Un estudio de fase 3, doble ciego, controlado con placebo que evalúa la monoterapia de rocatinlimab (AMG 451) en la dermatitis atópica (DA) de moderada a grave (ROCKET-Horizon) (ROCKET-Horizon)
2 de junio de 2026 actualizado por: Amgen
Estudio de fase 3, aleatorizado, de 24 semanas, 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 (ROCKET- Horizonte)
Los objetivos principales del estudio son:
- Evaluar la eficacia de rocatinlimab en comparación con el placebo en la Semana 24, evaluada mediante la Evaluación global del investigador validado para la dermatitis atópica (vIGA-AD).
- Evaluar la eficacia de rocatinlimab en comparación con el placebo en la semana 24, evaluada mediante el índice de área y gravedad del eccema (EASI).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
726
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
-
-
-
Bad Bentheim, Alemania, 48455
- Fachklinik Bad Bentheim
-
Berlin, Alemania, 10247
- Hautzentrum Friedrichshain - Dermatologie
-
Berlin, Alemania, 13672
- Clinical Research Services Berlin GmbH
-
Halle, Alemania, 06120
- Klinikum der Medizinischen Fakultaet der Martin-Luther-Universitaet Halle-Wittenberg
-
Hamburg, Alemania, 20354
- Dermatologikum Hamburg
-
Kiel, Alemania, 24105
- Universitaetsklinikum Schleswig-Holstein
-
Leipzig, Alemania, 04103
- Velocity Clinical Research
-
Münster, Alemania, 48149
- Universitaetsklinikum Muenster
-
Osnabrück, Alemania, 49074
- KliFOs Klinische Forschung Osnabrueck
-
Remscheid, Alemania, 42897
- Hautarztpraxis Mortazawi
-
Wuppertal, Alemania, 42283
- Helios Klinikum Wuppertal
-
-
-
-
New South Wales
-
Darlinghurst, New South Wales, Australia, 2010
- St George Dermatology and Skin Cancer Centre
-
Kogarah, New South Wales, Australia, 2217
- Premier Specialists
-
-
Victoria
-
Box Hill, Victoria, Australia, 3128
- Box Hill Hospital
-
Carlton, Victoria, Australia, 3053
- Skin Health Institute
-
East Melbourne, Victoria, Australia, 3002
- Sinclair Dermatology
-
Melbourne, Victoria, Australia, 3004
- The Alfred Hospital
-
Parkville, Victoria, Australia, 3050
- The Royal Melbourne Hospital
-
-
-
-
Paraná
-
Curitiba, Paraná, Brasil, 80030-110
- CETI - Centro de Estudo em Terapias Inovadoras
-
-
São Paulo
-
São Bernardo do Campo, São Paulo, Brasil, 09715-090
- Centro Multidisciplinar de Estudos Clínicos - CEMEC
-
São José dos Campos, São Paulo, Brasil, 12243-280
- ISPEM - Instituto São Jose dos Campos em Pesquisas Medicas
-
-
-
-
-
Brussels, Bélgica, 1070
- Hopital Erasme
-
Herstal, Bélgica, 4040
- Clinique Andre Renard
-
Maldegem, Bélgica, 9990
- Dermatologie Maldegem
-
-
-
-
Alberta
-
Calgary, Alberta, Canadá, T3E 0B2
- Beacon Dermatology
-
-
British Columbia
-
Surrey, British Columbia, Canadá, V3R 6A7
- Doctor Chih-Ho Hong Medical Incorporated
-
-
Ontario
-
Etobicoke, Ontario, Canadá, M8X 1Y9
- Kingsway Clinical Research
-
Markham, Ontario, Canadá, L3P 1X3
- Lynderm Research Inc
-
Oakville, Ontario, Canadá, L6J 7W5
- The Centre for Clinical Trials Inc
-
Peterborough, Ontario, Canadá, K9J 5K2
- SKiN Centre for Dermatology
-
Richmond Hill, Ontario, Canadá, L4B 1A5
- The Centre for Dermatology
-
Toronto, Ontario, Canadá, M4W 2N4
- Research Toronto
-
Windsor, Ontario, Canadá, N8T 1E6
- XLR8 Medical Research, Incorporated
-
-
Quebec
-
Québec, Quebec, Canadá, G1V 4X7
- Centre de Recherche Dermatologique du Quebec metropolitain
-
Sherbrooke, Quebec, Canadá, J1G 1X9
- Clinique Dermatologique de Sherbrooke
-
-
-
-
-
Kutná Hora, Chequia, 284 01
- Kozni ambulance Kutna Hora sro
-
Nový Jičín, Chequia, 741 01
- Nemocnice Novy Jicin as
-
Pardubice, Chequia, 530 02
- CCR Czech as
-
Pilsen, Chequia, 305 99
- Fakultni Nemocnice Plzen
-
Prague, Chequia, 130 00
- CCR Prague sro
-
Prague, Chequia, 120 00
- Dermamedest sro
-
Prague, Chequia, 106 00
- Kozni ambulance Fialova sro
-
Prague, Chequia, 150 00
- Praglandia sro
-
Svitavy, Chequia, 568 02
- Dermatologicka ambulance MUDr Petr Trestik
-
-
-
-
-
Ansansi, Gyeonggido, Corea del Sur, 15355
- Korea University Ansan Hospital
-
Bucheon-si, Gyeonggi-do, Corea del Sur, 14584
- Soon Chun Hyang University Bucheon Hospital
-
Busan, Corea del Sur, 49241
- Pusan National University Hospital
-
Daegu, Corea del Sur, 41944
- Kyungpook National University Hospital
-
Gwangju, Corea del Sur, 61453
- Chosun University Hospital
-
Incheon, Corea del Sur, 22332
- Inha University Hospital
-
Incheon, Corea del Sur, 21431
- The Catholic University of Korea Incheon St Marys Hospital
-
Seongnam-si, Gyeonggi-do, Corea del Sur, 13620
- Seoul National University Bundang Hospital
-
Seoul, Corea del Sur, 03080
- Seoul National University Hospital
-
Seoul, Corea del Sur, 05505
- Asan Medical Center
-
Seoul, Corea del Sur, 03722
- Severance Hospital, Yonsei University Health System
-
Seoul, Corea del Sur, 05278
- Kyung Hee University Hospital at Gangdong
-
Seoul, Corea del Sur, 02841
- Korea University Anam Hospital
-
Seoul, Corea del Sur, 05030
- Konkuk University Medical Center
-
Seoul, Corea del Sur, 06973
- Chung-Ang University Hospital
-
Seoul, Corea del Sur, 07441
- Hallym University Kangnam Sacred Heart Hospital
-
Seoul, Corea del Sur, 04564
- National Medical Center
-
Seoul, Corea del Sur, 07804
- Ewha Womans University Seoul Hospital
-
Seoul, Corea del Sur, 06591
- The Catholic Univ of Korea Seoul St Marys Hospital
-
Suwon-si, Gyeonggi-do, Corea del Sur, 16499
- Ajou University Hospital
-
-
-
-
-
Hellerup, Dinamarca, 2900
- Gentofte Hospital
-
Odense, Dinamarca, 5000
- Odense University Hospital
-
-
-
-
-
Madrid, España, 28034
- Hospital Universitario Ramon y Cajal
-
Madrid, España, 28046
- Hospital Universitario La Paz
-
Majadahonda, España, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
-
-
Andalusia
-
Seville, Andalusia, España, 41009
- Hospital Universitario Virgen Macarena
-
-
Navarre
-
Pamplona, Navarre, España, 31008
- Clinica Universidad de Navarra
-
-
Valencia
-
Alicante, Valencia, España, 03010
- Hospital General Universitario de Alicante
-
Manises, Valencia, España, 46940
- Hospital de Manises
-
Valencia, Valencia, España, 46015
- Hospital Arnau de Vilanova de Valencia
-
-
-
-
Arizona
-
Litchfield Park, Arizona, Estados Unidos, 85340
- Research Solutions of Arizona, PC
-
Scottsdale, Arizona, Estados Unidos, 85260
- Center for Dermatology and Plastic Surgery
-
-
Arkansas
-
Fayetteville, Arkansas, Estados Unidos, 72703
- Clinical Trials Institute of Northwest Arkansas
-
Hot Springs, Arkansas, Estados Unidos, 71913
- Burke Pharmaceutical Research
-
-
California
-
Chula Vista, California, Estados Unidos, 91911
- Velocity Clinical Research Chula Vista
-
Dublin, California, Estados Unidos, 94568
- West Coast Research LLC
-
Encinitas, California, Estados Unidos, 92024
- California Dermatology and Clinical Research Institute
-
Fremont, California, Estados Unidos, 94538
- Center for Dermatology Clinical Research Inc
-
La Mesa, California, Estados Unidos, 91942
- Velocity Clinical Research - San Diego
-
North Hollywood, California, Estados Unidos, 91606
- Velocity Clinical Research - North Hollywood
-
Palmdale, California, Estados Unidos, 93551
- Cura Clinical Research
-
San Francisco, California, Estados Unidos, 94115
- University of California at San Francisco, Dermatology Clinic at Mount Zion
-
Santa Monica, California, Estados Unidos, 90404
- Clinical Science Institute
-
-
Colorado
-
Castle Rock, Colorado, Estados Unidos, 80109
- Clarity Dermatology
-
Denver, Colorado, Estados Unidos, 80209
- Velocity Clinical Research - Denver
-
-
District of Columbia
-
Washington D.C., District of Columbia, Estados Unidos, 20016
- Foxhall Research Center
-
-
Florida
-
Cape Coral, Florida, Estados Unidos, 33991
- Renaissance Research and Medical Group
-
Coral Gables, Florida, Estados Unidos, 33134
- Driven Research LLC
-
Doral, Florida, Estados Unidos, 33172
- Saint Jude Clinical Research
-
Hialeah, Florida, Estados Unidos, 33012
- Direct Helpers Research Center
-
Margate, Florida, Estados Unidos, 33063
- Glick Skin Institute
-
Miami, Florida, Estados Unidos, 33176
- Miami Dade Medical Research Institute, LLC
-
Palmetto Bay, Florida, Estados Unidos, 33157
- Innovation Medical Research Center Inc
-
Tampa, Florida, Estados Unidos, 33612
- University of South Florida Health Morsani Center for Advanced Healthcare
-
-
Georgia
-
Sandy Springs, Georgia, Estados Unidos, 30328
- Advanced Medical Research Pc
-
-
Illinois
-
Normal, Illinois, Estados Unidos, 61761
- Sneeze, Wheeze, and Itch Associates, LLC
-
-
Indiana
-
South Bend, Indiana, Estados Unidos, 46617
- The South Bend Clinic LLP
-
West Lafayette, Indiana, Estados Unidos, 47906
- Options Research Group LLC
-
-
Kansas
-
Overland Park, Kansas, Estados Unidos, 66223
- Dermatology and Skin Cancer Center of Overland Park
-
-
Kentucky
-
Louisville, Kentucky, Estados Unidos, 40241
- DS Research
-
Murray, Kentucky, Estados Unidos, 42071
- Kentucky Advanced Medical Research LLC
-
-
Massachusetts
-
Brighton, Massachusetts, Estados Unidos, 02135
- MetroBoston Clinical Partners
-
-
Michigan
-
Farmington Hills, Michigan, Estados Unidos, 48334
- Wendy Sadoff MD Dermatology PC
-
Troy, Michigan, Estados Unidos, 48084
- Somerset Skin Centre
-
Troy, Michigan, Estados Unidos, 48084
- Revival Research Institute LLC
-
-
Nebraska
-
Omaha, Nebraska, Estados Unidos, 68144
- Advanced Dermatology of the Midlands
-
-
Nevada
-
Las Vegas, Nevada, Estados Unidos, 89117
- James Del Rosso Dermatology Research
-
Reno, Nevada, Estados Unidos, 89509
- Skin Cancer and Dermatology Institute
-
-
New Hampshire
-
Lebanon, New Hampshire, Estados Unidos, 03766
- Dartmouth-Hitchcock Medical Center
-
-
New Jersey
-
Riverdale, New Jersey, Estados Unidos, 07457
- Weiss Medical
-
-
New York
-
Horseheads, New York, Estados Unidos, 14845
- Corning Center for Clinical Research
-
Kew Gardens, New York, Estados Unidos, 11415
- Forest Hills Dermatology Group
-
Monroe, New York, Estados Unidos, 10950
- Crystal Run Healthcare
-
New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
-
New York, New York, Estados Unidos, 10022
- Ace Clinical Trials
-
New York, New York, Estados Unidos, 10128
- OptiSkin Medical
-
The Bronx, New York, Estados Unidos, 10467
- Montefiore Medical Center
-
-
North Carolina
-
Durham, North Carolina, Estados Unidos, 27713
- Duke South Durham
-
-
Ohio
-
Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati
-
Cincinnati, Ohio, Estados Unidos, 45236
- Bernstein Clinical Research Center LLC
-
Gahanna, Ohio, Estados Unidos, 43230
- The Ohio State University Dermatology East
-
-
Oregon
-
Grants Pass, Oregon, Estados Unidos, 97527
- Velocity Clinical Research - Grants Pass
-
Portland, Oregon, Estados Unidos, 97223
- Oregon Medical Research Center
-
-
Rhode Island
-
Warwick, Rhode Island, Estados Unidos, 02886
- Asthma and Allergy Physicians of Rhode Island Clinical Research Institute
-
-
Texas
-
Bellaire, Texas, Estados Unidos, 77401
- Bellaire Dermatology Associates
-
Cedar Park, Texas, Estados Unidos, 78613
- US Dermatology Partners Cedar Park
-
Dallas, Texas, Estados Unidos, 75225
- Alina Clinical Trials, LLC
-
Dallas, Texas, Estados Unidos, 75230
- Zenos Clinical Research, LLC
-
Houston, Texas, Estados Unidos, 77030
- The University of Texas Health Science Center at Houston
-
Houston, Texas, Estados Unidos, 77037
- MedCare Pharma - Houston
-
Lampasas, Texas, Estados Unidos, 76550
- FMCScience LLC
-
Lewisville, Texas, Estados Unidos, 75057
- Epic Clinical Research Incorporated
-
Missouri City, Texas, Estados Unidos, 77459
- Sienna Dermatology Research
-
San Antonio, Texas, Estados Unidos, 78218
- Texas Dermatology and Laser Specialists
-
San Antonio, Texas, Estados Unidos, 78229
- Dermatology Clinical Research Center of San Antonio
-
San Antonio, Texas, Estados Unidos, 78229
- Andante Research
-
-
Utah
-
Murray, Utah, Estados Unidos, 84107
- University of Utah Midvalley Dermatology
-
-
Virginia
-
Norfolk, Virginia, Estados Unidos, 23507
- Eastern Virginia Medical School
-
-
Washington
-
Spokane, Washington, Estados Unidos, 99202
- MultiCare Institute for Research and Innovation
-
-
-
-
-
Tallinn, Estonia, 13419
- North Estonia Medical Centre
-
Tartu, Estonia, 50106
- Clinical Research Centre
-
-
-
-
-
Helsinki, Finlandia, 00180
- CRST Helsinki
-
Helsinki, Finlandia, 00180
- CRST Turku
-
Oulu, Finlandia, 90029
- Oulun Yliopistollinen sairaala (OYS)
-
Tampere, Finlandia, 33100
- Terveystalo Tampere
-
-
-
-
Chiba
-
Matsudo-shi, Chiba, Japón, 271-0092
- Miyata Dermatology Clinic
-
Narita-shi, Chiba, Japón, 286-8520
- International University of Health and Welfare Narita Hospital
-
-
Hyōgo
-
Kobe, Hyōgo, Japón, 650-0017
- Kobe University Hospital
-
-
Kanagawa
-
Kawasaki-shi, Kanagawa, Japón, 216-8511
- St Marianna University Hospital
-
Sagamihara-shi, Kanagawa, Japón, 252-0392
- National Hospital Organization Sagamihara National Hospital
-
Yokohama, Kanagawa, Japón, 224-8503
- Showa University Northern Yokohama Hospital
-
-
Nagasaki
-
Nagasaki, Nagasaki, Japón, 852-8501
- Nagasaki University Hospital
-
-
Osaka
-
Habikino-shi, Osaka, Japón, 583-8588
- Osaka Habikino Medical Center
-
Sakai-shi, Osaka, Japón, 593-8324
- Dermatology and Ophthalmology Kume Clinic
-
-
Shizuoka
-
Hamamatsu, Shizuoka, Japón, 431-3192
- Hamamatsu University Hospital
-
-
Tokyo
-
Minato-ku, Tokyo, Japón, 108-0014
- Mita Dermatology Clinic
-
Shinagawa-ku, Tokyo, Japón, 142-8666
- Showa University Hospital
-
Shinjuku-ku, Tokyo, Japón, 161-8521
- Seibo International Catholic Hospital
-
Toshima-ku, Tokyo, Japón, 170-0002
- Sugamo Kobayashi Derma Clinic
-
-
Toyama
-
Takaoka-shi, Toyama, Japón, 933-0871
- Shirasaki dermatology clinic
-
-
-
-
-
Chihuahua City, México, 31203
- SCIENTIA Investigacion Clinica SC
-
Cuautitlán Izcalli, México, 54750
- Phylasis Clínicas Research S. De R. L. De C. V.
-
-
Michoacán
-
Morelia, Michoacán, México, 58249
- Clinica de Enfermedades Cronicas y de Procedimientos Especiales
-
-
-
-
-
Bialystok, Polonia, 15-879
- ClinicMed Daniluk Nowak Spolka Komandytowa
-
Chorzów, Polonia, 41-500
- Dermapolis Medical Dermatology Center dr n med Edyta Gebska
-
Gdansk, Polonia, 80-214
- Uniwersyteckie Centrum Kliniczne
-
Krakow, Polonia, 31-530
- Centermed krakow sp zoo
-
Lodz, Polonia, 90-349
- AppleTreeClinics Network Spzoo
-
Lodz, Polonia, 90-338
- Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna
-
Lodz, Polonia, 91-495
- Amicare Spolka z ograniczona odpowiedzialnoscia Spolka Komandytowa Amicare Centrum Medyczne
-
Lublin, Polonia, 20-078
- Clinical Best Solutions Sp zoo Spolka komandytowa
-
Poznan, Polonia, 61-731
- Clinical Research Center Spzoo Medic-R Spolka Komandytowa
-
Warsaw, Polonia, 02-625
- Evimed sp zoo centrum medyczne evimed
-
-
-
-
-
Almada, Portugal, 2801-951
- Hospital Garcia de Orta, EPE
-
Coimbra, Portugal, 3000-075
- Centro Hospitalar e Universitário de Coimbra, EPE
-
Lisbon, Portugal, 1998-018
- Hospital CUF Descobertas
-
Porto, Portugal, 4099-001
- Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio
-
Porto, Portugal, 4200-319
- Centro Hospitalar de Sao Joao EPE - Hospital de Sao Joao
-
-
-
-
-
Corby, Reino Unido, NN17 2UR
- Lakeside Healthcare
-
London, Reino Unido, SE1 9RT
- Guys Hospital
-
Southampton, Reino Unido, SO16 6YD
- Southampton General Hospital
-
-
-
-
-
Bucharest, Rumania, 020125
- Spitalul Clinic Colentina
-
-
-
-
-
Durban, Sudáfrica, 3630
- Hiway Medical Centre
-
-
Gauteng
-
Centurion, Gauteng, Sudáfrica, 0157
- Ryexo Clinical Research
-
Johannesburg, Gauteng, Sudáfrica, 2057
- About Allergy
-
-
-
-
-
Stockholm, Suecia, 171 76
- Karolinska Universitetssjukhuset Solna
-
-
-
-
-
Ankara, Turquía (Türkiye), 06230
- Hacettepe Universitesi Tip Fakultesi Hastanesi
-
Gaziantep, Turquía (Türkiye), 27310
- Gaziantep Universitesi Tip Fakultesi Hastanesi
-
Istanbul, Turquía (Türkiye), 34093
- Bezmialem Vakif Universitesi Hastanesi
-
Izmir, Turquía (Türkiye), 35620
- Bakircay Universitesi Cigli Egitim ve Arastirma Hastanesi
-
Kayseri, Turquía (Türkiye), 38030
- Erciyes Universitesi Tip Fakultesi Hastanesi
-
Kocaeli, Turquía (Türkiye), 41380
- Kocaeli Universitesi Tip Fakultesi Hastanesi
-
Sakarya, Turquía (Türkiye), 54050
- Sakarya Egitim ve Arastirma Hastanesi
-
-
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
- 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: Rocatinlimab
Rocatinlimab Dosis 1 cada 4 semanas (Q4W) durante 24 semanas con una dosis de carga en la Semana 2.
|
Rocatinlimab se administrará a través de una inyección subcutánea (SC).
Otros nombres:
|
|
Comparador de placebos: Placebo
Placebo Q4W durante 24 semanas con una dosis de carga en la Semana 2.
|
El placebo correspondiente se administrará a través de una inyección SC.
|
¿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 vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) (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 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 ≥ 4-point Reduction From Baseline in Weekly Average of 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 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 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
|
|
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 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 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 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
|
|
Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of 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 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
|
|
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
|
|
Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Periodo de tiempo: Baseline and Week 24
|
Weekly 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
|
|
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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
- Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
- Guttman-Yassky E, Kabashima K, Worm M, Luna PC, Hong HC, Chovatiya R, Bernstein JA, Kern JS, Ehst BD, Magnolo N, Herranz-Pinto P, Stein Gold L, Sofen H, Pink AE, Esfandiari E, Arai T, Yang Y, Shi R, Barragan C, Kricorian G, Schwartz-Sagi L, Bissonnette R. Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials. Lancet. 2026 Jan 3;407(10523):53-66. doi: 10.1016/S0140-6736(25)01865-3. Epub 2025 Nov 25.
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)
14 de diciembre de 2022
Finalización primaria (Actual)
5 de junio de 2024
Finalización del estudio (Actual)
27 de agosto de 2024
Fechas de registro del estudio
Enviado por primera vez
7 de diciembre de 2022
Primero enviado que cumplió con los criterios de control de calidad
7 de diciembre de 2022
Publicado por primera vez (Actual)
15 de diciembre de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
26 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Genéticas Congénitas
- Enfermedades del sistema inmunológico
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Enfermedades de la piel
- Enfermedades De La Piel Genéticas
- Enfermedades De La Piel Eccematosas
- Dermatitis
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Enfermedades de la piel y del tejido conectivo
- Dermatitis Atópica
- Eczema
- Agentes dermatológicos
- KHK4083
Otros números de identificación del estudio
- 20210143
- 2022-501538-44 (Otro identificador: EU CT Number)
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. .