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