield, Indiana, United States
Equity Medical
Bowling Green, Kentucky, United States
Kentucky Advanced Medical Research LLC
Murray, Kentucky, United States
Industrial Medicine Associates Clinical Research Advanced Dermatology Care
Monroe, Louisiana, United States
Aesthetic and Dermatology Center
Rockville, Maryland, United States
Derm Associates, PC
Rockville, Maryland, United States
Oakland Hills Dermatology
Auburn Hills, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Onyx Clinical Research
Flint, Michigan, United States
MediSearch Clinical Trials
Saint Joseph, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
Somnos Clinical Research
Lincoln, Nebraska, United States
Skin Cancer and Dermatology Institute
Reno, Nevada, United States
Allcutis Research
Portsmouth, New Hampshire, United States
The Dermatology Center of New Jersey
Bridgewater, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
Ace Clinical Trials
Brooklyn, New York, United States
Empire Dermatology
East Syracuse, New York, United States
Smart Medical Research Inc
Jackson Heights, New York, United States
Forest Hills Dermatology Group
Kew Gardens, New York, United States
Pioneer Clinical Research New York
New York, New York, United States
Cornell University - Weill Cornell Medicine
New York, New York, United States
Rochester Clinical Research
Rochester, New York, United States
Yeshiva University - Montefiore Medical Center
The Bronx, New York, United States
Duke South Durham
Durham, North Carolina, United States
Optima Research
Boardman, Ohio, United States
Apex Clinical Research Center LLC
Mayfield Heights, Ohio, United States
Epic Medical Research - Oklahoma
Chickasha, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Dermatology and Aesthetics of Oklahoma
Oklahoma City, Oklahoma, United States
Dermatology Research Center of Oklahoma, PLLC
Tulsa, Oklahoma, United States
Essential Medical Research LLC
Tulsa, Oklahoma, United States
Velocity Clinical Research - Grants Pass
Grants Pass, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Paddington Testing Company Inc
Philadelphia, Pennsylvania, United States
Rhode Island Hospital, Lifespan
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, United States
Coastal Pediatric Research
Summerville, South Carolina, United States
HealthStar Physicians Dermatology
Morristown, Tennessee, United States
The University of Texas Health Science Center at Houston
Bellaire, Texas, United States
US Dermatology Partners Cedar Park
Cedar Park, Texas, United States
Studies in Dermatology LLC
Cypress, Texas, United States
MedCare Pharma - Houston
Houston, Texas, United States
Tranquil Clinical Research
Houston, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
Long and Harris Dermatology
Lubbock, Texas, United States
Sms Clinical Research Limited Liability Company
Mesquite, Texas, United States
Sienna Dermatology Research
Missouri City, Texas, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States
Epiphany Dermatology
Southlake, Texas, United States
Pioneer Research Solutions
Sugar Land, Texas, United States
Tanner Clinic
Murray, Utah, United States
Dermatology Research of Utah, dba Providence Dermatology
Providence, Utah, United States
Jordan Valley Dermatology Center
South Jordan, Utah, United States
Maria M Ona MD PC
Franklin, Virginia, United States
Northwest Clinical Research Center
Bellevue, Washington, United States
Hopital Erasme
Brussels, , Belgium
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Brussels, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman
Liège, , Belgium
Dermatologie Maldegem
Maldegem, , Belgium
Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
Vitória, Espírito Santo, Brazil
Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
Salvador, Estado de Bahia, Brazil
Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh
Belo Horizonte, Minas Gerais, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Cecip Centro Est Clin Int Paulista
Jaú, São Paulo, Brazil
Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli
Ribeirão Preto, São Paulo, Brazil
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Instituto Pesquisa e Ensino em Saúde Infantil
São Paulo, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, São Paulo, Brazil
IBPClin Instituto Brasil de Pesquisa Clinica
Rio de Janeiro, , Brazil
Rejuvenation Dermatology Laser Calgary North
Calgary, Alberta, Canada
Lynderm Research Inc
Markham, Ontario, Canada
Dr SK Siddha Medicine Professional Corporation
Newmarket, Ontario, Canada
Allergy Research Canada Incorporated
Niagara Falls, Ontario, Canada
XLR8 Medical Research, Incorporated
Windsor, Ontario, Canada
Skinsense Medical Research
Saskatoon, Saskatchewan, Canada
Centro Dermatologico Dermisur
Osorno, , Chile
Centro Medico Skinmed Spa
Santiago, , Chile
Clinica Dermacross SA
Santiago, , Chile
Fundacion Innovacion Cardiovascular
Santiago, , Chile
Centro Internacional de Estudios Clinicos
Santiago, , Chile
Childrens Hospital Capital Institute of Pediatrics
Beijing, Beijing Municipality, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Beijing Childrens Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Childrens Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital Sun-Yat Sen University
Guangzhou, Guangdong, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital Sun Yat-sen University
Guangzhou, Guangdong, China
Nanyang First Peoples Hospital
Nanyang, Henan, China
The Central Hospital of Wuhan
Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangyin Hospital of Traditional Chinese Medicine
Jiangyin, Jiangsu, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Dalian Women and Childrens Medical Group
Dalian, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Chengdu Second Peoples Hospital
Chengdu, Sichuan, China
Suining Central Hospital
Suining, Sichuan, China
Kunming Childrens Hospital
Kunming, Yunnan, China
Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
Hangzhou, Zhejiang, China
Ningbo NO 2 Hospital
Ningbo, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
Hunan Childrens Hospital
Changsha, , China
Shenzhen Childrens Hospital
Shenzhen, , China
Special Hospital for Medical Rehabilitation Naftalan
Ivanić-Grad, , Croatia
University Hospital Centre Osijek
Osijek, , Croatia
Children s Hospital Zagreb
Zagreb, , Croatia
Sestre milosrdnice University Hospital Center
Zagreb, , Croatia
University Hospital Centre Zagreb
Zagreb, , Croatia
Hopital Prive d Antony
Antony, , France
Centre Hospitalier Regional Universitaire Brest Hopital Morvan
Brest, , France
Hôpital Saint-Joseph
Marseille, , France
Centre Hospitalier Universitaire de Nantes Hôtel Dieu
Nantes, , France
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, , France
Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
Rouen, , France
Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
Toulouse, , France
Fachklinik Bad Bentheim
Bad Bentheim, , Germany
Universitaetsklinikum Bonn
Bonn, , Germany
Rosenpark Research GmbH
Darmstadt, , Germany
Universitaetsklinikum Dresden
Dresden, , Germany
Universitaetsklinikum Erlangen
Erlangen, , Germany
Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
Frankfurt am Main, , Germany
Velocity Clinical Research
Leipzig, , Germany
Johannes Gutenberg Universitaet Mainz
Mainz, , Germany
Athens Naval Hospital
Athens, , Greece
Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
Athens, , Greece
Thoracic General Hospital Of Athens Sotiria
Athens, , Greece
Ippokratio General Hospital of Thessaloniki
Thessaloniki, , Greece
Clinexpert Kft
Budapest, , Hungary
Derma-B Egeszsegugyi es Szolgaltato Kft
Debrecen, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Kaposvár, , Hungary
Soroka Medical Center
Bear Sheva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Napoli, , Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
Perugia, , Italy
Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, , Italy
Central Clinic
Nagoya, Aichi-ken, Japan
Miyata Dermatology Clinic
Matsudo-shi, Chiba, Japan
Matsuo Clinic
Fukuoka, Fukuoka, Japan
Asahikawa City Hospital
Asahikawa-shi, Hokkaido, Japan
Takagi Dermatological Clinic
Obihiro-shi, Hokkaido, Japan
Yoshimura Child Clinic
Akashi-shi, Hyōgo, Japan
Katahira Dermatology Urology Clinic
Kagoshima, Kagoshima-ken, Japan
Nomura Dermatology Clinic
Yokohama, Kanagawa, Japan
Yokohama City Minato Red Cross Hospital
Yokohama, Kanagawa, Japan
Jouzan Hihuka Hinyoukika Clinic
Kumamoto, Kumamoto, Japan
Suizenji Dermatology Clinic
Kumamoto, Kumamoto, Japan
Yoshioka Dermatology Clinic
Neyagawa, Osaka, Japan
Dermatology and Ophthalmology Kume Clinic
Sakai-shi, Osaka, Japan
Hamamatsu University Hospital
Hamamatsu, Shizuoka, Japan
Naoko Dermatology Clinic
Setagaya-ku, Tokyo, Japan
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, Japan
Phylasis Clinicas Research Toluca
Toluca, , Mexico
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
Gdansk, , Poland
GynCentrum Sp zoo NZOZ Holsamed
Katowice, , Poland
Centrum Medyczne Angelius Provita
Katowice, , Poland
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
Krakow, , Poland
Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
Krakow, , Poland
AppleTreeClinics Network Spzoo
Lodz, , Poland
Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
Lodz, , Poland
Clinical Best Solutions Sp zoo Spolka Komandytowa
Lublin, , Poland
Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
Sosnowiec, , Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
Tarnów, , Poland
Klinika Osipowicz and Turkowski Sp zoo
Warsaw, , Poland
High Med Przychodnia Specjalistyczna
Warsaw, , Poland
Klinika Ambroziak Dermatologia
Warsaw, , Poland
Royalderm Agnieszka Nawrocka
Warsaw, , Poland
Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
Wroclaw, , Poland
Clinical Research of Puerto Rico
San Juan, , Puerto Rico
Gcm Medical Group, Psc
San Juan, , Puerto Rico
Dr Leventer Centre Clinica Dermatologie Bucuresti
Bucharest, , Romania
Derma Cluj
Cluj-Napoca, , Romania
Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
Cluj-Napoca, , Romania
Korea University Ansan Hospital
Ansansi, Gyeonggido, , South Korea
Nowon Eulji Medical Center, Eulji University
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
National Medical Center
Seoul, , South Korea
Kyung Hee University Hospital at Gangdong
Seoul, , South Korea
The Catholic University of Korea Seoul St Marys Hospital
Seoul, , South Korea
Chung-Ang University Hospital
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Ewha Womans University Seoul Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Sant Joan de Deu
Esplugues de Llobregat, Catalonia, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, , Thailand
Siriraj Hospital
Bangkok, , Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai, , Thailand
Thammasat University Hospital
Pathum Thani, , Thailand
Countries
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References
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Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2022-501586-50
Identifier Type: OTHER
Identifier Source: secondary_id
20210145
Identifier Type: -
Identifier Source: org_study_id
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