Un estudio para obtener más información sobre cómo funciona el risankizumab en participantes jóvenes con colitis ulcerosa (MIGHTY)
Un estudio de fase 3, múltiple centro para evaluar la farmacocinética, la eficacia y la seguridad de risankizumab con inducción abierta, mantenimiento doble ciego aleatorizado y períodos de extensión a largo plazo abiertos en sujetos pediátricos (2 a <18 años de edad) con moderada a la ulitis a la gravedad de
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed.
Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 sites worldwide.
Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 3
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ABBVIE CALL CENTER
- Número de teléfono: 844-663-3742
- Correo electrónico: abbvieclinicaltrials@abbvie.com
Ubicaciones de estudio
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Brandenburg
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Cottbus, Brandenburg, Alemania, 03048
- Reclutamiento
- Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023
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Hesse
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Kassel, Hesse, Alemania, 34125
- Reclutamiento
- Klinikum Kassel /ID# 271546
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Alemania, 48149
- Reclutamiento
- Universitaetsklinikum Muenster /ID# 271898
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São Paulo, Brasil, 01308-050
- Reclutamiento
- Hospital Sirio Libanes - Sao Paulo /ID# 271818
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Minas Gerais
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Juiz de Fora, Minas Gerais, Brasil, 36033-318
- Reclutamiento
- Galileo Medical Research /ID# 271817
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Paraná
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Curitiba, Paraná, Brasil, 80250-060
- Reclutamiento
- Hospital Pequeno Principe /ID# 271814
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Brussels, Bélgica, 1020
- Reclutamiento
- Hospital Universite Enfants Reine Fabiola /ID# 271860
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Liège, Bélgica, 4000
- Reclutamiento
- Centre Hospitalier Regional de la Citadelle /ID# 270459
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Brussels Capital
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Brussels, Brussels Capital, Bélgica, 1200
- Reclutamiento
- Cliniques Universitaires UCL Saint-Luc /ID# 270123
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Alberta
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Calgary, Alberta, Canadá, T3B 6A8
- Reclutamiento
- Alberta Children's Hospital /ID# 272635
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Edmonton, Alberta, Canadá, T6G 2B7
- Reclutamiento
- University of Alberta Hospital /ID# 271168
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Ontario
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London, Ontario, Canadá, N6A 5W9
- Reclutamiento
- London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157
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Gyeongsangnam-do
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Yangsan, Gyeongsangnam-do, Corea del Sur, 50612
- Reclutamiento
- Pusan National University Yangsan Hospital /ID# 272769
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Corea del Sur, 03080
- Reclutamiento
- Seoul National University Hospital /ID# 272852
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Seoul, Seoul Teugbyeolsi, Corea del Sur, 06351
- Reclutamiento
- Samsung Medical Center /ID# 272862
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Seoul, Seoul Teugbyeolsi, Corea del Sur, 03181
- Reclutamiento
- Kangbuk Samsung Hospital /ID# 273333
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Seoul, Seoul Teugbyeolsi, Corea del Sur, 03722
- Reclutamiento
- Yonsei University Health System - Severance Hospital /ID# 272894
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A Coruna
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A Coruña, A Coruna, España, 15006
- Reclutamiento
- Hospital Teresa Herrera - CHUAC /ID# 271459
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Madrid
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Majadahonda, Madrid, España, 28222
- Reclutamiento
- Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466
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Arizona
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Phoenix, Arizona, Estados Unidos, 85016
- Reclutamiento
- Phoenix Children's Hospital /ID# 273015
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California
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San Diego, California, Estados Unidos, 92123
- Reclutamiento
- Rady Children's Hospital /ID# 271873
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San Francisco, California, Estados Unidos, 94158
- Reclutamiento
- University of California San Francisco - Mission Bay /ID# 273022
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Florida
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Miami, Florida, Estados Unidos, 33155
- Reclutamiento
- Nicklaus Children's Hospital - Miami /ID# 271585
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Georgia
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Atlanta, Georgia, Estados Unidos, 30342
- Reclutamiento
- Childrens Center For Digestive Health Care /ID# 273228
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Illinois
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Chicago, Illinois, Estados Unidos, 60637
- Reclutamiento
- University of Chicago Medical Center /ID# 271588
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New Jersey
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Morristown, New Jersey, Estados Unidos, 07962
- Reclutamiento
- Goryeb Children's Hospital /ID# 271801
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- Reclutamiento
- University Hospitals Cleveland Medical Center /ID# 271831
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Reclutamiento
- The Children's Hospital of Philadelphia /ID# 273222
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Reclutamiento
- Upmc Children'S Hospital Of Pittsburgh /ID# 272328
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South Carolina
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Greenville, South Carolina, Estados Unidos, 29615
- Reclutamiento
- Patewood Medical Campus /ID# 272477
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Texas
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Dallas, Texas, Estados Unidos, 75235
- Reclutamiento
- University of Texas - Southwestern Medical Center /ID# 271835
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Thessaloniki, Grecia, 54642
- Reclutamiento
- General Hospital of Thessaloniki Hippokrateio /ID# 271939
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Attica
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Athens, Attica, Grecia, 11527
- Reclutamiento
- Thoracic General Hospital of Athens I Sotiria /ID# 270143
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Chaïdári, Attica, Grecia, 12462
- Reclutamiento
- University General Hospital Attikon /ID# 272361
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Trieste, Italia, 34137
- Reclutamiento
- Ospedale Infantile Burlo Garofolo /ID# 274442
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Foggia
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San Giovanni Rotondo, Foggia, Italia, 71013
- Reclutamiento
- Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889
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Napoli
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Naples, Napoli, Italia, 80131
- Reclutamiento
- Azienda Ospedaliera Universitaria Federico II - Naples /ID# 271895
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Roma
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Rome, Roma, Italia, 00168
- Reclutamiento
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967
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Fukushima, Japón, 960-1295
- Reclutamiento
- Fukushima Medical University Hospital /ID# 281178
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Aichi-ken
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Ōbu, Aichi-ken, Japón, 474-8710
- Reclutamiento
- Aichi Children's Health And Medical Center /ID# 280462
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Chiba
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Kashiwa-shi, Chiba, Japón, 277-0871
- Reclutamiento
- Tsujinaka Hospital - Kashiwanoha /ID# 280303
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Fukuoka
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Kurume-shi, Fukuoka, Japón, 830-0011
- Reclutamiento
- Kurume University Hospital /ID# 280792
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Gunma
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Maebashi, Gunma, Japón, 371-8511
- Reclutamiento
- Gunma University Hospital /ID# 281179
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Hyōgo
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Kobe, Hyōgo, Japón, 650-0017
- Reclutamiento
- Kobe University Hospital /ID# 281796
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Kumamoto
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Kumamoto, Kumamoto, Japón, 861-8520
- Reclutamiento
- Japanese Red Cross Kumamoto Hospital /ID# 280696
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Saga-ken
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Saga, Saga-ken, Japón, 849-8501
- Reclutamiento
- Saga University Hospital /ID# 281232
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Saitama
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Saitama-shi, Saitama, Japón, 330-8777
- Reclutamiento
- Saitama Children's Medical Center /ID# 280603
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Shizuoka
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Hamamatsu, Shizuoka, Japón, 431-3192
- Reclutamiento
- Hamamatsu University Hospital /ID# 281614
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Tokyo
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Bunkyo-ku, Tokyo, Japón, 113-8519
- Reclutamiento
- Institute of Science Tokyo Hospital /ID# 280694
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Bunkyo-ku, Tokyo, Japón, 113-8431
- Reclutamiento
- Juntendo University Hospital /ID# 280463
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Fuchu-shi, Tokyo, Japón, 183-8561
- Reclutamiento
- Tokyo Metropolitan Children's Medical Center /ID# 280791
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Setagaya City, Tokyo, Japón, 157-8535
- Reclutamiento
- National Center For Child Health And Development /ID# 280460
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polonia, 00-189
- Reclutamiento
- Centrum Zdrowia Mdm /ID# 276942
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Warsaw, Masovian Voivodeship, Polonia, 00-728
- Reclutamiento
- Medical Network Sp. z o.o. /ID# 276903
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polonia, 15-274
- Reclutamiento
- Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku /ID# 276771
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510620
- Reclutamiento
- Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 277962
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Henan
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Zhengzhou, Henan, Porcelana, 450018
- Reclutamiento
- Henan Children's Hospital Zhengzhou Children's Hospital /ID# 278794
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Hunan
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Changsha, Hunan, Porcelana, 410007
- Reclutamiento
- Hunan Children's Hospital /ID# 278111
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Jilin
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Changchun, Jilin, Porcelana, 130021
- Reclutamiento
- The First Hospital of Jilin University - Changchun /ID# 279290
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200025
- Reclutamiento
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 278113
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310018
- Reclutamiento
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 277994
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Hangzhou, Zhejiang, Porcelana, 310056
- Reclutamiento
- The Childrens Hospital of Zhejiang University School of Medicine /ID# 278815
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Liverpool, Reino Unido, L12 2AP
- Reclutamiento
- Alder Hey Children's NHS Foundation Trust /ID# 271533
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Cambridgeshire
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Cambridge, Cambridgeshire, Reino Unido, CB2 2QQ
- Reclutamiento
- Addenbrookes Hospital /ID# 271489
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England
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Sheffield, England, Reino Unido, S10 2TH
- Reclutamiento
- Sheffield Children's Hospital NHS Foundation Trust /ID# 271490
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Novi Sad, Serbia, 21000
- Reclutamiento
- Institute for Child and Youth Health Care of Vojvodina /ID# 269961
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Beograd
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Belgrade, Beograd, Serbia, 11000
- Reclutamiento
- University Children's Hospital /ID# 269960
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Belgrade-Vračar, Beograd, Serbia, 11000
- Reclutamiento
- Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696
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Stockholm County
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Solna, Stockholm County, Suecia, 171 64
- Reclutamiento
- Karolinska University Hospital Solna /ID# 271679
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Stockholm, Stockholm County, Suecia, 118 83
- Reclutamiento
- Sodersjukhuset /ID# 271678
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Västra Götaland County
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Gothenburg, Västra Götaland County, Suecia, 413 46
- Reclutamiento
- Sahlgrenska Universitetssjukhuset /ID# 271675
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Contacto:
- Site Coordinator
- Número de teléfono: +46313435865
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Taichung, Taiwán, 407219
- Reclutamiento
- Taichung Veterans General Hospital /ID# 269242
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Taipei, Taiwán, 100
- Reclutamiento
- National Taiwan University Hospital /ID# 269244
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).
- Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:
aminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol.
- Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. Documentation of pathology results consistent with the diagnosis of UC must be available.
Exclusion Criteria:
- Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection).
- Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: PK Cohort 1: SS1
Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All participants who complete SS1 are eligible to enter SS2 |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: PK Cohort 1: SS2 Dose A
Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: PK Cohort 1: SS2 Dose B
Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: PK Cohort 1: SS3 Dose A
Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: PK Cohort 1: SS3 Dose B
Cohort 1 will consist of 2 age groups (6 to < 12 years and 12 to < 18 years). SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: PK Cohort 2: SS1
Cohort 2 will enroll participants aged 2 to less than 6 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All subjects who complete SS1 are eligible to enter SS2. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: PK Cohort 2: SS2 Dose A
Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term extension SS3. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: PK Cohort 2: SS2 Dose B
Cohort 2 will enroll participants aged 2 to less than 6 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term extension SS3. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: PK Cohort 2: SS3 Dose A
Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: PK Cohort 2: SS3 Dose B
Cohort 2 will enroll participants aged 2 to less than 6 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: Expansion Cohort 3: SS1
Cohort 3 will enroll participants aged 2 to less than 18 years. SS1 is a 12-week induction period where participants will receive a weight-based dose of risankizumab. All participants who complete SS1 are eligible to enter SS2. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: Expansion Cohort 3: SS2 Dose A
Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: Expansion Cohort 3: SS2 Dose B
Cohort 3 will enroll participants aged 2 to less than 18 years. Participants who complete SS1 will be randomized into a 52-week maintenance phase (SS2) to receive double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long term extension SS3. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: Expansion Cohort 3: SS3 Dose A
Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
|
Experimental: Expansion Cohort 3: SS3 Dose B
Cohort 3 will enroll participants aged 2 to less than 18 years. SS3 is a 208-week extension period where participants receive risankizumab based on their response in SS2. |
Risankizumab intravenous (IV) infusion
Otros nombres:
Risankizumab subcutaneous (SC) injection
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)
Periodo de tiempo: At Week 64
|
Maximum observed plasma concentration (Cmax) |
At Week 64
|
|
PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)
Periodo de tiempo: At Week 64
|
Maximum observed plasma concentration (Cmax) |
At Week 64
|
|
PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)
Periodo de tiempo: At Week 64
|
Time to maximum plasma concentration (Tmax) |
At Week 64
|
|
PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)
Periodo de tiempo: At Week 64
|
Time to maximum plasma concentration (Tmax) |
At Week 64
|
|
PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)
Periodo de tiempo: At Week 64
|
Area under the serum concentration-time curve over the dosing interval (AUCtau) |
At Week 64
|
|
PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)
Periodo de tiempo: At Week 64
|
Area under the serum concentration-time curve over the dosing interval (AUCtau) |
At Week 64
|
|
Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) Among Week 12 Clinical Responders per mMS
Periodo de tiempo: At Week 64
|
Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1 |
At Week 64
|
|
Number of Participants With Adverse Events
Periodo de tiempo: Up to 292 Weeks
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related |
Up to 292 Weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cohorte de expansión 3: Logro de la remisión clínica por MMS
Periodo de tiempo: En la semana 12
|
En la semana 12
|
|
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Cohorte de expansión 3: Logro de la respuesta clínica por MMS
Periodo de tiempo: En la semana 12
|
En la semana 12
|
|
|
Cohorte de expansión 3: Logro de mejora endoscópica
Periodo de tiempo: En la semana 12
|
En la semana 12
|
|
|
Cohorte de expansión 3: respuesta sintomática por MMS parcial
Periodo de tiempo: En la semana 12
|
En la semana 12
|
|
|
Cohorte de expansión 3: Logro de la respuesta clínica por MMS entre los respondedores de la semana 12 por MMS
Periodo de tiempo: En la semana 64
|
En la semana 64
|
|
|
Cohorte de expansión 3: Logro de mejora endoscópica entre los respondedores de la semana 12 por MMS
Periodo de tiempo: En la semana 64
|
En la semana 64
|
|
|
Cohorte de expansión 3: Logro de remisión clínica libre de corticosteroides por MMS entre los respondedores de la semana 12 por MMS
Periodo de tiempo: En la semana 64
|
En la semana 64
|
|
|
PK Lead-In Cohort 1: Achievement of corticosteroid-free (at least 90 days without corticosteroid exposure) clinical remission per mMS at Week 64 among Week 12 responders per mMS
Periodo de tiempo: Up to Week 64
|
Up to Week 64
|
|
|
PK Lead-In Cohort 2: Achievement of corticosteroid-free (at least 90 days without corticosteroid exposure) clinical remission per mMS at Week 64 among Week 12 responders per mMS
Periodo de tiempo: Up to Week 64
|
Up to Week 64
|
|
|
PK Lead-In Cohort 1: Achievement of clinical remission per mMS among Week 12 responders per mMS
Periodo de tiempo: At Week 64
|
Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1 |
At Week 64
|
|
PK Lead-In Cohort 2: Achievement of clinical remission per mMS among Week 12 responders per mMS
Periodo de tiempo: At Week 64
|
Clinical remission on the mMS is defined as defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1 |
At Week 64
|
|
PK Lead-In Cohort 1: Achievement of clinical remission per mMS
Periodo de tiempo: At Week 12
|
Clinical remission on the mMS is defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1 |
At Week 12
|
|
PK Lead-In Cohort 2: Achievement of clinical remission per mMS
Periodo de tiempo: At Week 12
|
Clinical remission on the mMS is defined as Stool Frequency Subscore (SFS) ≤ 1 and not greater than Baseline, Rectal Bleeding Subscore (RBS) = 0, and Mayo Endoscopic Subscore (MES) ≤ 1 |
At Week 12
|
|
PK Lead-In Cohort 1: Achievement of clinical response per mMS
Periodo de tiempo: At Week 12
|
Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1. |
At Week 12
|
|
PK Lead-In Cohort 2: Achievement of clinical response per mMS
Periodo de tiempo: At Week 12
|
Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1. |
At Week 12
|
|
PK Lead-In Cohort 1: Achievement of endoscopic improvement
Periodo de tiempo: At Week 12
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 12
|
|
PK Lead-In Cohort 2: Achievement of endoscopic improvement
Periodo de tiempo: At Week 12
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 12
|
|
PK Lead-In Cohort 1: Symptomatic response per partial mMS
Periodo de tiempo: At Week 12
|
Symptomatic response per partial mMS is defined as decrease in partial mMS by ≥ 1 points and ≥ 30% from Baseline with decrease in RBS of ≥ 1 or an absolute RBS of 0 or 1. |
At Week 12
|
|
PK Lead-In Cohort 2: Symptomatic response per partial mMS
Periodo de tiempo: At Week 12
|
Symptomatic response per partial mMS is defined as decrease in partial mMS by ≥ 1 points and ≥ 30% from Baseline with decrease in RBS of ≥ 1 or an absolute RBS of 0 or 1. |
At Week 12
|
|
PK Lead-In Cohort 1: Achievement of clinical response per mMS among Week 12 responders per mMS
Periodo de tiempo: At Week 64
|
Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1. |
At Week 64
|
|
PK Lead-In Cohort 2: Achievement of clinical response per mMS among Week 12 responders per mMS
Periodo de tiempo: At Week 64
|
Clinical response per mMS is defined as decrease in mMS by ≥ 2 points and ≥ 30% from Baseline with a decrease in Rectal Bleeding Subscore (RBS) of ≥ 1 or an absolute RBS of 0 or 1. |
At Week 64
|
|
PK Lead-In Cohort 1: Achievement of endoscopic improvement among Week 12 responders per mMS
Periodo de tiempo: At Week 64
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 64
|
|
PK Lead-In Cohort 2: Achievement of endoscopic improvement among Week 12 responders per mMS
Periodo de tiempo: At Week 64
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 64
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: ABBVIE INC., AbbVie
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- M19-751
- 2024-514695-41-00 (Ctis)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Marco de tiempo para compartir IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Criterios de acceso compartido de IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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. .