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Un estudio que evalúa rocatinlimab en dermatitis atópica moderada a grave (ROCKET-IGNITE) (ROCKET-Ignite)

25 de junio de 2026 actualizado por: Amgen

Estudio de fase 3, de 24 semanas, aleatorizado, controlado con placebo, doble ciego para evaluar la eficacia, la seguridad y la tolerabilidad de la monoterapia con rocatinlimab (AMG 451) en sujetos adultos con dermatitis atópica (DA) de moderada a grave

El propósito de este estudio es evaluar la eficacia y seguridad de rocatinlimab en el tratamiento de monoterapia.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

769

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 10117
        • Charite - Universitaetsmedizin Berlin, Campus Mitte
      • Blankenfelde-Mahlow, Alemania, 15831
        • Dermatologische Gemeinschaftspraxis-Mahlow
      • Bochum, Alemania, 44793
        • Hautarztpraxis Dr Niesmann und Dr Othlinghaus
      • Darmstadt, Alemania, 64283
        • Rosenpark Research GmbH
      • Dresden, Alemania, 01307
        • Universitaetsklinikum Dresden
      • Düsseldorf, Alemania, 40225
        • Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
      • Essen, Alemania, 45174
        • Universitaetsklinikum Essen
      • Hamburg, Alemania, 20246
        • Institute for Health Services Research in Dermatology and Nursing
      • Heidelberg, Alemania, 69120
        • Universitaetsklinikum Heidelberg
      • Stuttgart, Alemania, 70178
        • Hautarztpraxis Dres Leitz und Kollegen
      • Tübingen, Alemania, 72076
        • Universitaetsklinikum Tuebingen
      • Wuppertal, Alemania, 42287
        • CentroDerm GmbH
  • 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 Clínicas 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
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 1C3
        • Alberta Derma Surgery Centre
      • Edmonton, Alberta, Canadá, T6H 4J8
        • Vida Clinical Research
    • Ontario
      • Ajax, Ontario, Canadá, L1S 7K8
        • CCA Medical Research Corporation
      • Barrie, Ontario, Canadá, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Centre
      • Hamilton, Ontario, Canadá, L8L 3C3
        • Leader Research
      • Mississauga, Ontario, Canadá, L4Y 4C5
        • DermEdge Research Incorporated
      • North York, Ontario, Canadá, M3B 3S6
        • Gordon Sussman Clinical Research Incorporated
      • North York, Ontario, Canadá, M3B 0A7
        • Canadian Dermatology Centre
      • Richmond Hill, Ontario, Canadá, L4E 4L6
        • Oak Ridges Aesthetics Centre
    • Quebec
      • Montreal, Quebec, Canadá, H2X 2V1
        • Innovaderm Research Inc
      • Québec, Quebec, Canadá, G1G 3Y8
        • Recherche Clinique Sigma Incorporated
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canadá, S7K 2C1
        • Skinsense Medical Research
  • Chequia
      • Náchod, Chequia, 547 01
        • Dermamedica, sro
      • Ostrava, Chequia, 702 00
        • CCR Ostrava sro
      • Pardubice, Chequia, 530 02
        • Pratia Pardubice as
      • Prague, Chequia, 180 81
        • Fakultni nemocnice Bulovka
      • Prague, Chequia, 100 00
        • Clintrial sro
      • Prague, Chequia, 130 00
        • Pratia Prague sro
      • Ústí nad Labem, Chequia, 401 13
        • Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
  • Corea del Sur
      • Ansansi, Gyeonggido, Corea del Sur, 15355
        • Korea University Ansan Hospital
      • Incheon, Corea del Sur, 21431
        • The Catholic University of Korea Incheon St Marys Hospital
      • Seoul, Corea del Sur, 03080
        • Seoul National University Hospital
      • Seoul, Corea del Sur, 05505
        • Asan Medical Center
      • Seoul, Corea del Sur, 08308
        • Korea University Guro Hospital
      • Seoul, Corea del Sur, 04564
        • National Medical Center
  • Croacia
      • Ivanić-Grad, Croacia, 10310
        • Special Hospital for Medical Rehabilitation Naftalan
      • Zagreb, Croacia, 10000
        • University Hospital Centre Zagreb
      • Zagreb, Croacia, 10000
        • Sestre milosrdnice University Hospital Center
  • Eslovaquia
      • Banská Bystrica, Eslovaquia, 975 17
        • Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
      • Bratislava, Eslovaquia, 851 01
        • Derma therapy, spol s ro
      • Svidník, Eslovaquia, 089 01
        • Sanare spol sro
      • Topoľčany, Eslovaquia, 955 01
        • Kaderma Majtan, sro
      • Trnava, Eslovaquia, 917 75
        • Fakultna Nemocnica Trnava
  • España
      • Madrid, España, 28006
        • Hospital Universitario de la Princesa
      • Madrid, España, 28031
        • Hospital Universitario Infanta Leonor
    • Andalusia
      • Córdoba, Andalusia, España, 14004
        • Hospital Universitario Reina Sofía
    • Aragon
      • Zaragoza, Aragon, España, 50009
        • Hospital Universitario Miguel Servet
    • Canary Islands
      • Las Palmas de Gran Canaria, Canary Islands, España, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrin
    • Catalonia
      • Badalona, Catalonia, España, 08916
        • Hospital Universitari Germans Trias i Pujol
      • L'Hospitalet de Llobregat, Catalonia, España, 08907
        • Hospital Universitari de Bellvitge
    • Galicia
      • Pontevedra, Galicia, España, 36001
        • Hospital Clínico Universitario de Santiago
    • Madrid
      • Pozuelo de Alarcón, Madrid, España, 28223
        • Hospital Universitario Quironsalud Madrid
    • Valencia
      • Valencia, Valencia, España, 46026
        • Hospital Universitari i Politècnic La Fe
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35244
        • Cahaba Dermatology and Skin Health Center
    • Arizona
      • Phoenix, Arizona, Estados Unidos, 85032
        • Alliance Dermatology and Mohs Center
    • California
      • Anaheim, California, Estados Unidos, 92801
        • Anaheim Clinical Trials
      • Fountain Valley, California, Estados Unidos, 92708
        • First Oc Dermatology
      • Glendale, California, Estados Unidos, 91203
        • Kaiser Permanente - Glendale Medical Center
      • Long Beach, California, Estados Unidos, 90805
        • Long Beach Research Institute
      • Los Angeles, California, Estados Unidos, 90045
        • Dermatology Research Associates
      • Los Angeles, California, Estados Unidos, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Sherman Oaks, California, Estados Unidos, 91403
        • Cura Clinical Research
    • Colorado
      • Centennial, Colorado, Estados Unidos, 80112
        • IMMUNOe Research Centers
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33486
        • Skin Care Research Incorporated
      • Delray Beach, Florida, Estados Unidos, 33484
        • Palm Beach Dermatology Group
      • Homestead, Florida, Estados Unidos, 33030
        • Global Research Associates
      • Miami, Florida, Estados Unidos, 33175
        • Healthy Life Research
      • Miami Lakes, Florida, Estados Unidos, 33014
        • Savin Medical Group LLC
      • Naples, Florida, Estados Unidos, 34102
        • Kirsch Dermatology LLC
      • Orlando, Florida, Estados Unidos, 32819
        • Pure Skin Dermatology and Aesthetics
      • St. Petersburg, Florida, Estados Unidos, 33709
        • Industrial Medicine Associates Ima Clinical Research Inc
      • Tampa, Florida, Estados Unidos, 33606
        • Genesis Clinical Research LLC
    • Idaho
      • Boise, Idaho, Estados Unidos, 83706
        • Treasure Valley Medical Research
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • DeNova Research
      • West Dundee, Illinois, Estados Unidos, 60118
        • Dundee Dermatology
    • Indiana
      • Plainfield, Indiana, Estados Unidos, 46168
        • The Indiana Clinical Trials Center PC
    • Maryland
      • Chevy Chase, Maryland, Estados Unidos, 20815
        • Institute for Asthma and Allergy
      • Towson, Maryland, Estados Unidos, 21204
        • Continental Clinical Solutions, LLC
    • Michigan
      • Detroit, Michigan, Estados Unidos, 48202
        • Henry Ford Health System
      • Flint, Michigan, Estados Unidos, 48532
        • Onyx Clinical Research
    • Missouri
      • Lee's Summit, Missouri, Estados Unidos, 64064
        • Dermatology and Skin Cancer Center of Lees Summit
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89106
        • Jubilee Clinical Research Inc
    • New Hampshire
      • Portsmouth, New Hampshire, Estados Unidos, 03801
        • Allcutis Research, Llc - Portsmouth
    • New Jersey
      • Cherry Hill, New Jersey, Estados Unidos, 08034
        • Continental Clinical Solutions - Cherry Hill
    • New York
      • Hartsdale, New York, Estados Unidos, 10530
        • Industrial Medicine Associates Ima Clinical Research Inc
      • New York, New York, Estados Unidos, 10075
        • Sadick Research Group
    • North Carolina
      • Charlotte, North Carolina, Estados Unidos, 28277
        • Dermatology Specialists of Charlotte
      • Charlotte, North Carolina, Estados Unidos, 28277
        • Onsite Clinical Solutions
      • Wilmington, North Carolina, Estados Unidos, 28405
        • Wilmington Dermatology Center
      • Winston-Salem, North Carolina, Estados Unidos, 27103
        • The Skin Surgery Center for Clinical Research
    • Ohio
      • Boardman, Ohio, Estados Unidos, 44512
        • Optima Research
      • Columbus, Ohio, Estados Unidos, 43213
        • ClinOhio Research Services
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73118
        • Unity Clinical Research
      • Tulsa, Oklahoma, Estados Unidos, 74132
        • Dermatology Research Center of Oklahoma, PLLC
      • Tulsa, Oklahoma, Estados Unidos, 74137
        • Essential Medical Research LLC
    • Oregon
      • Portland, Oregon, Estados Unidos, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Sugarloaf, Pennsylvania, Estados Unidos, 18249
        • DermDox Dermatology, LLC
    • Tennessee
      • Hermitage, Tennessee, Estados Unidos, 37076
        • Cumberland Skin Center
    • Texas
      • Dallas, Texas, Estados Unidos, 75230
        • Dermatology Treatment and Research Center PA
      • The Woodlands, Texas, Estados Unidos, 77380
        • The Woodlands Dermatology Associates
    • Virginia
      • Lynchburg, Virginia, Estados Unidos, 24501
        • Education and Research Foundation Inc
    • Washington
      • Mill Creek, Washington, Estados Unidos, 98012
        • Frontier Derm Partners
    • West Virginia
      • Morgantown, West Virginia, Estados Unidos, 26505
        • West Virginia Research Institute
  • Grecia
      • Athens, Grecia, 12462
        • University General Hospital Attikon
      • Athens, Grecia, 11521
        • Athens Naval Hospital
      • Athens, Grecia, 16121
        • Andreas Syngros Hospital Of Venereal And Dermatological Diseases
      • Athens, Grecia, 11527
        • Thoracic General Hospital Of Athens Sotiria
      • Ioannina, Grecia, 45500
        • University General Hospital of Ioannina
      • Larissa, Grecia, 41110
        • General University Hospital of Larissa
      • Thessaloniki, Grecia, 56403
        • Papageorgiou General Hospital
  • Hungría
      • Veszprém, Hungría, 8200
        • MedMare Bt
  • 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
  • Japón
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Japón, 480-1195
        • Aichi Medical University Hospital
      • Nagoya, Aichi-ken, Japón, 467-8602
        • Nagoya City University Hospital
      • Nagoya, Aichi-ken, Japón, 464-0821
        • Central Clinic
      • Nagoya, Aichi-ken, Japón, 457-8510
        • Japan Community Healthcare Organization Chukyo Hospital
    • Fukuoka
      • Fukuoka, Fukuoka, Japón, 819-0373
        • Matsuo Clinic
      • Fukuoka, Fukuoka, Japón, 814-0180
        • Fukuoka University Hospital
    • Fukushima
      • Fukushima, Fukushima, Japón, 960-1295
        • Fukushima Medical University Hospital
    • Hokkaido
      • Asahikawa-shi, Hokkaido, Japón, 070-8610
        • Asahikawa City Hospital
    • Ibaraki
      • Inashiki-gun, Ibaraki, Japón, 300-0395
        • Tokyo Medical University Ibaraki Medical Center
    • Ishikawa-ken
      • Nonoichi-shi, Ishikawa-ken, Japón, 921-8801
        • Kaji Dermatology Clinic
    • Iwate
      • Morioka, Iwate, Japón, 020-8505
        • Iwate Medical University Uchimaru Medical Center
    • Kagawa-ken
      • Marugame-shi, Kagawa-ken, Japón, 763-0074
        • Takeoka Dermatology Clinic
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japón, 211-8533
        • Nippon Medical School Musashikosugi Hospital
    • Kyoto
      • Kyoto, Kyoto, Japón, 607-8062
        • Rakuwakai Otowa Hospital
      • Kyoto, Kyoto, Japón, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
    • Osaka
      • Izumiotsu-shi, Osaka, Japón, 595-0025
        • Mochida Dermatology Clinic
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japón, 321-0293
        • Dokkyo Medical University Hospital
    • Tokyo
      • Itabashi-ku, Tokyo, Japón, 173-8610
        • Nihon University Itabashi Hospital
      • Itabashi-ku, Tokyo, Japón, 173-8606
        • Teikyo University Hospital
  • Letonia
      • Riga, Letonia, 1003
        • Outpatient clinic Veselibas Centrs 4
      • Riga, Letonia, LV-1013
        • Outpatient clinic Veselibascentrs 4
      • Talsi, Letonia, 3201
        • Smite Aija practice in dermatology and venerology
  • Países Bajos
      • Born, Países Bajos, 6121 XK
        • PreCare Trial and Recruitment
  • Polonia
      • Gdansk, Polonia, 80-280
        • AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
      • Katowice, Polonia, 40-611
        • Centrum Medyczne Angelius Provita
      • Lublin, Polonia, 20-080
        • Centrum Zdrowia i Urody Maxxmed
      • Malbork, Polonia, 82-200
        • Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
      • Nowa Sól, Polonia, 67-100
        • Twoja Przychodnia NCM
      • Poznan, Polonia, 61-293
        • Twoja Przychodnia PCM
      • Szczecin, Polonia, 71-500
        • Twoja Przychodnia SCM
      • Tarnów, Polonia, 33-100
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
      • Warsaw, Polonia, 02-962
        • Royalderm Agnieszka Nawrocka
      • Wroclaw, Polonia, 50-450
        • Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
  • Porcelana
      • Beijing, Porcelana, 100044
        • Peking University Peoples Hospital
      • Shanghai, Porcelana, 200443
        • Shanghai Skin Disease Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100191
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, Porcelana, 100050
        • Beijing Friendship Hospital, Capital Medical University
    • Fujian
      • Fuzhou, Fujian, Porcelana, 350000
        • The First Affiliated Hospital Of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510091
        • Dermatology Hospital of Southern Medical University
      • Guangzhou, Guangdong, Porcelana, 510120
        • Sun Yat-sen Memorial Hospital Sun Yat-sen university
      • Guangzhou, Guangdong, Porcelana, 510080
        • The First Affiliated Hospital ,Sun-Yat Sen University
    • Hebei
      • Shijiazhuang, Hebei, Porcelana, 050000
        • The First Hospital of Hebei Medical University
    • Henan
      • Nanyang, Henan, Porcelana, 473002
        • Nanyang First Peoples Hospital
      • Sanmenxia, Henan, Porcelana, 472099
        • Sanmenxia Central Hospital
    • Hubei
      • Wuhan, Hubei, Porcelana, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, Porcelana, 410011
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Jiangyin, Jiangsu, Porcelana, 214400
        • Jiangyin Hospital of Traditional Chinese Medicine
      • Wuxi, Jiangsu, Porcelana, 241023
        • Wuxi Peoples Hospital
    • Jiangxi
      • Nanchang, Jiangxi, Porcelana, 330000
        • Dermatology Hospital of Jiangxi Province
    • Jilin
      • Changchun, Jilin, Porcelana, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, Porcelana, 110001
        • The First Hospital of China Medical University
    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610021
        • Chengdu Second Peoples Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310003
        • The First Affiliated Hospital Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, Porcelana, 310020
        • Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, Porcelana, 310004
        • Zhejiang Provincial Peoples Hospital
      • Taizhou, Zhejiang, Porcelana, 318000
        • Taizhou Central Hospital
  • 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
  • Taiwán
      • Kaohsiung City, Taiwán, 83301
        • Kaohsiung Chang Gung Memorial Hospital
      • Tainan, Taiwán, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwán, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwán, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwán, 10449
        • MacKay Memorial Hospital Taipei Branch
      • Taoyuan, Taiwán, 33305
        • Linkou Chang Gung Memorial Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 100 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Edad ≥ 18 años con diagnóstico de EA según los Criterios de Consenso de la AAD (2014) presente durante al menos 6 meses
  • Antecedentes de respuesta inadecuada a TCS (Corticoesteroide tópico) de potencia media o alta dentro de los 6 meses (con o sin inhibidores tópicos de la calcineurina [TCI])
  • Puntuación EASI ≥16
  • Puntuación vIGA-AD ≥3
  • ≥10% del área de superficie corporal (BSA) de compromiso de AD
  • Escala de calificación numérica del peor prurito ≥ 4

Criterio de exclusión:

  • Tratamiento con un producto biológico dentro de las 12 semanas o 5 semividas, lo que sea más largo, antes del Día 1

  • Tratamiento con cualquiera de los siguientes medicamentos o terapias dentro de las 4 semanas o 5 semividas, lo que sea más largo, antes del Día 1:

    • corticosteroides sistémicos
    • Inmunosupresores sistémicos
    • Fototerapia
    • Inhibidores de la cinasa Janus

  • Tratamiento con cualquiera de los siguientes medicamentos o terapias dentro de 1 semana, antes del Día 1:

    • TCS de cualquier potencia
    • TCI
    • Medicamento antipruriginoso
    • Inhibidores tópicos de la fosfodiesterasa tipo 4
    • Otros agentes inmunosupresores tópicos

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Brazo A
Rocatinlimab Dosis 1 cada 4 semanas (Q4W) + dosis de carga en la Semana 2
Droga: Rocatinlimab
Los participantes recibirán Rocatinlimab por vía subcutánea.
Otros nombres:
  • AMG 451
Experimental: Brazo B
Rocatinlimab Dosis 2 Q4W + dosis de carga en la Semana 2
Droga: Rocatinlimab
Los participantes recibirán Rocatinlimab por vía subcutánea.
Otros nombres:
  • AMG 451
Comparador de placebos: Brazo C
Dosis de carga de placebo Q4W+ en la semana 2
Droga: Placebo
Los participantes recibirán un placebo por vía subcutánea.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants Who Achieved EASI 75 at Week 16
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Amgen

Investigadores

  • Director de estudio: MD, Amgen

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

31 de mayo de 2022

Finalización primaria (Actual)

28 de noviembre de 2024

Finalización del estudio (Actual)

13 de enero de 2025

Fechas de registro del estudio

Enviado por primera vez

24 de mayo de 2022

Primero enviado que cumplió con los criterios de control de calidad

31 de mayo de 2022

Publicado por primera vez (Actual)

1 de junio de 2022

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

25 de junio de 2026

Última verificación

1 de febrero de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Datos de pacientes individuales desidentificados para las variables necesarias para abordar la pregunta de investigación específica en una solicitud de intercambio de datos aprobada.

Marco de tiempo para compartir IPD

Las solicitudes de intercambio de datos relacionadas con este estudio se considerarán a partir de los 18 meses posteriores a la finalización del estudio y 1) el producto y la indicación han obtenido la autorización de comercialización tanto en los EE. UU. como en Europa o 2) el desarrollo clínico del producto y/o la indicación se interrumpe y los datos no se enviarán a las autoridades reguladoras. No hay una fecha límite para la elegibilidad para enviar una solicitud de intercambio de datos para este estudio.

Criterios de acceso compartido de IPD

Los investigadores calificados pueden enviar una solicitud que contenga los objetivos de la investigación, los productos de Amgen y el alcance de los estudios de Amgen, los criterios de valoración/resultados de interés, el plan de análisis estadístico, los requisitos de datos, el plan de publicación y las calificaciones de los investigadores. En general, Amgen no concede solicitudes externas de datos de pacientes individuales con el fin de reevaluar los problemas de seguridad y eficacia ya abordados en la etiqueta del producto. Las solicitudes son revisadas por un comité de asesores internos. Si no se aprueba, un Panel de Revisión Independiente de Intercambio de Datos arbitrará y tomará la decisión final. Tras la aprobación, la información necesaria para abordar la pregunta de investigación se proporcionará bajo los términos de un acuerdo de intercambio de datos. Esto puede incluir datos de pacientes individuales anonimizados y/o documentos de respaldo disponibles, que contengan fragmentos de código de análisis donde se proporcione en las especificaciones de análisis. Más detalles están disponibles en la siguiente URL.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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