Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-02 @ 1:39 AM
Study NCT ID:
NCT07199257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of GR1802 Injection in Patients With Seasonal Allergic Rhinitis.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Part one subjects received open-label treatment. Part two subjects received double-blind treatment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2025-09-22', 'lastUpdatePostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-05-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (AEs)(Part One)', 'timeFrame': 'up to 12 weeks'}, {'measure': 'Change from Baseline in rTNSS( reflective total nasal symptom scores)(Part Two)', 'timeFrame': 'up to 2 weeks', 'description': 'Scores range from 0 to 12, with higher scores indicating more severe symptoms.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in rTOSS( reflective total ocular symptom scores)(Part One/Two)', 'timeFrame': 'up to 2、4 weeks', 'description': 'Scores range from 0 to 9, with higher scores indicating more severe symptoms.'}, {'measure': 'Percentage Change from Baseline in rTNSS(Part One/Two)', 'timeFrame': 'up to 2、4 weeks', 'description': 'Scores range from 0 to 12, with higher scores indicating more severe symptoms.'}, {'measure': 'Mean change from baseline in iTNSS(instantaneous total nasal symptom scores)(Part One/Two)', 'timeFrame': 'week 2、4', 'description': 'Scores range from 0 to 12, with higher scores indicating more severe symptoms.'}, {'measure': 'Mean change from baseline in iTOSS(instantaneous total ocular symptom scores)(Part One/Two)', 'timeFrame': 'week 2、4', 'description': 'Scores range from 0 to 9, with higher scores indicating more severe symptoms.'}, {'measure': 'Change from baseline in RQLQ(Rhinoconjunctivitis Quality of Life Questionnaire) scores(Part One/Two)', 'timeFrame': 'week2、4', 'description': 'There are 28 questions in 7 fields，Each question is answered on a 7-point scale (0 to 6).'}, {'measure': 'Incidence of ADAs(Part One/Two)', 'timeFrame': 'up to 12 weeks'}, {'measure': 'drug concentration、Ctrough(Part One/Two)', 'timeFrame': 'up to 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis, Seasonal']}, 'descriptionModule': {'briefSummary': 'Allergic rhinitis (AR) is a non-infectious chronic inflammatory disease of the nasal mucosa mainly mediated by immunoglobulin E after exposure to allergens in atopic individuals. The typical symptoms of AR are paroxysmal sneezing, watery rhinorrhea, itching, and nasal congestion, which may be accompanied by ocular symptoms, including eye itching, tearing, redness, and burning sensation, which are more common in patients with hay fever allergies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n1. Voluntarily sign the informed consent form.\n2. Seasonal allergic rhinitis has been prevalent for at least 2 years.Positive for allergens associated with seasonal allergic rhinitis.\n3. Poor control of seasonal allergic rhinitis with nasal glucocorticoids or other therapeutic agents during the same pollen season in the past.\n4. Weight≥30kg.\n5. Symptom severity scores for the season met the enrollment criteria.\n\nMain Exclusion Criteria:\n\n1. Other nasal comorbidities or co-morbidities/states that may be present at the time of screening that affect efficacy determination.\n2. Subjects whose allergen exposures in their home or work environments may be expected to change significantly during the trial period.\n3. Subjects with poorly controlled recent asthma conditions.\n4. Presence of current or past history of infection of special concern, e.g., active tuberculosis, helminthic infections, severe herpes virus infections, etc.\n5. Previous use of anti-interleukin 4 receptor alpha subunit (IL4Rα) monoclonal antibody.\n6. Have a serious underlying medical condition that, in the opinion of the investigator, may pose a risk to subject safety by participation in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT07199257', 'briefTitle': 'A Study of GR1802 Injection in Patients With Seasonal Allergic Rhinitis.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genrix (Shanghai) Biopharmaceutical Co., Ltd.'}, 'officialTitle': 'A Multicenter Clinical Trial Evaluating the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of GR1802 Injection in Combination With Background Therapy in Patients With Seasonal Allergic Rhinitis.', 'orgStudyIdInfo': {'id': 'GR1802-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interleukin-4 receptor responder(Part One)', 'description': 'Part one', 'interventionNames': ['Biological: GR1802 injection']}, {'type': 'EXPERIMENTAL', 'label': 'Interleukin-4 receptor responder(Part Two)', 'description': 'Part two', 'interventionNames': ['Biological: GR1802 injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Part two', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'GR1802 injection', 'type': 'BIOLOGICAL', 'description': 'Recombinant fully human anti-IL4Rα monoclonal antibody drug.', 'armGroupLabels': ['Interleukin-4 receptor responder(Part One)', 'Interleukin-4 receptor responder(Part Two)']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'project manager', 'role': 'CONTACT', 'email': 'dongjie@genrixbio.com', 'phone': '021-50805988-8039'}, {'name': 'Zheng Liu, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongnan Hospital of Wuhan university', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'liaison officer', 'role': 'CONTACT', 'email': 'fangxiaoyan@genrixbio.com', 'phone': '021-50805988-8039'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genrix (Shanghai) Biopharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}