Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:27 AM
Study NCT ID:
NCT07483268
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Stapokibart Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) .
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '52 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-03-16', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence rate of adverse reactions (ADR).', 'timeFrame': 'From enrollment to the end of treatment at 52 weeks', 'description': 'Number of adverse events and severe adverse events, categorized according to medical dictionary for regulatory activities (MedDRA)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CRSWNP']}, 'descriptionModule': {'briefSummary': 'This study is a open label, prospective study to evaluate the safety of Stapokibart Injection in subjects with CRSwNP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participant who are treated with Stapokibart Injection for CRSwNP (according to the China-specific prescribing information) .', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants aged 18 years or older at the time of informed consent and provide voluntary informed consent to participate in the study before inclusion in the study.\n* Physician decision to treat the participant with Stapokibart Injection for CRSwNP (according to the China-specific prescribing information) made prior to and independently of the participant's participation in the study.\n\nExclusion Criteria:\n\n* Known history of allergic reaction to Stapokibart Injection.\n* Participants currently or plan participating in any interventional clinical trial.\n* Participants with hematologic malignancies.\n* Women with pregnant.\n* Any condition that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study."}, 'identificationModule': {'nctId': 'NCT07483268', 'briefTitle': 'A Study of Stapokibart Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) .', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chengdu Kangnuoxing Biopharma,Inc.'}, 'officialTitle': 'A Prospective Study of Stapokibart Injection in Patients With CRSwNP.', 'orgStudyIdInfo': {'id': 'CM310-102302'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Biological: Stapokibart']}], 'interventions': [{'name': 'Stapokibart', 'type': 'BIOLOGICAL', 'description': 'subcutaneous injection', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Qian Jia', 'role': 'CONTACT', 'email': 'clinicaltrial@keymedbio.com', 'phone': '028-88610620'}], 'facility': 'Beijing Tongren Hospital, CMU', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qian Jia', 'role': 'CONTACT', 'email': 'clinicaltrial@keymedbio.com', 'phone': '028-88610620'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu Kangnuoxing Biopharma,Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}