Studie hodnotící rocatinlimab v kombinaci s topickými kortikosteroidy a/nebo topickými inhibitory kalcineurinu u dospělých účastníků se středně těžkou až těžkou atopickou dermatitidou (AD) (ROCKET-SHUTTLE)
4. srpna 2026 aktualizováno: Amgen
Randomizovaná, 24týdenní, placebem kontrolovaná, dvojitě zaslepená studie fáze 3 k posouzení účinnosti, bezpečnosti a snášenlivosti rocatinlimabu (AMG 451) v kombinaci s topickými kortikosteroidy a/nebo topickými inhibitory kalcineurinu u dospělých pacientů se středně závažnou až těžká atopická dermatitida (AD) (ROCKET-SHUTTLE)
Koprimární cíle studie jsou:
- K vyhodnocení účinnosti rocatinlimabu v kombinaci s lokálním kortikosteroidem a/nebo lokálním inhibitorem kalcineurinu (TCS/TCI) ve srovnání s placebem v kombinaci s TCS/TCI v týdnu 24, hodnocené pomocí Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) .
- K vyhodnocení účinnosti rocatinlimabu v kombinaci s TCS/TCI ve srovnání s placebem v kombinaci s TCS/TCI v týdnu 24, hodnoceno pomocí Ekzémové oblasti a indexu závažnosti (EASI).
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
746
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
Buenos Aires
-
CABA, Buenos Aires, Argentina, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
-
La Plata, Buenos Aires, Argentina, B1902COS
- Framingham Centro Medico
-
Ramos Mejía, Buenos Aires, Argentina, 1704
- DIM Clinica Privada
-
-
Distrito Federal
-
Buenos Aires, Distrito Federal, Argentina, 1121
- Fundacion CIDEA
-
Buenos Aires, Distrito Federal, Argentina, 1054
- Buenos Aires Skin SA
-
Buenos Aires, Distrito Federal, Argentina, 1414
- Care- Centro de Alergia y Enfermedades Respiratorias
-
Buenos Aires, Distrito Federal, Argentina, 1425
- Psoriahue Medicina Interdisciplinaria SRL
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, Argentina, 2000
- Centro de Investigaciones Clinicas Instituto Especialidades De La Salud De Rosario
-
-
-
-
New South Wales
-
Botany, New South Wales, Austrálie, 2019
- Emeritus Research Sydney
-
Westmead, New South Wales, Austrálie, 2145
- Westmead Hospital
-
-
Queensland
-
Benowa, Queensland, Austrálie, 4217
- The Skin Centre
-
South Brisbane, Queensland, Austrálie, 4101
- Princess Alexandra Hospital
-
Woolloongabba, Queensland, Austrálie, 4102
- Veracity Clinical Research
-
-
Victoria
-
Camberwell, Victoria, Austrálie, 3124
- Emeritus Research Melbourne
-
-
-
-
-
Bruges, Belgie, 8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
-
Brussels, Belgie, 1090
- Universitair Ziekenhuis Brussel
-
Brussels, Belgie, 1020
- Centre Hospitalier Universitaire Brugmann
-
Brussels, Belgie, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
-
Ghent, Belgie, 9000
- Universitair Ziekenhuis Gent
-
Herstal, Belgie, 4040
- Clinique Andre Renard
-
Kortrijk, Belgie, 8500
- Dermatologie Handelskaai
-
Leuven, Belgie, 3000
- Universitaire Ziekenhuizen Leuven Gasthuisberg
-
Liège, Belgie, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
-
Loverval, Belgie, 6280
- Grand Hôpital de Charleroi
-
-
-
-
-
Dupnitsa, Bulharsko, 2600
- Medical Center Asklepii OOD
-
Pleven, Bulharsko, 5800
- Medical center Medconsult Pleven OOD
-
Sofia, Bulharsko, 1407
- Medical Center Excelsior OOD
-
Sofia, Bulharsko, 1431
- Diagnostic-Consultative Center Alexandrovska EOOD
-
Sofia, Bulharsko, 1463
- Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
-
-
-
-
-
Antony, Francie, 92160
- Hopital Prive d Antony
-
Bordeaux, Francie, Cedex
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
-
Brest, Francie, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
-
Lille, Francie, 59037
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
-
Lorient, Francie, 56322
- Centre Hospitalier de Bretagne Sud - Hopital du Scorff
-
Marseille, Francie, 13385
- Hôpital La Timone
-
Martigues, Francie, 13500
- Cabinet du Docteur Ruer-Mulard Mireille
-
Nantes, Francie, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
-
Nice, Francie, 06202
- Centre Hospitalier Universitaire Archet 2
-
Paris, Francie, 75020
- Hôpital Tenon
-
Paris, Francie, 75475
- Hopital Saint Louis
-
Paris, Francie, 75018
- Hopital Bichat Claude Bernard
-
Reims, Francie, 51100
- Polyclinique de Courlancy
-
Rennes, Francie, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
-
Rouen, Francie, 76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
-
Saint-Priest-en-Jarez, Francie, 42270
- Centre Hospitalier Universitaire Saint Etienne Hopital Nord
-
Toulon, Francie, 83800
- Hopital d instruction des armees sainte anne
-
-
-
-
-
Bergen op Zoom, Holandsko, 4624 VT
- Bravis Ziekenhuis
-
Groningen, Holandsko, 9700 RB
- Universitair Medisch Centrum Groningen
-
Utrecht, Holandsko, 3584 CX
- Universitair Medisch Centrum Utrecht
-
-
-
-
-
Genova, Itálie, 16132
- Ospedale Policlinico San Martino IRCCS
-
LAquila, Itálie, 67100
- Ospedale San Salvatore
-
Roma, Itálie, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
-
Rozzano MI, Itálie, 20089
- IRCCS Istituto Clinico Humanitas
-
-
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japonsko, 454-0803
- Fukui Dermatology Clinic
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japonsko, 812-0013
- Ekihigashi Dermatology Allergy Clinic
-
-
Hokkaido
-
Obihiro-shi, Hokkaido, Japonsko, 080-0013
- Takagi Dermatological Clinic Branch
-
Sapporo, Hokkaido, Japonsko, 060-0063
- Medical Corporation Kojinkai Sapporo Skin Clinic
-
-
Kagoshima-ken
-
Kagoshima, Kagoshima-ken, Japonsko, 890-0063
- Katahira Dermatology Urology Clinic
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, Japonsko, 211-0063
- Kosugi Dermatology Clinic
-
Yokohama, Kanagawa, Japonsko, 221-0825
- Nomura Dermatology Clinic
-
-
Kumamoto
-
Kumamoto, Kumamoto, Japonsko, 860-0066
- Jouzan Hihuka Hinyoukika Clinic
-
Kumamoto, Kumamoto, Japonsko, 862-0950
- Suizenji Dermatology Clinic
-
-
Osaka
-
Neyagawa, Osaka, Japonsko, 572-0838
- Yoshioka Dermatology Clinic
-
-
Shizuoka
-
Hamamatsu, Shizuoka, Japonsko, 430-0929
- JA Shizuoka Kohseiren Enshu Hospital
-
-
Tokyo
-
Adachi-ku, Tokyo, Japonsko, 120-0034
- Mildix Skin Clinic
-
Setagaya-ku, Tokyo, Japonsko, 158-0097
- Naoko Dermatology Clinic
-
Shinagawa-ku, Tokyo, Japonsko, 141-8625
- NTT Medical Center Tokyo
-
Shinjuku-ku, Tokyo, Japonsko, 169-0075
- Yamate Dermatology Clinic
-
-
-
-
Alberta
-
Calgary, Alberta, Kanada, T2J 7E1
- Dermatology Research Institute Incorporated
-
Edmonton, Alberta, Kanada, T5J 3S9
- Laser Rejuvenation Clinics Edmonton D T Incorporated
-
Edmonton, Alberta, Kanada, T6G 1C3
- Alberta Derma Surgery Centre
-
-
British Columbia
-
Surrey, British Columbia, Kanada, V3V 0C6
- Enverus Medical Research
-
-
Manitoba
-
Winnipeg, Manitoba, Kanada, R3M 3Z4
- Wiseman Dermatology Research Incorporated
-
-
Ontario
-
Coburg, Ontario, Kanada, K9A 4J9
- Skin Health
-
London, Ontario, Kanada, N6A 2C2
- Centricity Research London
-
Newmarket, Ontario, Kanada, L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
-
Niagara Falls, Ontario, Kanada, L2H 1H5
- Allergy Research Canada Incorporated
-
North Bay, Ontario, Kanada, P1B 3Z7
- North Bay Dermatology Centre
-
Ottawa, Ontario, Kanada, K2C 3N2
- Dermatology Ottawa Research Centre
-
Ottawa, Ontario, Kanada, K2C 3N2
- JRB Research Incorporated
-
Richmond Hill, Ontario, Kanada, L4B 1A5
- The Centre for Dermatology
-
Toronto, Ontario, Kanada, M2N 3A6
- North York Research Incorporated
-
Toronto, Ontario, Kanada, M3H 5Y8
- Toronto Research Centre Inc
-
Waterloo, Ontario, Kanada, N2J 1C4
- Alliance Clinical Trials
-
-
Quebec
-
Montreal, Quebec, Kanada, H2X 2V1
- Innovaderm Research Inc
-
Montreal, Quebec, Kanada, H1Y 3L1
- Clinique de Dermatologie Rosemont
-
Québec, Quebec, Kanada, G1W 4R4
- Centre de Recherche Saint-Louis
-
Québec, Quebec, Kanada, G1V 4T3
- Diex Recherche Québec
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Kanada, S7T 0G3
- Saskatoon Dermatology Centre
-
-
-
-
Johor
-
Johor Bahru, Johor, Malajsie, 81100
- Hospital Sultan Ismail
-
-
Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, Malajsie, 50586
- Hospital Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, Malajsie, 59100
- University Malaya Medical Centre
-
Kuala Lumpur, Kuala Lumpur, Malajsie, 56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
-
-
Perak
-
Ipoh, Perak, Malajsie, 30450
- Hospital Raja Permaisuri Bainun
-
-
Pulau Pinang
-
George Town, Pulau Pinang, Malajsie, 10990
- Hospital Pulau Pinang
-
-
Sabah
-
Kota Kinabalu, Sabah, Malajsie, 88586
- Queen Elizabeth Hospital
-
-
-
-
-
Budapest, Maďarsko, 1036
- Obudai Egeszsegugyi Centrum Kft
-
Budapest, Maďarsko, 1027
- Csalogany Orvosi Kozpont
-
Budapest, Maďarsko, 1033
- Clinexpert Kft
-
Békéscsaba, Maďarsko, 5600
- Trial Pharma Kft
-
Debrecen, Maďarsko, 4032
- Debreceni Egyetem Klinikai Kozpont
-
Gyöngyös, Maďarsko, 3200
- Gyongyosi Bugat Pal Korhaz
-
Kaposvár, Maďarsko, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
-
Orosháza, Maďarsko, 5900
- DermaMed Research Kft
-
Szolnok, Maďarsko, 5000
- Allergo-Derm Bakos Kft
-
Zalaegerszeg, Maďarsko, 8900
- Obudai Egeszsegugyi Centrum Kft
-
-
-
-
-
Frankfurt am Main, Německo, 60590
- Universitaetsklinikum Frankfurt
-
Göttingen, Německo, 37075
- Universitaetsmedizin Goettingen - Georg-August-Universitaet
-
Hamburg, Německo, 22391
- MensingDerma Research GmbH
-
Hamburg, Německo, 20537
- TFS Trial Form Support GmbH
-
Hanover, Německo, 30625
- Medizinische Hochschule Hannover
-
Hanover, Německo, 30159
- Hautaerzte Zentrum Hannover
-
Mainz, Německo, 55101
- Universitaetsmedizin Mainz
-
Memmingen, Německo, 87700
- Beldio Research Gmbh
-
Merzing, Německo, 66663
- Hautmedizin Saar
-
München, Německo, 80802
- Klinikum rechts der Isar der TUM
-
-
-
-
-
Chorzów, Polsko, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
-
Katowice, Polsko, 40-600
- GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
-
Krakow, Polsko, 30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
-
Lodz, Polsko, 90-349
- AppleTreeClinics Network Spzoo
-
Lodz, Polsko, 90-752
- Ip Clinic Sp zoo
-
Szczecin, Polsko, 71-500
- Twoja Przychodnia SCM
-
Wroclaw, Polsko, 51-503
- DermMedica Spzoo Centrum Columbus
-
-
-
-
-
Caguas, Portoriko, 00727-9507
- Doctor Samuel Sanchez PSC
-
-
-
-
-
Graz, Rakousko, 8036
- Medizinische Universitaet Graz
-
Innsbruck, Rakousko, 6020
- Medizinische Universitaet Innsbruck
-
Salzburg, Rakousko, 5020
- Landeskrankenhaus Salzburg
-
Vienna, Rakousko, 1030
- Klinik Landstrasse
-
Vienna, Rakousko, 1130
- Klinik Hietzing
-
-
-
-
-
Brasov, Rumunsko, 500112
- Theramed Healthcare SRL
-
Cluj-Napoca, Rumunsko, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
-
Târgu Mureş, Rumunsko, 540613
- Spitalul Clinic Judetean Mures
-
-
-
-
-
Singapore, Singapur, 308205
- National Skin Centre
-
Singapore, Singapur, 168753
- Singapore General Hospital
-
Singapore, Singapur, 117599
- National University Hospital
-
-
-
-
-
Bardejov, Slovensko, 085 01
- Maxderm, sro
-
Bratislava, Slovensko, 813 69
- Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
-
Prešov, Slovensko, 081 81
- Fakultna nemocnica s poliklinikou JA Reimana Presov
-
Svidník, Slovensko, 089 01
- Sanare spol sro
-
-
-
-
-
Ljubljana, Slovinsko, 1000
- Univerzitetni klinicni center Ljubljana
-
Maribor, Slovinsko, 2000
- Univerzitetni Klinicni Center Maribor
-
-
-
-
-
Bath, Spojené království, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
-
Dudley, Spojené království, DY1 2HQ
- Russells Hall Hospital
-
Isleworth, Spojené království, TW7 6AF
- West Middlesex University Hospital
-
London, Spojené království, NW3 2PF
- The Royal Free Hospital
-
Salford, Spojené království, M6 8HD
- Salford Care Organisation
-
Shipley, Spojené království, BD18 3SA
- Accellacare Yorkshire
-
-
-
-
Alabama
-
Birmingham, Alabama, Spojené státy, 35233
- The University of Alabama at Birmingham
-
-
Arizona
-
Phoenix, Arizona, Spojené státy, 85006
- Medical Dermatology Specialists
-
Phoenix, Arizona, Spojené státy, 85018
- Southwest Skin Specialists
-
Sun City West, Arizona, Spojené státy, 85375
- US Dermatology Partners Sun City West
-
-
Arkansas
-
North Little Rock, Arkansas, Spojené státy, 72117
- Arkansas Research Trials, LLC
-
-
California
-
Bakersfield, California, Spojené státy, 93301
- Kern Research Inc
-
Los Angeles, California, Spojené státy, 90056
- Wallace Medical Group Inc
-
Los Angeles, California, Spojené státy, 90033
- Keck Medicine of University of Southern California
-
Palmdale, California, Spojené státy, 93551
- Antelope Valley Clinical Trials
-
Sacramento, California, Spojené státy, 95816
- University of California at Davis Medical Center
-
Sacramento, California, Spojené státy, 95823
- Kaiser Permanente South Sacramento Medical Center
-
San Diego, California, Spojené státy, 92120
- Acclaim Clinical Research
-
San Francisco, California, Spojené státy, 94132
- Synergy Dermatology
-
San Francisco, California, Spojené státy, 94118
- Kaiser Permanente Medical Center - Oakland
-
San Francisco, California, Spojené státy, 94118
- Kaiser Permanente Medical Center - San Francisco
-
-
Florida
-
Tampa, Florida, Spojené státy, 33609
- TrueBlue Clinical Research
-
Tampa, Florida, Spojené státy, 33615
- Olympian Clinical Research - Tampa
-
-
Georgia
-
Alpharetta, Georgia, Spojené státy, 30022
- Atlanta Dermatology, Vein and Research Center, PC
-
Atlanta, Georgia, Spojené státy, 30315
- Divine Dermatology and Aesthetics
-
-
Illinois
-
Skokie, Illinois, Spojené státy, 60077
- Northshore University Healthsystem
-
-
Indiana
-
Clarksville, Indiana, Spojené státy, 47129
- DS Research
-
Indianapolis, Indiana, Spojené státy, 46250
- Dawes Fretzin Clinical Research Group, LLC
-
-
Kansas
-
Leawood, Kansas, Spojené státy, 66211
- Dermatology and Skin Cancer Center Leawood
-
-
Louisiana
-
Monroe, Louisiana, Spojené státy, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
-
-
Maryland
-
Rockville, Maryland, Spojené státy, 20850
- Aesthetic and Dermatology Center
-
-
Michigan
-
Ann Arbor, Michigan, Spojené státy, 48109
- University of Michigan Medical Center
-
Auburn Hills, Michigan, Spojené státy, 48326
- Oakland Hills Dermatology
-
-
Nebraska
-
Lincoln, Nebraska, Spojené státy, 68505
- Somnos Clinical Research
-
Omaha, Nebraska, Spojené státy, 68144
- Skin Specialists PC
-
-
Nevada
-
Las Vegas, Nevada, Spojené státy, 89119
- Vivida Dermatology
-
North Las Vegas, Nevada, Spojené státy, 89030
- Las Vegas Clinical Trials
-
-
New Jersey
-
Hackensack, New Jersey, Spojené státy, 07601
- Schweiger Dermatology Group, PC Research Division
-
-
New Mexico
-
Albuquerque, New Mexico, Spojené státy, 87102
- Albuquerque Clinical Trials Incorporated
-
-
New York
-
The Bronx, New York, Spojené státy, 10455
- CHEAR Center LLC
-
-
North Carolina
-
Wilmington, North Carolina, Spojené státy, 28401
- Accellacare of Wilmington
-
-
Ohio
-
Bexley, Ohio, Spojené státy, 43209
- Bexley Dermatology Research
-
-
Oregon
-
Medford, Oregon, Spojené státy, 97504
- Velocity Clinical Research Inc
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Spojené státy, 19103
- Paddington Testing Company Inc
-
Pittsburgh, Pennsylvania, Spojené státy, 15213
- University of Pittsburgh Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Spojené státy, 57702
- Health Concepts
-
-
Texas
-
Austin, Texas, Spojené státy, 78759
- US Dermatology Partners Jollyville
-
El Paso, Texas, Spojené státy, 79925
- Newco 3A Research LLC
-
Kerrville, Texas, Spojené státy, 78028
- Sante Clinical Research
-
Plano, Texas, Spojené státy, 75025
- Texas Dermatology Research Center
-
-
Virginia
-
Norfolk, Virginia, Spojené státy, 23502
- Virginia Dermatology and Skin Cancer Center
-
-
-
-
-
Ankara, Turecko (Türkiye), 06800
- Ankara Bilkent Sehir Hastanesi
-
Istanbul, Turecko (Türkiye), 34390
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
-
Istanbul, Turecko (Türkiye), 34662
- Acibadem Altunizade Hastanesi
-
Istanbul, Turecko (Türkiye), 34899
- Marmara Universitesi Tip Fakultesi Hastanesi
-
Samsun, Turecko (Türkiye), 55200
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
-
-
-
-
-
Beijing, Čína, 100044
- Peking University Peoples Hospital
-
Shanghai, Čína, 200443
- Shanghai Skin Disease Hospital
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Čína, 100191
- Peking University Third Hospital
-
Beijing, Beijing Municipality, Čína, 100050
- Beijing Friendship hospital, Capital Medical University
-
-
Fujian
-
Fuzhou, Fujian, Čína, 350000
- The First Affiliated Hospital of Fujian Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, Čína, 510091
- Dermatology Hospital of Southern Medical University
-
Guangzhou, Guangdong, Čína, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
-
Guangzhou, Guangdong, Čína, 510080
- The First Affiliated Hospital ,Sun-Yat Sen University
-
Shantou, Guangdong, Čína, 515041
- The Fist Affiliated Hospital of Shantou University Medical College
-
Shenzhen, Guangdong, Čína, 518101
- Shenzhen Qianhai Shekou Free Trade Zone Hospital
-
-
Henan
-
Nanyang, Henan, Čína, 473002
- Nanyang First Peoples Hospital
-
-
Hubei
-
Wuhan, Hubei, Čína, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
-
-
Jiangsu
-
Wuxi, Jiangsu, Čína, 214001
- Wuxi Second Peoples Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, Čína, 330000
- Dermatology Hospital of Jiangxi Province
-
-
Jilin
-
Changchun, Jilin, Čína, 130021
- The First Hospital of Jilin University
-
-
Sichuan
-
Chengdu, Sichuan, Čína, 610017
- Chengdu Second Peoples Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, Čína, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
-
Hangzhou, Zhejiang, Čína, 310016
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
-
Hangzhou, Zhejiang, Čína, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
-
Ningbo, Zhejiang, Čína, 315010
- The First Affiliation Hospital Of Ningbo University
-
Taizhou, Zhejiang, Čína, 318000
- Taizhou Central Hospital
-
-
-
-
-
Athens, Řecko, 11525
- 401 General Military Hospital Of Athens
-
Athens, Řecko, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
-
Heraklion, Řecko, 71500
- University General Hospital of Heraklion
-
Nea Ionia, Řecko, 14233
- General Hospital Of Nea Ionia Konstantopouleio Patision
-
Piraeus, Řecko, 18536
- Geniko Nosokomeio Peiraia Tzaneio
-
Thessaloniki, Řecko, 54642
- Ippokratio General Hospital of Thessaloniki
-
-
-
-
-
Madrid, Španělsko, 28041
- Hospital Universitario 12 de Octubre
-
Pontevedra, Španělsko, 36001
- Complexo Hospitalario Universitario de Pontevedra
-
-
Basque Country
-
Bilbao, Basque Country, Španělsko, 48013
- Hospital Universitario Basurto
-
-
Catalonia
-
Barcelona, Catalonia, Španělsko, 08036
- Hospital Clinic i Provincial de Barcelona
-
-
Valencia
-
Valencia, Valencia, Španělsko, 46014
- Hospital General Universitario de Valencia
-
-
-
-
-
Bern, Švýcarsko, 3010
- Inselspital Bern
-
Geneva, Švýcarsko, 1211
- Hopitaux Universitaires de Geneve
-
Lausanne, Švýcarsko, 1011
- Centre Hospitalier Universitaire Vaudois
-
Sankt Gallen, Švýcarsko, 9007
- Kantonsspital Sankt Gallen
-
Zurich, Švýcarsko, 8091
- Universitaetsspital Zuerich
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 100 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria pro zařazení:
- Věk ≥ 18 let s diagnózou AD podle AAD (American Academy of Dermatology) Consensus Criteria (2014) přítomnou alespoň 6 měsíců
- Anamnéza nedostatečné odpovědi na TCS střední nebo vyšší účinnosti během 6 měsíců (s nebo bez TCI)
- EASI skóre ≥16
- vIGA-AD skóre ≥3
- ≥10 % tělesného povrchu (BSA) postižení AD
- Numerická hodnotící stupnice nejhoršího pruritu ≥ 4
Kritéria vyloučení:
- Léčba biologickým přípravkem do 12 týdnů nebo 5 poločasů, podle toho, co je delší, před 1. dnem
Léčba kterýmkoli z následujících léků nebo terapií během 4 týdnů nebo 5 poločasů, podle toho, co je delší, před 1. dnem:
- Systémové kortikosteroidy
- Systémová imunosupresiva
- Fototerapie
- Inhibitory Janus kinázy
Léčba kterýmkoli z následujících léků nebo terapií během 1 týdne před 1. dnem:
- TCS
- TCI
- Činidla proti svědění
- Lokální inhibitory fosfodiesterázy typu 4
- Další lokální imunosupresiva
- Kombinované topické látky včetně TCS jakékoli účinnosti nebo TCI, inhibitory PDE4 nebo jiné topické imunosupresivní látky
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Rocatinlimab dávka 1 + TCS/TCI
Rocatinlimab Dávka 1 každé 4 týdny (Q4W) po dobu 24 týdnů + TCS/TCI + nasycovací dávka v týdnu 2.
|
Subkutánní (SC) injekce
Ostatní jména:
|
|
Experimentální: Rocatinlimab dávka 2 + TCS/TCI
Rocatinlimab Dávka 2 Q4W po dobu 24 týdnů + TCS/TCI + nasycovací dávka v týdnu 2.
|
Subkutánní (SC) injekce
Ostatní jména:
|
|
Komparátor placeba: Placebo + TCS/TCI
Placebo Q4W po dobu 24 týdnů + TCS/TCI + nasycovací dávka v týdnu 2.
|
SC injekce
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Ředitel studie: MD, Amgen
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
21. února 2023
Primární dokončení (Aktuální)
15. září 2024
Dokončení studie (Aktuální)
4. prosince 2024
Termíny zápisu do studia
První předloženo
2. února 2023
První předloženo, které splnilo kritéria kontroly kvality
2. února 2023
První zveřejněno (Aktuální)
13. února 2023
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
6. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
4. srpna 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 20210144
- 2022-501585-22-00 (Identifikátor registru: CTIS (EU))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Ve schválené žádosti o sdílení dat byly odstraněny údaje o jednotlivých pacientech pro proměnné nezbytné k řešení konkrétní výzkumné otázky.
Časový rámec sdílení IPD
Žádosti o sdílení údajů týkající se této studie budou posuzovány počínaje 18 měsíci po ukončení studie a buď 1) přípravku a indikaci bylo uděleno povolení k uvedení na trh v USA i Evropě, nebo 2) klinický vývoj produktu a/nebo indikace bude ukončen a údaje nebudou předloženy regulačním orgánům.
Neexistuje žádné konečné datum pro způsobilost k odeslání žádosti o sdílení údajů pro tuto studii.
Kritéria přístupu pro sdílení IPD
Kvalifikovaní výzkumní pracovníci mohou předložit žádost obsahující cíle výzkumu, produkt(y) Amgen a studii/studie Amgen v rozsahu, sledované sledované cíle/výsledky, plán statistické analýzy, požadavky na data, plán publikace a kvalifikaci výzkumného pracovníka(ů).
Společnost Amgen obecně neschvaluje externí žádosti o údaje o jednotlivých pacientech za účelem přehodnocení otázek bezpečnosti a účinnosti, které již byly popsány v označení produktu.
Žádosti posuzuje komise interních poradců.
Pokud nebude schválen, rozhodne nezávislý kontrolní panel sdílení dat a učiní konečné rozhodnutí.
Po schválení budou poskytnuty informace nezbytné k řešení výzkumné otázky za podmínek dohody o sdílení dat.
To může zahrnovat anonymizované údaje o jednotlivých pacientech a/nebo dostupné podpůrné dokumenty obsahující fragmenty kódu analýzy, pokud jsou uvedeny ve specifikacích analýzy.
Další podrobnosti jsou k dispozici na níže uvedené adrese URL.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .