nctId: NCT06260163 id: CR109251 id: 2022-001285-35 type: EUDRACT_NUMBER id: CNTO1959PUC3001 type: OTHER domain: Janssen Research & Development, LLC id: 2022-502238-22-00 type: REGISTRY domain: EUCT number briefTitle: A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis acronym: QUASAR Jr overallStatus: RECRUITING date: 2024-01-19 date: 2028-05-22 date: 2028-08-14 date: 2024-02-15 date: 2024-04-24 name: Janssen Research & Development, LLC class: INDUSTRY briefSummary: 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. conditions: Colitis, Ulcerative studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: DOUBLE whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 120 type: ESTIMATED name: Guselkumab Subcutaneous name: Matching Placebo name: Guselkumab Intravenous measure: Percentage of Participants with Clinical Remission at Week 56 measure: Percentage of Participants with Clinical Remission at Week 12 measure: Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12 measure: Percentage of Participants with Symptomatic Remission at Week 12 measure: United States: Percentage of Participants with Endoscopic Improvement at Week 12 measure: European Union: Percentage of Participants with Endoscopic Healing at Week 12 measure: Percentage of Participants with Clinical Response at Week 12 measure: Percentage of Participants with Symptomatic Remission at Week 56 measure: United States: Percentage of Participants With Endoscopic Improvement at Week 56 measure: European Union: Percentage of Participants With Endoscopic Healing at Week 56 measure: Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56 measure: Percentage of Participants with Clinical Response at Week 56 measure: Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56 measure: Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12 measure: Percentage of Participants Who Achieve Endoscopic Normalization at Week 56 measure: Percentage of Participants With PUCAI Remission at Week 56 measure: Serum Concentration of Guselkumab During Induction Phase measure: Serum Concentration of Guselkumab During Maintenance Phase measure: Number of Participants with Incidence of Anti-guselkumab Antibodies measure: Percentage of Participants with Adverse Events (AEs) measure: Percentage of Participants with Serious Adverse Events (SAEs) measure: Percentage of Participants with AEs Leading to Discontinuation of Study Intervention sex: ALL minimumAge: 2 Years maximumAge: 17 Years stdAges: CHILD facility: Riley Hospital for Children status: RECRUITING city: Indianapolis state: Indiana zip: 46202 country: United States lat: 39.76838 lon: -86.15804 facility: UZ Gent status: RECRUITING city: Gent zip: 9000 country: Belgium lat: 51.05 lon: 3.71667 facility: UZ Brussel status: RECRUITING city: Jette zip: 1090 country: Belgium lat: 50.87309 lon: 4.33419 facility: Capital Institute of Pediatrics status: RECRUITING city: Beijing zip: 100020 country: China lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital status: RECRUITING city: Beijing zip: 100191 country: China lat: 39.9075 lon: 116.39723 facility: Changzhou No 2 Peoples Hospital status: RECRUITING city: Changzhou City zip: 213004 country: China facility: The Childrens Hospital Zhejiang University School Of Medicine status: RECRUITING city: Hangzhou zip: 310005 country: China lat: 30.29365 lon: 120.16142 facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine status: RECRUITING city: Hangzhou zip: 310016 country: China lat: 30.29365 lon: 120.16142 facility: Ruijin Hospital, Shanghai Jiao Tong University status: RECRUITING city: Shanghai zip: 200025 country: China lat: 31.22222 lon: 121.45806 facility: Shengjing Hospital of China Medical University status: RECRUITING city: Shenyang zip: 110004 country: China lat: 41.79222 lon: 123.43278 facility: Hvidovre Hospital status: RECRUITING city: Hvidovre zip: 2650 country: Denmark lat: 55.65719 lon: 12.47364 facility: AOU Policlinico Umberto I status: RECRUITING city: Roma zip: 00161 country: Italy lat: 41.89193 lon: 12.51133 facility: Kanazawa University Hospital status: RECRUITING city: Kanazawa zip: 920-8641 country: Japan lat: 36.6 lon: 136.61667 facility: Kobe University Hospital status: RECRUITING city: Kobe zip: 650-0017 country: Japan lat: 34.6913 lon: 135.183 facility: Japanese Red Cross Kumamoto Hospital status: RECRUITING city: Kumamoto zip: 861-8520 country: Japan lat: 32.80589 lon: 130.69182 facility: Shinshu University Hospital status: RECRUITING city: Matsumoto zip: 390-8621 country: Japan lat: 36.23333 lon: 137.96667 facility: Saga University Hospital status: RECRUITING city: Saga zip: 849-8501 country: Japan lat: 33.23333 lon: 130.3 facility: Tokyo Medical University Hospital status: RECRUITING city: Shinjuku zip: 160-0023 country: Japan lat: 35.2946 lon: 139.57059 facility: Osaka Medical and Pharmaceutical University Hospital status: RECRUITING city: Takatsuki zip: 569-8686 country: Japan lat: 34.84833 lon: 135.61678 facility: Saiseikai Yokohamashi Tobu Hospital status: RECRUITING city: Yokohama zip: 230-8765 country: Japan lat: 35.43333 lon: 139.65 facility: Korczowski Bartosz Gabinet Lekarski status: RECRUITING city: Rzeszow zip: 35-302 country: Poland lat: 50.04132 lon: 21.99901 facility: Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus status: RECRUITING city: Warszawa zip: 04 501 country: Poland lat: 52.22977 lon: 21.01178 facility: Instytut Pomnik Centrum Zdrowia Dziecka status: RECRUITING city: Warszawa zip: 04 730 country: Poland lat: 52.22977 lon: 21.01178 facility: Gazi University Medical Faculty status: RECRUITING city: Ankara zip: 06560 country: Turkey lat: 39.91987 lon: 32.85427 hasResults: False