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Studie hodnotící Rocatinlimab u středně těžké až těžké atopické dermatitidy (ROCKET-IGNITE) (ROCKET-Ignite)

25. června 2026 aktualizováno: Amgen

Fáze 3, 24týdenní, randomizovaná, placebem kontrolovaná, dvojitě zaslepená studie k posouzení účinnosti, bezpečnosti a snášenlivosti rocatinlimabu (AMG 451) v monoterapii u dospělých pacientů se středně těžkou až těžkou atopickou dermatitidou (AD)

Účelem této studie je zhodnotit účinnost a bezpečnost rocatinlimabu v monoterapeutické léčbě.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

769

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

  • Argentina
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1027AAP
        • Cinme - Centro de Investigaciones Metabolicas
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1426ABP
        • Fundacion Respirar
      • Derqui, Pilar, Buenos Aires, Argentina, B1629ODT
        • Hospital Universitario Austral
      • San Miguel, Buenos Aires, Argentina, 1663
        • Centro Dermatologico Schejtman
    • Distrito Federal
      • Buenos Aires, Distrito Federal, Argentina, 1425
        • Instituto de Neumonologia y Dermatologia
      • Buenos Aires, Distrito Federal, Argentina, 1425
        • InAER - Investigaciones en Alergia y Enfermedades Respiratorias
      • CABA, Distrito Federal, Argentina, C1012AAY
        • Conexa Investigacion Clinica SA
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Fundacion Estudios Clinicos
      • Rosario, Santa Fe Province, Argentina, 2000
        • Instituto de Diagnostico Abc American British Cowdray
  • Brazílie
      • Rio de Janeiro, Brazílie, 20241-180
        • IBPClin Instituto Brasil de Pesquisa Clinica
      • São Paulo, Brazílie, 06454-010
        • Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazílie, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazílie, 90160-093
        • Hospital Ernesto Dornelles
    • São Paulo
      • Botucatu, São Paulo, Brazílie, 18618-686
        • Upeclin-Pesq Clin FacMed Botucatu
      • Santo André, São Paulo, Brazílie, 09060-870
        • Fundacao Abc - Centro Univ Fmabc
      • Santo André, São Paulo, Brazílie, 09030-010
        • Hosp e Maternidade Dr Christovao da Gama
      • Sorocaba, São Paulo, Brazílie, 18040-425
        • Consultoria Medica e Pesquisa Clinica Cmpc
  • Chorvatsko
      • Ivanić-Grad, Chorvatsko, 10310
        • Special Hospital for Medical Rehabilitation Naftalan
      • Zagreb, Chorvatsko, 10000
        • University Hospital Centre Zagreb
      • Zagreb, Chorvatsko, 10000
        • Sestre milosrdnice University Hospital Center
  • Holandsko
      • Born, Holandsko, 6121 XK
        • PreCare Trial and Recruitment
  • Itálie
      • Chieti, Itálie, 66100
        • Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
      • Milan, Itálie, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Perugia, Itálie, 06156
        • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
      • Roma, Itálie, 00161
        • Azienda Ospedaliera Policlinico Umberto I
      • Torino, Itálie, 10126
        • Azienda Ospedaliera Citta della Salute e della Scienza di Torino
  • Japonsko
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Japonsko, 480-1195
        • Aichi Medical University Hospital
      • Nagoya, Aichi-ken, Japonsko, 467-8602
        • Nagoya City University Hospital
      • Nagoya, Aichi-ken, Japonsko, 464-0821
        • Central Clinic
      • Nagoya, Aichi-ken, Japonsko, 457-8510
        • Japan Community Healthcare Organization Chukyo Hospital
    • Fukuoka
      • Fukuoka, Fukuoka, Japonsko, 819-0373
        • Matsuo Clinic
      • Fukuoka, Fukuoka, Japonsko, 814-0180
        • Fukuoka University Hospital
    • Fukushima
      • Fukushima, Fukushima, Japonsko, 960-1295
        • Fukushima Medical University Hospital
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japonsko, 070-8610
        • Asahikawa City Hospital
    • Ibaraki
      • Inashiki-gun, Ibaraki, Japonsko, 300-0395
        • Tokyo Medical University Ibaraki Medical Center
    • Ishikawa-ken
      • Nonoichi-shi, Ishikawa-ken, Japonsko, 921-8801
        • Kaji Dermatology Clinic
    • Iwate
      • Morioka, Iwate, Japonsko, 020-8505
        • Iwate Medical University Uchimaru Medical Center
    • Kagawa-ken
      • Marugame-shi, Kagawa-ken, Japonsko, 763-0074
        • Takeoka Dermatology Clinic
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japonsko, 211-8533
        • Nippon Medical School Musashikosugi Hospital
    • Kyoto
      • Kyoto, Kyoto, Japonsko, 607-8062
        • Rakuwakai Otowa Hospital
      • Kyoto, Kyoto, Japonsko, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
    • Osaka
      • Izumiotsu-shi, Osaka, Japonsko, 595-0025
        • Mochida Dermatology Clinic
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japonsko, 321-0293
        • Dokkyo Medical University Hospital
    • Tokyo
      • Itabashi-ku, Tokyo, Japonsko, 173-8610
        • Nihon University Itabashi Hospital
      • Itabashi-ku, Tokyo, Japonsko, 173-8606
        • Teikyo University Hospital
  • Jižní Korea
      • Ansansi, Gyeonggido, Jižní Korea, 15355
        • Korea University Ansan Hospital
      • Incheon, Jižní Korea, 21431
        • The Catholic University of Korea Incheon St Marys Hospital
      • Seoul, Jižní Korea, 03080
        • Seoul National University Hospital
      • Seoul, Jižní Korea, 05505
        • Asan Medical Center
      • Seoul, Jižní Korea, 08308
        • Korea University Guro Hospital
      • Seoul, Jižní Korea, 04564
        • National Medical Center
  • Kanada
    • Alberta
      • Edmonton, Alberta, Kanada, T6G 1C3
        • Alberta Derma Surgery Centre
      • Edmonton, Alberta, Kanada, T6H 4J8
        • Vida Clinical Research
    • Ontario
      • Ajax, Ontario, Kanada, L1S 7K8
        • CCA Medical Research Corporation
      • Barrie, Ontario, Kanada, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Centre
      • Hamilton, Ontario, Kanada, L8L 3C3
        • LEADER Research
      • Mississauga, Ontario, Kanada, L4Y 4C5
        • DermEdge Research Incorporated
      • North York, Ontario, Kanada, M3B 3S6
        • Gordon Sussman Clinical Research Incorporated
      • North York, Ontario, Kanada, M3B 0A7
        • Canadian Dermatology Centre
      • Richmond Hill, Ontario, Kanada, L4E 4L6
        • Oak Ridges Aesthetics Centre
    • Quebec
      • Montreal, Quebec, Kanada, H2X 2V1
        • Innovaderm Research Inc
      • Québec, Quebec, Kanada, G1G 3Y8
        • Recherche Clinique Sigma Incorporated
    • Saskatchewan
      • Saskatoon, Saskatchewan, Kanada, S7K 2C1
        • Skinsense Medical Research
  • Lotyšsko
      • Riga, Lotyšsko, 1003
        • Outpatient clinic Veselibas Centrs 4
      • Riga, Lotyšsko, LV-1013
        • Outpatient clinic Veselibascentrs 4
      • Talsi, Lotyšsko, 3201
        • Smite Aija practice in dermatology and venerology
  • Maďarsko
      • Veszprém, Maďarsko, 8200
        • Medmare Bt
  • Německo
      • Berlin, Německo, 10117
        • Charite - Universitaetsmedizin Berlin, Campus Mitte
      • Blankenfelde-Mahlow, Německo, 15831
        • Dermatologische Gemeinschaftspraxis-Mahlow
      • Bochum, Německo, 44793
        • Hautarztpraxis Dr Niesmann und Dr Othlinghaus
      • Darmstadt, Německo, 64283
        • Rosenpark Research GmbH
      • Dresden, Německo, 01307
        • Universitaetsklinikum Dresden
      • Düsseldorf, Německo, 40225
        • Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
      • Essen, Německo, 45174
        • Universitaetsklinikum Essen
      • Hamburg, Německo, 20246
        • Institute for Health Services Research in Dermatology and Nursing
      • Heidelberg, Německo, 69120
        • Universitaetsklinikum Heidelberg
      • Stuttgart, Německo, 70178
        • Hautarztpraxis Dres Leitz und Kollegen
      • Tübingen, Německo, 72076
        • Universitaetsklinikum Tuebingen
      • Wuppertal, Německo, 42287
        • CentroDerm GmbH
  • Polsko
      • Gdansk, Polsko, 80-280
        • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
      • Katowice, Polsko, 40-611
        • Centrum Medyczne Angelius Provita
      • Lublin, Polsko, 20-080
        • Centrum Zdrowia i Urody Maxxmed
      • Malbork, Polsko, 82-200
        • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
      • Nowa Sól, Polsko, 67-100
        • Twoja przychodnia Ncm
      • Poznan, Polsko, 61-293
        • Twoja przychodnia Pcm
      • Szczecin, Polsko, 71-500
        • Twoja Przychodnia SCM
      • Tarnów, Polsko, 33-100
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
      • Warsaw, Polsko, 02-962
        • Royalderm Agnieszka Nawrocka
      • Wroclaw, Polsko, 50-450
        • Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
  • Portoriko
      • San Juan, Portoriko, 00909
        • Clinical Research of Puerto Rico
  • Portugalsko
      • Lisbon, Portugalsko, 1998-018
        • Hospital Cuf Descobertas
      • Lisbon, Portugalsko, 1500-458
        • Hospital Lusiadas Lisboa
      • Matosinhos Municipality, Portugalsko, 4464-513
        • Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
      • Porto, Portugalsko, 4099-001
        • Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
  • Slovensko
      • Banská Bystrica, Slovensko, 975 17
        • Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
      • Bratislava, Slovensko, 851 01
        • Derma therapy, spol s ro
      • Svidník, Slovensko, 089 01
        • Sanare spol sro
      • Topoľčany, Slovensko, 955 01
        • Kaderma Majtan, sro
      • Trnava, Slovensko, 917 75
        • Fakultna nemocnica Trnava
  • Spojené státy
    • Alabama
      • Birmingham, Alabama, Spojené státy, 35244
        • Cahaba Dermatology and Skin Health Center
    • Arizona
      • Phoenix, Arizona, Spojené státy, 85032
        • Alliance Dermatology and Mohs Center
    • California
      • Anaheim, California, Spojené státy, 92801
        • Anaheim Clinical Trials
      • Fountain Valley, California, Spojené státy, 92708
        • First OC Dermatology
      • Glendale, California, Spojené státy, 91203
        • Kaiser Permanente - Glendale Medical Center
      • Long Beach, California, Spojené státy, 90805
        • Long Beach Research Institute
      • Los Angeles, California, Spojené státy, 90045
        • Dermatology Research Associates
      • Los Angeles, California, Spojené státy, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Sherman Oaks, California, Spojené státy, 91403
        • Cura Clinical Research
    • Colorado
      • Centennial, Colorado, Spojené státy, 80112
        • IMMUNOe Research Centers
    • Florida
      • Boca Raton, Florida, Spojené státy, 33486
        • Skin Care Research Incorporated
      • Delray Beach, Florida, Spojené státy, 33484
        • Palm Beach Dermatology Group
      • Homestead, Florida, Spojené státy, 33030
        • Global Research Associates
      • Miami, Florida, Spojené státy, 33175
        • Healthy Life Research
      • Miami Lakes, Florida, Spojené státy, 33014
        • Savin Medical Group LLC
      • Naples, Florida, Spojené státy, 34102
        • Kirsch Dermatology LLC
      • Orlando, Florida, Spojené státy, 32819
        • Pure Skin Dermatology and Aesthetics
      • St. Petersburg, Florida, Spojené státy, 33709
        • Industrial Medicine Associates Ima Clinical Research Inc
      • Tampa, Florida, Spojené státy, 33606
        • Genesis Clinical Research LLC
    • Idaho
      • Boise, Idaho, Spojené státy, 83706
        • Treasure Valley Medical Research
    • Illinois
      • Chicago, Illinois, Spojené státy, 60611
        • DeNova Research
      • West Dundee, Illinois, Spojené státy, 60118
        • Dundee Dermatology
    • Indiana
      • Plainfield, Indiana, Spojené státy, 46168
        • The Indiana Clinical Trials Center PC
    • Maryland
      • Chevy Chase, Maryland, Spojené státy, 20815
        • Institute for Asthma and Allergy
      • Towson, Maryland, Spojené státy, 21204
        • Continental Clinical Solutions, LLC
    • Michigan
      • Detroit, Michigan, Spojené státy, 48202
        • Henry Ford Health System
      • Flint, Michigan, Spojené státy, 48532
        • Onyx Clinical Research
    • Missouri
      • Lee's Summit, Missouri, Spojené státy, 64064
        • Dermatology and Skin Cancer Center of Lees Summit
    • Nevada
      • Las Vegas, Nevada, Spojené státy, 89106
        • Jubilee Clinical Research Inc
    • New Hampshire
      • Portsmouth, New Hampshire, Spojené státy, 03801
        • Allcutis Research, Llc - Portsmouth
    • New Jersey
      • Cherry Hill, New Jersey, Spojené státy, 08034
        • Continental Clinical Solutions - Cherry Hill
    • New York
      • Hartsdale, New York, Spojené státy, 10530
        • Industrial Medicine Associates Ima Clinical Research Inc
      • New York, New York, Spojené státy, 10075
        • Sadick Research Group
    • North Carolina
      • Charlotte, North Carolina, Spojené státy, 28277
        • Dermatology Specialists of Charlotte
      • Charlotte, North Carolina, Spojené státy, 28277
        • Onsite Clinical Solutions
      • Wilmington, North Carolina, Spojené státy, 28405
        • Wilmington Dermatology Center
      • Winston-Salem, North Carolina, Spojené státy, 27103
        • The Skin Surgery Center for Clinical Research
    • Ohio
      • Boardman, Ohio, Spojené státy, 44512
        • Optima Research
      • Columbus, Ohio, Spojené státy, 43213
        • ClinOhio Research Services
    • Oklahoma
      • Oklahoma City, Oklahoma, Spojené státy, 73118
        • Unity Clinical Research
      • Tulsa, Oklahoma, Spojené státy, 74132
        • Dermatology Research Center of Oklahoma, PLLC
      • Tulsa, Oklahoma, Spojené státy, 74137
        • Essential Medical Research LLC
    • Oregon
      • Portland, Oregon, Spojené státy, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Sugarloaf, Pennsylvania, Spojené státy, 18249
        • DermDox Dermatology, LLC
    • Tennessee
      • Hermitage, Tennessee, Spojené státy, 37076
        • Cumberland Skin Center
    • Texas
      • Dallas, Texas, Spojené státy, 75230
        • Dermatology Treatment and Research Center PA
      • The Woodlands, Texas, Spojené státy, 77380
        • The Woodlands Dermatology Associates
    • Virginia
      • Lynchburg, Virginia, Spojené státy, 24501
        • Education and Research Foundation Inc
    • Washington
      • Mill Creek, Washington, Spojené státy, 98012
        • Frontier Derm Partners
    • West Virginia
      • Morgantown, West Virginia, Spojené státy, 26505
        • West Virginia Research Institute
  • Tchaj-wan
      • Kaohsiung City, Tchaj-wan, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Tainan, Tchaj-wan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Tchaj-wan, 10002
        • National Taiwan University Hospital
      • Taipei, Tchaj-wan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Tchaj-wan, 10449
        • Mackay Memorial Hospital Taipei Branch
      • Taoyuan, Tchaj-wan, 33305
        • Linkou Chang Gung Memorial Hospital
  • Česko
      • Náchod, Česko, 547 01
        • Dermamedica, sro
      • Ostrava, Česko, 702 00
        • CCR Ostrava sro
      • Pardubice, Česko, 530 02
        • Pratia Pardubice as
      • Prague, Česko, 180 81
        • Fakultni nemocnice Bulovka
      • Prague, Česko, 100 00
        • Clintrial sro
      • Prague, Česko, 130 00
        • Pratia Prague sro
      • Ústí nad Labem, Česko, 401 13
        • Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
  • Čína
      • 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
    • Hebei
      • Shijiazhuang, Hebei, Čína, 050000
        • The first Hospital of Hebei Medical University
    • Henan
      • Nanyang, Henan, Čína, 473002
        • Nanyang First Peoples Hospital
      • Sanmenxia, Henan, Čína, 472099
        • Sanmenxia Central Hospital
    • Hubei
      • Wuhan, Hubei, Čína, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, Čína, 410011
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Jiangyin, Jiangsu, Čína, 214400
        • Jiangyin Hospital of Traditional Chinese Medicine
      • Wuxi, Jiangsu, Čína, 241023
        • Wuxi Peoples Hospital
    • Jiangxi
      • Nanchang, Jiangxi, Čína, 330000
        • Dermatology Hospital of Jiangxi Province
    • Jilin
      • Changchun, Jilin, Čína, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, Čína, 110001
        • The First Hospital of China Medical University
    • Sichuan
      • Chengdu, Sichuan, Čína, 610021
        • Chengdu Second Peoples Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Čína, 310003
        • The First Affiliated Hospital Zhejiang University School Of Medicine
      • Hangzhou, Zhejiang, Čína, 310020
        • Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, Čína, 310004
        • Zhejiang provincial Peoples Hospital
      • Taizhou, Zhejiang, Čína, 318000
        • Taizhou Central Hospital
  • Řecko
      • Athens, Řecko, 12462
        • University General Hospital Attikon
      • Athens, Řecko, 11521
        • Athens Naval Hospital
      • Athens, Řecko, 16121
        • Andreas Syngros Hospital Of Venereal And Dermatological Diseases
      • Athens, Řecko, 11527
        • Thoracic General Hospital Of Athens Sotiria
      • Ioannina, Řecko, 45500
        • University General Hospital of Ioannina
      • Larissa, Řecko, 41110
        • General University Hospital of Larissa
      • Thessaloniki, Řecko, 56403
        • Papageorgiou General Hospital
  • Španělsko
      • Madrid, Španělsko, 28006
        • Hospital Universitario de la Princesa
      • Madrid, Španělsko, 28031
        • Hospital Universitario Infanta Leonor
    • Andalusia
      • Córdoba, Andalusia, Španělsko, 14004
        • Hospital Universitario Reina Sofía
    • Aragon
      • Zaragoza, Aragon, Španělsko, 50009
        • Hospital Universitario Miguel Servet
    • Canary Islands
      • Las Palmas de Gran Canaria, Canary Islands, Španělsko, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrin
    • Catalonia
      • Badalona, Catalonia, Španělsko, 08916
        • Hospital Universitari Germans Trias i Pujol
      • L'Hospitalet de Llobregat, Catalonia, Španělsko, 08907
        • Hospital Universitari de Bellvitge
    • Galicia
      • Pontevedra, Galicia, Španělsko, 36001
        • Hospital Clinico Universitario de Santiago
    • Madrid
      • Pozuelo de Alarcón, Madrid, Španělsko, 28223
        • Hospital Universitario Quironsalud Madrid
    • Valencia
      • Valencia, Valencia, Španělsko, 46026
        • Hospital Universitari i Politecnic La Fe

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 Consensus Criteria (2014) přítomnou alespoň 6 měsíců
  • Anamnéza nedostatečné odpovědi na TCS (topický kortikosteroid) střední nebo vyšší účinnosti během 6 měsíců (s nebo bez topických inhibitorů kalcineurinu [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 jakékoli potence
    • TCI
    • Lék proti svědění
    • Lokální inhibitory fosfodiesterázy typu 4
    • Další lokální imunosupresiva

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: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Rameno A
Rocatinlimab Dávka 1 každé 4 týdny (Q4W) + nasycovací dávka v týdnu 2
Lék: Rocatinlimab
Účastníci dostanou Rocatinlimab subkutánně.
Ostatní jména:
  • AMG 451
Experimentální: Rameno B
Rocatinlimab Dávka 2 Q4W + nasycovací dávka v týdnu 2
Lék: Rocatinlimab
Účastníci dostanou Rocatinlimab subkutánně.
Ostatní jména:
  • AMG 451
Komparátor placeba: Rameno C
Placebo Q4W+ nasycovací dávka v týdnu 2
Lék: Placebo
Účastníci dostanou placebo subkutánně.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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," the participant met rIGA 0/1; if "No," they did not. If vIGA-AD = 0, the participant met rIGA 0/1. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved ≥ 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

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 ≥ 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
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
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 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 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
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 ≥ 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 daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 24
Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
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 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 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 ≥ 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 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 more severe symptoms of AD. Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points. A negative change from baseline indicated a reduction in AD severity.
Baseline and Week 24
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. Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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
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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Amgen

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.

Obecné publikace

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)

31. května 2022

Primární dokončení (Aktuální)

28. listopadu 2024

Dokončení studie (Aktuální)

13. ledna 2025

Termíny zápisu do studia

První předloženo

24. května 2022

První předloženo, které splnilo kritéria kontroly kvality

31. května 2022

První zveřejněno (Aktuální)

1. června 2022

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

25. června 2026

Naposledy ověřeno

1. února 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 20210142
  • 2022-501540-15-00 (Ctis)

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 související s touto studií budou zvažovány počínaje 18 měsíci po ukončení studie a buď 1) produktu 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 výbor 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 .

Klinické studie na Atopická dermatitida

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Denmark

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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