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En undersøgelse, der evaluerer Rocatinlimab i moderat til svær atopisk dermatitis (ROCKET-IGNITE) (ROCKET-Ignite)

25. juni 2026 opdateret af: Amgen

En fase 3, 24-ugers, randomiseret, placebokontrolleret, dobbeltblind undersøgelse til vurdering af effektivitet, sikkerhed og tolerabilitet af rocatinlimab (AMG 451) monoterapi hos voksne patienter med moderat til svær atopisk dermatitis (AD)

Formålet med denne undersøgelse er at evaluere effektiviteten og sikkerheden af ​​rocatinlimab i monoterapibehandling.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

769

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Alder ≥ 18 år med diagnose AD i henhold til AAD Consensus Criteria (2014) til stede i mindst 6 måneder
  • Anamnese med utilstrækkelig respons på TCS (topisk kortikosteroid) af middel eller højere styrke inden for 6 måneder (med eller uden topiske calcineurinhæmmere [TCI])
  • EASI-score ≥16
  • vIGA-AD-score ≥3
  • ≥10 % kropsoverfladeareal (BSA) af AD-involvering
  • Værste pruritus numerisk vurderingsskala ≥ 4

Ekskluderingskriterier:

  • Behandling med et biologisk produkt inden for 12 uger eller 5 halveringstider, alt efter hvad der er længst, før dag 1

  • Behandling med nogen af ​​følgende medikamenter eller terapier inden for 4 uger eller 5 halveringstider, alt efter hvad der er længst, før dag 1:

    • Systemiske kortikosteroider
    • Systemiske immunsuppressiva
    • Fototerapi
    • Janus kinase hæmmere

  • Behandling med nogen af ​​følgende medikamenter eller terapier inden for 1 uge før dag 1:

    • TCS af enhver styrke
    • TCI
    • Anti-pruritisk lægemiddel
    • Topiske phosphodiesterase type 4-hæmmere
    • Andre topiske immunsuppressive midler

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A
Rocatinlimab dosis 1 hver 4. uge (Q4W) + startdosis ved uge 2
Medicin: Rocatinlimab
Deltagerne vil modtage Rocatinlimab subkutant.
Andre navne:
  • AMG 451
Eksperimentel: Arm B
Rocatinlimab Dosis 2 Q4W + startdosis i uge 2
Medicin: Rocatinlimab
Deltagerne vil modtage Rocatinlimab subkutant.
Andre navne:
  • AMG 451
Placebo komparator: Arm C
Placebo Q4W+ startdosis ved uge 2
Medicin: Placebo
Deltagerne vil modtage placebo subkutant.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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," 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
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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 ≥ 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
Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
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 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 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
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 ≥ 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 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
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 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 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 ≥ 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 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 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
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. 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
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
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

Samarbejdspartnere og efterforskere

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Sponsor

Amgen

Efterforskere

  • Studieleder: MD, Amgen

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. maj 2022

Primær færdiggørelse (Faktiske)

28. november 2024

Studieafslutning (Faktiske)

13. januar 2025

Datoer for studieregistrering

Først indsendt

24. maj 2022

Først indsendt, der opfyldte QC-kriterier

31. maj 2022

Først opslået (Faktiske)

1. juni 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juni 2026

Sidst verificeret

1. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Afidentificerede individuelle patientdata for variabler, der er nødvendige for at løse det specifikke forskningsspørgsmål i en godkendt anmodning om datadeling.

IPD-delingstidsramme

Anmodninger om datadeling i forbindelse med denne undersøgelse vil blive overvejet begyndende 18 måneder efter, at undersøgelsen er afsluttet, og enten 1) produktet og indikationen er blevet udstedt markedsføringstilladelse i både USA og Europa eller 2) den kliniske udvikling af produktet og/eller indikationen ophører og dataene vil ikke blive sendt til de regulerende myndigheder. Der er ingen slutdato for berettigelse til at indsende en anmodning om datadeling for denne undersøgelse.

IPD-delingsadgangskriterier

Kvalificerede forskere kan indsende en anmodning, der indeholder forskningsmålene, Amgen-produktet/-erne og Amgen-undersøgelsen/-undersøgelserne i omfang, endepunkter/resultater af interesse, statistisk analyseplan, datakrav, publikationsplan og forskerens/forskernes kvalifikationer. Generelt imødekommer Amgen ikke eksterne anmodninger om individuelle patientdata med det formål at revurdere sikkerheds- og effektivitetsspørgsmål, der allerede er behandlet i produktmærkningen. Anmodninger gennemgås af et udvalg af interne rådgivere. Hvis den ikke godkendes, vil et uafhængigt datadelingspanel mægle og træffe den endelige beslutning. Efter godkendelse vil oplysninger, der er nødvendige for at løse forskningsspørgsmålet, blive leveret i henhold til vilkårene i en datadelingsaftale. Dette kan omfatte anonymiserede individuelle patientdata og/eller tilgængelige understøttende dokumenter, der indeholder fragmenter af analysekode, hvor det er angivet i analysespecifikationerne. Yderligere detaljer er tilgængelige på URL'en nedenfor.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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