Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-27 @ 1:26 PM
Study NCT ID:
NCT07310095
Status:
RECRUITING
Last Update Posted:
2026-03-17
First Post:
2025-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000588857', 'term': 'guselkumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2025-12-16', 'studyFirstSubmitQcDate': '2025-12-16', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Clinical Remission At Week 48', 'timeFrame': 'At Week 48', 'description': "Clinical remission is defined as less than (\\<) 150-point reduction in Crohn's Disease Activity Index (CDAI) score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48', 'timeFrame': 'At Weeks 12, 24 and 48', 'description': "Clinical response is defined as greater than or equal to (\\>=) 100-point reduction from baseline in CDAI score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities."}, {'measure': 'Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24', 'timeFrame': 'At Weeks 12 and 24', 'description': "Clinical remission is defined as \\< 150-point reduction in CDAI score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities."}, {'measure': 'Percentage of Participants Achieving Endoscopic Response', 'timeFrame': 'At Weeks 24 and 48', 'description': "Endoscopic response is defined as \\>= 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. The SES-CD is based on the evaluation of 4 variables: (ulcers - scored according to size, proportion of the surface covered by ulcers according to extent, proportion of affected surface with any other lesions according to extent, stenosis \\[single or multiple, and whether the colonoscopy could pass through the narrow lumen\\]), each considered in 5 segments of the bowel (the ileum, ascending colon, transverse colon, descending colon, and rectum). An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 60. Higher scores indicating severe disease."}, {'measure': 'Percentage of Participants Achieving Endoscopic Remission', 'timeFrame': 'At Weeks 24 and 48', 'description': 'Endoscopic remission is defined as SES-CD less than or equal to (\\<=) 2 in any individual component. The SES-CD is based on the evaluation of 4 variables: (ulcers - scored according to size, proportion of the surface covered by ulcers according to extent, proportion of affected surface with any other lesions according to extent, stenosis \\[single or multiple, and whether the colonoscopy could pass through the narrow lumen\\]), each considered in 5 segments of the bowel (the ileum, ascending colon, transverse colon, descending colon, and rectum). An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 60. Higher scores indicating severe disease.'}, {'measure': 'Baseline Characteristics of Participants With Endoscopic Remission: Age', 'timeFrame': 'Baseline', 'description': 'Baseline characteristics of participants (age) with endoscopic remission will be reported.'}, {'measure': 'Baseline Characteristics of Participants With Endoscopic Remission: Sex', 'timeFrame': 'Baseline', 'description': 'Baseline characteristics of participants (sex) with endoscopic remission will be reported.'}, {'measure': 'Baseline Characteristics of Participants With Endoscopic Remission: Height', 'timeFrame': 'Baseline', 'description': 'Baseline characteristics of participants (height) with endoscopic remission will be reported.'}, {'measure': 'Baseline Characteristics of Participants With Endoscopic Remission: Weight', 'timeFrame': 'Baseline', 'description': 'Baseline characteristics of participants (weight) with endoscopic remission will be reported.'}, {'measure': 'Baseline Characteristics of Participants With Endoscopic Remission: History of Advanced Treatment, Concomitant Medications', 'timeFrame': 'Baseline', 'description': 'Baseline characteristics of participants (history of advanced treatment, concomitant medications) with endoscopic remission will be reported.'}, {'measure': 'Baseline Characteristics of Participants With Endoscopic Remission: Comorbidities', 'timeFrame': 'Baseline', 'description': 'Baseline characteristics of participants (comorbidities) with endoscopic remission will be reported.'}, {'measure': 'Baseline Characteristics of Participants With Endoscopic Remission: Surgeries and Procedures', 'timeFrame': 'Baseline', 'description': 'Baseline characteristics of participants (surgeries and procedures such as apheresis) with endoscopic remission will be reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has a confirmed diagnosis of Crohn's disease (CD)\n* Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (\\>=) 220 and either mean daily stool frequency (SF) count \\>= 4 or mean daily abdominal pain (AP) score \\>=2\n* Participants had received at least two doses of ustekinumab (UST) (induction of 6 milligram \\[mg\\]/kilogram \\[kg\\] intravenous \\[IV\\] followed by 90 mg subcutaneous \\[SC\\] at week 8) as the instruction manual\n* Initially responded to UST induction therapy and then lose response to UST\n* During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic\n\nExclusion Criteria:\n\n* Have responded well to treatment with UST in a dosing regime that is not in line with to the approved recommended dosing (for example, multiple intravenous induction) experienced optimized treatment with UST(not as instruction manual)\n* Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months\n* Is currently enrolled in an interventional clinical study\n* Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome\n* Have a current or be suspected to have an abscess"}, 'identificationModule': {'nctId': 'NCT07310095', 'briefTitle': "A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Xian-Janssen Pharmaceutical Ltd.'}, 'officialTitle': "Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab", 'orgStudyIdInfo': {'id': 'CNTO1959CRD4007'}, 'secondaryIdInfos': [{'id': 'CNTO1959CRD4007', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guselkumab Treatment', 'description': 'Participants will receive Guselkumab intravenously (IV) every 4 weeks during the induction phase, followed by subcutaneous (SC) administration of Guselkumab every 4 weeks from Week 12 through Week 44 as maintenance therapy.', 'interventionNames': ['Drug: Guselkumab (GUS)']}], 'interventions': [{'name': 'Guselkumab (GUS)', 'type': 'DRUG', 'otherNames': ['TREMFYA'], 'description': 'Guselkumab will be administered intravenously or by subcutaneous injection.', 'armGroupLabels': ['Guselkumab Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510060', 'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital Sun Yat sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510655', 'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The Sixth Affiliated Hospital Sun Yat sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '310018', 'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Sir Run Run Shaw Hospital Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '200031', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Study Contact', 'role': 'CONTACT', 'email': 'Participate-In-This-Study1@its.jnj.com', 'phone': '844-434-4210'}], 'overallOfficials': [{'name': "Xi'an Janssen Pharmaceutical Clinical Trial", 'role': 'STUDY_DIRECTOR', 'affiliation': "Xi'an Janssen Pharmaceutical"}]}, 'ipdSharingStatementModule': {'url': 'https://innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': 'The data sharing policy of Johnson \\& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xian-Janssen Pharmaceutical Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}