궤양 성 대장염을 앓고있는 젊은 참가자들에게 Risankikimab의 작동 방식에 대해 더 많이 배우는 연구 (MIGHTY)
개방형 표지 유도, 무작위 이중 맹검 유지 및 개방형 장기 연장 기간 (2 ~ 18 세)의 오픈 라벨 장기 연장 기간 (2 ~ 18 세)의 오픈 라벨 장기 연장 기간을 갖는 리시 칸 주맙의 약동학, 효능 및 안전성을 평가하기위한 3 단계, 다중 센터 연구.
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.
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: ABBVIE CALL CENTER
- 전화번호: 844-663-3742
- 이메일: abbvieclinicaltrials@abbvie.com
연구 장소
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Thessaloniki, 그리스, 54642
- 모병
- General Hospital of Thessaloniki Hippokrateio /ID# 271939
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Attica
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Athens, Attica, 그리스, 11527
- 모병
- Thoracic General Hospital of Athens I Sotiria /ID# 270143
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Chaïdári, Attica, 그리스, 12462
- 모병
- University General Hospital Attikon /ID# 272361
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Taichung, 대만, 407219
- 모병
- Taichung Veterans General Hospital /ID# 269242
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Taipei, 대만, 100
- 모병
- National Taiwan University Hospital /ID# 269244
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Gyeongsangnam-do
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Yangsan, Gyeongsangnam-do, 대한민국, 50612
- 모병
- Pusan National University Yangsan Hospital /ID# 272769
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, 대한민국, 03080
- 모병
- Seoul National University Hospital /ID# 272852
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Seoul, Seoul Teugbyeolsi, 대한민국, 06351
- 모병
- Samsung Medical Center /ID# 272862
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Seoul, Seoul Teugbyeolsi, 대한민국, 03181
- 모병
- Kangbuk Samsung Hospital /ID# 273333
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Seoul, Seoul Teugbyeolsi, 대한민국, 03722
- 모병
- Yonsei University Health System - Severance Hospital /ID# 272894
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Brandenburg
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Cottbus, Brandenburg, 독일, 03048
- 모병
- Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023
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Hesse
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Kassel, Hesse, 독일, 34125
- 모병
- Klinikum Kassel /ID# 271546
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North Rhine-Westphalia
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Münster, North Rhine-Westphalia, 독일, 48149
- 모병
- Universitaetsklinikum Muenster /ID# 271898
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Arizona
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Phoenix, Arizona, 미국, 85016
- 모병
- Phoenix Children's Hospital /ID# 273015
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California
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San Diego, California, 미국, 92123
- 모병
- Rady Children's Hospital /ID# 271873
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San Francisco, California, 미국, 94158
- 모병
- University of California San Francisco - Mission Bay /ID# 273022
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Florida
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Miami, Florida, 미국, 33155
- 모병
- Nicklaus Children's Hospital - Miami /ID# 271585
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Georgia
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Atlanta, Georgia, 미국, 30342
- 모병
- Childrens Center For Digestive Health Care /ID# 273228
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Illinois
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Chicago, Illinois, 미국, 60637
- 모병
- University of Chicago Medical Center /ID# 271588
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New Jersey
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Morristown, New Jersey, 미국, 07962
- 모병
- Goryeb Children's Hospital /ID# 271801
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Ohio
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Cleveland, Ohio, 미국, 44106
- 모병
- University Hospitals Cleveland Medical Center /ID# 271831
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19104
- 모병
- The Children's Hospital of Philadelphia /ID# 273222
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Pittsburgh, Pennsylvania, 미국, 15224
- 모병
- Upmc Children'S Hospital Of Pittsburgh /ID# 272328
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South Carolina
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Greenville, South Carolina, 미국, 29615
- 모병
- Patewood Medical Campus /ID# 272477
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Texas
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Dallas, Texas, 미국, 75235
- 모병
- University of Texas - Southwestern Medical Center /ID# 271835
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Brussels, 벨기에, 1020
- 모병
- Hospital Universite Enfants Reine Fabiola /ID# 271860
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Liège, 벨기에, 4000
- 모병
- Centre Hospitalier Regional de la Citadelle /ID# 270459
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Brussels Capital
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Brussels, Brussels Capital, 벨기에, 1200
- 모병
- Cliniques Universitaires UCL Saint-Luc /ID# 270123
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São Paulo, 브라질, 01308-050
- 모병
- Hospital Sirio Libanes - Sao Paulo /ID# 271818
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Minas Gerais
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Juiz de Fora, Minas Gerais, 브라질, 36033-318
- 모병
- Galileo Medical Research /ID# 271817
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Paraná
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Curitiba, Paraná, 브라질, 80250-060
- 모병
- Hospital Pequeno Principe /ID# 271814
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Novi Sad, 세르비아, 21000
- 모병
- Institute for Child and Youth Health Care of Vojvodina /ID# 269961
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Beograd
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Belgrade, Beograd, 세르비아, 11000
- 모병
- University Children's Hospital /ID# 269960
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Belgrade-Vračar, Beograd, 세르비아, 11000
- 모병
- Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696
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Stockholm County
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Solna, Stockholm County, 스웨덴, 171 64
- 모병
- Karolinska University Hospital Solna /ID# 271679
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Stockholm, Stockholm County, 스웨덴, 118 83
- 모병
- Sodersjukhuset /ID# 271678
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Västra Götaland County
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Gothenburg, Västra Götaland County, 스웨덴, 413 46
- 모병
- Sahlgrenska Universitetssjukhuset /ID# 271675
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연락하다:
- Site Coordinator
- 전화번호: +46313435865
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A Coruna
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A Coruña, A Coruna, 스페인, 15006
- 모병
- Hospital Teresa Herrera - CHUAC /ID# 271459
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Madrid
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Majadahonda, Madrid, 스페인, 28222
- 모병
- Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466
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Liverpool, 영국, L12 2AP
- 모병
- Alder Hey Children's NHS Foundation Trust /ID# 271533
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Cambridgeshire
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Cambridge, Cambridgeshire, 영국, CB2 2QQ
- 모병
- Addenbrookes Hospital /ID# 271489
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England
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Sheffield, England, 영국, S10 2TH
- 모병
- Sheffield Children's Hospital NHS Foundation Trust /ID# 271490
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Trieste, 이탈리아, 34137
- 모병
- Ospedale Infantile Burlo Garofolo /ID# 274442
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Foggia
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San Giovanni Rotondo, Foggia, 이탈리아, 71013
- 모병
- Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889
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Napoli
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Naples, Napoli, 이탈리아, 80131
- 모병
- Azienda Ospedaliera Universitaria Federico II - Naples /ID# 271895
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Roma
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Rome, Roma, 이탈리아, 00168
- 모병
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967
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Fukushima, 일본, 960-1295
- 모병
- Fukushima Medical University Hospital /ID# 281178
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Aichi-ken
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Ōbu, Aichi-ken, 일본, 474-8710
- 모병
- Aichi Children's Health And Medical Center /ID# 280462
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Chiba
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Kashiwa-shi, Chiba, 일본, 277-0871
- 모병
- Tsujinaka Hospital - Kashiwanoha /ID# 280303
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Fukuoka
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Kurume-shi, Fukuoka, 일본, 830-0011
- 모병
- Kurume University Hospital /ID# 280792
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Gunma
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Maebashi, Gunma, 일본, 371-8511
- 모병
- Gunma University Hospital /ID# 281179
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Hyōgo
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Kobe, Hyōgo, 일본, 650-0017
- 모병
- Kobe University Hospital /ID# 281796
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Kumamoto
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Kumamoto, Kumamoto, 일본, 861-8520
- 모병
- Japanese Red Cross Kumamoto Hospital /ID# 280696
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Saga-ken
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Saga, Saga-ken, 일본, 849-8501
- 모병
- Saga University Hospital /ID# 281232
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Saitama
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Saitama-shi, Saitama, 일본, 330-8777
- 모병
- Saitama Children's Medical Center /ID# 280603
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Shizuoka
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Hamamatsu, Shizuoka, 일본, 431-3192
- 모병
- Hamamatsu University Hospital /ID# 281614
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Tokyo
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Bunkyo-ku, Tokyo, 일본, 113-8519
- 모병
- Institute of Science Tokyo Hospital /ID# 280694
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Bunkyo-ku, Tokyo, 일본, 113-8431
- 모병
- Juntendo University Hospital /ID# 280463
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Fuchu-shi, Tokyo, 일본, 183-8561
- 모병
- Tokyo Metropolitan Children's Medical Center /ID# 280791
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Setagaya City, Tokyo, 일본, 157-8535
- 모병
- National Center For Child Health And Development /ID# 280460
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Guangdong
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Guangzhou, Guangdong, 중국, 510620
- 모병
- Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 277962
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Henan
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Zhengzhou, Henan, 중국, 450018
- 모병
- Henan Children's Hospital Zhengzhou Children's Hospital /ID# 278794
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Hunan
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Changsha, Hunan, 중국, 410007
- 모병
- Hunan Children's Hospital /ID# 278111
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Jilin
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Changchun, Jilin, 중국, 130021
- 모병
- The First Hospital of Jilin University - Changchun /ID# 279290
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200025
- 모병
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 278113
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Zhejiang
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Hangzhou, Zhejiang, 중국, 310018
- 모병
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 277994
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Hangzhou, Zhejiang, 중국, 310056
- 모병
- The Childrens Hospital of Zhejiang University School of Medicine /ID# 278815
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Alberta
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Calgary, Alberta, 캐나다, T3B 6A8
- 모병
- Alberta Children's Hospital /ID# 272635
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Edmonton, Alberta, 캐나다, T6G 2B7
- 모병
- University of Alberta Hospital /ID# 271168
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Ontario
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London, Ontario, 캐나다, N6A 5W9
- 모병
- London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, 폴란드, 00-189
- 모병
- Centrum Zdrowia Mdm /ID# 276942
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Warsaw, Masovian Voivodeship, 폴란드, 00-728
- 모병
- Medical Network Sp. z o.o. /ID# 276903
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, 폴란드, 15-274
- 모병
- Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku /ID# 276771
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
|
실험적: 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
다른 이름들:
Risankizumab subcutaneous (SC) injection
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)
기간: At Week 64
|
Maximum observed plasma concentration (Cmax) |
At Week 64
|
|
PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)
기간: At Week 64
|
Maximum observed plasma concentration (Cmax) |
At Week 64
|
|
PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)
기간: At Week 64
|
Time to maximum plasma concentration (Tmax) |
At Week 64
|
|
PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
확장 코호트 3 : MMS 당 임상 완화의 달성
기간: 12 주차
|
12 주차
|
|
|
확장 코호트 3 : MMS 당 임상 반응의 달성
기간: 12 주차
|
12 주차
|
|
|
확장 코호트 3 : 내시경 개선의 달성
기간: 12 주차
|
12 주차
|
|
|
확장 코호트 3 : 부분 MMS 당 증상 반응
기간: 12 주차
|
12 주차
|
|
|
확장 코호트 3 : MMS 당 12 주 동안 MMS 당 임상 반응 성취
기간: 64 주에
|
64 주에
|
|
|
확장 코호트 3 : MMS 당 12 주차 응답자 간 내시경 개선 성취
기간: 64 주에
|
64 주에
|
|
|
확장 코호트 3 : MMS 당 12 주차 응답자 중 mms 당 코르티코 스테로이드가없는 임상 완화의 달성
기간: 64 주에
|
64 주에
|
|
|
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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: At Week 12
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 12
|
|
PK Lead-In Cohort 2: Achievement of endoscopic improvement
기간: At Week 12
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 12
|
|
PK Lead-In Cohort 1: Symptomatic response per partial mMS
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: At Week 64
|
Endoscopic improvement defined as MES ≤ 1 |
At Week 64
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: ABBVIE INC., AbbVie
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- M19-751
- 2024-514695-41-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
IPD 공유 기간
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
IPD 공유 액세스 기준
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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