中等度から重度のアトピー性皮膚炎（AD）の思春期被験者におけるロカチンリマブ（AMG 451）を評価する研究 (ROCKET-ASTRO)
2026年8月6日 更新者：Amgen
中等度から重度のアトピー性皮膚炎 (AD) の思春期被験者におけるロカチンリマブ (AMG 451) の有効性、安全性、忍容性を評価するための再無作為化を伴う第 3 相、無作為化、52 週間、プラセボ対照、二重盲検試験 ( ROCKET-ASTRO)
この研究の目的は、思春期の被験者の単剤療法および併用療法におけるロカチンリマブの有効性と安全性を評価することです。
調査の概要
研究の種類
介入
入学 (実際)
532
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Alabama
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Birmingham、Alabama、アメリカ、35244
- Cahaba Dermatology and Skin Health Center
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Cullman、Alabama、アメリカ、35058
- AllerVie Clinical Research- Cullman
-
-
Arizona
-
Tucson、Arizona、アメリカ、85745
- Eclipse Clinical Research
-
-
Arkansas
-
North Little Rock、Arkansas、アメリカ、72117
- Arkansas Research Trials, LLC
-
-
California
-
Fremont、California、アメリカ、94538
- Center for Dermatology Clinical Research Inc
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Fullerton、California、アメリカ、92831
- Doc1 Healthcare Systems Incorporated
-
Inglewood、California、アメリカ、90301
- Axon Clinical Research
-
Laguna Niguel、California、アメリカ、92677
- Avance Clinical Trials
-
Palmdale、California、アメリカ、93551
- Cura Clinical Research
-
Sacramento、California、アメリカ、95815
- Integrative Skin Science and Research
-
Sacramento、California、アメリカ、95816
- University of California at Davis Medical Center
-
San Diego、California、アメリカ、92123
- Allergy and Asthma Medical Group and Research Center
-
San Diego、California、アメリカ、92123
- University of California at San Diego Rady Childrens Hospital San Diego
-
Santa Monica、California、アメリカ、90404
- Clinical Science Institute
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Sherman Oaks、California、アメリカ、91403
- Cura Clinical Research Sherman Oaks
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Colorado
-
Denver、Colorado、アメリカ、80209
- Velocity Clinical Research - Denver
-
-
District of Columbia
-
Washington D.C.、District of Columbia、アメリカ、20010
- Childrens National Medical Center
-
-
Florida
-
Brandon、Florida、アメリカ、33511
- Clinical Research of Brandon
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Clearwater、Florida、アメリカ、33761
- Academic Alliance in Dermatology - Saint Petersburg Office
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Coral Springs、Florida、アメリカ、33071
- Corazon United States of America, LLC doing business as Life Clinical Trials
-
Delray Beach、Florida、アメリカ、33484
- Palm Beach Dermatology Group
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Hialeah、Florida、アメリカ、33012
- Direct Helpers Research Center
-
Margate、Florida、アメリカ、33063
- Glick Skin Institute
-
Miami、Florida、アメリカ、33155
- Miami Clinical Research
-
Miami、Florida、アメリカ、33176
- ara Professionals Limited Liability Corporation
-
Miami Lakes、Florida、アメリカ、33014
- Savin Medical Group LLC
-
Miami Lakes、Florida、アメリカ、33016
- Angels Clinical Research Institute
-
Miami Lakes、Florida、アメリカ、33014
- Deluxe Health Care LLC
-
Orange City、Florida、アメリカ、32763
- Optimal Research Sites, LLC
-
Orlando、Florida、アメリカ、32819
- Clinical Research Investments
-
Orlando、Florida、アメリカ、32819
- Clinical Associates of Orlando Limited Liability Company
-
Tampa、Florida、アメリカ、33612
- University of South Florida
-
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Georgia
-
Columbus、Georgia、アメリカ、31904
- Centricity Research Columbus
-
Sandy Springs、Georgia、アメリカ、30328
- Advanced Medical Research Pc
-
Savannah、Georgia、アメリカ、31419
- Divine Dermatology and Aesthetics
-
Thomasville、Georgia、アメリカ、31792
- McIntosh Clinic PC
-
-
Idaho
-
Boise、Idaho、アメリカ、83706-1345
- Treasure Valley Medical Research
-
Meridian、Idaho、アメリカ、83642
- Velocity Clinical Research - Boise
-
-
Illinois
-
Skokie、Illinois、アメリカ、60077
- NorthShore University HealthSystem Clinical Trials Center
-
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Indiana
-
Indianapolis、Indiana、アメリカ、46250
- Dawes Fretzin Clinical Research Group, LLC
-
New Albany、Indiana、アメリカ、47150
- Southern Indiana Clinical Trials
-
Plainfield、Indiana、アメリカ、46168
- The Indiana Clinical Trials Center PC
-
-
Kentucky
-
Bowling Green、Kentucky、アメリカ、42104
- Equity Medical
-
Murray、Kentucky、アメリカ、42071
- Kentucky Advanced Medical Research LLC
-
-
Louisiana
-
Monroe、Louisiana、アメリカ、71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
-
-
Maryland
-
Rockville、Maryland、アメリカ、20850
- Aesthetic and Dermatology Center
-
Rockville、Maryland、アメリカ、20850
- Derm Associates, PC
-
-
Michigan
-
Auburn Hills、Michigan、アメリカ、48326
- Oakland Hills Dermatology
-
Detroit、Michigan、アメリカ、48202
- Henry Ford Health System
-
Flint、Michigan、アメリカ、48532
- Onyx Clinical Research
-
-
Missouri
-
Saint Joseph、Missouri、アメリカ、64506
- MediSearch Clinical Trials
-
St Louis、Missouri、アメリカ、63110
- Saint Louis University
-
-
Nebraska
-
Lincoln、Nebraska、アメリカ、68505
- Somnos Clinical Research
-
-
Nevada
-
Reno、Nevada、アメリカ、89509
- Skin Cancer and Dermatology Institute
-
-
New Hampshire
-
Portsmouth、New Hampshire、アメリカ、03801
- Allcutis Research
-
-
New Jersey
-
Bridgewater、New Jersey、アメリカ、08807
- The Dermatology Center of New Jersey
-
-
New Mexico
-
Albuquerque、New Mexico、アメリカ、87102
- University of New Mexico
-
-
New York
-
Brooklyn、New York、アメリカ、11211
- Ace Clinical Trials
-
East Syracuse、New York、アメリカ、13057
- Empire Dermatology
-
Jackson Heights、New York、アメリカ、11372
- Smart Medical Research Inc
-
Kew Gardens、New York、アメリカ、11415
- Forest Hills Dermatology Group
-
New York、New York、アメリカ、10016
- Pioneer Clinical Research New York
-
New York、New York、アメリカ、10075
- Cornell University - Weill Cornell Medicine
-
Rochester、New York、アメリカ、14609
- Rochester Clinical Research
-
The Bronx、New York、アメリカ、10467
- Yeshiva University - Montefiore Medical Center
-
-
North Carolina
-
Durham、North Carolina、アメリカ、27713
- Duke South Durham
-
-
Ohio
-
Boardman、Ohio、アメリカ、44512
- Optima Research
-
Mayfield Heights、Ohio、アメリカ、44124
- Apex Clinical Research Center LLC
-
-
Oklahoma
-
Chickasha、Oklahoma、アメリカ、73018
- Epic Medical Research - Oklahoma
-
Oklahoma City、Oklahoma、アメリカ、73112
- Lynn Health Science Institute
-
Oklahoma City、Oklahoma、アメリカ、73120
- Dermatology and Aesthetics of Oklahoma
-
Tulsa、Oklahoma、アメリカ、74132
- Dermatology Research Center of Oklahoma, PLLC
-
Tulsa、Oklahoma、アメリカ、74137
- Essential Medical Research LLC
-
-
Oregon
-
Grants Pass、Oregon、アメリカ、97527
- Velocity Clinical Research - Grants Pass
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Portland、Oregon、アメリカ、97239
- Oregon Health and Science University
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19103
- Paddington Testing Company Inc
-
-
Rhode Island
-
Providence、Rhode Island、アメリカ、02903
- Rhode Island Hospital, Lifespan
-
-
South Carolina
-
Charleston、South Carolina、アメリカ、29425
- Medical University of South Carolina
-
North Charleston、South Carolina、アメリカ、29420
- National Allergy and Asthma Research, LLC
-
Summerville、South Carolina、アメリカ、29486
- Coastal Pediatric Research
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Tennessee
-
Morristown、Tennessee、アメリカ、37813
- HealthStar Physicians Dermatology
-
-
Texas
-
Bellaire、Texas、アメリカ、77401
- The University of Texas Health Science Center at Houston
-
Cedar Park、Texas、アメリカ、78613
- US Dermatology Partners Cedar Park
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Cypress、Texas、アメリカ、77429
- Studies in Dermatology LLC
-
Houston、Texas、アメリカ、77037
- MedCare Pharma - Houston
-
Houston、Texas、アメリカ、77098
- Tranquil Clinical Research
-
Kerrville、Texas、アメリカ、78028
- Sante Clinical Research
-
Lubbock、Texas、アメリカ、79424
- Long and Harris Dermatology
-
Mesquite、Texas、アメリカ、75149
- Sms Clinical Research Limited Liability Company
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Missouri City、Texas、アメリカ、77459
- Sienna Dermatology Research
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San Antonio、Texas、アメリカ、78218
- Texas Dermatology and Laser Specialists
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Southlake、Texas、アメリカ、76092
- Epiphany Dermatology
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Sugar Land、Texas、アメリカ、77479
- Pioneer Research Solutions
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Utah
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Murray、Utah、アメリカ、84107
- Tanner Clinic
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Providence、Utah、アメリカ、84332
- Dermatology Research of Utah, dba Providence Dermatology
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South Jordan、Utah、アメリカ、84095
- Jordan Valley Dermatology Center
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Virginia
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Franklin、Virginia、アメリカ、23851
- Maria M Ona MD PC
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Washington
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Bellevue、Washington、アメリカ、98007
- Northwest Clinical Research Center
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-
-
-
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Bear Sheva、イスラエル、8410101
- Soroka Medical Center
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Ramat Gan、イスラエル、5262000
- Sheba medical center
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Tel Aviv、イスラエル、6423906
- Sourasky Medical Center
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-
-
-
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Milan、イタリア、20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Naples、イタリア、80131
- Azienda Ospedaliera Universitaria Luigi Vanvitelli
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Perugia、イタリア、06129
- Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
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Torino、イタリア、10126
- Presidio Molinette Azienda Ospedaliera Citta della Salute e della Scienza di Torino
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-
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Alberta
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Calgary、Alberta、カナダ、T3K 6B8
- Rejuvenation Dermatology Laser Calgary North
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Ontario
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Markham、Ontario、カナダ、L3P 1X3
- Lynderm Research Inc
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Newmarket、Ontario、カナダ、L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
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Niagara Falls、Ontario、カナダ、L2H 1H5
- Allergy Research Canada Incorporated
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Windsor、Ontario、カナダ、N8T 1E6
- XLR8 Medical Research, Incorporated
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Saskatchewan
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Saskatoon、Saskatchewan、カナダ、S7K 2C1
- Skinsense Medical Research
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-
-
-
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Athens、ギリシャ、11521
- Athens Naval Hospital
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Athens、ギリシャ、11527
- Thoracic General Hospital Of Athens Sotiria
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Athens、ギリシャ、11527
- Athens General Childrens Hospital Panagioti And Aglaia Kyriakou
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Thessaloniki、ギリシャ、54643
- Ippokratio General Hospital of Thessaloniki
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-
-
-
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Ivanić-Grad、クロアチア、10310
- Special Hospital for Medical Rehabilitation Naftalan
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Osijek、クロアチア、31000
- University Hospital Centre Osijek
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Zagreb、クロアチア、10000
- University Hospital Centre Zagreb
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Zagreb、クロアチア、10000
- Sestre milosrdnice University Hospital Center
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Zagreb、クロアチア、10000
- Children s Hospital Zagreb
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-
-
-
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Madrid、スペイン、28046
- Hospital Universitario La Paz
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Madrid、スペイン、28007
- Hospital General Universitario Gregorio Marañón
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Catalonia
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Barcelona、Catalonia、スペイン、08041
- Hospital de La Santa Creu i Sant Pau
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Esplugues de Llobregat、Catalonia、スペイン、08950
- Hospital Sant Joan de Déu
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Navarre
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Pamplona、Navarre、スペイン、31008
- Clinica Universidad de Navarra
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-
-
-
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Bangkok、タイ、10330
- King Chulalongkorn Memorial Hospital
-
Bangkok、タイ、10700
- Siriraj Hospital
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Chiang Mai、タイ、50200
- Maharaj Nakorn Chiang Mai Hospital
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Pathum Thani、タイ、12120
- Thammasat University Hospital
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-
-
-
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Osorno、チリ、5310644
- Centro Dermatologico Dermisur
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Santiago、チリ、7640881
- Clinica Dermacross SA
-
Santiago、チリ、7580206
- Centro Medico Skinmed Spa
-
Santiago、チリ、8380465
- Fundacion Innovacion Cardiovascular
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Santiago、チリ、8420383
- Centro Internacional de Estudios Clínicos
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-
-
-
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Bad Bentheim、ドイツ、48455
- Fachklinik Bad Bentheim
-
Bonn、ドイツ、53127
- Universitaetsklinikum Bonn
-
Darmstadt、ドイツ、64283
- Rosenpark Research GmbH
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Dresden、ドイツ、01307
- Universitaetsklinikum Dresden
-
Erlangen、ドイツ、91054
- Universitaetsklinikum Erlangen
-
Frankfurt am Main、ドイツ、60590
- Klinikum und Fachbereich Medizin Johann Wolfgang Goethe-Universitaet Frankfurt am Main
-
Leipzig、ドイツ、04103
- Velocity Clinical Research
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Mainz、ドイツ、55101
- Johannes Gutenberg Universitaet Mainz
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-
-
-
-
Budapest、ハンガリー、1033
- Clinexpert Kft
-
Debrecen、ハンガリー、4032
- Debreceni Egyetem Klinikai Kozpont
-
Debrecen、ハンガリー、4031
- Derma-B Egeszsegugyi es Szolgaltato Kft
-
Kaposvár、ハンガリー、7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
-
-
-
-
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Antony、フランス、92160
- Hopital Prive d Antony
-
Brest、フランス、29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
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Marseille、フランス、13285
- Hôpital Saint-Joseph
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Nantes、フランス、44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
-
Rennes、フランス、35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
-
Rouen、フランス、76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
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Toulouse、フランス、31059
- Centre Hospitalier Universitaire de Toulouse, Hopital Larrey
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-
-
-
-
Rio de Janeiro、ブラジル、20241-180
- IBPClin Instituto Brasil de Pesquisa Clinica
-
-
Espírito Santo
-
Vitória、Espírito Santo、ブラジル、29055-450
- Centro do Diagnostico e Pesquisa da Osteoporose do Espirito Santo
-
-
Estado de Bahia
-
Salvador、Estado de Bahia、ブラジル、41820-020
- Clinica Instituto Bahiano de Imunoterapia - Medicina, Reumatologia e Dermatologia ltda
-
-
Minas Gerais
-
Belo Horizonte、Minas Gerais、ブラジル、30575-180
- Centro de Pesquisa Clínica da Universidade de Belo Horizonte - Unibh
-
-
Rio Grande do Sul
-
Porto Alegre、Rio Grande do Sul、ブラジル、90035-903
- Hospital de Clinicas de Porto Alegre
-
Porto Alegre、Rio Grande do Sul、ブラジル、90020-090
- Irmandade da Santa Casa de Misericórdia de Porto Alegre
-
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São Paulo
-
Jaú、São Paulo、ブラジル、17201-130
- Cecip Centro Est Clin Int Paulista
-
Ribeirão Preto、São Paulo、ブラジル、14026-020
- Le Plume Dermatologia- Clinica de Dermatologia Dra Beatriz Elias Eirelli
-
São José do Rio Preto、São Paulo、ブラジル、15090-000
- Hospital de Base de Sao Jose do Rio Preto
-
São Paulo、São Paulo、ブラジル、01228-200
- Instituto Pesquisa e Ensino em Saúde Infantil
-
São Paulo、São Paulo、ブラジル、05403-002
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
-
-
-
-
-
San Juan、プエルトリコ、00917
- GCM Medical Group, PSC
-
San Juan、プエルトリコ、00909
- Clinical Research of Puerto Rico
-
-
-
-
-
Brussels、ベルギー、1070
- Hopital Erasme
-
Brussels、ベルギー、1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
-
Ghent、ベルギー、9000
- Universitair Ziekenhuis Gent
-
Liège、ベルギー、4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
-
Maldegem、ベルギー、9990
- Dermatologie Maldegem
-
-
-
-
-
Gdansk、ポーランド、80-214
- Uniwersyteckie Centrum Kliniczne
-
Gdansk、ポーランド、80-280
- AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
-
Katowice、ポーランド、40-611
- Centrum Medyczne Angelius Provita
-
Katowice、ポーランド、40-600
- GynCentrum Sp zoo NZOZ Holsamed
-
Krakow、ポーランド、30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
-
Krakow、ポーランド、31-559
- Diamond Clinic Spolka z Ograniczona Odpowiedzialnoscia Diamond Medical Center
-
Lodz、ポーランド、90-349
- AppleTreeClinics Network Spzoo
-
Lodz、ポーランド、91-495
- Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
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Lublin、ポーランド、20-011
- Clinical Best Solutions Sp zoo Spolka komandytowa
-
Sosnowiec、ポーランド、41-200
- Centrum Zdrowia Dziecka i Rodziny Im Jana Pawla II w Sosnowcu Osrodek Badan Klinicznych
-
Tarnów、ポーランド、33-100
- Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
-
Warsaw、ポーランド、02-962
- Royalderm Agnieszka Nawrocka
-
Warsaw、ポーランド、02-953
- Klinika Ambroziak Dermatologia
-
Warsaw、ポーランド、00-716
- Klinika Osipowicz and Turkowski Sp zoo
-
Warsaw、ポーランド、01-817
- High Med Przychodnia Specjalistyczna
-
Wroclaw、ポーランド、50-450
- Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
-
-
-
-
-
Toluca、メキシコ、50090
- Phylasis Clinicas Research Toluca
-
-
-
-
-
Bucharest、ルーマニア、011216
- Dr Leventer Centre Clinica Dermatologie Bucuresti
-
Cluj-Napoca、ルーマニア、400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
-
Cluj-Napoca、ルーマニア、400105
- Derma Cluj
-
-
-
-
-
Changsha、中国、410007
- Hunan Childrens Hospital
-
Shenzhen、中国、518038
- Shenzhen Childrens Hospital
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100191
- Peking University Third Hospital
-
Beijing、Beijing Municipality、中国、100020
- Childrens Hospital Capital Institute of Pediatrics
-
Beijing、Beijing Municipality、中国、100044
- Peking University Peoples Hospital
-
Beijing、Beijing Municipality、中国、100045
- Beijing Childrens Hospital, Capital Medical University
-
-
Chongqing Municipality
-
Chongqing、Chongqing Municipality、中国、400014
- Childrens Hospital of Chongqing Medical University
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510091
- Dermatology Hospital of Southern Medical University
-
Guangzhou、Guangdong、中国、510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
-
Guangzhou、Guangdong、中国、510080
- The First Affiliated Hospital Sun-Yat Sen University
-
-
Henan
-
Nanyang、Henan、中国、473002
- Nanyang First Peoples Hospital
-
-
Hubei
-
Wuhan、Hubei、中国、430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
-
Wuhan、Hubei、中国、430014
- The Central Hospital of Wuhan
-
-
Jiangsu
-
Jiangyin、Jiangsu、中国、214400
- Jiangyin Hospital of Traditional Chinese Medicine
-
-
Jilin
-
Changchun、Jilin、中国、130021
- The First Bethune Hospital of Jilin University
-
-
Liaoning
-
Dalian、Liaoning、中国、116011
- Dalian Women and Childrens Medical Group
-
-
Ningxia
-
Yinchuan、Ningxia、中国、750003
- General Hospital of Ningxia Medical University
-
-
Shanghai Municipality
-
Shanghai、Shanghai Municipality、中国、200443
- Shanghai Skin Disease Hospital
-
-
Sichuan
-
Chengdu、Sichuan、中国、610021
- Chengdu Second Peoples Hospital
-
Suining、Sichuan、中国、629099
- Suining Central Hospital
-
-
Yunnan
-
Kunming、Yunnan、中国、650103
- Kunming Childrens Hospital
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310020
- Affiliated Hangzhou First Peoples Hospital School of Medicine Westlake University
-
Ningbo、Zhejiang、中国、315010
- Ningbo NO 2 Hospital
-
Taizhou、Zhejiang、中国、318000
- Taizhou Central Hospital
-
-
-
-
-
Kaohsiung City、台湾、83301
- Kaohsiung Chang Gung Memorial Hospital
-
Taipei、台湾、10002
- National Taiwan University Hospital
-
Taipei、台湾、11217
- Taipei Veterans General Hospital
-
Taoyuan、台湾、33305
- Linkou Chang Gung Memorial Hospital
-
-
-
-
Aichi-ken
-
Nagoya、Aichi-ken、日本、464-0821
- Central Clinic
-
-
Chiba
-
Matsudo-shi、Chiba、日本、271-0092
- Miyata Dermatology Clinic
-
-
Fukuoka
-
Fukuoka、Fukuoka、日本、819-0373
- Matsuo Clinic
-
-
Hokkaido
-
Asahikawa-shi、Hokkaido、日本、070-8610
- Asahikawa City Hospital
-
Obihiro-shi、Hokkaido、日本、080-0013
- Takagi Dermatological Clinic
-
-
Hyōgo
-
Akashi-shi、Hyōgo、日本、674-0068
- Yoshimura Child Clinic
-
-
Kagoshima-ken
-
Kagoshima、Kagoshima-ken、日本、890-0063
- Katahira Dermatology Urology Clinic
-
-
Kanagawa
-
Yokohama、Kanagawa、日本、231-8682
- Yokohama City Minato Red Cross Hospital
-
Yokohama、Kanagawa、日本、221-0825
- Nomura Dermatology Clinic
-
-
Kumamoto
-
Kumamoto、Kumamoto、日本、860-0066
- Jouzan Hihuka Hinyoukika Clinic
-
Kumamoto、Kumamoto、日本、862-0950
- Suizenji Dermatology Clinic
-
-
Osaka
-
Neyagawa、Osaka、日本、572-0838
- Yoshioka Dermatology Clinic
-
Sakai-shi、Osaka、日本、593-8324
- Dermatology and Ophthalmology Kume Clinic
-
-
Shizuoka
-
Hamamatsu、Shizuoka、日本、431-3192
- Hamamatsu University Hospital
-
-
Tokyo
-
Setagaya-ku、Tokyo、日本、158-0097
- Naoko Dermatology Clinic
-
Shinagawa-ku、Tokyo、日本、141-8625
- NTT Medical Center Tokyo
-
-
-
-
-
Ansansi, Gyeonggido、韓国、15355
- Korea University Ansan Hospital
-
Seoul、韓国、03080
- Seoul National University Hospital
-
Seoul、韓国、03722
- Severance Hospital Yonsei University Health System
-
Seoul、韓国、01830
- Nowon Eulji Medical Center, Eulji University
-
Seoul、韓国、05278
- Kyung Hee University Hospital at Gangdong
-
Seoul、韓国、06591
- The Catholic University of Korea Seoul St Marys Hospital
-
Seoul、韓国、08308
- Korea University Guro Hospital
-
Seoul、韓国、06973
- Chung-Ang University Hospital
-
Seoul、韓国、07441
- Hallym University Kangnam Sacred Heart Hospital
-
Seoul、韓国、04564
- National Medical Center
-
Seoul、韓国、07804
- Ewha Womans University Seoul Hospital
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
12年～17年 (子)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- -1日目の年齢が12歳以上から18歳未満。
- -スクリーニング時の体重が40kg以上。
- -6か月以内に中程度またはより高い効力のTCSに対する不適切な反応の履歴（TCIの有無にかかわらず）。
- -EASIスコアが16以上。
- vIGA-AD スコアが 3 以上。
- -AD関与の体表面積（BSA）が10％以上。
- 最悪のそう痒 NRS ≥ 4。
除外基準:
- -1日目の前の12週間または5半減期のいずれか長い方以内の生物学的製剤による治療。
-1日目の前の4週間または5半減期のいずれか長い方以内に、次の薬物療法または療法のいずれかによる治療：
- 全身性コルチコステロイド
- 全身性免疫抑制剤
- 光線療法
- 経口または局所ヤヌスキナーゼ阻害剤
-1日目の前の1週間以内に、次の薬物療法または治療法のいずれかによる治療：
- TCS
- TCI
- 外用ホスホジエステラーゼ4型阻害剤
- その他の外用免疫抑制剤
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：アーム A: 投与量 1
パート 1 (初期); 0週目から24週目まで：ロカチンリマブを4週間ごと（Q4W）に1回、2週目に負荷量で24週間投与（併用療法コホート内の場合は+局所コルチコステロイド（TCS）/局所カルシニューリン阻害剤（TCI））。 パート 2 (メンテナンス期間); 24週目から52週目：パート1の応答者は、24週目にロカチンリマブ1用量Q4Wまたは8週間ごと（Q8W）で28週間（併用療法コホート内の場合は+TCS/TCI）に再ランダム化されます。 |
皮下（SC）注射
他の名前：
|
|
実験的：アーム B: 投与量 2
パート 1 (初期); 0週目から24週目まで：ロカチンリマブを24週間Q4Wで2回投与し、2週目に負荷量を投与する（併用療法コホート内の場合は+TCS/TCI）。 パート 2 (メンテナンス期間); 24週目から52週目：パート1の反応者は、24週目に、ロカチンリマブの2用量を28週間Q4WまたはQ8Wに再ランダム化されます（併用療法コホート内の場合はTCS/TCIを併用）。 |
皮下（SC）注射
他の名前：
|
|
実験的：アーム C: プラセボ
パート 1 (初期); 0週目から24週目まで：プラセボQ4Wを24週間、2週目に負荷量を投与（併用療法コホート内の場合は+TCS/TCI）。 パート 2 (メンテナンス期間); 24週目から52週目：パート1の応答者は、24週目に再割り当てされ、プラセボQ4Wを28週間投与します（併用療法コホート内の場合はTCS/TCIを併用）。 |
皮下注射
|
|
実験的：アーム D: 非盲検用量 1
パート2;第２４週から第５２週：パート１の非反応者は、第２４週にロカチンリマブ非盲検用量１をＱ４Ｗで２８週間投与するよう再割り当てされる（併用療法コホート内の場合はＴＣＳ／ＴＣＩを併用）。
アーム A、B、または C 維持期間の参加者は、24 週目以降に再発した場合、ロカチンリマブ非盲検用量 1 Q4W (併用療法コホート内の場合は TCS/TCI を併用) に再割り当てされます。
|
皮下（SC）注射
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：Baseline and 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.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved EASI 75 at Week 24
時間枠：Baseline and 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.
|
Baseline and Week 24
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
時間枠：Baseline and 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.
|
Baseline and Week 16
|
|
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
時間枠：Baseline and Week 16
|
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.
|
Baseline and Week 16
|
|
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
時間枠：Baseline and Week 24
|
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.
|
Baseline and Week 24
|
|
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
時間枠：Baseline and 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 classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in POEM Score at Week 24
時間枠：Baseline and 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.
|
Baseline and Week 24
|
|
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
時間枠：Baseline and 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.
|
Baseline and Week 24
|
|
Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
時間枠：Baseline and 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.
|
Baseline and Week 16
|
|
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
時間枠：Baseline and 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 classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
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
時間枠：Baseline and 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 classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
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
時間枠：Baseline and Week 24
|
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.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved vIGA-AD 0/1 at Week 16
時間枠：Baseline and 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.
|
Baseline and Week 16
|
|
Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
時間枠：Baseline and 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.
|
Baseline and Week 16
|
|
Change From Baseline in SCORAD Itch VAS Score at Week 24
時間枠：Baseline and 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.
|
Baseline and Week 24
|
|
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
時間枠：Baseline and 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.
|
Baseline and Week 24
|
|
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
時間枠：Baseline and 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 classified as nonresponders at all subsequent time points.
|
Baseline and Week 16
|
|
Number of Participants Who Achieved vIGA-AD 0/1 at Week 24
時間枠：Baseline and 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.
|
Baseline and Week 24
|
|
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
時間枠：Baseline and Week 24
|
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.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
時間枠：Baseline and 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.
|
Baseline and Week 24
|
|
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 16
時間枠：Up to Week 16
|
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
|
Up to Week 16
|
|
Percentage of Participants Who Initiated Rescue Therapy for AD at or Before Week 24
時間枠：Up to Week 24
|
Percentage of participants who initiated rescue therapy for AD were provided by each treatment group descriptively during initiation treatment period.
|
Up to Week 24
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
時間枠：Baseline and 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.
|
Baseline and Week 16
|
|
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
時間枠：Baseline and 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.
|
Baseline and Week 24
|
|
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
時間枠：Baseline and Week 24
|
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.
|
Baseline and Week 24
|
|
Change From Baseline in DLQI Score at Week 24 For Participants ≥ 16 Years Old at Enrollment
時間枠：Baseline and Week 24
|
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.
|
Baseline and Week 24
|
|
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 24 For Participants < 16 Years Old at Enrollment
時間枠：Baseline and Week 24
|
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.
|
Baseline and Week 24
|
|
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
時間枠：Baseline and 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 classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
時間枠：Baseline and 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 classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Change From Baseline in HADS-anxiety Subscale Score at Week 24
時間枠：Baseline and 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.
|
Baseline and Week 24
|
|
Change From Baseline in HADS-depression Subscale Score at Week 24
時間枠：Baseline and 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.
|
Baseline and Week 24
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：MD、Amgen
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2023年4月20日
一次修了 (実際)
2025年2月27日
研究の完了 (実際)
2025年11月25日
試験登録日
最初に提出
2023年1月20日
QC基準を満たした最初の提出物
2023年1月20日
最初の投稿 (実際)
2023年1月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月28日
QC基準を満たした最後の更新が送信されました
2026年8月6日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 20210145
- 2022-501586-50 (その他の識別子：EUCTR)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
承認されたデータ共有リクエストで特定の研究課題に対処するために必要な変数の匿名化された個々の患者データ。
IPD 共有時間枠
この研究に関連するデータ共有リクエストは、研究が終了してから 18 か月後に開始され、1) 米国とヨーロッパの両方で製品と適応症に販売承認が付与されているか、2) 製品および/または適応症の臨床開発が中止されていると見なされます。データは規制当局に提出されません。
この調査のデータ共有リクエストを送信する資格の終了日はありません。
IPD 共有アクセス基準
有資格の研究者は、研究目的、範囲内の Amgen 製品および Amgen 研究/研究、関心のあるエンドポイント/結果、統計分析計画、データ要件、出版計画、および研究者の資格を含む要求を提出することができます。
一般に、アムジェン社は、製品ラベルですでに対処されている安全性と有効性の問題を再評価する目的で、個々の患者データに対する外部からの要求を許可しません.
要求は、内部アドバイザーの委員会によって審査されます。
承認されない場合、データ共有の独立審査委員会が仲裁を行い、最終決定を下します。
承認されると、研究課題に対処するために必要な情報が、データ共有契約の条件に基づいて提供されます。
これには、匿名化された個々の患者データおよび/または分析仕様で提供される分析コードのフラグメントを含む利用可能なサポート ドキュメントが含まれる場合があります。
詳細は下記ＵＲＬにて。
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。