Badanie, aby dowiedzieć się więcej o tym, jak Risankizumab działa u młodych uczestników z wrzodziejącym zapaleniem jelita grubego (MIGHTY)
Wieloośrodkowe badanie fazy 3 w celu oceny farmakokinetyki, skuteczności i bezpieczeństwa risankizumabu z indukcją otwartego znaku, randomizowaną podwójnie ślepą podtrzymanie i długoterminowe okresy rozszerzenia u pacjentów pediatrycznych (w wieku od 2 do 18 lat) z umiarkowanie do silnie aktywnego zapalenia koloni
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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 3
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: ABBVIE CALL CENTER
- Numer telefonu: 844-663-3742
- E-mail: abbvieclinicaltrials@abbvie.com
Lokalizacje studiów
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Brussels, Belgia, 1020
- Rekrutacyjny
- Hospital Universite Enfants Reine Fabiola /ID# 271860
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Liège, Belgia, 4000
- Rekrutacyjny
- Centre Hospitalier Regional de la Citadelle /ID# 270459
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Brussels Capital
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Brussels, Brussels Capital, Belgia, 1200
- Rekrutacyjny
- Cliniques Universitaires UCL Saint-Luc /ID# 270123
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São Paulo, Brazylia, 01308-050
- Rekrutacyjny
- Hospital Sirio Libanes - Sao Paulo /ID# 271818
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Minas Gerais
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Juiz de Fora, Minas Gerais, Brazylia, 36033-318
- Rekrutacyjny
- Galileo Medical Research /ID# 271817
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Paraná
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Curitiba, Paraná, Brazylia, 80250-060
- Rekrutacyjny
- Hospital Pequeno Principe /ID# 271814
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Guangdong
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Guangzhou, Guangdong, Chiny, 510620
- Rekrutacyjny
- Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 277962
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Henan
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Zhengzhou, Henan, Chiny, 450018
- Rekrutacyjny
- Henan Children's Hospital Zhengzhou Children's Hospital /ID# 278794
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Hunan
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Changsha, Hunan, Chiny, 410007
- Rekrutacyjny
- Hunan Children's Hospital /ID# 278111
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Jilin
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Changchun, Jilin, Chiny, 130021
- Rekrutacyjny
- The First Hospital of Jilin University - Changchun /ID# 279290
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chiny, 200025
- Rekrutacyjny
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 278113
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Zhejiang
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Hangzhou, Zhejiang, Chiny, 310018
- Rekrutacyjny
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 277994
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Hangzhou, Zhejiang, Chiny, 310056
- Rekrutacyjny
- The Childrens Hospital of Zhejiang University School of Medicine /ID# 278815
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Thessaloniki, Grecja, 54642
- Rekrutacyjny
- General Hospital of Thessaloniki Hippokrateio /ID# 271939
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Attica
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Athens, Attica, Grecja, 11527
- Rekrutacyjny
- Thoracic General Hospital of Athens I Sotiria /ID# 270143
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Chaïdári, Attica, Grecja, 12462
- Rekrutacyjny
- University General Hospital Attikon /ID# 272361
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A Coruna
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A Coruña, A Coruna, Hiszpania, 15006
- Rekrutacyjny
- Hospital Teresa Herrera - CHUAC /ID# 271459
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Madrid
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Majadahonda, Madrid, Hiszpania, 28222
- Rekrutacyjny
- Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466
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Fukushima, Japonia, 960-1295
- Rekrutacyjny
- Fukushima Medical University Hospital /ID# 281178
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Aichi-ken
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Ōbu, Aichi-ken, Japonia, 474-8710
- Rekrutacyjny
- Aichi Children's Health And Medical Center /ID# 280462
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Chiba
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Kashiwa-shi, Chiba, Japonia, 277-0871
- Rekrutacyjny
- Tsujinaka Hospital - Kashiwanoha /ID# 280303
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Fukuoka
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Kurume-shi, Fukuoka, Japonia, 830-0011
- Rekrutacyjny
- Kurume University Hospital /ID# 280792
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Gunma
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Maebashi, Gunma, Japonia, 371-8511
- Rekrutacyjny
- Gunma University Hospital /ID# 281179
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Hyōgo
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Kobe, Hyōgo, Japonia, 650-0017
- Rekrutacyjny
- Kobe University Hospital /ID# 281796
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Kumamoto
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Kumamoto, Kumamoto, Japonia, 861-8520
- Rekrutacyjny
- Japanese Red Cross Kumamoto Hospital /ID# 280696
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Saga-ken
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Saga, Saga-ken, Japonia, 849-8501
- Rekrutacyjny
- Saga University Hospital /ID# 281232
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Saitama
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Saitama-shi, Saitama, Japonia, 330-8777
- Rekrutacyjny
- Saitama Children's Medical Center /ID# 280603
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Shizuoka
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Hamamatsu, Shizuoka, Japonia, 431-3192
- Rekrutacyjny
- Hamamatsu University Hospital /ID# 281614
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Tokyo
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Bunkyo-ku, Tokyo, Japonia, 113-8519
- Rekrutacyjny
- Institute of Science Tokyo Hospital /ID# 280694
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Bunkyo-ku, Tokyo, Japonia, 113-8431
- Rekrutacyjny
- Juntendo University Hospital /ID# 280463
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Fuchu-shi, Tokyo, Japonia, 183-8561
- Rekrutacyjny
- Tokyo Metropolitan Children's Medical Center /ID# 280791
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Setagaya City, Tokyo, Japonia, 157-8535
- Rekrutacyjny
- National Center For Child Health And Development /ID# 280460
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Alberta
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Calgary, Alberta, Kanada, T3B 6A8
- Rekrutacyjny
- Alberta Children's Hospital /ID# 272635
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Edmonton, Alberta, Kanada, T6G 2B7
- Rekrutacyjny
- University of Alberta Hospital /ID# 271168
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Ontario
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London, Ontario, Kanada, N6A 5W9
- Rekrutacyjny
- London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157
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Gyeongsangnam-do
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Yangsan, Gyeongsangnam-do, Korea Południowa, 50612
- Rekrutacyjny
- Pusan National University Yangsan Hospital /ID# 272769
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Korea Południowa, 03080
- Rekrutacyjny
- Seoul National University Hospital /ID# 272852
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Seoul, Seoul Teugbyeolsi, Korea Południowa, 06351
- Rekrutacyjny
- Samsung Medical Center /ID# 272862
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Seoul, Seoul Teugbyeolsi, Korea Południowa, 03181
- Rekrutacyjny
- Kangbuk Samsung Hospital /ID# 273333
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Seoul, Seoul Teugbyeolsi, Korea Południowa, 03722
- Rekrutacyjny
- Yonsei University Health System - Severance Hospital /ID# 272894
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Brandenburg
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Cottbus, Brandenburg, Niemcy, 03048
- Rekrutacyjny
- Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023
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Hesse
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Kassel, Hesse, Niemcy, 34125
- Rekrutacyjny
- Klinikum Kassel /ID# 271546
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, Niemcy, 48149
- Rekrutacyjny
- Universitaetsklinikum Muenster /ID# 271898
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polska, 00-189
- Rekrutacyjny
- Centrum Zdrowia Mdm /ID# 276942
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Warsaw, Masovian Voivodeship, Polska, 00-728
- Rekrutacyjny
- Medical Network Sp. z o.o. /ID# 276903
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polska, 15-274
- Rekrutacyjny
- Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku /ID# 276771
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Novi Sad, Serbia, 21000
- Rekrutacyjny
- Institute for Child and Youth Health Care of Vojvodina /ID# 269961
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Beograd
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Belgrade, Beograd, Serbia, 11000
- Rekrutacyjny
- University Children's Hospital /ID# 269960
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Belgrade-Vračar, Beograd, Serbia, 11000
- Rekrutacyjny
- Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696
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Arizona
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Phoenix, Arizona, Stany Zjednoczone, 85016
- Rekrutacyjny
- Phoenix Children's Hospital /ID# 273015
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California
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San Diego, California, Stany Zjednoczone, 92123
- Rekrutacyjny
- Rady Children's Hospital /ID# 271873
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San Francisco, California, Stany Zjednoczone, 94158
- Rekrutacyjny
- University of California San Francisco - Mission Bay /ID# 273022
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Florida
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Miami, Florida, Stany Zjednoczone, 33155
- Rekrutacyjny
- Nicklaus Children's Hospital - Miami /ID# 271585
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30342
- Rekrutacyjny
- Childrens Center For Digestive Health Care /ID# 273228
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60637
- Rekrutacyjny
- University of Chicago Medical Center /ID# 271588
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New Jersey
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Morristown, New Jersey, Stany Zjednoczone, 07962
- Rekrutacyjny
- Goryeb Children's Hospital /ID# 271801
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44106
- Rekrutacyjny
- University Hospitals Cleveland Medical Center /ID# 271831
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Rekrutacyjny
- The Children's Hospital of Philadelphia /ID# 273222
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15224
- Rekrutacyjny
- Upmc Children'S Hospital Of Pittsburgh /ID# 272328
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South Carolina
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Greenville, South Carolina, Stany Zjednoczone, 29615
- Rekrutacyjny
- Patewood Medical Campus /ID# 272477
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Texas
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Dallas, Texas, Stany Zjednoczone, 75235
- Rekrutacyjny
- University of Texas - Southwestern Medical Center /ID# 271835
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Stockholm County
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Solna, Stockholm County, Szwecja, 171 64
- Rekrutacyjny
- Karolinska University Hospital Solna /ID# 271679
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Stockholm, Stockholm County, Szwecja, 118 83
- Rekrutacyjny
- Sodersjukhuset /ID# 271678
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Västra Götaland County
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Gothenburg, Västra Götaland County, Szwecja, 413 46
- Rekrutacyjny
- Sahlgrenska Universitetssjukhuset /ID# 271675
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Kontakt:
- Site Coordinator
- Numer telefonu: +46313435865
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Taichung, Tajwan, 407219
- Rekrutacyjny
- Taichung Veterans General Hospital /ID# 269242
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Taipei, Tajwan, 100
- Rekrutacyjny
- National Taiwan University Hospital /ID# 269244
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Trieste, Włochy, 34137
- Rekrutacyjny
- Ospedale Infantile Burlo Garofolo /ID# 274442
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Foggia
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San Giovanni Rotondo, Foggia, Włochy, 71013
- Rekrutacyjny
- Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889
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Napoli
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Naples, Napoli, Włochy, 80131
- Rekrutacyjny
- Azienda Ospedaliera Universitaria Federico II - Naples /ID# 271895
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Roma
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Rome, Roma, Włochy, 00168
- Rekrutacyjny
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967
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Liverpool, Zjednoczone Królestwo, L12 2AP
- Rekrutacyjny
- Alder Hey Children's NHS Foundation Trust /ID# 271533
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Cambridgeshire
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Cambridge, Cambridgeshire, Zjednoczone Królestwo, CB2 2QQ
- Rekrutacyjny
- Addenbrookes Hospital /ID# 271489
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England
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Sheffield, England, Zjednoczone Królestwo, S10 2TH
- Rekrutacyjny
- Sheffield Children's Hospital NHS Foundation Trust /ID# 271490
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie sekwencyjne
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
|
Eksperymentalny: 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
Inne nazwy:
Risankizumab subcutaneous (SC) injection
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)
Ramy czasowe: At Week 64
|
Maximum observed plasma concentration (Cmax) |
At Week 64
|
|
PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)
Ramy czasowe: At Week 64
|
Maximum observed plasma concentration (Cmax) |
At Week 64
|
|
PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)
Ramy czasowe: At Week 64
|
Time to maximum plasma concentration (Tmax) |
At Week 64
|
|
PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Kohorta ekspansji 3: Osiągnięcie remisji klinicznej na MMS
Ramy czasowe: W 12. tygodniu
|
W 12. tygodniu
|
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Kohorta ekspansji 3: Osiągnięcie odpowiedzi klinicznej na MMS
Ramy czasowe: W 12. tygodniu
|
W 12. tygodniu
|
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Kohorta ekspansji 3: Osiągnięcie poprawy endoskopowej
Ramy czasowe: W 12. tygodniu
|
W 12. tygodniu
|
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Kohorta ekspansji 3: Odpowiedź objawowa na częściowe MMS
Ramy czasowe: W 12. tygodniu
|
W 12. tygodniu
|
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Kohorta ekspansji 3: Osiągnięcie odpowiedzi klinicznej na MMS wśród respondentów tygodnia 12 na MMS
Ramy czasowe: W 64 tygodniu
|
W 64 tygodniu
|
|
|
Kohorta ekspansji 3: Osiągnięcie poprawy endoskopowej wśród osób udzielających ratowników na MMS
Ramy czasowe: W 64 tygodniu
|
W 64 tygodniu
|
|
|
Kohorta ekspansji 3: Osiągnięcie remisji klinicznej bez kortykosteroidów na mm
Ramy czasowe: W 64 tygodniu
|
W 64 tygodniu
|
|
|
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: At Week 12
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 12
|
|
PK Lead-In Cohort 2: Achievement of endoscopic improvement
Ramy czasowe: At Week 12
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 12
|
|
PK Lead-In Cohort 1: Symptomatic response per partial mMS
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: At Week 64
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 64
|
Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: ABBVIE INC., AbbVie
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- M19-751
- 2024-514695-41-00 (Ctis)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Ramy czasowe udostępniania IPD
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
Kryteria dostępu do udostępniania IPD
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .