중등도에서 중증의 아토피성 피부염(AD) 성인 참가자를 대상으로 국소 코르티코스테로이드 및/또는 국소 칼시뉴린 억제제와 함께 Rocatinlimab을 평가하는 연구 (ROCKET-SHUTTLE)
2026년 8월 4일 업데이트: Amgen
중등도의 성인 피험자에서 국소 코르티코스테로이드 및/또는 국소 칼시뉴린 억제제와 병용한 Rocatinlimab(AMG 451)의 효능, 안전성 및 내약성을 평가하기 위한 3상, 무작위, 24주, 위약 대조, 이중 맹검 연구 중증 아토피성 피부염(AD)(ROCKET-SHUTTLE)
연구의 공동 목적은 다음과 같습니다.
- 국소 코르티코스테로이드 및/또는 국소 칼시뉴린 억제제(TCS/TCI)와 병용한 로카틴리맙의 효능을 24주차에 TCS/TCI와 병용한 위약과 비교하여 검증된 조사자의 아토피성 피부염에 대한 글로벌 평가(vIGA-AD)를 사용하여 평가했습니다. .
- 24주차에 TCS/TCI와 병용한 로카틴리맙의 효능을 TCS/TCI와 병용한 위약과 비교하여 Eczema Area and Severity Index(EASI)를 사용하여 평가했습니다.
연구 개요
연구 유형
중재적
등록 (실제)
746
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Athens, 그리스, 11525
- 401 General Military Hospital Of Athens
-
Athens, 그리스, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
-
Heraklion, 그리스, 71500
- University General Hospital of Heraklion
-
Nea Ionia, 그리스, 14233
- General Hospital Of Nea Ionia Konstantopouleio Patision
-
Piraeus, 그리스, 18536
- Geniko Nosokomeio Peiraia Tzaneio
-
Thessaloniki, 그리스, 54642
- Ippokratio General Hospital of Thessaloniki
-
-
-
-
-
Bergen op Zoom, 네덜란드, 4624 VT
- Bravis Ziekenhuis
-
Groningen, 네덜란드, 9700 RB
- Universitair Medisch Centrum Groningen
-
Utrecht, 네덜란드, 3584 CX
- Universitair Medisch Centrum Utrecht
-
-
-
-
-
Frankfurt am Main, 독일, 60590
- Universitaetsklinikum Frankfurt
-
Göttingen, 독일, 37075
- Universitaetsmedizin Goettingen - Georg-August-Universitaet
-
Hamburg, 독일, 22391
- MensingDerma Research GmbH
-
Hamburg, 독일, 20537
- TFS Trial Form Support GmbH
-
Hanover, 독일, 30625
- Medizinische Hochschule Hannover
-
Hanover, 독일, 30159
- Hautaerzte Zentrum Hannover
-
Mainz, 독일, 55101
- Universitaetsmedizin Mainz
-
Memmingen, 독일, 87700
- Beldio Research Gmbh
-
Merzing, 독일, 66663
- Hautmedizin Saar
-
München, 독일, 80802
- Klinikum rechts der Isar der TUM
-
-
-
-
-
Brasov, 루마니아, 500112
- Theramed Healthcare SRL
-
Cluj-Napoca, 루마니아, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
-
Târgu Mureş, 루마니아, 540613
- Spitalul Clinic Judetean Mures
-
-
-
-
Johor
-
Johor Bahru, Johor, 말레이시아, 81100
- Hospital Sultan Ismail
-
-
Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, 말레이시아, 50586
- Hospital Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, 말레이시아, 59100
- University Malaya Medical Centre
-
Kuala Lumpur, Kuala Lumpur, 말레이시아, 56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
-
-
Perak
-
Ipoh, Perak, 말레이시아, 30450
- Hospital Raja Permaisuri Bainun
-
-
Pulau Pinang
-
George Town, Pulau Pinang, 말레이시아, 10990
- Hospital Pulau Pinang
-
-
Sabah
-
Kota Kinabalu, Sabah, 말레이시아, 88586
- Queen Elizabeth Hospital
-
-
-
-
Alabama
-
Birmingham, Alabama, 미국, 35233
- The University of Alabama at Birmingham
-
-
Arizona
-
Phoenix, Arizona, 미국, 85006
- Medical Dermatology Specialists
-
Phoenix, Arizona, 미국, 85018
- Southwest Skin Specialists
-
Sun City West, Arizona, 미국, 85375
- US Dermatology Partners Sun City West
-
-
Arkansas
-
North Little Rock, Arkansas, 미국, 72117
- Arkansas Research Trials, LLC
-
-
California
-
Bakersfield, California, 미국, 93301
- Kern Research Inc
-
Los Angeles, California, 미국, 90056
- Wallace Medical Group Inc
-
Los Angeles, California, 미국, 90033
- Keck Medicine of University of Southern California
-
Palmdale, California, 미국, 93551
- Antelope Valley Clinical Trials
-
Sacramento, California, 미국, 95816
- University of California at Davis Medical Center
-
Sacramento, California, 미국, 95823
- Kaiser Permanente South Sacramento Medical Center
-
San Diego, California, 미국, 92120
- Acclaim Clinical Research
-
San Francisco, California, 미국, 94132
- Synergy Dermatology
-
San Francisco, California, 미국, 94118
- Kaiser Permanente Medical Center - Oakland
-
San Francisco, California, 미국, 94118
- Kaiser Permanente Medical Center - San Francisco
-
-
Florida
-
Tampa, Florida, 미국, 33609
- TrueBlue Clinical Research
-
Tampa, Florida, 미국, 33615
- Olympian Clinical Research - Tampa
-
-
Georgia
-
Alpharetta, Georgia, 미국, 30022
- Atlanta Dermatology, Vein and Research Center, PC
-
Atlanta, Georgia, 미국, 30315
- Divine Dermatology and Aesthetics
-
-
Illinois
-
Skokie, Illinois, 미국, 60077
- Northshore University Healthsystem
-
-
Indiana
-
Clarksville, Indiana, 미국, 47129
- DS Research
-
Indianapolis, Indiana, 미국, 46250
- Dawes Fretzin Clinical Research Group, LLC
-
-
Kansas
-
Leawood, Kansas, 미국, 66211
- Dermatology and Skin Cancer Center Leawood
-
-
Louisiana
-
Monroe, Louisiana, 미국, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
-
-
Maryland
-
Rockville, Maryland, 미국, 20850
- Aesthetic and Dermatology Center
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48109
- University of Michigan Medical Center
-
Auburn Hills, Michigan, 미국, 48326
- Oakland Hills Dermatology
-
-
Nebraska
-
Lincoln, Nebraska, 미국, 68505
- Somnos Clinical Research
-
Omaha, Nebraska, 미국, 68144
- Skin Specialists PC
-
-
Nevada
-
Las Vegas, Nevada, 미국, 89119
- Vivida Dermatology
-
North Las Vegas, Nevada, 미국, 89030
- Las Vegas Clinical Trials
-
-
New Jersey
-
Hackensack, New Jersey, 미국, 07601
- Schweiger Dermatology Group, PC Research Division
-
-
New Mexico
-
Albuquerque, New Mexico, 미국, 87102
- Albuquerque Clinical Trials Incorporated
-
-
New York
-
The Bronx, New York, 미국, 10455
- CHEAR Center LLC
-
-
North Carolina
-
Wilmington, North Carolina, 미국, 28401
- Accellacare of Wilmington
-
-
Ohio
-
Bexley, Ohio, 미국, 43209
- Bexley Dermatology Research
-
-
Oregon
-
Medford, Oregon, 미국, 97504
- Velocity Clinical Research Inc
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19103
- Paddington Testing Company Inc
-
Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, 미국, 57702
- Health Concepts
-
-
Texas
-
Austin, Texas, 미국, 78759
- US Dermatology Partners Jollyville
-
El Paso, Texas, 미국, 79925
- Newco 3A Research LLC
-
Kerrville, Texas, 미국, 78028
- Sante Clinical Research
-
Plano, Texas, 미국, 75025
- Texas Dermatology Research Center
-
-
Virginia
-
Norfolk, Virginia, 미국, 23502
- Virginia Dermatology and Skin Cancer Center
-
-
-
-
-
Bruges, 벨기에, 8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
-
Brussels, 벨기에, 1090
- Universitair Ziekenhuis Brussel
-
Brussels, 벨기에, 1020
- Centre Hospitalier Universitaire Brugmann
-
Brussels, 벨기에, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
-
Ghent, 벨기에, 9000
- Universitair Ziekenhuis Gent
-
Herstal, 벨기에, 4040
- Clinique Andre Renard
-
Kortrijk, 벨기에, 8500
- Dermatologie Handelskaai
-
Leuven, 벨기에, 3000
- Universitaire Ziekenhuizen Leuven Gasthuisberg
-
Liège, 벨기에, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
-
Loverval, 벨기에, 6280
- Grand Hôpital de Charleroi
-
-
-
-
-
Dupnitsa, 불가리아, 2600
- Medical Center Asklepii OOD
-
Pleven, 불가리아, 5800
- Medical center Medconsult Pleven OOD
-
Sofia, 불가리아, 1407
- Medical Center Excelsior OOD
-
Sofia, 불가리아, 1431
- Diagnostic-Consultative Center Alexandrovska EOOD
-
Sofia, 불가리아, 1463
- Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
-
-
-
-
-
Bern, 스위스, 3010
- Inselspital Bern
-
Geneva, 스위스, 1211
- Hopitaux Universitaires de Geneve
-
Lausanne, 스위스, 1011
- Centre Hospitalier Universitaire Vaudois
-
Sankt Gallen, 스위스, 9007
- Kantonsspital Sankt Gallen
-
Zurich, 스위스, 8091
- Universitaetsspital Zuerich
-
-
-
-
-
Madrid, 스페인, 28041
- Hospital Universitario 12 de Octubre
-
Pontevedra, 스페인, 36001
- Complexo Hospitalario Universitario de Pontevedra
-
-
Basque Country
-
Bilbao, Basque Country, 스페인, 48013
- Hospital Universitario Basurto
-
-
Catalonia
-
Barcelona, Catalonia, 스페인, 08036
- Hospital Clinic i Provincial de Barcelona
-
-
Valencia
-
Valencia, Valencia, 스페인, 46014
- Hospital General Universitario de Valencia
-
-
-
-
-
Bardejov, 슬로바키아, 085 01
- Maxderm, sro
-
Bratislava, 슬로바키아, 813 69
- Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
-
Prešov, 슬로바키아, 081 81
- Fakultna nemocnica s poliklinikou JA Reimana Presov
-
Svidník, 슬로바키아, 089 01
- Sanare spol sro
-
-
-
-
-
Ljubljana, 슬로베니아, 1000
- Univerzitetni klinicni center Ljubljana
-
Maribor, 슬로베니아, 2000
- Univerzitetni Klinicni Center Maribor
-
-
-
-
-
Singapore, 싱가포르, 308205
- National Skin Centre
-
Singapore, 싱가포르, 168753
- Singapore General Hospital
-
Singapore, 싱가포르, 117599
- National University Hospital
-
-
-
-
Buenos Aires
-
CABA, Buenos Aires, 아르헨티나, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
-
La Plata, Buenos Aires, 아르헨티나, B1902COS
- Framingham Centro Medico
-
Ramos Mejía, Buenos Aires, 아르헨티나, 1704
- DIM Clinica Privada
-
-
Distrito Federal
-
Buenos Aires, Distrito Federal, 아르헨티나, 1121
- Fundacion CIDEA
-
Buenos Aires, Distrito Federal, 아르헨티나, 1054
- Buenos Aires Skin SA
-
Buenos Aires, Distrito Federal, 아르헨티나, 1414
- Care- Centro de Alergia y Enfermedades Respiratorias
-
Buenos Aires, Distrito Federal, 아르헨티나, 1425
- Psoriahue Medicina Interdisciplinaria SRL
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, 아르헨티나, 2000
- Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
-
-
-
-
-
Bath, 영국, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
-
Dudley, 영국, DY1 2HQ
- Russells Hall Hospital
-
Isleworth, 영국, TW7 6AF
- West Middlesex University Hospital
-
London, 영국, NW3 2PF
- The Royal Free Hospital
-
Salford, 영국, M6 8HD
- Salford Care Organisation
-
Shipley, 영국, BD18 3SA
- Accellacare Yorkshire
-
-
-
-
-
Graz, 오스트리아, 8036
- Medizinische Universitaet Graz
-
Innsbruck, 오스트리아, 6020
- Medizinische Universitaet Innsbruck
-
Salzburg, 오스트리아, 5020
- Landeskrankenhaus Salzburg
-
Vienna, 오스트리아, 1030
- Klinik Landstrasse
-
Vienna, 오스트리아, 1130
- Klinik Hietzing
-
-
-
-
-
Genova, 이탈리아, 16132
- Ospedale Policlinico San Martino IRCCS
-
LAquila, 이탈리아, 67100
- Ospedale San Salvatore
-
Roma, 이탈리아, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
-
Rozzano MI, 이탈리아, 20089
- IRCCS Istituto Clinico Humanitas
-
-
-
-
Aichi-ken
-
Nagoya, Aichi-ken, 일본, 454-0803
- Fukui Dermatology Clinic
-
-
Fukuoka
-
Fukuoka, Fukuoka, 일본, 812-0013
- Ekihigashi Dermatology Allergy Clinic
-
-
Hokkaido
-
Obihiro-shi, Hokkaido, 일본, 080-0013
- Takagi Dermatological Clinic Branch
-
Sapporo, Hokkaido, 일본, 060-0063
- Medical Corporation Kojinkai Sapporo Skin Clinic
-
-
Kagoshima-ken
-
Kagoshima, Kagoshima-ken, 일본, 890-0063
- Katahira Dermatology Urology Clinic
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, 일본, 211-0063
- Kosugi Dermatology Clinic
-
Yokohama, Kanagawa, 일본, 221-0825
- Nomura Dermatology Clinic
-
-
Kumamoto
-
Kumamoto, Kumamoto, 일본, 860-0066
- Jouzan Hihuka Hinyoukika Clinic
-
Kumamoto, Kumamoto, 일본, 862-0950
- Suizenji Dermatology Clinic
-
-
Osaka
-
Neyagawa, Osaka, 일본, 572-0838
- Yoshioka Dermatology Clinic
-
-
Shizuoka
-
Hamamatsu, Shizuoka, 일본, 430-0929
- JA Shizuoka Kohseiren Enshu Hospital
-
-
Tokyo
-
Adachi-ku, Tokyo, 일본, 120-0034
- Mildix Skin Clinic
-
Setagaya-ku, Tokyo, 일본, 158-0097
- Naoko Dermatology Clinic
-
Shinagawa-ku, Tokyo, 일본, 141-8625
- NTT Medical Center Tokyo
-
Shinjuku-ku, Tokyo, 일본, 169-0075
- Yamate Dermatology Clinic
-
-
-
-
-
Beijing, 중국, 100044
- Peking University Peoples Hospital
-
Shanghai, 중국, 200443
- Shanghai Skin Disease Hospital
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, 중국, 100191
- Peking University Third Hospital
-
Beijing, Beijing Municipality, 중국, 100050
- Beijing Friendship hospital, Capital Medical University
-
-
Fujian
-
Fuzhou, Fujian, 중국, 350000
- The First Affiliated Hospital of Fujian Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510091
- Dermatology Hospital of Southern Medical University
-
Guangzhou, Guangdong, 중국, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
-
Guangzhou, Guangdong, 중국, 510080
- The First Affiliated Hospital ,Sun-Yat Sen University
-
Shantou, Guangdong, 중국, 515041
- The Fist Affiliated Hospital of Shantou University Medical College
-
Shenzhen, Guangdong, 중국, 518101
- Shenzhen Qianhai Shekou Free Trade Zone Hospital
-
-
Henan
-
Nanyang, Henan, 중국, 473002
- Nanyang First Peoples Hospital
-
-
Hubei
-
Wuhan, Hubei, 중국, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
-
-
Jiangsu
-
Wuxi, Jiangsu, 중국, 214001
- Wuxi Second Peoples Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, 중국, 330000
- Dermatology Hospital of Jiangxi Province
-
-
Jilin
-
Changchun, Jilin, 중국, 130021
- The First Hospital of Jilin University
-
-
Sichuan
-
Chengdu, Sichuan, 중국, 610017
- Chengdu Second Peoples Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
-
Hangzhou, Zhejiang, 중국, 310016
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
-
Hangzhou, Zhejiang, 중국, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
-
Ningbo, Zhejiang, 중국, 315010
- The First Affiliation Hospital Of Ningbo University
-
Taizhou, Zhejiang, 중국, 318000
- Taizhou Central Hospital
-
-
-
-
Alberta
-
Calgary, Alberta, 캐나다, T2J 7E1
- Dermatology Research Institute Incorporated
-
Edmonton, Alberta, 캐나다, T5J 3S9
- Laser Rejuvenation Clinics Edmonton D T Incorporated
-
Edmonton, Alberta, 캐나다, T6G 1C3
- Alberta Derma Surgery Centre
-
-
British Columbia
-
Surrey, British Columbia, 캐나다, V3V 0C6
- Enverus Medical Research
-
-
Manitoba
-
Winnipeg, Manitoba, 캐나다, R3M 3Z4
- Wiseman Dermatology Research Incorporated
-
-
Ontario
-
Coburg, Ontario, 캐나다, K9A 4J9
- Skin Health
-
London, Ontario, 캐나다, N6A 2C2
- Centricity Research London
-
Newmarket, Ontario, 캐나다, L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
-
Niagara Falls, Ontario, 캐나다, L2H 1H5
- Allergy Research Canada Incorporated
-
North Bay, Ontario, 캐나다, P1B 3Z7
- North Bay Dermatology Centre
-
Ottawa, Ontario, 캐나다, K2C 3N2
- Dermatology Ottawa Research Centre
-
Ottawa, Ontario, 캐나다, K2C 3N2
- JRB Research Incorporated
-
Richmond Hill, Ontario, 캐나다, L4B 1A5
- The Centre for Dermatology
-
Toronto, Ontario, 캐나다, M2N 3A6
- North York Research Incorporated
-
Toronto, Ontario, 캐나다, M3H 5Y8
- Toronto Research Centre Inc
-
Waterloo, Ontario, 캐나다, N2J 1C4
- Alliance Clinical Trials
-
-
Quebec
-
Montreal, Quebec, 캐나다, H2X 2V1
- Innovaderm Research Inc
-
Montreal, Quebec, 캐나다, H1Y 3L1
- Clinique de Dermatologie Rosemont
-
Québec, Quebec, 캐나다, G1W 4R4
- Centre de Recherche Saint-Louis
-
Québec, Quebec, 캐나다, G1V 4T3
- Diex Recherche Québec
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, 캐나다, S7T 0G3
- Saskatoon Dermatology Centre
-
-
-
-
-
Ankara, 터키 (Türkiye), 06800
- Ankara Bilkent Sehir Hastanesi
-
Istanbul, 터키 (Türkiye), 34390
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
-
Istanbul, 터키 (Türkiye), 34662
- Acibadem Altunizade Hastanesi
-
Istanbul, 터키 (Türkiye), 34899
- Marmara Universitesi Tip Fakultesi Hastanesi
-
Samsun, 터키 (Türkiye), 55200
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
-
-
-
-
-
Chorzów, 폴란드, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
-
Katowice, 폴란드, 40-600
- GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
-
Krakow, 폴란드, 30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
-
Lodz, 폴란드, 90-349
- AppleTreeClinics Network Spzoo
-
Lodz, 폴란드, 90-752
- Ip Clinic Sp zoo
-
Szczecin, 폴란드, 71-500
- Twoja Przychodnia SCM
-
Wroclaw, 폴란드, 51-503
- DermMedica Spzoo Centrum Columbus
-
-
-
-
-
Caguas, 푸에르토 리코, 00727-9507
- Doctor Samuel Sanchez PSC
-
-
-
-
-
Antony, 프랑스, 92160
- Hopital Prive d Antony
-
Bordeaux, 프랑스, Cedex
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
-
Brest, 프랑스, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
-
Lille, 프랑스, 59037
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
-
Lorient, 프랑스, 56322
- Centre Hospitalier de Bretagne Sud - Hopital du Scorff
-
Marseille, 프랑스, 13385
- Hôpital La Timone
-
Martigues, 프랑스, 13500
- Cabinet du Docteur Ruer-Mulard Mireille
-
Nantes, 프랑스, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
-
Nice, 프랑스, 06202
- Centre Hospitalier Universitaire Archet 2
-
Paris, 프랑스, 75020
- Hôpital Tenon
-
Paris, 프랑스, 75475
- Hopital Saint Louis
-
Paris, 프랑스, 75018
- Hopital Bichat Claude Bernard
-
Reims, 프랑스, 51100
- Polyclinique de Courlancy
-
Rennes, 프랑스, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
-
Rouen, 프랑스, 76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
-
Saint-Priest-en-Jarez, 프랑스, 42270
- Centre Hospitalier Universitaire Saint Etienne Hopital Nord
-
Toulon, 프랑스, 83800
- Hopital d instruction des armees sainte anne
-
-
-
-
-
Budapest, 헝가리, 1036
- Obudai Egeszsegugyi Centrum Kft
-
Budapest, 헝가리, 1027
- Csalogany Orvosi Kozpont
-
Budapest, 헝가리, 1033
- Clinexpert Kft
-
Békéscsaba, 헝가리, 5600
- Trial Pharma Kft
-
Debrecen, 헝가리, 4032
- Debreceni Egyetem Klinikai Kozpont
-
Gyöngyös, 헝가리, 3200
- Gyongyosi Bugat Pal Korhaz
-
Kaposvár, 헝가리, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
-
Orosháza, 헝가리, 5900
- DermaMed Research Kft
-
Szolnok, 헝가리, 5000
- Allergo-Derm Bakos Kft
-
Zalaegerszeg, 헝가리, 8900
- Obudai Egeszsegugyi Centrum Kft
-
-
-
-
New South Wales
-
Botany, New South Wales, 호주, 2019
- Emeritus Research Sydney
-
Westmead, New South Wales, 호주, 2145
- Westmead Hospital
-
-
Queensland
-
Benowa, Queensland, 호주, 4217
- The Skin Centre
-
South Brisbane, Queensland, 호주, 4101
- Princess Alexandra Hospital
-
Woolloongabba, Queensland, 호주, 4102
- Veracity Clinical Research
-
-
Victoria
-
Camberwell, Victoria, 호주, 3124
- Emeritus Research Melbourne
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- AAD(American Academy of Dermatology) 합의 기준(2014)에 따라 AD 진단을 받은 18세 이상의 연령이 최소 6개월 동안 존재
- 6개월 이내에 중간 또는 더 높은 효능의 TCS에 대한 부적절한 반응의 이력(TCI 유무에 관계없이)
- EASI 점수 ≥16
- vIGA-AD 점수 ≥3
- AD 침범의 ≥10% 체표면적(BSA)
- 최악의 가려움증 수치 등급 척도 ≥ 4
제외 기준:
- 1일 이전에 12주 또는 5 반감기 중 더 긴 기간 내에 생물학적 제제로 치료
1일 이전에 4주 또는 5 반감기 중 더 긴 기간 내에 다음 약물 또는 요법 중 하나로 치료:
- 전신 코르티코스테로이드
- 전신 면역억제제
- 광선 요법
- 야누스 키나제 억제제
1일 전, 1주일 이내에 다음 약물 또는 요법 중 하나로 치료:
- TCS
- TCI
- 항소양제
- 국소 포스포디에스테라제 4형 억제제
- 기타 국소 면역억제제
- 모든 효능의 TCS 또는 TCI, PDE4 억제제 또는 기타 국소 면역억제제를 포함한 복합 국소제
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 로카틴리맙 용량 1 + TCS/TCI
24주 동안 4주마다(Q4W) Rocatinlimab 용량 1 + TCS/TCI + 2주차 부하 용량.
|
피하(SC) 주사
다른 이름들:
|
|
실험적: 로카틴리맙 용량 2 + TCS/TCI
24주 동안 Rocatinlimab 용량 2 Q4W + TCS/TCI + 2주차 부하 용량.
|
피하(SC) 주사
다른 이름들:
|
|
위약 비교기: 위약 + TCS/TCI
24주 동안 위약 Q4W + TCS/TCI + 2주차 부하 용량.
|
SC 주입
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 연구 책임자: MD, Amgen
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2023년 2월 21일
기본 완료 (실제)
2024년 9월 15일
연구 완료 (실제)
2024년 12월 4일
연구 등록 날짜
최초 제출
2023년 2월 2일
QC 기준을 충족하는 최초 제출
2023년 2월 2일
처음 게시됨 (실제)
2023년 2월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 6일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 4일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20210144
- 2022-501585-22-00 (레지스트리 식별자: CTIS (EU))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
승인된 데이터 공유 요청에서 특정 연구 질문을 해결하는 데 필요한 변수에 대해 식별되지 않은 개별 환자 데이터.
IPD 공유 기간
이 연구와 관련된 데이터 공유 요청은 연구가 종료되고 1) 제품 및 적응증이 미국과 유럽 모두에서 시판 허가를 받았거나 2) 제품 및/또는 적응증에 대한 임상 개발이 중단된 후 18개월부터 고려됩니다. 데이터는 규제 당국에 제출되지 않습니다.
이 연구에 대한 데이터 공유 요청을 제출할 수 있는 자격에 대한 종료 날짜는 없습니다.
IPD 공유 액세스 기준
자격을 갖춘 연구원은 연구 목표, 범위 내 Amgen 제품 및 Amgen 연구/연구, 종점/관심 결과, 통계 분석 계획, 데이터 요구 사항, 출판 계획 및 연구원 자격을 포함하는 요청을 제출할 수 있습니다.
일반적으로 Amgen은 제품 라벨링에서 이미 언급된 안전성 및 효능 문제를 재평가할 목적으로 개별 환자 데이터에 대한 외부 요청을 허용하지 않습니다.
요청은 내부 고문 위원회에서 검토합니다.
승인되지 않은 경우 데이터 공유 독립 검토 패널이 중재하고 최종 결정을 내립니다.
승인되면 연구 질문을 해결하는 데 필요한 정보가 데이터 공유 계약 조건에 따라 제공됩니다.
여기에는 익명화된 개별 환자 데이터 및/또는 분석 사양에 제공된 분석 코드의 일부를 포함하는 사용 가능한 지원 문서가 포함될 수 있습니다.
자세한 내용은 아래 URL에서 확인할 수 있습니다.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .