이상 반응, 질병 활동의 변화, 정맥 및 피하 리산키주맙이 중등도에서 중증의 활동성 크론병이 있는 소아 참가자의 신체를 통해 이동하는 방식을 평가하기 위한 연구 (RISE)
공개 표지 유도, 무작위 이중맹검 유지, 소아 피험자(2~18세 미만)의 장기 연장을 통해 리산키주맙의 약동학, 효능 및 안전성을 평가하기 위한 제3상 다기관 연구 중등도에서 중증 활동성 크론병
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever. This study will assess the pharmacokinetics, efficacy, and safety of risankizumab in pediatric participants with moderately to severely active CD aged 2 to < 18 years old who have had intolerance or inadequate response to other therapies.
Risankizumab is an approved drug for adults with plaque psoriasis, psoriatic arthritis, and CD and is being developed for the treatment of CD 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 induction regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Approximately 110 pediatric participants with CD will be enrolled at around 100 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
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: ABBVIE CALL CENTER
- 전화번호: 844-663-3742
- 이메일: abbvieclinicaltrials@abbvie.com
연구 장소
-
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North Holland
-
Amsterdam, North Holland, 네덜란드, 1105 AZ
- 모병
- Amsterdam University Medical Center /ID# 254827
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-
-
-
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Changhua City, Changhua County, 대만, 50006
- 모병
- Changhua Christian Hospital /ID# 256082
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Taipei, 대만, 100
- 모병
- National Taiwan University Hospital /ID# 255679
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-
-
-
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Daegu, 대한민국, 41404
- 모병
- Kyungpook National University Chilgok Hospital /ID# 255817
-
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, 대한민국, 03080
- 모병
- Seoul National University Hospital /ID# 255318
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Seoul, Seoul Teugbyeolsi, 대한민국, 06351
- 모병
- Samsung Medical Center /ID# 255284
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Seoul, Seoul Teugbyeolsi, 대한민국, 03722
- 모병
- Yonsei University Health System - Severance Hospital /ID# 256976
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-
-
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Bavaria
-
Munich, Bavaria, 독일, 80337
- 모병
- Dr. von Haunerschen Kinderspital /ID# 255577
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North Rhine-Westphalia
-
Münster, North Rhine-Westphalia, 독일, 48149
- 모병
- Universitaetsklinikum Muenster /ID# 256762
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-
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Arizona
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Phoenix, Arizona, 미국, 85016-7710
- 모병
- Phoenix Children's Hospital /ID# 255766
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Arkansas
-
Little Rock, Arkansas, 미국, 72202
- 완전한
- Arkansas Children's Hospital /ID# 255762
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California
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Oakland, California, 미국, 94609
- 모병
- UCSF Benioff Children's Hospital - Oakland /ID# 258327
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Colorado
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Aurora, Colorado, 미국, 80045
- 모병
- Children's Hospital Colorado - Aurora /ID# 255764
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Florida
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Orlando, Florida, 미국, 32806-1141
- 모병
- Arnold Palmer Hospital for Children Center Digestive Health and Nutrition-Orland /ID# 255437
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Indiana
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Indianapolis, Indiana, 미국, 46202
- 모병
- Indiana University Health Riley Hospital for Children /ID# 256454
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Massachusetts
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Waltham, Massachusetts, 미국, 02451
- 모병
- Massachusetts General Hospital - Mass General Waltham /ID# 255767
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Minnesota
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Minneapolis, Minnesota, 미국, 55413-2195
- 모병
- MNGI Digestive Health, P. A. /ID# 255366
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New Jersey
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Morristown, New Jersey, 미국, 07960
- 모병
- Goryeb Childrens Hospital /ID# 256452
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New York
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New York, New York, 미국, 10029
- 모병
- Icahn School of Medicine at Mount Sinai /ID# 254880
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Ohio
-
Cleveland, Ohio, 미국, 44195
- 모병
- Cleveland Clinic - Cleveland /ID# 256453
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연락하다:
- Site Coordinator
- 전화번호: 216-636-2007
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-
-
-
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Brussels, 벨기에, 1020
- 모병
- Hospital Universite Enfants Reine Fabiola /ID# 255112
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Liège, 벨기에, 4000
- 모병
- Groupe Sante CHC - Clinique du MontLegia /ID# 255620
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Antwerpen
-
Edegem, Antwerpen, 벨기에, 2650
- 모병
- Uza /Id# 255114
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Brussels Capital
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Brussels, Brussels Capital, 벨기에, 1200
- 모병
- Cliniques Universitaires UCL Saint-Luc /ID# 255108
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Jette, Brussels Capital, 벨기에, 1090
- 모병
- Universitair Ziekenhuis Brussel /ID# 255109
-
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, 벨기에, 3000
- 모병
- Universitair Ziekenhuis Leuven /ID# 255098
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-
-
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Plovdiv, 불가리아, 4002
- 모병
- UMHAT Sveti Georgi EAD /ID# 255386
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Sofia, 불가리아, 1606
- 완전한
- Specialized Hospital For Active Treatment Of Children Diseases Prof. Ivan Mitev /ID# 255384
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Varna, 불가리아, 9009
- 모병
- UMHAT Multiprofile Hospital for Active Treatment Sveta Marina /ID# 256358
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Stockholm County
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Stockholm, Stockholm County, 스웨덴, 118 83
- 모병
- Sodersjukhuset /ID# 255239
-
Stockholm, Stockholm County, 스웨덴, 171 76
- 모병
- Astrid Lindgrens Barnsjukhus /ID# 255240
-
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Västra Götaland County
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Gothenburg, Västra Götaland County, 스웨덴, 413 46
- 모병
- Sahlgrenska Universitetssjukhuset /ID# 255236
-
연락하다:
- Site Coordinator
- 전화번호: +46313435865
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Bern, 스위스, 3010
- 모병
- Inselspital, Universitaetsspital Bern /ID# 255321
-
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Canton of Zurich
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Zurich, Canton of Zurich, 스위스, 8032
- 모병
- Kinderspital Zurich - Eleonorenstiftung /ID# 255337
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-
-
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Madrid, 스페인, 28009
- 완전한
- Hospital Infantil Universitario Nino Jesus /ID# 255012
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Málaga, 스페인, 29011
- 모병
- Hospital Regional Universitario de Malaga /ID# 257553
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A Coruna
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Ferrol, A Coruna, 스페인, 15405
- 모병
- Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 255614
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-
-
-
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Birmingham, 영국, B4 6NH
- 모병
- Birmingham Women's and Children's NHS Foundation Trust /ID# 255759
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England
-
Sheffield, England, 영국, S10 2TH
- 모병
- Sheffield Children's Hospital NHS Foundation Trust /ID# 255758
-
연락하다:
- Site Coordinator
- 전화번호: +44 114 273 0522
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Greater London
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London, Greater London, 영국, E1 2ES
- 모병
- Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 255757
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Central District
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Petah Tikva, Central District, 이스라엘, 4920235
- 모병
- Schneider Children's Medical Center /ID# 254950
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Jerusalem
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Jerusalem, Jerusalem, 이스라엘, 91031
- 모병
- Shaare Zedek Medical Center /ID# 254951
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-
-
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Messina, 이탈리아, 98125
- 모병
- Azienda Ospedaliera Universitaria Gaetano Martino /ID# 255044
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Genova
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Genoa, Genova, 이탈리아, 16147
- 모병
- IRCCS Istituto Giannina Gaslini /ID# 255262
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Napoli
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Naples, Napoli, 이탈리아, 80131
- 모병
- Azienda Ospedaliera Universitaria Federico II - Naples /ID# 255045
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Roma
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Rome, Roma, 이탈리아, 00165
- 모병
- Ospedale Pediatrico Bambino Gesu /ID# 255043
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Aichi-ken
-
Ōbu, Aichi-ken, 일본, 474-8710
- 모병
- Aichi Children's Health And Medical Center /ID# 272085
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Chiba
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Kashiwa-shi, Chiba, 일본, 277-0871
- 모병
- Tsujinaka Hospital - Kashiwanoha /ID# 268409
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Fukuoka
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Kurume-shi, Fukuoka, 일본, 830-0011
- 모병
- Kurume University Hospital /ID# 268418
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Gunma
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Maebashi, Gunma, 일본, 371-8511
- 모병
- Gunma University Hospital /ID# 270560
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Kumamoto
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Kumamoto, Kumamoto, 일본, 861-8520
- 모병
- Japanese Red Cross Kumamoto Hospital /ID# 268586
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Osaka
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Izumi-Shi, Osaka, 일본, 594-1101
- 모병
- Osaka Women's and Children's Hospital /ID# 268419
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Saitama
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Saitama-shi, Saitama, 일본, 330-8777
- 모병
- Saitama Children's Medical Center /ID# 268410
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Tokyo
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Bunkyo-ku, Tokyo, 일본, 113-8519
- 모병
- Institute of Science Tokyo Hospital /ID# 269175
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Fuchu-shi, Tokyo, 일본, 183-8561
- 모병
- Tokyo Metropolitan Children's Medical Center /ID# 268415
-
Setagaya City, Tokyo, 일본, 157-8535
- 모병
- National Center For Child Health And Development /ID# 268420
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-
-
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100045
- 모병
- Beijing Children's Hospital /ID# 256081
-
Beijing, Beijing Municipality, 중국, 100191
- 모병
- Peking University Third Hospital /ID# 255876
-
연락하다:
- Site Coordinator
- 전화번호: +86 010-82266699
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510620
- 모병
- Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 255428
-
Guangzhou, Guangdong, 중국, 510655
- 모병
- The Sixth Affiliated Hospital of Sun Yat-sen University /ID# 270589
-
-
Henan
-
Zhengzhou, Henan, 중국, 450018
- 모병
- Henan Children's Hospital Zhengzhou Children's Hospital /ID# 255562
-
-
Hunan
-
Changsha, Hunan, 중국, 410007
- 모병
- Hunan Children's Hospital /ID# 255610
-
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Jiangxi
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Nanchang, Jiangxi, 중국, 330006
- 모병
- Jiangxi Provincial Children's Hospital /ID# 255564
-
-
Liaoning
-
Shenyang, Liaoning, 중국, 110022
- 모병
- Shengjing Hospital of China Medical University /ID# 255563
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, 중국, 200062
- 모병
- Children's Hospital of Shanghai /ID# 255531
-
Shanghai, Shanghai Municipality, 중국, 200065
- 모병
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 255688
-
-
-
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Praha 17
-
Prague, Praha 17, 체코, 128 00
- 완전한
- Vseobecna Fakultni nemocnice v Praze /ID# 256096
-
-
Praha 5
-
Prague, Praha 5, 체코, 150 06
- 완전한
- Fakultni nemocnice Motol a Homolka /ID# 256547
-
-
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Alberta
-
Calgary, Alberta, 캐나다, T3B 6A8
- 모병
- Alberta Children's Hospital /ID# 255357
-
Edmonton, Alberta, 캐나다, T6G 1C9
- 모병
- Edmonton Clinic Health Academy /ID# 255361
-
-
British Columbia
-
Vancouver, British Columbia, 캐나다, V6H 3V4
- 모병
- BC Children's Hospital /ID# 255359
-
-
Ontario
-
London, Ontario, 캐나다, N6A 5W9
- 모병
- London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 258598
-
-
-
-
-
Ankara, 터키 (Türkiye), 06560
- 모병
- Gazi University Medical Faculty /ID# 255086
-
Istanbul, 터키 (Türkiye), 34453
- 모병
- Sariyer Hamidiye Etfal Egitim Ve Araştirma Hastanesi /ID# 257143
-
Istanbul, 터키 (Türkiye), 34899
- 모병
- Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 261020
-
Kocaeli, 터키 (Türkiye), 41380
- 모병
- Kocaeli University Med Faculty /ID# 256922
-
-
-
-
Kuyavian-Pomeranian Voivodeship
-
Torun, Kuyavian-Pomeranian Voivodeship, 폴란드, 87-100
- 완전한
- Gastromed Sp. z o.o /ID# 255939
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, 폴란드, 04-730
- 모병
- Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 255938
-
-
-
-
-
Dorado, 푸에르토 리코, 00646
- 모병
- Puerto Rico Health Institute /ID# 255071
-
San Juan, 푸에르토 리코, 00909-1711
- 모병
- Clinical Research Puerto Rico /ID# 266479
-
-
-
-
-
Paris, 프랑스, 75015
- 모병
- AP-HP - Hopital Necker /ID# 255608
-
-
Centre-Val de Loire
-
Tours, Centre-Val de Loire, 프랑스, 37044
- 모병
- CHRU Tours - Hopital Gatien de Clocheville /ID# 255052
-
-
New Aquitaine
-
Bordeaux, New Aquitaine, 프랑스, 33076
- 모병
- Chu Bordeaux - Hopital Pellegrin /ID# 257060
-
-
Occitanie
-
Toulouse, Occitanie, 프랑스, 31059
- 모병
- CHU Toulouse - Hopital Paule de Viguier /ID# 255609
-
-
Rhone
-
Bron, Rhone, 프랑스, 69500
- 모병
- Hospices Civils de Lyon - Hopital Femme Mere Enfant /ID# 255443
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Pediatric individuals, 2 to < 18 years old
- Must have moderately to severely active CD, as defined by the PCDAI score > 30 assessed at Baseline
- Must have endoscopic evidence of mucosal inflammation as documented by the SES-CD of ≥ 6 for ileocolonic or colonic disease (or SES-CD of ≥ 4 for isolated ileal disease)
- Demonstrated intolerance or inadequate response to one or more of the following categories of drugs: aminosalicylates (This drug class is not sufficient for eligibility for subjects in France, Italy, Netherlands, Spain, and Sweden), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), IMMs, and/or biologic therapies
Exclusion Criteria:
-
History of hereditary fructose intolerance (a rare genetic condition) or an allergic reaction or significant sensitivity to constituents of the study drug (and its excipients) and/or other products in the same class
-
Any of the following medical disorders:
-
Current diagnosis of ulcerative colitis, indeterminate colitis, or monogenic IBD.
-
A diagnosis of CD prior to 2 years of age.
-
A diagnosis or suspected diagnosis of a primary immunodeficiency.
-
Currently known complications of CD such as:
- Active abscess (abdominal or perianal);
- Symptomatic bowel strictures;
- > 2 missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum;
- Fulminant colitis;
- Toxic megacolon;
- Or any other manifestation that might require surgery while enrolled in the study.
-
Ostomy or ileoanal pouch.
-
Diagnosis of short gut or short bowel syndrome.
-
Surgical bowel resection within the past 3 months prior to Baseline (excluding gastrointestinal surgeries which are not bowel resections such as appendectomy or ostomy closure), or a history of >3 bowel resections.
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 순차적 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
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. |
Intravenous (IV) Infusion
다른 이름들:
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. |
Intravenous (IV) Infusion
다른 이름들:
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. |
Intravenous (IV) Infusion
다른 이름들:
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. |
Intravenous (IV) Infusion
다른 이름들:
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. |
Intravenous (IV) Infusion
다른 이름들:
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. |
Intravenous (IV) Infusion
다른 이름들:
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. |
Intravenous (IV) Infusion
다른 이름들:
Subcutaneous (SC) Injection
다른 이름들:
|
|
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. |
Intravenous (IV) Infusion
다른 이름들:
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. |
Intravenous (IV) Infusion
다른 이름들:
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. |
Intravenous (IV) Infusion
다른 이름들:
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. |
Intravenous (IV) Infusion
다른 이름들:
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. |
Intravenous (IV) Infusion
다른 이름들:
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 subjects who complete SS1 are eligible to enter SS2. |
Intravenous (IV) Infusion
다른 이름들:
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 either double-blind risankizumab Dose A. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3. |
Intravenous (IV) Infusion
다른 이름들:
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 either double-blind risankizumab Dose B. Participants who complete SS2 will have the opportunity to enter the open-label long-term-extension SS3. |
Intravenous (IV) Infusion
다른 이름들:
Subcutaneous (SC) Injection
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cohort 3 (Substudy 2): Percentage of Participants Achieving Pediatric Crohn's Disease Activity Index (PCDAI) Clinical Remission
기간: At 64 weeks
|
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10. |
At 64 weeks
|
|
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per Simple Endoscopic Score for Crohn's Disease (SES-CD)
기간: At 64 weeks
|
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). |
At 64 weeks
|
|
Cohorts 1 & 2: Maximum Observed Serum Concentration (Cmax) of Risankizumab
기간: Up to approximately Week 64
|
Cmax of risankizumab |
Up to approximately Week 64
|
|
Cohorts 1 & 2: Time to Cmax (Tmax) of Risankizumab
기간: Up to approximately 64 weeks
|
Tmax of risankizumab |
Up to approximately 64 weeks
|
|
Cohorts 1 & 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau) of Risankizumab
기간: Up to approximately 64 weeks
|
AUCtau of risankizumab |
Up to approximately 64 weeks
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cohort 3 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
기간: At 12 weeks
|
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10. |
At 12 weeks
|
|
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
기간: At 12 weeks
|
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). |
At 12 weeks
|
|
Cohort 3 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
기간: At 12 weeks
|
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader. |
At 12 weeks
|
|
Cohort 3 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
기간: At 64 weeks
|
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader. |
At 64 weeks
|
|
Cohort 3 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
기간: At 64 weeks
|
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit. |
At 64 weeks
|
|
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving PCDAI Clinical Remission
기간: At 64 weeks
|
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10. |
At 64 weeks
|
|
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Response per SES-CD
기간: At 64 weeks
|
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). |
At 64 weeks
|
|
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving PCDAI Clinical Remission
기간: At 12 weeks
|
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. Clinical remission was defined as PCDAI ≤ 10. |
At 12 weeks
|
|
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Response per SES-CD
기간: At 12 weeks
|
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD > 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline). |
At 12 weeks
|
|
Cohorts 1 & 2 (Substudy 1): Percentage of Participants Achieving Endoscopic Remission per SES-CD
기간: At 12 weeks
|
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader. |
At 12 weeks
|
|
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Endoscopic Remission per SES-CD
기간: At 64 weeks
|
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic remission is defined as SES-CD ≤ 4 with at least a 2-point reduction from Baseline and no sub-score > 1, as scored by a central reader. |
At 64 weeks
|
|
Cohorts 1 & 2 (Substudy 2): Percentage of Participants Achieving Corticosteroid-Free Clinical Remission per PCDAI
기간: At 64 weeks
|
PCDAI is an index used to measure disease activity of pediatric patients with Crohn's disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. PCDAI corticosteroid-free remission was defined as discontinued corticosteroid use at least 90 consecutive days prior to the respective visit, with a PCDAI ≤ 10 at that visit. |
At 64 weeks
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: ABBVIE INC., AbbVie
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- M16-194
- 2022-502050-14-00 (기타 식별자: EU CT)
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
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