En studie som vurderer Rocatinlimab i kombinasjon med aktuelle kortikosteroider og/eller lokale kalsineurinhemmere hos voksne deltakere med moderat til alvorlig atopisk dermatitt (AD) (ROCKET-SHUTTLE)
4. august 2026 oppdatert av: Amgen
En fase 3, randomisert, 24-ukers, placebokontrollert, dobbeltblind studie for å vurdere effektiviteten, sikkerheten og toleransen til Rocatinlimab (AMG 451) i kombinasjon med topikale kortikosteroider og/eller lokale kalsineurinhemmere hos voksne personer med moderat- til alvorlig atopisk dermatitt (AD) (RACKET-SHUTTLE)
De primære målene for studien er å:
- For å evaluere effekten av rocatinlimab i kombinasjon med lokal kortikosteroid og/eller lokal kalsineurinhemmer (TCS/TCI), sammenlignet med placebo i kombinasjon med TCS/TCI ved uke 24, vurdert ved bruk av Validated Investigator's Global Assessment for Atopisk Dermatitt (vIGA-AD) .
- For å evaluere effekten av rocatinlimab, i kombinasjon med TCS/TCI, sammenlignet med placebo i kombinasjon med TCS/TCI ved uke 24, vurdert ved bruk av Eczema Area and Severity Index (EASI).
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
746
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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, Australia, 2019
- Emeritus Research Sydney
-
Westmead, New South Wales, Australia, 2145
- Westmead Hospital
-
-
Queensland
-
Benowa, Queensland, Australia, 4217
- The Skin Centre
-
South Brisbane, Queensland, Australia, 4101
- Princess Alexandra Hospital
-
Woolloongabba, Queensland, Australia, 4102
- Veracity Clinical Research
-
-
Victoria
-
Camberwell, Victoria, Australia, 3124
- Emeritus Research Melbourne
-
-
-
-
-
Bruges, Belgia, 8000
- Algemeen Ziekenhuis Sint-Jan Brugge-Oostende
-
Brussels, Belgia, 1090
- Universitair Ziekenhuis Brussel
-
Brussels, Belgia, 1020
- Centre Hospitalier Universitaire Brugmann
-
Brussels, Belgia, 1200
- Universite Catholique de Louvain Cliniques Universitaires Saint Luc
-
Ghent, Belgia, 9000
- Universitair Ziekenhuis Gent
-
Herstal, Belgia, 4040
- Clinique Andre Renard
-
Kortrijk, Belgia, 8500
- Dermatologie Handelskaai
-
Leuven, Belgia, 3000
- Universitaire Ziekenhuizen Leuven Gasthuisberg
-
Liège, Belgia, 4000
- Centre Hospitalier Universitaire de Liege - Sart Tilman
-
Loverval, Belgia, 6280
- Grand Hôpital de Charleroi
-
-
-
-
-
Dupnitsa, Bulgaria, 2600
- Medical Center Asklepii OOD
-
Pleven, Bulgaria, 5800
- Medical center Medconsult Pleven OOD
-
Sofia, Bulgaria, 1407
- Medical Center Excelsior OOD
-
Sofia, Bulgaria, 1431
- Diagnostic-Consultative Center Alexandrovska EOOD
-
Sofia, Bulgaria, 1463
- Diagnostic-Consultative Center - Fokus-5 - Medical Institution for Outpatient Care OOD
-
-
-
-
Alberta
-
Calgary, Alberta, Canada, T2J 7E1
- Dermatology Research Institute Incorporated
-
Edmonton, Alberta, Canada, T5J 3S9
- Laser Rejuvenation Clinics Edmonton D T Incorporated
-
Edmonton, Alberta, Canada, T6G 1C3
- Alberta Derma Surgery Centre
-
-
British Columbia
-
Surrey, British Columbia, Canada, V3V 0C6
- Enverus Medical Research
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3M 3Z4
- Wiseman Dermatology Research Incorporated
-
-
Ontario
-
Coburg, Ontario, Canada, K9A 4J9
- Skin Health
-
London, Ontario, Canada, N6A 2C2
- Centricity Research London
-
Newmarket, Ontario, Canada, L3Y 5G8
- Dr SK Siddha Medicine Professional Corporation
-
Niagara Falls, Ontario, Canada, L2H 1H5
- Allergy Research Canada Incorporated
-
North Bay, Ontario, Canada, P1B 3Z7
- North Bay Dermatology Centre
-
Ottawa, Ontario, Canada, K2C 3N2
- Dermatology Ottawa Research Centre
-
Ottawa, Ontario, Canada, K2C 3N2
- JRB Research Incorporated
-
Richmond Hill, Ontario, Canada, L4B 1A5
- The Centre for Dermatology
-
Toronto, Ontario, Canada, M2N 3A6
- North York Research Incorporated
-
Toronto, Ontario, Canada, M3H 5Y8
- Toronto Research Centre Inc
-
Waterloo, Ontario, Canada, N2J 1C4
- Alliance Clinical Trials
-
-
Quebec
-
Montreal, Quebec, Canada, H2X 2V1
- Innovaderm Research Inc
-
Montreal, Quebec, Canada, H1Y 3L1
- Clinique de Dermatologie Rosemont
-
Québec, Quebec, Canada, G1W 4R4
- Centre de Recherche Saint-Louis
-
Québec, Quebec, Canada, G1V 4T3
- Diex Recherche Québec
-
-
Saskatchewan
-
Saskatoon, Saskatchewan, Canada, S7T 0G3
- Saskatoon Dermatology Centre
-
-
-
-
Alabama
-
Birmingham, Alabama, Forente stater, 35233
- The University of Alabama at Birmingham
-
-
Arizona
-
Phoenix, Arizona, Forente stater, 85006
- Medical Dermatology Specialists
-
Phoenix, Arizona, Forente stater, 85018
- Southwest Skin Specialists
-
Sun City West, Arizona, Forente stater, 85375
- US Dermatology Partners Sun City West
-
-
Arkansas
-
North Little Rock, Arkansas, Forente stater, 72117
- Arkansas Research Trials, LLC
-
-
California
-
Bakersfield, California, Forente stater, 93301
- Kern Research Inc
-
Los Angeles, California, Forente stater, 90056
- Wallace Medical Group Inc
-
Los Angeles, California, Forente stater, 90033
- Keck Medicine of University of Southern California
-
Palmdale, California, Forente stater, 93551
- Antelope Valley Clinical Trials
-
Sacramento, California, Forente stater, 95816
- University of California at Davis Medical Center
-
Sacramento, California, Forente stater, 95823
- Kaiser Permanente South Sacramento Medical Center
-
San Diego, California, Forente stater, 92120
- Acclaim Clinical Research
-
San Francisco, California, Forente stater, 94132
- Synergy Dermatology
-
San Francisco, California, Forente stater, 94118
- Kaiser Permanente Medical Center - Oakland
-
San Francisco, California, Forente stater, 94118
- Kaiser Permanente Medical Center - San Francisco
-
-
Florida
-
Tampa, Florida, Forente stater, 33609
- TrueBlue Clinical Research
-
Tampa, Florida, Forente stater, 33615
- Olympian Clinical Research - Tampa
-
-
Georgia
-
Alpharetta, Georgia, Forente stater, 30022
- Atlanta Dermatology, Vein and Research Center, PC
-
Atlanta, Georgia, Forente stater, 30315
- Divine Dermatology and Aesthetics
-
-
Illinois
-
Skokie, Illinois, Forente stater, 60077
- Northshore University Healthsystem
-
-
Indiana
-
Clarksville, Indiana, Forente stater, 47129
- DS Research
-
Indianapolis, Indiana, Forente stater, 46250
- Dawes Fretzin Clinical Research Group, LLC
-
-
Kansas
-
Leawood, Kansas, Forente stater, 66211
- Dermatology and Skin Cancer Center Leawood
-
-
Louisiana
-
Monroe, Louisiana, Forente stater, 71201
- Industrial Medicine Associates Clinical Research Advanced Dermatology Care
-
-
Maryland
-
Rockville, Maryland, Forente stater, 20850
- Aesthetic and Dermatology Center
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan Medical Center
-
Auburn Hills, Michigan, Forente stater, 48326
- Oakland Hills Dermatology
-
-
Nebraska
-
Lincoln, Nebraska, Forente stater, 68505
- Somnos Clinical Research
-
Omaha, Nebraska, Forente stater, 68144
- Skin Specialists PC
-
-
Nevada
-
Las Vegas, Nevada, Forente stater, 89119
- Vivida Dermatology
-
North Las Vegas, Nevada, Forente stater, 89030
- Las Vegas Clinical Trials
-
-
New Jersey
-
Hackensack, New Jersey, Forente stater, 07601
- Schweiger Dermatology Group, PC Research Division
-
-
New Mexico
-
Albuquerque, New Mexico, Forente stater, 87102
- Albuquerque Clinical Trials Incorporated
-
-
New York
-
The Bronx, New York, Forente stater, 10455
- CHEAR Center LLC
-
-
North Carolina
-
Wilmington, North Carolina, Forente stater, 28401
- Accellacare of Wilmington
-
-
Ohio
-
Bexley, Ohio, Forente stater, 43209
- Bexley Dermatology Research
-
-
Oregon
-
Medford, Oregon, Forente stater, 97504
- Velocity Clinical Research Inc
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19103
- Paddington Testing Company Inc
-
Pittsburgh, Pennsylvania, Forente stater, 15213
- University of Pittsburgh Medical Center
-
-
South Dakota
-
Rapid City, South Dakota, Forente stater, 57702
- Health Concepts
-
-
Texas
-
Austin, Texas, Forente stater, 78759
- US Dermatology Partners Jollyville
-
El Paso, Texas, Forente stater, 79925
- Newco 3A Research LLC
-
Kerrville, Texas, Forente stater, 78028
- Sante Clinical Research
-
Plano, Texas, Forente stater, 75025
- Texas Dermatology Research Center
-
-
Virginia
-
Norfolk, Virginia, Forente stater, 23502
- Virginia Dermatology and Skin Cancer Center
-
-
-
-
-
Antony, Frankrike, 92160
- Hopital Prive d Antony
-
Bordeaux, Frankrike, Cedex
- Centre Hospitalier Universitaire de Bordeaux - Hopital Saint Andre
-
Brest, Frankrike, 29200
- Centre Hospitalier Regional Universitaire Brest Hopital Morvan
-
Lille, Frankrike, 59037
- Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
-
Lorient, Frankrike, 56322
- Centre Hospitalier de Bretagne Sud - Hopital du Scorff
-
Marseille, Frankrike, 13385
- Hôpital La Timone
-
Martigues, Frankrike, 13500
- Cabinet du Docteur Ruer-Mulard Mireille
-
Nantes, Frankrike, 44093
- Centre Hospitalier Universitaire de Nantes Hôtel Dieu
-
Nice, Frankrike, 06202
- Centre Hospitalier Universitaire Archet 2
-
Paris, Frankrike, 75020
- Hôpital Tenon
-
Paris, Frankrike, 75475
- Hopital Saint Louis
-
Paris, Frankrike, 75018
- Hopital Bichat Claude Bernard
-
Reims, Frankrike, 51100
- Polyclinique de Courlancy
-
Rennes, Frankrike, 35033
- Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
-
Rouen, Frankrike, 76031
- Centre Hospitalier Universitaire de Rouen - Hopital Charles Nicolle
-
Saint-Priest-en-Jarez, Frankrike, 42270
- Centre Hospitalier Universitaire Saint Etienne Hopital Nord
-
Toulon, Frankrike, 83800
- Hopital d instruction des armees sainte anne
-
-
-
-
-
Athens, Hellas, 11525
- 401 General Military Hospital Of Athens
-
Athens, Hellas, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
-
Heraklion, Hellas, 71500
- University General Hospital of Heraklion
-
Nea Ionia, Hellas, 14233
- General Hospital Of Nea Ionia Konstantopouleio Patision
-
Piraeus, Hellas, 18536
- Geniko Nosokomeio Peiraia Tzaneio
-
Thessaloniki, Hellas, 54642
- Ippokratio General Hospital of Thessaloniki
-
-
-
-
-
Genova, Italia, 16132
- Ospedale Policlinico San Martino IRCCS
-
LAquila, Italia, 67100
- Ospedale San Salvatore
-
Roma, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
-
Rozzano MI, Italia, 20089
- IRCCS Istituto Clinico Humanitas
-
-
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 454-0803
- Fukui Dermatology Clinic
-
-
Fukuoka
-
Fukuoka, Fukuoka, Japan, 812-0013
- Ekihigashi Dermatology Allergy Clinic
-
-
Hokkaido
-
Obihiro-shi, Hokkaido, Japan, 080-0013
- Takagi Dermatological Clinic Branch
-
Sapporo, Hokkaido, Japan, 060-0063
- Medical Corporation Kojinkai Sapporo Skin Clinic
-
-
Kagoshima-ken
-
Kagoshima, Kagoshima-ken, Japan, 890-0063
- Katahira Dermatology Urology Clinic
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, Japan, 211-0063
- Kosugi Dermatology Clinic
-
Yokohama, Kanagawa, Japan, 221-0825
- Nomura Dermatology Clinic
-
-
Kumamoto
-
Kumamoto, Kumamoto, Japan, 860-0066
- Jouzan Hihuka Hinyoukika Clinic
-
Kumamoto, Kumamoto, Japan, 862-0950
- Suizenji Dermatology Clinic
-
-
Osaka
-
Neyagawa, Osaka, Japan, 572-0838
- Yoshioka Dermatology Clinic
-
-
Shizuoka
-
Hamamatsu, Shizuoka, Japan, 430-0929
- JA Shizuoka Kohseiren Enshu Hospital
-
-
Tokyo
-
Adachi-ku, Tokyo, Japan, 120-0034
- Mildix Skin Clinic
-
Setagaya-ku, Tokyo, Japan, 158-0097
- Naoko Dermatology Clinic
-
Shinagawa-ku, Tokyo, Japan, 141-8625
- NTT Medical Center Tokyo
-
Shinjuku-ku, Tokyo, Japan, 169-0075
- Yamate Dermatology Clinic
-
-
-
-
-
Beijing, Kina, 100044
- Peking University Peoples Hospital
-
Shanghai, Kina, 200443
- Shanghai Skin Disease Hospital
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100191
- Peking University Third Hospital
-
Beijing, Beijing Municipality, Kina, 100050
- Beijing Friendship hospital, Capital Medical University
-
-
Fujian
-
Fuzhou, Fujian, Kina, 350000
- The First Affiliated Hospital of Fujian Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510091
- Dermatology Hospital of Southern Medical University
-
Guangzhou, Guangdong, Kina, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
-
Guangzhou, Guangdong, Kina, 510080
- The First Affiliated Hospital ,Sun-Yat Sen University
-
Shantou, Guangdong, Kina, 515041
- The Fist Affiliated Hospital of Shantou University Medical College
-
Shenzhen, Guangdong, Kina, 518101
- Shenzhen Qianhai Shekou Free Trade Zone Hospital
-
-
Henan
-
Nanyang, Henan, Kina, 473002
- Nanyang First Peoples Hospital
-
-
Hubei
-
Wuhan, Hubei, Kina, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
-
-
Jiangsu
-
Wuxi, Jiangsu, Kina, 214001
- Wuxi Second Peoples Hospital
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330000
- Dermatology Hospital of Jiangxi Province
-
-
Jilin
-
Changchun, Jilin, Kina, 130021
- The First Hospital of Jilin University
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610017
- Chengdu Second Peoples Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
-
Hangzhou, Zhejiang, Kina, 310016
- Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine
-
Hangzhou, Zhejiang, Kina, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
-
Ningbo, Zhejiang, Kina, 315010
- The First Affiliation Hospital Of Ningbo University
-
Taizhou, Zhejiang, Kina, 318000
- Taizhou Central Hospital
-
-
-
-
Johor
-
Johor Bahru, Johor, Malaysia, 81100
- Hospital Sultan Ismail
-
-
Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, Malaysia, 50586
- Hospital Kuala Lumpur
-
Kuala Lumpur, Kuala Lumpur, Malaysia, 59100
- University Malaya Medical Centre
-
Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
- Pusat Perubatan Universiti Kebangsaan Malaysia
-
-
Perak
-
Ipoh, Perak, Malaysia, 30450
- Hospital Raja Permaisuri Bainun
-
-
Pulau Pinang
-
George Town, Pulau Pinang, Malaysia, 10990
- Hospital Pulau Pinang
-
-
Sabah
-
Kota Kinabalu, Sabah, Malaysia, 88586
- Queen Elizabeth Hospital
-
-
-
-
-
Bergen op Zoom, Nederland, 4624 VT
- Bravis Ziekenhuis
-
Groningen, Nederland, 9700 RB
- Universitair Medisch Centrum Groningen
-
Utrecht, Nederland, 3584 CX
- Universitair Medisch Centrum Utrecht
-
-
-
-
-
Chorzów, Polen, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
-
Katowice, Polen, 40-600
- GynCentrum Spzoo NZOZ Holsamed - Oddzial Libero
-
Krakow, Polen, 30-002
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski Pawel Brzewski SpCywilna
-
Lodz, Polen, 90-349
- AppleTreeClinics Network Spzoo
-
Lodz, Polen, 90-752
- Ip Clinic Sp zoo
-
Szczecin, Polen, 71-500
- Twoja Przychodnia SCM
-
Wroclaw, Polen, 51-503
- DermMedica Spzoo Centrum Columbus
-
-
-
-
-
Caguas, Puerto Rico, 00727-9507
- Doctor Samuel Sanchez PSC
-
-
-
-
-
Brasov, Romania, 500112
- Theramed Healthcare SRL
-
Cluj-Napoca, Romania, 400431
- Institutul Regional de Gastroenterologie si Hepatologie Prof Dr Octavian Fodor
-
Târgu Mureş, Romania, 540613
- Spitalul Clinic Judetean Mures
-
-
-
-
-
Singapore, Singapore, 308205
- National Skin Centre
-
Singapore, Singapore, 168753
- Singapore General Hospital
-
Singapore, Singapore, 117599
- National University Hospital
-
-
-
-
-
Bardejov, Slovakia, 085 01
- Maxderm, sro
-
Bratislava, Slovakia, 813 69
- Univerzitna nemocnica Bratislava - Nemocnica Stare Mesto
-
Prešov, Slovakia, 081 81
- Fakultna nemocnica s poliklinikou JA Reimana Presov
-
Svidník, Slovakia, 089 01
- Sanare spol sro
-
-
-
-
-
Ljubljana, Slovenia, 1000
- Univerzitetni klinicni center Ljubljana
-
Maribor, Slovenia, 2000
- Univerzitetni Klinicni Center Maribor
-
-
-
-
-
Madrid, Spania, 28041
- Hospital Universitario 12 de Octubre
-
Pontevedra, Spania, 36001
- Complexo Hospitalario Universitario de Pontevedra
-
-
Basque Country
-
Bilbao, Basque Country, Spania, 48013
- Hospital Universitario Basurto
-
-
Catalonia
-
Barcelona, Catalonia, Spania, 08036
- Hospital Clinic i Provincial de Barcelona
-
-
Valencia
-
Valencia, Valencia, Spania, 46014
- Hospital General Universitario de Valencia
-
-
-
-
-
Bath, Storbritannia, BA1 3NG
- Royal United Hospitals Bath NHS Foundation Trust
-
Dudley, Storbritannia, DY1 2HQ
- Russells Hall Hospital
-
Isleworth, Storbritannia, TW7 6AF
- West Middlesex University Hospital
-
London, Storbritannia, NW3 2PF
- The Royal Free Hospital
-
Salford, Storbritannia, M6 8HD
- Salford Care Organisation
-
Shipley, Storbritannia, BD18 3SA
- Accellacare Yorkshire
-
-
-
-
-
Bern, Sveits, 3010
- Inselspital Bern
-
Geneva, Sveits, 1211
- Hopitaux Universitaires de Geneve
-
Lausanne, Sveits, 1011
- Centre Hospitalier Universitaire Vaudois
-
Sankt Gallen, Sveits, 9007
- Kantonsspital Sankt Gallen
-
Zurich, Sveits, 8091
- Universitaetsspital Zuerich
-
-
-
-
-
Ankara, Tyrkia (Türkiye), 06800
- Ankara Bilkent Sehir Hastanesi
-
Istanbul, Tyrkia (Türkiye), 34390
- Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi
-
Istanbul, Tyrkia (Türkiye), 34662
- Acibadem Altunizade Hastanesi
-
Istanbul, Tyrkia (Türkiye), 34899
- Marmara Universitesi Tip Fakultesi Hastanesi
-
Samsun, Tyrkia (Türkiye), 55200
- Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
-
-
-
-
-
Frankfurt am Main, Tyskland, 60590
- Universitaetsklinikum Frankfurt
-
Göttingen, Tyskland, 37075
- Universitaetsmedizin Goettingen - Georg-August-Universitaet
-
Hamburg, Tyskland, 22391
- MensingDerma Research GmbH
-
Hamburg, Tyskland, 20537
- TFS Trial Form Support GmbH
-
Hanover, Tyskland, 30625
- Medizinische Hochschule Hannover
-
Hanover, Tyskland, 30159
- Hautaerzte Zentrum Hannover
-
Mainz, Tyskland, 55101
- Universitaetsmedizin Mainz
-
Memmingen, Tyskland, 87700
- Beldio Research Gmbh
-
Merzing, Tyskland, 66663
- Hautmedizin Saar
-
München, Tyskland, 80802
- Klinikum rechts der Isar der TUM
-
-
-
-
-
Budapest, Ungarn, 1036
- Obudai Egeszsegugyi Centrum Kft
-
Budapest, Ungarn, 1027
- Csalogany Orvosi Kozpont
-
Budapest, Ungarn, 1033
- Clinexpert Kft
-
Békéscsaba, Ungarn, 5600
- Trial Pharma Kft
-
Debrecen, Ungarn, 4032
- Debreceni Egyetem Klinikai Kozpont
-
Gyöngyös, Ungarn, 3200
- Gyongyosi Bugat Pal Korhaz
-
Kaposvár, Ungarn, 7400
- Somogy Varmegyei Kaposi Mor Oktato Korhaz
-
Orosháza, Ungarn, 5900
- DermaMed Research Kft
-
Szolnok, Ungarn, 5000
- Allergo-Derm Bakos Kft
-
Zalaegerszeg, Ungarn, 8900
- Obudai Egeszsegugyi Centrum Kft
-
-
-
-
-
Graz, Østerrike, 8036
- Medizinische Universitaet Graz
-
Innsbruck, Østerrike, 6020
- Medizinische Universitaet Innsbruck
-
Salzburg, Østerrike, 5020
- Landeskrankenhaus Salzburg
-
Vienna, Østerrike, 1030
- Klinik Landstrasse
-
Vienna, Østerrike, 1130
- Klinik Hietzing
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 100 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
- Alder ≥ 18 år med diagnose AD i henhold til AAD (American Academy of Dermatology) Consensus Criteria (2014) til stede i minst 6 måneder
- Anamnese med utilstrekkelig respons på TCS med middels eller høyere styrke innen 6 måneder (med eller uten TCI)
- EASI-score ≥16
- vIGA-AD-score ≥3
- ≥10 % kroppsoverflateareal (BSA) av AD-involvering
- Verste pruritus numerisk vurderingsskala ≥ 4
Ekskluderingskriterier:
- Behandling med et biologisk produkt innen 12 uker eller 5 halveringstider, avhengig av hva som er lengst, før dag 1
Behandling med noen av følgende medisiner eller terapier innen 4 uker eller 5 halveringstider, avhengig av hva som er lengst, før dag 1:
- Systemiske kortikosteroider
- Systemiske immundempende midler
- Fototerapi
- Janus kinasehemmere
Behandling med noen av følgende medisiner eller terapier innen 1 uke, før dag 1:
- TCS
- TCI
- Antikløemidler
- Aktuelle fosfodiesterase type 4-hemmere
- Andre aktuelle immunsuppressive midler
- Lokale kombinasjonsmidler inkludert TCS av en hvilken som helst styrke eller TCI, PDE4-hemmere eller andre topiske immunsuppressive midler
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Rocatinlimab Dose 1 + TCS/TCI
Rocatinlimab Dose 1 hver 4. uke (Q4W) i 24 uker + TCS/TCI + startdose ved uke 2.
|
Subkutan (SC) injeksjon
Andre navn:
|
|
Eksperimentell: Rocatinlimab Dose 2 + TCS/TCI
Rocatinlimab Dose 2 Q4W i 24 uker + TCS/TCI + startdose ved uke 2.
|
Subkutan (SC) injeksjon
Andre navn:
|
|
Placebo komparator: Placebo + TCS/TCI
Placebo Q4W i 24 uker + TCS/TCI + ladningsdose ved uke 2.
|
SC-injeksjon
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants Who Achieved EASI 75 at Week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: MD, Amgen
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. februar 2023
Primær fullføring (Faktiske)
15. september 2024
Studiet fullført (Faktiske)
4. desember 2024
Datoer for studieregistrering
Først innsendt
2. februar 2023
Først innsendt som oppfylte QC-kriteriene
2. februar 2023
Først lagt ut (Faktiske)
13. februar 2023
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. august 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 20210144
- 2022-501585-22-00 (Registeridentifikator: CTIS (EU))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Avidentifiserte individuelle pasientdata for variabler som er nødvendige for å løse det spesifikke forskningsspørsmålet i en godkjent forespørsel om datadeling.
IPD-delingstidsramme
Forespørsler om datadeling knyttet til denne studien vil bli vurdert med start 18 måneder etter at studien er avsluttet og enten 1) produktet og indikasjonen har fått markedsføringstillatelse i både USA og Europa eller 2) klinisk utvikling for produktet og/eller indikasjonen avbrytes og dataene vil ikke bli sendt til regulerende myndigheter.
Det er ingen sluttdato for kvalifisering til å sende inn en forespørsel om datadeling for denne studien.
Tilgangskriterier for IPD-deling
Kvalifiserte forskere kan sende inn en forespørsel som inneholder forskningsmålene, Amgen-produktet(e) og Amgen-studien/studiene i omfang, endepunkter/resultater av interesse, statistisk analyseplan, datakrav, publiseringsplan og kvalifikasjonene til forskeren(e).
Generelt innvilger ikke Amgen eksterne forespørsler om individuelle pasientdata med det formål å revurdere sikkerhets- og effektspørsmål som allerede er behandlet i produktmerkingen.
Forespørsler vurderes av en komité med interne rådgivere.
Hvis den ikke blir godkjent, vil et uavhengig granskningspanel for datadeling dømme og ta den endelige avgjørelsen.
Ved godkjenning vil informasjon som er nødvendig for å løse forskningsspørsmålet, gis i henhold til vilkårene i en datadelingsavtale.
Dette kan inkludere anonymiserte individuelle pasientdata og/eller tilgjengelige støttedokumenter, som inneholder fragmenter av analysekode der det er gitt i analysespesifikasjonene.
Ytterligere detaljer er tilgjengelig på URL-en nedenfor.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .