[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643826":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":96,"collaborators":41,"id":98,"slug":41,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":103,"eligibilityCriteria":104,"healthyVolunteers":99,"sex":105,"minAge":106,"maxAge":41,"enrollmentInfo":107,"targetDuration":41,"studyType":110,"phases":111,"briefSummary":113,"conditions":114,"keywords":41,"overallStatus":46,"whyStopped":41,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"JNJ-78934804","EXPERIMENTAL","Participants will receive JNJ-78934804 induction dose, at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long-term extension (LTE) phase.",[13],"Drug: JNJ-78934804",{"label":15,"type":16,"description":17,"interventionNames":18},"Guselkumab","ACTIVE_COMPARATOR","Participants will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind treatment phase (Week 48) and who may benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.",[13,19],"Drug: Guselkumab",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","JNJ-78934804 will be administered subcutaneously.",[15,9],[26],"JNJ-4804",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Guselkumab will be administered subcutaneously.",[15],[31],"TREMFYA",[33],{"name":34,"affiliation":5,"role":35},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Study Contact","CONTACT","844-434-4210",null,"Participate-In-This-Study1@its.jnj.com",[44,57,67,77,86],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":41},"Clinnova Research","RECRUITING","Anaheim","California","92805","United States",{"type":52,"coordinates":53},"Point",[54,55],-117.9145,33.83529,{"lat":55,"lon":54},{"facility":58,"status":46,"city":59,"state":60,"zip":61,"country":50,"cosmosGeoPoint":62,"geoPoint":66,"contacts":41},"Peak Gastroenterology Associates","Colorado Springs","Colorado","80907",{"type":52,"coordinates":63},[64,65],-104.82136,38.83388,{"lat":65,"lon":64},{"facility":68,"status":46,"city":69,"state":70,"zip":71,"country":50,"cosmosGeoPoint":72,"geoPoint":76,"contacts":41},"GCP Clinical Research","Tampa","Florida","33609",{"type":52,"coordinates":73},[74,75],-82.45843,27.94752,{"lat":75,"lon":74},{"facility":78,"status":46,"city":79,"state":79,"zip":80,"country":50,"cosmosGeoPoint":81,"geoPoint":85,"contacts":41},"New York Gastroenterology Associates","New York","10075",{"type":52,"coordinates":82},[83,84],-74.00597,40.71427,{"lat":84,"lon":83},{"facility":87,"status":46,"city":88,"state":41,"zip":89,"country":90,"cosmosGeoPoint":91,"geoPoint":95,"contacts":41},"Kagoshima IBD Gastroenterology Clinic","Kagoshima","892-0843","Japan",{"type":52,"coordinates":92},[93,94],130.55,31.56667,{"lat":94,"lon":93},{"type":97,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100643826",false,"NCT07577843","A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease","A Phase 3, Randomized, Double-blind, and Active-controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease","DUET ENCORE-CD","Inclusion criteria:\n\n* Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (\\>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD\n* Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score \\>= 220 but less than or equal to (\\\u003C=) 450 and either: a. Mean daily stool frequency (SF) count \\>= 4.0, based on the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \\>= 2.0, based on the unweighted CDAI component of abdominal pain (AP)\n* Have moderately to severely active ileal and\u002For colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria\n* Have had an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies\n\nExclusion criteria:\n\n* Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC\n* Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study\n* Presence of draining (that is, functioning) stoma or ostomy\n* Has a history of short bowel syndrome, is missing greater than (\\>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention\n* Currently has or is suspected of having an abscess","ALL","18 Years",{"count":108,"type":109},460,"ESTIMATED","INTERVENTIONAL",[112],"PHASE3","The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active Crohn's disease (a long-term, progressive \\[worsens with time\\] and life-threatening disease of the intestine).",[115],"Crohn Disease","2026-06-04",{"date":118,"type":119},"2026-06-08","ACTUAL",{"date":121,"type":119},"2026-05-22",{"date":123,"type":109},"2030-07-12",{"name":5,"class":6},5]