Uno studio per saperne di più su come funziona Risankizumab nei giovani partecipanti con colite ulcerosa (MIGHTY)
Uno studio di Fase 3, multicentrico per valutare la farmacocinetica, l'efficacia e la sicurezza del risannanità con induzione in aperto, manutenzione randomizzata in doppio cieco e periodi di estensione a lungo termine in apertura in soggetti pediatrici (2-18 anni di età)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: ABBVIE CALL CENTER
- Numero di telefono: 844-663-3742
- Email: abbvieclinicaltrials@abbvie.com
Luoghi di studio
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Brussels, Belgio, 1020
- Reclutamento
- Hospital Universite Enfants Reine Fabiola /ID# 271860
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Liège, Belgio, 4000
- Reclutamento
- Centre Hospitalier Regional de la Citadelle /ID# 270459
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Brussels Capital
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Brussels, Brussels Capital, Belgio, 1200
- Reclutamento
- Cliniques Universitaires UCL Saint-Luc /ID# 270123
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São Paulo, Brasile, 01308-050
- Reclutamento
- Hospital Sirio Libanes - Sao Paulo /ID# 271818
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Minas Gerais
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Juiz de Fora, Minas Gerais, Brasile, 36033-318
- Reclutamento
- Galileo Medical Research /ID# 271817
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Paraná
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Curitiba, Paraná, Brasile, 80250-060
- Reclutamento
- Hospital Pequeno Principe /ID# 271814
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
- Reclutamento
- Alberta Children's Hospital /ID# 272635
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Edmonton, Alberta, Canada, T6G 2B7
- Reclutamento
- University of Alberta Hospital /ID# 271168
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Ontario
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London, Ontario, Canada, N6A 5W9
- Reclutamento
- London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157
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Guangdong
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Guangzhou, Guangdong, Cina, 510620
- Reclutamento
- Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 277962
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Henan
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Zhengzhou, Henan, Cina, 450018
- Reclutamento
- Henan Children's Hospital Zhengzhou Children's Hospital /ID# 278794
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Hunan
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Changsha, Hunan, Cina, 410007
- Reclutamento
- Hunan Children's Hospital /ID# 278111
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Jilin
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Changchun, Jilin, Cina, 130021
- Reclutamento
- The First Hospital of Jilin University - Changchun /ID# 279290
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200025
- Reclutamento
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 278113
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Zhejiang
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Hangzhou, Zhejiang, Cina, 310018
- Reclutamento
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 277994
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Hangzhou, Zhejiang, Cina, 310056
- Reclutamento
- The Childrens Hospital of Zhejiang University School of Medicine /ID# 278815
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Gyeongsangnam-do
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Yangsan, Gyeongsangnam-do, Corea del Sud, 50612
- Reclutamento
- Pusan National University Yangsan Hospital /ID# 272769
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Corea del Sud, 03080
- Reclutamento
- Seoul National University Hospital /ID# 272852
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Seoul, Seoul Teugbyeolsi, Corea del Sud, 06351
- Reclutamento
- Samsung Medical Center /ID# 272862
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Seoul, Seoul Teugbyeolsi, Corea del Sud, 03181
- Reclutamento
- Kangbuk Samsung Hospital /ID# 273333
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Seoul, Seoul Teugbyeolsi, Corea del Sud, 03722
- Reclutamento
- Yonsei University Health System - Severance Hospital /ID# 272894
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Brandenburg
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Cottbus, Brandenburg, Germania, 03048
- Reclutamento
- Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023
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Hesse
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Kassel, Hesse, Germania, 34125
- Reclutamento
- Klinikum Kassel /ID# 271546
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Germania, 48149
- Reclutamento
- Universitaetsklinikum Muenster /ID# 271898
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Fukushima, Giappone, 960-1295
- Reclutamento
- Fukushima Medical University Hospital /ID# 281178
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Aichi-ken
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Ōbu, Aichi-ken, Giappone, 474-8710
- Reclutamento
- Aichi Children's Health And Medical Center /ID# 280462
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Chiba
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Kashiwa-shi, Chiba, Giappone, 277-0871
- Reclutamento
- Tsujinaka Hospital - Kashiwanoha /ID# 280303
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Fukuoka
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Kurume-shi, Fukuoka, Giappone, 830-0011
- Reclutamento
- Kurume University Hospital /ID# 280792
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Gunma
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Maebashi, Gunma, Giappone, 371-8511
- Reclutamento
- Gunma University Hospital /ID# 281179
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Hyōgo
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Kobe, Hyōgo, Giappone, 650-0017
- Reclutamento
- Kobe University Hospital /ID# 281796
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Kumamoto
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Kumamoto, Kumamoto, Giappone, 861-8520
- Reclutamento
- Japanese Red Cross Kumamoto Hospital /ID# 280696
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Saga-ken
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Saga, Saga-ken, Giappone, 849-8501
- Reclutamento
- Saga University Hospital /ID# 281232
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Saitama
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Saitama-shi, Saitama, Giappone, 330-8777
- Reclutamento
- Saitama Children's Medical Center /ID# 280603
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Shizuoka
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Hamamatsu, Shizuoka, Giappone, 431-3192
- Reclutamento
- Hamamatsu University Hospital /ID# 281614
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Tokyo
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Bunkyo-ku, Tokyo, Giappone, 113-8519
- Reclutamento
- Institute of Science Tokyo Hospital /ID# 280694
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Bunkyo-ku, Tokyo, Giappone, 113-8431
- Reclutamento
- Juntendo University Hospital /ID# 280463
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Fuchu-shi, Tokyo, Giappone, 183-8561
- Reclutamento
- Tokyo Metropolitan Children's Medical Center /ID# 280791
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Setagaya City, Tokyo, Giappone, 157-8535
- Reclutamento
- National Center For Child Health And Development /ID# 280460
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Thessaloniki, Grecia, 54642
- Reclutamento
- General Hospital of Thessaloniki Hippokrateio /ID# 271939
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Attica
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Athens, Attica, Grecia, 11527
- Reclutamento
- Thoracic General Hospital of Athens I Sotiria /ID# 270143
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Chaïdári, Attica, Grecia, 12462
- Reclutamento
- University General Hospital Attikon /ID# 272361
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Trieste, Italia, 34137
- Reclutamento
- Ospedale Infantile Burlo Garofolo /ID# 274442
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Foggia
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San Giovanni Rotondo, Foggia, Italia, 71013
- Reclutamento
- 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
- Reclutamento
- Azienda Ospedaliera Universitaria Federico II - Naples /ID# 271895
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Roma
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Rome, Roma, Italia, 00168
- Reclutamento
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polonia, 00-189
- Reclutamento
- Centrum Zdrowia Mdm /ID# 276942
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Warsaw, Masovian Voivodeship, Polonia, 00-728
- Reclutamento
- Medical Network Sp. z o.o. /ID# 276903
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polonia, 15-274
- Reclutamento
- Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku /ID# 276771
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Liverpool, Regno Unito, L12 2AP
- Reclutamento
- Alder Hey Children's NHS Foundation Trust /ID# 271533
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Cambridgeshire
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Cambridge, Cambridgeshire, Regno Unito, CB2 2QQ
- Reclutamento
- Addenbrookes Hospital /ID# 271489
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England
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Sheffield, England, Regno Unito, S10 2TH
- Reclutamento
- Sheffield Children's Hospital NHS Foundation Trust /ID# 271490
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Novi Sad, Serbia, 21000
- Reclutamento
- Institute for Child and Youth Health Care of Vojvodina /ID# 269961
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Beograd
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Belgrade, Beograd, Serbia, 11000
- Reclutamento
- University Children's Hospital /ID# 269960
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Belgrade-Vračar, Beograd, Serbia, 11000
- Reclutamento
- Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696
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A Coruna
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A Coruña, A Coruna, Spagna, 15006
- Reclutamento
- Hospital Teresa Herrera - CHUAC /ID# 271459
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Madrid
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Majadahonda, Madrid, Spagna, 28222
- Reclutamento
- Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466
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Arizona
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Phoenix, Arizona, Stati Uniti, 85016
- Reclutamento
- Phoenix Children's Hospital /ID# 273015
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California
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San Diego, California, Stati Uniti, 92123
- Reclutamento
- Rady Children's Hospital /ID# 271873
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San Francisco, California, Stati Uniti, 94158
- Reclutamento
- University of California San Francisco - Mission Bay /ID# 273022
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Florida
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Miami, Florida, Stati Uniti, 33155
- Reclutamento
- Nicklaus Children's Hospital - Miami /ID# 271585
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Georgia
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Atlanta, Georgia, Stati Uniti, 30342
- Reclutamento
- Childrens Center For Digestive Health Care /ID# 273228
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Illinois
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Chicago, Illinois, Stati Uniti, 60637
- Reclutamento
- University of Chicago Medical Center /ID# 271588
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New Jersey
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Morristown, New Jersey, Stati Uniti, 07962
- Reclutamento
- Goryeb Children's Hospital /ID# 271801
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Ohio
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Cleveland, Ohio, Stati Uniti, 44106
- Reclutamento
- University Hospitals Cleveland Medical Center /ID# 271831
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- Reclutamento
- The Children's Hospital of Philadelphia /ID# 273222
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Pittsburgh, Pennsylvania, Stati Uniti, 15224
- Reclutamento
- Upmc Children'S Hospital Of Pittsburgh /ID# 272328
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South Carolina
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Greenville, South Carolina, Stati Uniti, 29615
- Reclutamento
- Patewood Medical Campus /ID# 272477
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Texas
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Dallas, Texas, Stati Uniti, 75235
- Reclutamento
- University of Texas - Southwestern Medical Center /ID# 271835
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Stockholm County
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Solna, Stockholm County, Svezia, 171 64
- Reclutamento
- Karolinska University Hospital Solna /ID# 271679
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Stockholm, Stockholm County, Svezia, 118 83
- Reclutamento
- Sodersjukhuset /ID# 271678
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Västra Götaland County
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Gothenburg, Västra Götaland County, Svezia, 413 46
- Reclutamento
- Sahlgrenska Universitetssjukhuset /ID# 271675
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Contatto:
- Site Coordinator
- Numero di telefono: +46313435865
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Taichung, Taiwan, 407219
- Reclutamento
- Taichung Veterans General Hospital /ID# 269242
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Taipei, Taiwan, 100
- Reclutamento
- National Taiwan University Hospital /ID# 269244
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
|
Sperimentale: 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
Altri nomi:
Risankizumab subcutaneous (SC) injection
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)
Lasso di tempo: At Week 64
|
Maximum observed plasma concentration (Cmax) |
At Week 64
|
|
PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)
Lasso di tempo: At Week 64
|
Maximum observed plasma concentration (Cmax) |
At Week 64
|
|
PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)
Lasso di tempo: At Week 64
|
Time to maximum plasma concentration (Tmax) |
At Week 64
|
|
PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Coorte di espansione 3: raggiungimento della remissione clinica per MMS
Lasso di tempo: Alla settimana 12
|
Alla settimana 12
|
|
|
Coorte di espansione 3: raggiungimento della risposta clinica per MMS
Lasso di tempo: Alla settimana 12
|
Alla settimana 12
|
|
|
Coorte di espansione 3: raggiungimento del miglioramento endoscopico
Lasso di tempo: Alla settimana 12
|
Alla settimana 12
|
|
|
Coorte di espansione 3: risposta sintomatica per MMS parziale
Lasso di tempo: Alla settimana 12
|
Alla settimana 12
|
|
|
Coorte di espansione 3: raggiungimento della risposta clinica per MMS tra i soccorritori della settimana 12 per MMS
Lasso di tempo: Alla settimana 64
|
Alla settimana 64
|
|
|
Coorte di espansione 3: raggiungimento del miglioramento endoscopico tra i soccorritori della settimana 12 per MMS
Lasso di tempo: Alla settimana 64
|
Alla settimana 64
|
|
|
Coorte di espansione 3: raggiungimento della remissione clinica senza corticosteroidi per MMS tra i soccorritori della settimana 12 per MMS
Lasso di tempo: Alla settimana 64
|
Alla settimana 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At Week 12
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 12
|
|
PK Lead-In Cohort 2: Achievement of endoscopic improvement
Lasso di tempo: At Week 12
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 12
|
|
PK Lead-In Cohort 1: Symptomatic response per partial mMS
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At Week 64
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 64
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: ABBVIE INC., AbbVie
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- M19-751
- 2024-514695-41-00 (Ctis)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Criteri di accesso alla condivisione IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .