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En studie som evaluerer Rocatinlimab ved moderat til alvorlig atopisk dermatitt (ROCKET-IGNITE) (ROCKET-Ignite)

25. juni 2026 oppdatert av: Amgen

En fase 3, 24-ukers, randomisert, placebokontrollert, dobbeltblind studie for å vurdere effektiviteten, sikkerheten og toleransen til Rocatinlimab (AMG 451) monoterapi hos voksne personer med moderat til alvorlig atopisk dermatitt (AD)

Hensikten med denne studien er å evaluere effekten og sikkerheten til rocatinlimab i monoterapibehandling.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

769

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

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 Neumonología Y Dermatología
      • 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
  • Brasil
      • Rio de Janeiro, Brasil, 20241-180
        • IBPClin Instituto Brasil de Pesquisa Clinica
      • São Paulo, Brasil, 06454-010
        • Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brasil, 90160-093
        • Hospital Ernesto Dornelles
    • São Paulo
      • Botucatu, São Paulo, Brasil, 18618-686
        • Upeclin-Pesq Clin FacMed Botucatu
      • Santo André, São Paulo, Brasil, 09060-870
        • Fundacao Abc - Centro Univ Fmabc
      • Santo André, São Paulo, Brasil, 09030-010
        • Hosp e Maternidade Dr Christovao da Gama
      • Sorocaba, São Paulo, Brasil, 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
  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35244
        • Cahaba Dermatology and Skin Health Center
    • Arizona
      • Phoenix, Arizona, Forente stater, 85032
        • Alliance Dermatology and Mohs Center
    • California
      • Anaheim, California, Forente stater, 92801
        • Anaheim Clinical Trials
      • Fountain Valley, California, Forente stater, 92708
        • First OC Dermatology
      • Glendale, California, Forente stater, 91203
        • Kaiser Permanente - Glendale Medical Center
      • Long Beach, California, Forente stater, 90805
        • Long Beach Research Institute
      • Los Angeles, California, Forente stater, 90045
        • Dermatology Research Associates
      • Los Angeles, California, Forente stater, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Sherman Oaks, California, Forente stater, 91403
        • Cura Clinical Research
    • Colorado
      • Centennial, Colorado, Forente stater, 80112
        • IMMUNOe Research Centers
    • Florida
      • Boca Raton, Florida, Forente stater, 33486
        • Skin Care Research Incorporated
      • Delray Beach, Florida, Forente stater, 33484
        • Palm Beach Dermatology Group
      • Homestead, Florida, Forente stater, 33030
        • Global Research Associates
      • Miami, Florida, Forente stater, 33175
        • Healthy Life Research
      • Miami Lakes, Florida, Forente stater, 33014
        • Savin Medical Group LLC
      • Naples, Florida, Forente stater, 34102
        • Kirsch Dermatology LLC
      • Orlando, Florida, Forente stater, 32819
        • Pure Skin Dermatology and Aesthetics
      • St. Petersburg, Florida, Forente stater, 33709
        • Industrial Medicine Associates Ima Clinical Research Inc
      • Tampa, Florida, Forente stater, 33606
        • Genesis Clinical Research LLC
    • Idaho
      • Boise, Idaho, Forente stater, 83706
        • Treasure Valley Medical Research
    • Illinois
      • Chicago, Illinois, Forente stater, 60611
        • DeNova Research
      • West Dundee, Illinois, Forente stater, 60118
        • Dundee Dermatology
    • Indiana
      • Plainfield, Indiana, Forente stater, 46168
        • The Indiana Clinical Trials Center PC
    • Maryland
      • Chevy Chase, Maryland, Forente stater, 20815
        • Institute for Asthma and Allergy
      • Towson, Maryland, Forente stater, 21204
        • Continental Clinical Solutions, LLC
    • Michigan
      • Detroit, Michigan, Forente stater, 48202
        • Henry Ford Health System
      • Flint, Michigan, Forente stater, 48532
        • Onyx Clinical Research
    • Missouri
      • Lee's Summit, Missouri, Forente stater, 64064
        • Dermatology and Skin Cancer Center of Lees Summit
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89106
        • Jubilee Clinical Research Inc
    • New Hampshire
      • Portsmouth, New Hampshire, Forente stater, 03801
        • Allcutis Research, Llc - Portsmouth
    • New Jersey
      • Cherry Hill, New Jersey, Forente stater, 08034
        • Continental Clinical Solutions - Cherry Hill
    • New York
      • Hartsdale, New York, Forente stater, 10530
        • Industrial Medicine Associates Ima Clinical Research Inc
      • New York, New York, Forente stater, 10075
        • Sadick Research Group
    • North Carolina
      • Charlotte, North Carolina, Forente stater, 28277
        • Dermatology Specialists of Charlotte
      • Charlotte, North Carolina, Forente stater, 28277
        • Onsite Clinical Solutions
      • Wilmington, North Carolina, Forente stater, 28405
        • Wilmington Dermatology Center
      • Winston-Salem, North Carolina, Forente stater, 27103
        • The Skin Surgery Center for Clinical Research
    • Ohio
      • Boardman, Ohio, Forente stater, 44512
        • Optima Research
      • Columbus, Ohio, Forente stater, 43213
        • ClinOhio Research Services
    • Oklahoma
      • Oklahoma City, Oklahoma, Forente stater, 73118
        • Unity Clinical Research
      • Tulsa, Oklahoma, Forente stater, 74132
        • Dermatology Research Center of Oklahoma, PLLC
      • Tulsa, Oklahoma, Forente stater, 74137
        • Essential Medical Research LLC
    • Oregon
      • Portland, Oregon, Forente stater, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Sugarloaf, Pennsylvania, Forente stater, 18249
        • DermDox Dermatology, LLC
    • Tennessee
      • Hermitage, Tennessee, Forente stater, 37076
        • Cumberland Skin Center
    • Texas
      • Dallas, Texas, Forente stater, 75230
        • Dermatology Treatment and Research Center PA
      • The Woodlands, Texas, Forente stater, 77380
        • The Woodlands Dermatology Associates
    • Virginia
      • Lynchburg, Virginia, Forente stater, 24501
        • Education and Research Foundation Inc
    • Washington
      • Mill Creek, Washington, Forente stater, 98012
        • Frontier Derm Partners
    • West Virginia
      • Morgantown, West Virginia, Forente stater, 26505
        • West Virginia Research Institute
  • Hellas
      • Athens, Hellas, 12462
        • University General Hospital Attikon
      • Athens, Hellas, 11521
        • Athens Naval Hospital
      • Athens, Hellas, 16121
        • Andreas Syngros Hospital Of Venereal And Dermatological Diseases
      • Athens, Hellas, 11527
        • Thoracic General Hospital Of Athens Sotiria
      • Ioannina, Hellas, 45500
        • University General Hospital Of Ioannina
      • Larissa, Hellas, 41110
        • General University Hospital of Larissa
      • Thessaloniki, Hellas, 56403
        • Papageorgiou General Hospital
  • Italia
      • Chieti, Italia, 66100
        • Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
      • Milan, Italia, 20122
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
      • Perugia, Italia, 06156
        • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
      • Roma, Italia, 00161
        • Azienda Ospedaliera Policlinico Umberto I
      • Torino, Italia, 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
  • Kroatia
      • Ivanić-Grad, Kroatia, 10310
        • Special Hospital for Medical Rehabilitation Naftalan
      • Zagreb, Kroatia, 10000
        • University Hospital Centre Zagreb
      • Zagreb, Kroatia, 10000
        • Sestre milosrdnice University Hospital Center
  • Latvia
      • Riga, Latvia, 1003
        • Outpatient clinic Veselibas Centrs 4
      • Riga, Latvia, LV-1013
        • Outpatient clinic Veselibascentrs 4
      • Talsi, Latvia, 3201
        • Smite Aija practice in dermatology and venerology
  • Nederland
      • Born, Nederland, 6121 XK
        • PreCare Trial and Recruitment
  • 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
  • Slovakia
      • Banská Bystrica, Slovakia, 975 17
        • Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
      • Bratislava, Slovakia, 851 01
        • Derma therapy, spol s ro
      • Svidník, Slovakia, 089 01
        • Sanare spol sro
      • Topoľčany, Slovakia, 955 01
        • Kaderma Majtan, sro
      • Trnava, Slovakia, 917 75
        • Fakultna Nemocnica Trnava
  • Spania
      • Madrid, Spania, 28006
        • Hospital Universitario de La Princesa
      • Madrid, Spania, 28031
        • Hospital Universitario Infanta Leonor
    • Andalusia
      • Córdoba, Andalusia, Spania, 14004
        • Hospital Universitario Reina Sofia
    • Aragon
      • Zaragoza, Aragon, Spania, 50009
        • Hospital Universitario Miguel Servet
    • Canary Islands
      • Las Palmas de Gran Canaria, Canary Islands, Spania, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrin
    • Catalonia
      • Badalona, Catalonia, Spania, 08916
        • Hospital Universitari Germans Trias i Pujol
      • L'Hospitalet de Llobregat, Catalonia, Spania, 08907
        • Hospital Universitari de Bellvitge
    • Galicia
      • Pontevedra, Galicia, Spania, 36001
        • Hospital Clínico Universitario de Santiago
    • Madrid
      • Pozuelo de Alarcón, Madrid, Spania, 28223
        • Hospital Universitario Quironsalud Madrid
    • Valencia
      • Valencia, Valencia, Spania, 46026
        • Hospital Universitari i Politecnic La Fe
  • Sør -Korea
      • Ansansi, Gyeonggido, Sør -Korea, 15355
        • Korea University Ansan Hospital
      • Incheon, Sør -Korea, 21431
        • The Catholic University of Korea Incheon St Marys Hospital
      • Seoul, Sør -Korea, 03080
        • Seoul National University Hospital
      • Seoul, Sør -Korea, 05505
        • Asan Medical Center
      • Seoul, Sør -Korea, 08308
        • Korea University Guro Hospital
      • Seoul, Sør -Korea, 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
  • Tsjekkia
      • Náchod, Tsjekkia, 547 01
        • Dermamedica, sro
      • Ostrava, Tsjekkia, 702 00
        • CCR Ostrava sro
      • Pardubice, Tsjekkia, 530 02
        • Pratia Pardubice as
      • Prague, Tsjekkia, 180 81
        • Fakultní nemocnice Bulovka
      • Prague, Tsjekkia, 100 00
        • Clintrial sro
      • Prague, Tsjekkia, 130 00
        • Pratia Prague sro
      • Ústí nad Labem, Tsjekkia, 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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Alder ≥ 18 år med diagnose AD i henhold til AAD Consensus Criteria (2014) til stede i minst 6 måneder
  • Anamnese med utilstrekkelig respons på TCS (Topical Corticosteroid) med middels eller høyere styrke innen 6 måneder (med eller uten topikale kalsineurinhemmere [TCI])
  • EASI-score ≥16
  • vIGA-AD-score ≥3
  • ≥10 % kroppsoverflateareal (BSA) av AD-involvering
  • Verste pruritus numerisk vurderingsskala ≥ 4

Ekskluderingskriterier:

  • Behandling med et biologisk produkt innen 12 uker eller 5 halveringstider, avhengig av hva som er lengst, før dag 1

  • Behandling med noen av følgende medisiner eller terapier innen 4 uker eller 5 halveringstider, avhengig av hva som er lengst, før dag 1:

    • Systemiske kortikosteroider
    • Systemiske immundempende midler
    • Fototerapi
    • Janus kinasehemmere

  • Behandling med noen av følgende medisiner eller terapier innen 1 uke, før dag 1:

    • TCS av enhver styrke
    • TCI
    • Anti-pruritisk stoff
    • Aktuelle fosfodiesterase type 4-hemmere
    • Andre aktuelle immunsuppressive midler

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Arm A
Rocatinlimab Dose 1 hver 4. uke (Q4W) + startdose ved uke 2
Legemiddel: Rocatinlimab
Deltakerne vil få Rocatinlimab subkutant.
Andre navn:
  • AMG 451
Eksperimentell: Arm B
Rocatinlimab Dose 2 Q4W + startdose ved uke 2
Legemiddel: Rocatinlimab
Deltakerne vil få Rocatinlimab subkutant.
Andre navn:
  • AMG 451
Placebo komparator: Arm C
Placebo Q4W+ startdose ved uke 2
Legemiddel: Placebo
Deltakerne vil få placebo subkutant.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
Tidsramme
Number of Participants Who Achieved EASI 75 at Week 16
Tidsramme: Baseline and Week 16
EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions. It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification. The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease. EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score. Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
Baseline and Week 16
Number of Participants Who Achieved a ≥ 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Amgen

Etterforskere

  • Studieleder: MD, Amgen

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. mai 2022

Primær fullføring (Faktiske)

28. november 2024

Studiet fullført (Faktiske)

13. januar 2025

Datoer for studieregistrering

Først innsendt

24. mai 2022

Først innsendt som oppfylte QC-kriteriene

31. mai 2022

Først lagt ut (Faktiske)

1. juni 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. juni 2026

Sist bekreftet

1. februar 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Avidentifiserte individuelle pasientdata for variabler som er nødvendige for å adressere det spesifikke forskningsspørsmålet i en godkjent forespørsel om datadeling.

IPD-delingstidsramme

Forespørsler om datadeling knyttet til denne studien vil bli vurdert med start 18 måneder etter at studien er avsluttet og enten 1) produktet og indikasjonen har fått markedsføringstillatelse i både USA og Europa eller 2) klinisk utvikling for produktet og/eller indikasjonen avbrytes og dataene vil ikke bli sendt til regulerende myndigheter. Det er ingen sluttdato for kvalifisering til å sende inn en forespørsel om datadeling for denne studien.

Tilgangskriterier for IPD-deling

Kvalifiserte forskere kan sende inn en forespørsel som inneholder forskningsmålene, Amgen-produktet(e) og Amgen-studien/studiene i omfang, endepunkter/resultater av interesse, statistisk analyseplan, datakrav, publiseringsplan og kvalifikasjonene til forskeren(e). Generelt innvilger ikke Amgen eksterne forespørsler om individuelle pasientdata med det formål å revurdere sikkerhets- og effektspørsmål som allerede er behandlet i produktmerkingen. Forespørsler vurderes av et utvalg av interne rådgivere. Hvis den ikke blir godkjent, vil et uavhengig granskningspanel for datadeling dømme og ta den endelige avgjørelsen. Ved godkjenning vil informasjon som er nødvendig for å løse forskningsspørsmålet, bli gitt under vilkårene i en datadelingsavtale. Dette kan inkludere anonymiserte individuelle pasientdata og/eller tilgjengelige støttedokumenter, som inneholder fragmenter av analysekode der det er gitt i analysespesifikasjonene. Ytterligere detaljer er tilgjengelig på URL-en nedenfor.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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