中等度から重度のアトピー性皮膚炎（AD）の成人参加者における局所コルチコステロイドおよび/または局所カルシニューリン阻害剤と組み合わせたロカチンリマブを評価する研究 (ROCKET-SHUTTLE)
2026年8月4日 更新者：Amgen
中等度の成人被験者における局所コルチコステロイドおよび/または局所カルシニューリン阻害剤と組み合わせたロカチンリマブ（AMG 451）の有効性、安全性、および忍容性を評価するための第3相、無作為化、24週間、プラセボ対照、二重盲検試験～重度のアトピー性皮膚炎 (AD) (ROCKET-SHUTTLE)
この研究の主な目的は次のとおりです。
- Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) を使用して評価された、局所コルチコステロイドおよび/または局所カルシニューリン阻害剤 (TCS/TCI) と組み合わせたロカチンリマブの有効性を、24 週目に TCS/TCI と組み合わせたプラセボと比較して評価する.
- 24 週目に、TCS/TCI と組み合わせたロカチンリマブの有効性を、TCS/TCI と組み合わせたプラセボと比較して評価し、湿疹の面積と重症度指数 (EASI) を使用して評価しました。
調査の概要
研究の種類
介入
入学 (実際)
746
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、35233
- The University of Alabama at Birmingham
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Arizona
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Phoenix、Arizona、アメリカ、85006
- Medical Dermatology Specialists
-
Phoenix、Arizona、アメリカ、85018
- Southwest Skin Specialists
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Sun City West、Arizona、アメリカ、85375
- US Dermatology Partners Sun City West
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-
Arkansas
-
North Little Rock、Arkansas、アメリカ、72117
- Arkansas Research Trials, LLC
-
-
California
-
Bakersfield、California、アメリカ、93301
- Kern Research Inc
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Los Angeles、California、アメリカ、90056
- Wallace Medical Group Inc
-
Los Angeles、California、アメリカ、90033
- Keck Medicine of University of Southern California
-
Palmdale、California、アメリカ、93551
- Antelope Valley Clinical Trials
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Sacramento、California、アメリカ、95816
- University of California at Davis Medical Center
-
Sacramento、California、アメリカ、95823
- Kaiser Permanente South Sacramento Medical Center
-
San Diego、California、アメリカ、92120
- Acclaim Clinical Research
-
San Francisco、California、アメリカ、94132
- Synergy Dermatology
-
San Francisco、California、アメリカ、94118
- Kaiser Permanente Medical Center - Oakland
-
San Francisco、California、アメリカ、94118
- Kaiser Permanente Medical Center - San Francisco
-
-
Florida
-
Tampa、Florida、アメリカ、33609
- TrueBlue Clinical Research
-
Tampa、Florida、アメリカ、33615
- Olympian Clinical Research - Tampa
-
-
Georgia
-
Alpharetta、Georgia、アメリカ、30022
- Atlanta Dermatology, Vein and Research Center, PC
-
Atlanta、Georgia、アメリカ、30315
- Divine Dermatology and Aesthetics
-
-
Illinois
-
Skokie、Illinois、アメリカ、60077
- Northshore University Healthsystem
-
-
Indiana
-
Clarksville、Indiana、アメリカ、47129
- DS Research
-
Indianapolis、Indiana、アメリカ、46250
- Dawes Fretzin Clinical Research Group, LLC
-
-
Kansas
-
Leawood、Kansas、アメリカ、66211
- Dermatology and Skin Cancer Center Leawood
-
-
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
-
-
Michigan
-
Ann Arbor、Michigan、アメリカ、48109
- University of Michigan Medical Center
-
Auburn Hills、Michigan、アメリカ、48326
- Oakland Hills Dermatology
-
-
Nebraska
-
Lincoln、Nebraska、アメリカ、68505
- Somnos Clinical Research
-
Omaha、Nebraska、アメリカ、68144
- Skin Specialists PC
-
-
Nevada
-
Las Vegas、Nevada、アメリカ、89119
- Vivida Dermatology
-
North Las Vegas、Nevada、アメリカ、89030
- Las Vegas Clinical Trials
-
-
New Jersey
-
Hackensack、New Jersey、アメリカ、07601
- Schweiger Dermatology Group, PC Research Division
-
-
New Mexico
-
Albuquerque、New Mexico、アメリカ、87102
- Albuquerque Clinical Trials Incorporated
-
-
New York
-
The Bronx、New York、アメリカ、10455
- CHEAR Center LLC
-
-
North Carolina
-
Wilmington、North Carolina、アメリカ、28401
- Accellacare of Wilmington
-
-
Ohio
-
Bexley、Ohio、アメリカ、43209
- Bexley Dermatology Research
-
-
Oregon
-
Medford、Oregon、アメリカ、97504
- Velocity Clinical Research Inc
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19103
- Paddington Testing Company Inc
-
Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh Medical Center
-
-
South Dakota
-
Rapid City、South Dakota、アメリカ、57702
- Health Concepts
-
-
Texas
-
Austin、Texas、アメリカ、78759
- US Dermatology Partners Jollyville
-
El Paso、Texas、アメリカ、79925
- Newco 3A Research LLC
-
Kerrville、Texas、アメリカ、78028
- Sante Clinical Research
-
Plano、Texas、アメリカ、75025
- Texas Dermatology Research Center
-
-
Virginia
-
Norfolk、Virginia、アメリカ、23502
- Virginia Dermatology and Skin Cancer Center
-
-
-
-
Buenos Aires
-
CABA、Buenos Aires、アルゼンチン、C1027AAP
- CINME - Centro De Investigaciones Metabolicas
-
La Plata、Buenos Aires、アルゼンチン、B1902COS
- Framingham Centro Medico
-
Ramos Mejía、Buenos Aires、アルゼンチン、1704
- DIM Clinica Privada
-
-
Distrito Federal
-
Buenos Aires、Distrito Federal、アルゼンチン、1121
- Fundacion CIDEA
-
Buenos Aires、Distrito Federal、アルゼンチン、1054
- Buenos Aires Skin SA
-
Buenos Aires、Distrito Federal、アルゼンチン、1414
- Care- Centro de Alergia y Enfermedades Respiratorias
-
Buenos Aires、Distrito Federal、アルゼンチン、1425
- Psoriahue Medicina Interdisciplinaria SRL
-
-
Santa Fe Province
-
Rosario、Santa Fe Province、アルゼンチン、2000
- Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
-
-
-
-
-
Bath、イギリス、BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
-
Dudley、イギリス、DY1 2HQ
- Russells Hall Hospital
-
Isleworth、イギリス、TW7 6AF
- West Middlesex University Hospital
-
London、イギリス、NW3 2PF
- The Royal Free Hospital
-
Salford、イギリス、M6 8HD
- Salford Care Organisation
-
Shipley、イギリス、BD18 3SA
- Accellacare Yorkshire
-
-
-
-
-
Genova、イタリア、16132
- Ospedale Policlinico San Martino IRCCS
-
LAquila、イタリア、67100
- Ospedale San Salvatore
-
Roma、イタリア、00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
-
Rozzano MI、イタリア、20089
- IRCCS Istituto Clinico Humanitas
-
-
-
-
-
Bergen op Zoom、オランダ、4624 VT
- Bravis Ziekenhuis
-
Groningen、オランダ、9700 RB
- Universitair Medisch Centrum Groningen
-
Utrecht、オランダ、3584 CX
- Universitair Medisch Centrum Utrecht
-
-
-
-
New South Wales
-
Botany、New South Wales、オーストラリア、2019
- Emeritus Research Sydney
-
Westmead、New South Wales、オーストラリア、2145
- Westmead Hospital
-
-
Queensland
-
Benowa、Queensland、オーストラリア、4217
- The Skin Centre
-
South Brisbane、Queensland、オーストラリア、4101
- Princess Alexandra Hospital
-
Woolloongabba、Queensland、オーストラリア、4102
- Veracity Clinical Research
-
-
Victoria
-
Camberwell、Victoria、オーストラリア、3124
- Emeritus Research Melbourne
-
-
-
-
-
Graz、オーストリア、8036
- Medizinische Universitaet Graz
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Innsbruck、オーストリア、6020
- Medizinische Universitaet Innsbruck
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Salzburg、オーストリア、5020
- Landeskrankenhaus Salzburg
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Vienna、オーストリア、1030
- Klinik Landstrasse
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Vienna、オーストリア、1130
- Klinik Hietzing
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-
-
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Alberta
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Calgary、Alberta、カナダ、T2J 7E1
- Dermatology Research Institute Incorporated
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Edmonton、Alberta、カナダ、T5J 3S9
- Laser Rejuvenation Clinics Edmonton D T Incorporated
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Edmonton、Alberta、カナダ、T6G 1C3
- Alberta Derma Surgery Centre
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British Columbia
-
Surrey、British Columbia、カナダ、V3V 0C6
- Enverus Medical Research
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Manitoba
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Winnipeg、Manitoba、カナダ、R3M 3Z4
- Wiseman Dermatology Research Incorporated
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Ontario
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Coburg、Ontario、カナダ、K9A 4J9
- Skin Health
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London、Ontario、カナダ、N6A 2C2
- Centricity Research London
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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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North Bay、Ontario、カナダ、P1B 3Z7
- North Bay Dermatology Centre
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Ottawa、Ontario、カナダ、K2C 3N2
- Dermatology Ottawa Research Centre
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Ottawa、Ontario、カナダ、K2C 3N2
- JRB Research Incorporated
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Richmond Hill、Ontario、カナダ、L4B 1A5
- The Centre for Dermatology
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Toronto、Ontario、カナダ、M2N 3A6
- North York Research Incorporated
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Toronto、Ontario、カナダ、M3H 5Y8
- Toronto Research Centre Inc
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Waterloo、Ontario、カナダ、N2J 1C4
- Alliance Clinical Trials
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Quebec
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Montreal、Quebec、カナダ、H2X 2V1
- Innovaderm Research Inc
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Montreal、Quebec、カナダ、H1Y 3L1
- Clinique de Dermatologie Rosemont
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Québec、Quebec、カナダ、G1W 4R4
- Centre de Recherche Saint-Louis
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Québec、Quebec、カナダ、G1V 4T3
- Diex Recherche Québec
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Saskatchewan
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Saskatoon、Saskatchewan、カナダ、S7T 0G3
- Saskatoon Dermatology Centre
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-
-
-
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Athens、ギリシャ、11525
- 401 General Military Hospital Of Athens
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Athens、ギリシャ、16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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Heraklion、ギリシャ、71500
- University General Hospital of Heraklion
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Nea Ionia、ギリシャ、14233
- General Hospital Of Nea Ionia Konstantopouleio Patision
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Piraeus、ギリシャ、18536
- Geniko Nosokomeio Peiraia Tzaneio
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Thessaloniki、ギリシャ、54642
- Ippokratio General Hospital of Thessaloniki
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-
-
-
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Singapore、シンガポール、308205
- National Skin Centre
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Singapore、シンガポール、168753
- Singapore General Hospital
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Singapore、シンガポール、117599
- National University Hospital
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-
-
-
-
Bern、スイス、3010
- Inselspital Bern
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Geneva、スイス、1211
- Hopitaux Universitaires de Geneve
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Lausanne、スイス、1011
- Centre Hospitalier Universitaire Vaudois
-
Sankt Gallen、スイス、9007
- Kantonsspital Sankt Gallen
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Zurich、スイス、8091
- Universitaetsspital Zuerich
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-
-
-
-
Madrid、スペイン、28041
- Hospital Universitario 12 de Octubre
-
Pontevedra、スペイン、36001
- Complexo Hospitalario Universitario de Pontevedra
-
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Basque Country
-
Bilbao、Basque Country、スペイン、48013
- Hospital Universitario Basurto
-
-
Catalonia
-
Barcelona、Catalonia、スペイン、08036
- Hospital Clinic i Provincial de Barcelona
-
-
Valencia
-
Valencia、Valencia、スペイン、46014
- Hospital General Universitario de Valencia
-
-
-
-
-
Bardejov、スロバキア、085 01
- Maxderm, sro
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Bratislava、スロバキア、813 69
- Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
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Prešov、スロバキア、081 81
- Fakultna nemocnica s poliklinikou JA Reimana Presov
-
Svidník、スロバキア、089 01
- Sanare spol sro
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-
-
-
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Ljubljana、スロベニア、1000
- Univerzitetni klinicni center Ljubljana
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Maribor、スロベニア、2000
- Univerzitetni Klinicni Center Maribor
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-
-
-
-
Ankara、トルコ（Türkiye）、06800
- Ankara Bilkent Sehir Hastanesi
-
Istanbul、トルコ（Türkiye）、34390
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
-
Istanbul、トルコ（Türkiye）、34662
- Acibadem Altunizade Hastanesi
-
Istanbul、トルコ（Türkiye）、34899
- Marmara Universitesi Tip Fakultesi Hastanesi
-
Samsun、トルコ（Türkiye）、55200
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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-
-
-
-
Frankfurt am Main、ドイツ、60590
- Universitaetsklinikum Frankfurt
-
Göttingen、ドイツ、37075
- Universitaetsmedizin Goettingen - Georg-August-Universitaet
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Hamburg、ドイツ、22391
- MensingDerma Research GmbH
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Hamburg、ドイツ、20537
- TFS Trial Form Support GmbH
-
Hanover、ドイツ、30625
- Medizinische Hochschule Hannover
-
Hanover、ドイツ、30159
- Hautaerzte Zentrum Hannover
-
Mainz、ドイツ、55101
- Universitaetsmedizin Mainz
-
Memmingen、ドイツ、87700
- Beldio Research Gmbh
-
Merzing、ドイツ、66663
- Hautmedizin Saar
-
München、ドイツ、80802
- Klinikum rechts der Isar der TUM
-
-
-
-
-
Budapest、ハンガリー、1036
- Obudai Egeszsegugyi Centrum Kft
-
Budapest、ハンガリー、1027
- Csalogany Orvosi Kozpont
-
Budapest、ハンガリー、1033
- Clinexpert Kft
-
Békéscsaba、ハンガリー、5600
- Trial Pharma Kft
-
Debrecen、ハンガリー、4032
- Debreceni Egyetem Klinikai Kozpont
-
Gyöngyös、ハンガリー、3200
- Gyongyosi Bugat Pal Korhaz
-
Kaposvár、ハンガリー、7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
-
Orosháza、ハンガリー、5900
- DermaMed Research Kft
-
Szolnok、ハンガリー、5000
- Allergo-Derm Bakos Kft
-
Zalaegerszeg、ハンガリー、8900
- Obudai Egeszsegugyi Centrum Kft
-
-
-
-
-
Antony、フランス、92160
- Hopital Prive d Antony
-
Bordeaux、フランス、Cedex
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
-
Brest、フランス、29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
-
Lille、フランス、59037
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
-
Lorient、フランス、56322
- Centre Hospitalier de Bretagne Sud - Hopital du Scorff
-
Marseille、フランス、13385
- Hôpital La Timone
-
Martigues、フランス、13500
- Cabinet du Docteur Ruer-Mulard Mireille
-
Nantes、フランス、44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
-
Nice、フランス、06202
- Centre Hospitalier Universitaire Archet 2
-
Paris、フランス、75020
- Hôpital Tenon
-
Paris、フランス、75475
- Hopital Saint Louis
-
Paris、フランス、75018
- Hopital Bichat Claude Bernard
-
Reims、フランス、51100
- Polyclinique de Courlancy
-
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
-
Saint-Priest-en-Jarez、フランス、42270
- Centre Hospitalier Universitaire Saint Etienne Hopital Nord
-
Toulon、フランス、83800
- Hopital d instruction des armees sainte anne
-
-
-
-
-
Dupnitsa、ブルガリア、2600
- Medical Center Asklepii OOD
-
Pleven、ブルガリア、5800
- Medical center Medconsult Pleven OOD
-
Sofia、ブルガリア、1407
- Medical Center Excelsior OOD
-
Sofia、ブルガリア、1431
- Diagnostic-Consultative Center Alexandrovska EOOD
-
Sofia、ブルガリア、1463
- Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
-
-
-
-
-
Caguas、プエルトリコ、00727-9507
- Doctor Samuel Sanchez PSC
-
-
-
-
-
Bruges、ベルギー、8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
-
Brussels、ベルギー、1090
- Universitair Ziekenhuis Brussel
-
Brussels、ベルギー、1020
- Centre Hospitalier Universitaire Brugmann
-
Brussels、ベルギー、1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
-
Ghent、ベルギー、9000
- Universitair Ziekenhuis Gent
-
Herstal、ベルギー、4040
- Clinique Andre Renard
-
Kortrijk、ベルギー、8500
- Dermatologie Handelskaai
-
Leuven、ベルギー、3000
- Universitaire Ziekenhuizen Leuven Gasthuisberg
-
Liège、ベルギー、4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
-
Loverval、ベルギー、6280
- Grand Hôpital de Charleroi
-
-
-
-
-
Chorzów、ポーランド、41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
-
Katowice、ポーランド、40-600
- GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
-
Krakow、ポーランド、30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
-
Lodz、ポーランド、90-349
- AppleTreeClinics Network Spzoo
-
Lodz、ポーランド、90-752
- Ip Clinic Sp zoo
-
Szczecin、ポーランド、71-500
- Twoja Przychodnia SCM
-
Wroclaw、ポーランド、51-503
- DermMedica Spzoo Centrum Columbus
-
-
-
-
Johor
-
Johor Bahru、Johor、マレーシア、81100
- Hospital Sultan Ismail
-
-
Kuala Lumpur
-
Kuala Lumpur、Kuala Lumpur、マレーシア、50586
- Hospital Kuala Lumpur
-
Kuala Lumpur、Kuala Lumpur、マレーシア、59100
- University Malaya Medical Centre
-
Kuala Lumpur、Kuala Lumpur、マレーシア、56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
-
-
Perak
-
Ipoh、Perak、マレーシア、30450
- Hospital Raja Permaisuri Bainun
-
-
Pulau Pinang
-
George Town、Pulau Pinang、マレーシア、10990
- Hospital Pulau Pinang
-
-
Sabah
-
Kota Kinabalu、Sabah、マレーシア、88586
- Queen Elizabeth Hospital
-
-
-
-
-
Brasov、ルーマニア、500112
- Theramed Healthcare SRL
-
Cluj-Napoca、ルーマニア、400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
-
Târgu Mureş、ルーマニア、540613
- Spitalul Clinic Judetean Mures
-
-
-
-
-
Beijing、中国、100044
- Peking University Peoples Hospital
-
Shanghai、中国、200443
- Shanghai Skin Disease Hospital
-
-
Beijing Municipality
-
Beijing、Beijing Municipality、中国、100191
- Peking University Third Hospital
-
Beijing、Beijing Municipality、中国、100050
- Beijing Friendship hospital, Capital Medical University
-
-
Fujian
-
Fuzhou、Fujian、中国、350000
- The First Affiliated Hospital of Fujian 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
-
Shantou、Guangdong、中国、515041
- The Fist Affiliated Hospital of Shantou University Medical College
-
Shenzhen、Guangdong、中国、518101
- Shenzhen Qianhai Shekou Free Trade Zone Hospital
-
-
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
-
-
Jiangsu
-
Wuxi、Jiangsu、中国、214001
- Wuxi Second Peoples Hospital
-
-
Jiangxi
-
Nanchang、Jiangxi、中国、330000
- Dermatology Hospital of Jiangxi Province
-
-
Jilin
-
Changchun、Jilin、中国、130021
- The First Hospital of Jilin University
-
-
Sichuan
-
Chengdu、Sichuan、中国、610017
- Chengdu Second Peoples Hospital
-
-
Zhejiang
-
Hangzhou、Zhejiang、中国、310003
- The First Affiliated Hospital Zhejiang University School of Medicine
-
Hangzhou、Zhejiang、中国、310016
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
-
Hangzhou、Zhejiang、中国、310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
-
Ningbo、Zhejiang、中国、315010
- The First Affiliation Hospital Of Ningbo University
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Taizhou、Zhejiang、中国、318000
- Taizhou Central Hospital
-
-
-
-
Aichi-ken
-
Nagoya、Aichi-ken、日本、454-0803
- Fukui Dermatology Clinic
-
-
Fukuoka
-
Fukuoka、Fukuoka、日本、812-0013
- Ekihigashi Dermatology Allergy Clinic
-
-
Hokkaido
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Obihiro-shi、Hokkaido、日本、080-0013
- Takagi Dermatological Clinic Branch
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Sapporo、Hokkaido、日本、060-0063
- Medical Corporation Kojinkai Sapporo Skin Clinic
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-
Kagoshima-ken
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Kagoshima、Kagoshima-ken、日本、890-0063
- Katahira Dermatology Urology Clinic
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Kanagawa
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Kawasaki-shi、Kanagawa、日本、211-0063
- Kosugi Dermatology Clinic
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Yokohama、Kanagawa、日本、221-0825
- Nomura Dermatology Clinic
-
-
Kumamoto
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Kumamoto、Kumamoto、日本、860-0066
- Jouzan Hihuka Hinyoukika Clinic
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Kumamoto、Kumamoto、日本、862-0950
- Suizenji Dermatology Clinic
-
-
Osaka
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Neyagawa、Osaka、日本、572-0838
- Yoshioka Dermatology Clinic
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Shizuoka
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Hamamatsu、Shizuoka、日本、430-0929
- JA Shizuoka Kohseiren Enshu Hospital
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Tokyo
-
Adachi-ku、Tokyo、日本、120-0034
- Mildix Skin Clinic
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Setagaya-ku、Tokyo、日本、158-0097
- Naoko Dermatology Clinic
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Shinagawa-ku、Tokyo、日本、141-8625
- NTT Medical Center Tokyo
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Shinjuku-ku、Tokyo、日本、169-0075
- Yamate Dermatology Clinic
-
-
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
18年～100年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
説明
包含基準:
- -AAD（米国皮膚科学会）によるADの診断を受けた18歳以上の年齢 合意基準（2014） 少なくとも6か月間存在する
- -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≧16
- vIGA-ADスコア≧3
- AD関与の体表面積（BSA）が10%以上
- 最悪のかゆみの数値評価尺度 ≥ 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
- 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
- 鎮痒剤
- 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
- -任意の効力のTCSまたはTCI、PDE4阻害剤、または他の局所免疫抑制剤を含む局所薬剤の併用
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：ロカチンリマブ用量 1 + TCS/TCI
ロカチンリマブを 4 週間ごとに 1 回 (Q4W) 24 週間 + TCS/TCI + 2 週目に負荷量。
|
皮下（SC）注射
他の名前：
|
|
実験的：ロカチンリマブ用量 2 + TCS/TCI
ロカチンリマブ用量 2 Q4W を 24 週間 + TCS/TCI + 2 週目に負荷用量。
|
皮下（SC）注射
他の名前：
|
|
プラセボコンパレーター：プラセボ + TCS/TCI
24 週間のプラセボ Q4W + TCS/TCI + 2 週目の負荷用量。
|
皮下注射
|
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 ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (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
|
|
Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (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
|
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 vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (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
|
|
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 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.
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 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 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
|
|
Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) With a ≥ 2-Point Reduction From Baseline (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 Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
時間枠：Baseline and Week 24
|
The severity of facial AD was assessed using the Facial AD Severity Scale (FASS).
The FASS was an instrument used to rate the overall severity of facial AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
|
Baseline and Week 24
|
|
Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline
時間枠：Baseline and Week 24
|
The severity of hand AD was assessed using the Hand Atopic Dermatitis Severity Scale (HASS).
The HASS was an instrument used to rate the overall severity of hand AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease.
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 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 adult 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
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 adult 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
|
|
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 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 a greater impact of AD.
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 a greater impact of AD.
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 a greater impact of AD.
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 impact of AD.
|
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 a greater impact of AD.
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 impact of AD.
|
Baseline and Week 24
|
|
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 ≥ 4-point Reduction From Baseline in Weekly Average of Daily 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 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
|
|
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 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
|
|
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 score 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 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 score 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 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
|
|
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 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
|
|
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 ≥ 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 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 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
|
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。
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2月21日
一次修了 (実際)
2024年9月15日
研究の完了 (実際)
2024年12月4日
試験登録日
最初に提出
2023年2月2日
QC基準を満たした最初の提出物
2023年2月2日
最初の投稿 (実際)
2023年2月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月6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4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
- 20210144
- 2022-501585-22-00 (レジストリ識別子：CTIS (EU))
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。