Studie, která se dozví více o tom, jak risankizumab pracuje u mladých účastníků s ulcerativní kolitidou (MIGHTY)
Studie fáze 3, vícecentrická studie pro vyhodnocení farmakokinetiky, účinnosti a bezpečnosti risankizumabu s otevřenou indukcí, randomizované dvojitě slepé údržbu a dlouhodobá prodlužovací období u pediatrických subjektů (2 až 18 let) s mírnou odvahou aktivní ulcerativní kolitidou
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.
Přehled studie
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: ABBVIE CALL CENTER
- Telefonní číslo: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Studijní místa
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Brussels, Belgie, 1020
- Nábor
- Hospital Universite Enfants Reine Fabiola /ID# 271860
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Liège, Belgie, 4000
- Nábor
- Centre Hospitalier Regional de la Citadelle /ID# 270459
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Brussels Capital
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Brussels, Brussels Capital, Belgie, 1200
- Nábor
- Cliniques Universitaires UCL Saint-Luc /ID# 270123
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São Paulo, Brazílie, 01308-050
- Nábor
- Hospital Sirio Libanes - Sao Paulo /ID# 271818
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Minas Gerais
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Juiz de Fora, Minas Gerais, Brazílie, 36033-318
- Nábor
- Galileo Medical Research /ID# 271817
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Paraná
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Curitiba, Paraná, Brazílie, 80250-060
- Nábor
- Hospital Pequeno Principe /ID# 271814
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Trieste, Itálie, 34137
- Nábor
- Ospedale Infantile Burlo Garofolo /ID# 274442
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Foggia
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San Giovanni Rotondo, Foggia, Itálie, 71013
- Nábor
- Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889
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Napoli
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Naples, Napoli, Itálie, 80131
- Nábor
- Azienda Ospedaliera Universitaria Federico II - Naples /ID# 271895
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Roma
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Rome, Roma, Itálie, 00168
- Nábor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967
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Fukushima, Japonsko, 960-1295
- Nábor
- Fukushima Medical University Hospital /ID# 281178
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Aichi-ken
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Ōbu, Aichi-ken, Japonsko, 474-8710
- Nábor
- Aichi Children's Health And Medical Center /ID# 280462
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Chiba
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Kashiwa-shi, Chiba, Japonsko, 277-0871
- Nábor
- Tsujinaka Hospital - Kashiwanoha /ID# 280303
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Fukuoka
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Kurume-shi, Fukuoka, Japonsko, 830-0011
- Nábor
- Kurume University Hospital /ID# 280792
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Gunma
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Maebashi, Gunma, Japonsko, 371-8511
- Nábor
- Gunma University Hospital /ID# 281179
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Hyōgo
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Kobe, Hyōgo, Japonsko, 650-0017
- Nábor
- Kobe University Hospital /ID# 281796
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Kumamoto
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Kumamoto, Kumamoto, Japonsko, 861-8520
- Nábor
- Japanese Red Cross Kumamoto Hospital /ID# 280696
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Saga-ken
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Saga, Saga-ken, Japonsko, 849-8501
- Nábor
- Saga University Hospital /ID# 281232
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Saitama
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Saitama-shi, Saitama, Japonsko, 330-8777
- Nábor
- Saitama Children's Medical Center /ID# 280603
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Shizuoka
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Hamamatsu, Shizuoka, Japonsko, 431-3192
- Nábor
- Hamamatsu University Hospital /ID# 281614
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Tokyo
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Bunkyo-ku, Tokyo, Japonsko, 113-8519
- Nábor
- Institute of Science Tokyo Hospital /ID# 280694
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Bunkyo-ku, Tokyo, Japonsko, 113-8431
- Nábor
- Juntendo University Hospital /ID# 280463
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Fuchu-shi, Tokyo, Japonsko, 183-8561
- Nábor
- Tokyo Metropolitan Children's Medical Center /ID# 280791
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Setagaya City, Tokyo, Japonsko, 157-8535
- Nábor
- National Center For Child Health And Development /ID# 280460
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Gyeongsangnam-do
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Yangsan, Gyeongsangnam-do, Jižní Korea, 50612
- Nábor
- Pusan National University Yangsan Hospital /ID# 272769
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Jižní Korea, 03080
- Nábor
- Seoul National University Hospital /ID# 272852
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Seoul, Seoul Teugbyeolsi, Jižní Korea, 06351
- Nábor
- Samsung Medical Center /ID# 272862
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Seoul, Seoul Teugbyeolsi, Jižní Korea, 03181
- Nábor
- Kangbuk Samsung Hospital /ID# 273333
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Seoul, Seoul Teugbyeolsi, Jižní Korea, 03722
- Nábor
- Yonsei University Health System - Severance Hospital /ID# 272894
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Alberta
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Calgary, Alberta, Kanada, T3B 6A8
- Nábor
- Alberta Children's Hospital /ID# 272635
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Edmonton, Alberta, Kanada, T6G 2B7
- Nábor
- University of Alberta Hospital /ID# 271168
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Ontario
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London, Ontario, Kanada, N6A 5W9
- Nábor
- London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157
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Brandenburg
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Cottbus, Brandenburg, Německo, 03048
- Nábor
- Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023
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Hesse
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Kassel, Hesse, Německo, 34125
- Nábor
- Klinikum Kassel /ID# 271546
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Německo, 48149
- Nábor
- Universitaetsklinikum Muenster /ID# 271898
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polsko, 00-189
- Nábor
- Centrum Zdrowia Mdm /ID# 276942
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Warsaw, Masovian Voivodeship, Polsko, 00-728
- Nábor
- Medical Network Sp. z o.o. /ID# 276903
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polsko, 15-274
- Nábor
- Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku /ID# 276771
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Liverpool, Spojené království, L12 2AP
- Nábor
- Alder Hey Children's NHS Foundation Trust /ID# 271533
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Cambridgeshire
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Cambridge, Cambridgeshire, Spojené království, CB2 2QQ
- Nábor
- Addenbrookes Hospital /ID# 271489
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England
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Sheffield, England, Spojené království, S10 2TH
- Nábor
- Sheffield Children's Hospital NHS Foundation Trust /ID# 271490
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Arizona
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Phoenix, Arizona, Spojené státy, 85016
- Nábor
- Phoenix Children's Hospital /ID# 273015
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California
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San Diego, California, Spojené státy, 92123
- Nábor
- Rady Children's Hospital /ID# 271873
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San Francisco, California, Spojené státy, 94158
- Nábor
- University of California San Francisco - Mission Bay /ID# 273022
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Florida
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Miami, Florida, Spojené státy, 33155
- Nábor
- Nicklaus Children's Hospital - Miami /ID# 271585
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Georgia
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Atlanta, Georgia, Spojené státy, 30342
- Nábor
- Childrens Center For Digestive Health Care /ID# 273228
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Illinois
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Chicago, Illinois, Spojené státy, 60637
- Nábor
- University of Chicago Medical Center /ID# 271588
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New Jersey
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Morristown, New Jersey, Spojené státy, 07962
- Nábor
- Goryeb Children's Hospital /ID# 271801
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Ohio
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Cleveland, Ohio, Spojené státy, 44106
- Nábor
- University Hospitals Cleveland Medical Center /ID# 271831
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Pennsylvania
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Philadelphia, Pennsylvania, Spojené státy, 19104
- Nábor
- The Children's Hospital of Philadelphia /ID# 273222
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Pittsburgh, Pennsylvania, Spojené státy, 15224
- Nábor
- Upmc Children'S Hospital Of Pittsburgh /ID# 272328
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South Carolina
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Greenville, South Carolina, Spojené státy, 29615
- Nábor
- Patewood Medical Campus /ID# 272477
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Texas
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Dallas, Texas, Spojené státy, 75235
- Nábor
- University of Texas - Southwestern Medical Center /ID# 271835
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Novi Sad, Srbsko, 21000
- Nábor
- Institute for Child and Youth Health Care of Vojvodina /ID# 269961
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Beograd
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Belgrade, Beograd, Srbsko, 11000
- Nábor
- University Children's Hospital /ID# 269960
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Belgrade-Vračar, Beograd, Srbsko, 11000
- Nábor
- Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696
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Taichung, Tchaj-wan, 407219
- Nábor
- Taichung Veterans General Hospital /ID# 269242
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Taipei, Tchaj-wan, 100
- Nábor
- National Taiwan University Hospital /ID# 269244
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Guangdong
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Guangzhou, Guangdong, Čína, 510620
- Nábor
- Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 277962
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Henan
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Zhengzhou, Henan, Čína, 450018
- Nábor
- Henan Children's Hospital Zhengzhou Children's Hospital /ID# 278794
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Hunan
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Changsha, Hunan, Čína, 410007
- Nábor
- Hunan Children's Hospital /ID# 278111
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Jilin
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Changchun, Jilin, Čína, 130021
- Nábor
- The First Hospital of Jilin University - Changchun /ID# 279290
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Čína, 200025
- Nábor
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 278113
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Zhejiang
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Hangzhou, Zhejiang, Čína, 310018
- Nábor
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 277994
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Hangzhou, Zhejiang, Čína, 310056
- Nábor
- The Childrens Hospital of Zhejiang University School of Medicine /ID# 278815
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Thessaloniki, Řecko, 54642
- Nábor
- General Hospital of Thessaloniki Hippokrateio /ID# 271939
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Attica
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Athens, Attica, Řecko, 11527
- Nábor
- Thoracic General Hospital of Athens I Sotiria /ID# 270143
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Chaïdári, Attica, Řecko, 12462
- Nábor
- University General Hospital Attikon /ID# 272361
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A Coruna
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A Coruña, A Coruna, Španělsko, 15006
- Nábor
- Hospital Teresa Herrera - CHUAC /ID# 271459
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Madrid
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Majadahonda, Madrid, Španělsko, 28222
- Nábor
- Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466
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Stockholm County
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Solna, Stockholm County, Švédsko, 171 64
- Nábor
- Karolinska University Hospital Solna /ID# 271679
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Stockholm, Stockholm County, Švédsko, 118 83
- Nábor
- Sodersjukhuset /ID# 271678
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Västra Götaland County
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Gothenburg, Västra Götaland County, Švédsko, 413 46
- Nábor
- Sahlgrenska Universitetssjukhuset /ID# 271675
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Kontakt:
- Site Coordinator
- Telefonní číslo: +46313435865
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
|
Experimentální: 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
Ostatní jména:
Risankizumab subcutaneous (SC) injection
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)
Časové okno: At Week 64
|
Maximum observed plasma concentration (Cmax) |
At Week 64
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PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)
Časové okno: At Week 64
|
Maximum observed plasma concentration (Cmax) |
At Week 64
|
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PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)
Časové okno: At Week 64
|
Time to maximum plasma concentration (Tmax) |
At Week 64
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PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)
Časové okno: At Week 64
|
Time to maximum plasma concentration (Tmax) |
At Week 64
|
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PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)
Časové okno: At Week 64
|
Area under the serum concentration-time curve over the dosing interval (AUCtau) |
At Week 64
|
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PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)
Časové okno: At Week 64
|
Area under the serum concentration-time curve over the dosing interval (AUCtau) |
At Week 64
|
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Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) Among Week 12 Clinical Responders per mMS
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Expanzní kohorta 3: Dosažení klinické remise na MMS
Časové okno: Ve 12. týdnu
|
Ve 12. týdnu
|
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Expanzní kohorta 3: Dosažení klinické odpovědi na MMS
Časové okno: Ve 12. týdnu
|
Ve 12. týdnu
|
|
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Expanzní kohorta 3: Dosažení endoskopického zlepšení
Časové okno: Ve 12. týdnu
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Ve 12. týdnu
|
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Expanzní kohorta 3: Symptomatická odpověď na částečné MMS
Časové okno: Ve 12. týdnu
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Ve 12. týdnu
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Expanzní kohorta 3: Dosažení klinické odpovědi na MMS u respondentů 12. týdne na MMS
Časové okno: V 64. týdnu
|
V 64. týdnu
|
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Rozšíření kohorty 3: Dosažení endoskopického zlepšení u respondentů 12. týdne na MMS
Časové okno: V 64. týdnu
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V 64. týdnu
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Expanzní kohorta 3: Dosažení klinické remise bez kortikosteroidů na MMS u respondentů 12. týdne na MMS
Časové okno: V 64. týdnu
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V 64. týdnu
|
|
|
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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: At Week 12
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 12
|
|
PK Lead-In Cohort 2: Achievement of endoscopic improvement
Časové okno: At Week 12
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 12
|
|
PK Lead-In Cohort 1: Symptomatic response per partial mMS
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: At Week 64
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 64
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: ABBVIE INC., AbbVie
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- M19-751
- 2024-514695-41-00 (Ctis)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Časový rámec sdílení IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Kritéria přístupu pro sdílení IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .