중등도 내지 중증 활동성 궤양성 대장염 소아 참가자를 대상으로 한 구셀쿠맙 연구 (QUASAR Jr)
중등도에서 중증 활동성 궤양성 대장염을 앓고 있는 소아 참가자를 대상으로 구셀쿠맙의 효능, 안전성 및 약동학을 평가하기 위한 제3상 무작위 배정, 공개 라벨 유도, 이중 맹검 유지, 병렬 그룹, 다기관 프로토콜
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
-
Lørenskog, 노르웨이, 1478
- Akershus Universitetssykehus
-
Oslo, 노르웨이, 0450
- Oslo University Hospital
-
Tromsø, 노르웨이, 9030
- Universitetssykehuset Nord-Norge HF
-
Trondheim, 노르웨이, 7030
- St. Olavs Hospital
-
-
-
-
-
Aarhus N, 덴마크, 8200
- Aarhus Universitetshospital
-
Hvidovre, 덴마크, 2650
- Hvidovre Hospital
-
-
-
-
California
-
Oakland, California, 미국, 94609
- Children's Hospital Oakland
-
-
Indiana
-
Indianapolis, Indiana, 미국, 46202
- Riley Hospital for Children
-
-
New York
-
Lake Success, New York, 미국, 11042
- NYU Langone Health
-
-
-
-
-
Charleroi, 벨기에, 6042
- CHU Charleroi Chimay
-
Ghent, 벨기에, 9000
- UZ Gent
-
Jette, 벨기에, 1090
- UZ Brussel
-
Leuven, 벨기에, 3000
- UZ Leuven
-
-
-
-
-
Madrid, 스페인, 28009
- Hosp. Infantil Univ. Nino Jesus
-
Sabadell, 스페인, 08028
- Corporacio Sanitari Parc Tauli
-
Valencia, 스페인, 46026
- Hosp. Univ. I Politecni La Fe
-
-
-
-
-
Bergamo, 이탈리아, 24127
- ASST Papa Giovanni XXIII Bergamo
-
Bologna, 이탈리아, 40133
- Azienda USL di Bologna - Ospedale Maggiore
-
Florence, 이탈리아, 50139
- AOU Meyer
-
Pescara, 이탈리아, 65124
- Ospedale S. Spirito, Azienda Sanitaria Pescara
-
Roma, 이탈리아, 00161
- AOU Policlinico Umberto I
-
Roma, 이탈리아, 00165
- IRCCS Ospedale Pediatrico Bambino Gesu
-
San Giovanni Rotondo, 이탈리아, 71013
- Casa Sollievo della Sofferenza
-
Trieste, 이탈리아, 34137
- IRCCS Materno Infantile Burlo Garofolo
-
-
-
-
-
Fuchū, 일본, 183 8561
- Tokyo Metropolitan Children's Medical Center
-
Kanazawa, 일본, 920 8641
- Kanazawa University Hospital
-
Kobe, 일본, 650 0017
- Kobe University Hospital
-
Kumamoto, 일본, 861 8520
- Japanese Red Cross Kumamoto Hospital
-
Matsumoto, 일본, 390 8621
- Shinshu University Hospital
-
Saga, 일본, 849-8501
- Saga University Hospital
-
Setagaya Ku, 일본, 157 8535
- National Center for Child Health and Development
-
Shinjuku, 일본, 160 0023
- Tokyo Medical University Hospital
-
Takatsuki, 일본, 569-8686
- Osaka Medical and Pharmaceutical University Hospital
-
Yokohama, 일본, 230-8765
- Saiseikai Yokohamashi Tobu Hospital
-
-
-
-
-
Beijing, 중국, 100191
- Peking University Third Hospital
-
Beijing, 중국, 100020
- Capital Center For Children's health Capital Medical University
-
Changzhou, 중국, 213004
- Changzhou No 2 Peoples Hospital
-
Hangzhou, 중국, 310016
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
-
Hangzhou, 중국, 310005
- The Childrens Hospital Zhejiang University School Of Medicine
-
Shanghai, 중국, 200025
- Ruijin Hospital Shanghai Jiao Tong University
-
Shenyang, 중국, 110055
- Shengjing Hospital Of China Medical University
-
Zhengzhou, 중국, 450052
- Henan Children's Hospital, Zhengzhou Children's Hospital
-
-
-
-
-
Ankara, 터키 (Türkiye), 06560
- Gazi University Medical Faculty
-
Ankara, 터키 (Türkiye), 6620
- Ankara University Medical Faculty
-
Istanbul, 터키 (Türkiye), 34899
- Marmara University Pendik Training Hospital
-
Istanbul, 터키 (Türkiye), 34098
- Istanbul University Cerrahpasa Medical Faculty
-
-
-
-
-
Lisbon, 포르투갈, 1649-035
- Uls Santa Maria - Hosp. Santa Maria
-
Porto, 포르투갈, 4200 319
- Uls Sao Joao - Hosp. Sao Joao
-
Porto, 포르투갈, 4050-651
- Uls Santo Antonio - Cmin
-
-
-
-
-
Gdansk, 폴란드, 80 803
- Copernicus Podmiot Leczniczy Sp. z o.o
-
Rzeszów, 폴란드, 35-302
- Korczowski Bartosz Gabinet Lekarski
-
Warsaw, 폴란드, 04 501
- Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus
-
Warsaw, 폴란드, 04 730
- Instytut Pomnik Centrum Zdrowia Dziecka
-
-
-
-
-
Bron, 프랑스, 69677
- Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant
-
Dijon, 프랑스, 21000
- Hopital Francois Mitterand
-
Lille, 프랑스, 59037
- CHRU Lille
-
Paris, 프랑스, 75019
- APHP Hopital Robert Debre
-
Toulouse, 프랑스, 31059
- CHU Toulouse
-
-
-
-
-
Nedlands, 호주, 6009
- The Kids Research Institute Australia on behalf of the Centre for Child Health Research
-
South Brisbane, 호주, 4101
- Mater Hospital Brisbane Inflammatory Bowel Diseases
-
Westmead, 호주, 2145
- The Children's Hospital at Westmead
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent for screening
- A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
- Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy
- Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
- Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids
Exclusion Criteria:
- Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon
- Presence of a stoma
- Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
- Have severe colitis or have evidence of Crohn's Disease (CD)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Open-label Induction Phase: Guselkumab Intravenously (IV)
Participants will receive a guselkumab dose IV based on their body weight (BW) during the 12-week open-label induction phase. |
Guselkumab will be administered intravenously.
다른 이름들:
|
|
실험적: Open-label Induction Phase: Guselkumab Subcutaneously (SC)
Participants will receive a guselkumab dose SC based on their BW during the 12-week open-label induction phase. |
Guselkumab will be administered subcutaneously.
다른 이름들:
|
|
실험적: Double-blind Maintenance Phase: Guselkumab Dose Regimen 1
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 1 SC based on their BW up to Week 56. |
Guselkumab will be administered subcutaneously.
다른 이름들:
|
|
실험적: Double-blind Maintenance Phase: Guselkumab Dose Regimen 2
At the end of the induction phase, Week 12 responders will be randomized into the double-blind maintenance phase to receive guselkumab dose regimen 2 SC based on their BW up to Week 56. |
Guselkumab will be administered subcutaneously.
다른 이름들:
|
|
실험적: Open-label Maintenance Phase: Guselkumab SC
Week 12 non-responders will not be randomized and will enter an open-label maintenance phase to receive guselkumab SC dosing regimen based on their body weight up to Week 56. |
Guselkumab will be administered subcutaneously.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants with Clinical Remission at Week 56
기간: Week 56
|
Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline. |
Week 56
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants with Clinical Response at Week 12
기간: Week 12
|
Percentage of participants with clinical response as assessed by modified Mayo score at Week 12 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. |
Week 12
|
|
Percentage of Participants with Clinical Remission at Week 12
기간: Week 12
|
Percentage of participants with clinical remission at Week 12 as assessed by modified Mayo score will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline. |
Week 12
|
|
Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12
기간: Week 12
|
Percentage of participants with PUCAI remission at Week 12 will be reported. It comprises 6 scales and ranges between 0 and 85 points. The scales are abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission. |
Week 12
|
|
Percentage of Participants with Symptomatic Remission at Week 12
기간: Week 12
|
Percentage of participants with symptomatic remission at Week 12 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. |
Week 12
|
|
United States: Percentage of Participants with Endoscopic Improvement at Week 12
기간: Week 12
|
Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
Week 12
|
|
European Union: Percentage of Participants with Endoscopic Healing at Week 12
기간: Week 12
|
Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 12 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
Week 12
|
|
Percentage of Participants with Clinical Response at Week 56
기간: Week 56
|
Percentage of participants with clinical response as assessed by modified Mayo score at Week 56 will be reported. Modified Mayo score is a 3-component (stool frequency, rectal bleeding, and endoscopy subscores) assessment and does not include the physician's global assessment. A decrease from baseline in the modified Mayo score by >= 30 percent and >= 2 points, with either a decrease from baseline in the rectal bleeding subscore of >= 1 or a rectal bleeding subscore of 0 or 1. |
Week 56
|
|
Percentage of Participants With PUCAI Remission at Week 56
기간: Week 56
|
Percentage of participants with PUCAI remission at Week 56 will be reported. PUCAI comprises of 6 scales and ranges between 0 and 85 points. The scales are: abdominal pain, rectal bleeding, stool consistency, number of stools, nocturnal bowel movement, and activity level. The PUCAI score is calculated as the sum of the 6 subscores. A PUCAI score of less than (<) 10 indicates remission. |
Week 56
|
|
Percentage of Participants with Symptomatic Remission at Week 56
기간: Week 56
|
Percentage of participants with symptomatic remission at Week 56 will be reported. Symptomatic remission is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. |
Week 56
|
|
Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12
기간: Week 56
|
Percentage of participants with symptomatic remission at Week 56 among participants who had symptomatic remission at Week 12 will be reported. Symptomatic remission score is defined as a stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0, where the stool frequency subscore has not increased from induction baseline. |
Week 56
|
|
United States: Percentage of Participants With Endoscopic Improvement at Week 56
기간: Week 56
|
Percentage of participants with endoscopic improvement as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic improvement is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
Week 56
|
|
European Union: Percentage of Participants With Endoscopic Healing at Week 56
기간: Week 56
|
Percentage of participants with endoscopic healing as assessed by Mayo endoscopy subscore at Week 56 will be reported. Endoscopic healing is defined as the Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy. |
Week 56
|
|
Percentage of Participants Who Achieve Endoscopic Normalization at Week 56
기간: Week 56
|
Percentage of participants who achieve endoscopic normalization with an endoscopy subscore of 0 at Week 56 will be reported. |
Week 56
|
|
Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56
기간: Week 56
|
Percentage of participants histo-endoscopic mucosal healing per endoscopy subscore and histologic improvement at Week 56 will be reported. Histologic-endoscopic mucosal healing is defined as achieving a combination of histologic improvement and endoscopic improvement (US) or endoscopic healing (EU) (endoscopy subscore of 0 or 1). |
Week 56
|
|
Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56
기간: Week 56
|
Percentage of participants with corticosteroid-free clinical remission at Week 56 will be reported. Corticosteroid free clinical remission is defined as a Mayo stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline (Week 0), and not receiving corticosteroids for at least 8 weeks prior to Week 56 |
Week 56
|
|
Serum Concentration of Guselkumab During Induction Phase
기간: From Week 0 to Week 12
|
Serum samples will be analyzed to determine concentrations of guselkumab overtime. |
From Week 0 to Week 12
|
|
Serum Concentration of Guselkumab During Maintenance Phase
기간: From Week 12 to Week 56
|
Serum samples will be analyzed to determine concentrations of guselkumab over time. |
From Week 12 to Week 56
|
|
Number of Participants with Incidence of Anti-guselkumab Antibodies
기간: Up to Week 68
|
Number of participants with anti-guselkumab antibodies for all study treatment regimens will be assessed. |
Up to Week 68
|
|
Percentage of Participants with Adverse Events (AEs)
기간: Up to Week 68
|
Percentage of participants with AEs will be reported. An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. |
Up to Week 68
|
|
Percentage of Participants with Serious Adverse Events (SAEs)
기간: Up to Week 68
|
Percentage of participants with SAEs will be reported. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. |
Up to Week 68
|
|
Percentage of Participants with AEs Leading to Discontinuation of Study Intervention
기간: Up to Week 68
|
Percentage of participants with AEs leading to discontinuation of study intervention will be reported. |
Up to Week 68
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
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
기타 연구 ID 번호
- CR109251
- 2022-001285-35 (EudraCT 번호)
- CNTO1959PUC3001 (기타 식별자: Janssen Research & Development, LLC)
- 2022-502238-22-00 (레지스트리 식별자: EUCT number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .