Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-09 @ 10:06 AM
Study NCT ID:
NCT07459556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Study of Stapokibart Injection in Patients With Seasonal Allergic Rhinitis (SAR)
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': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-05', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', '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 10 weeks', 'description': 'Number of of Adverse Reactions （ADRs） is calculated based on Adverse Events （AEs） and Serious Adverse Events （SAEs） that were assessed by the investigator as related to the study drug and categorized according to the Medical Dictionary for Regulatory Activities （MedDRA）.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['SAR']}, 'descriptionModule': {'briefSummary': 'This study is an open label, prospective study to evaluate the safety of Stapokibart Injection in subjects with SAR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Participants who are treated with Stapokibart Injection for SAR at the physician's discretion (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 SAR (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': 'NCT07459556', 'briefTitle': 'A Prospective Study of Stapokibart Injection in Patients With Seasonal Allergic Rhinitis (SAR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chengdu Kangnuoxing Biopharma,Inc.'}, 'officialTitle': 'A Prospective Study of Stapokibart Injection in Patients With SAR', 'orgStudyIdInfo': {'id': 'CM310-107301'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group of Stapokibart Injection', 'interventionNames': ['Biological: Stapokibart']}], 'interventions': [{'name': 'Stapokibart', 'type': 'BIOLOGICAL', 'description': 'subcutaneous injection', 'armGroupLabels': ['Group of Stapokibart Injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', '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'}}}}