Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-01-01 @ 1:01 PM
Study NCT ID:
NCT06438757
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-07
First Post:
2024-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of JYB1904 in Patients With Allergic Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069444', 'term': 'Omalizumab'}], 'ancestors': [{'id': 'D000888', 'term': 'Antibodies, Anti-Idiotypic'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2024-05-27', 'studyFirstSubmitQcDate': '2024-05-27', 'lastUpdatePostDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum concentrations of JYB1904', 'timeFrame': 'Baseline through 337 days post-dose', 'description': 'Serum concentrations of JYB1904, assessed by pre-specified methods'}, {'measure': 'Serum concentrations of IgE', 'timeFrame': 'Baseline through 337 days post-dose', 'description': 'Serum concentrations of IgE, assessed by pre-specified methods'}, {'measure': 'Adverse Events(AEs)', 'timeFrame': 'Baseline through 337 days post-dose', 'description': 'Incidence and features of AEs assessed by CTCAE v5.0, and related safety parameters analysis'}], 'secondaryOutcomes': [{'measure': 'Times of protocol-defined asthma exacerbations during the 24-week treatment period', 'timeFrame': 'Baseline through 168 days post-dose', 'description': 'Times of protocol-defined asthma exacerbations during the 24-week treatment period'}, {'measure': 'Change in spirometry measures of forced expiratory volume in one second (FEV1) in 24 weeks', 'timeFrame': 'Baseline through 24 weeks post-dose', 'description': 'forced expiratory volume in one second (FEV1)'}, {'measure': 'Serum concentrations of anti-drug antibody (ADA)', 'timeFrame': 'Baseline through 337 days post-dose', 'description': 'Serum ADA assessed by pre-specified methods, and related immunogenic features analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Asthma']}, 'descriptionModule': {'briefSummary': 'This phase IIa trial is meant to evaluate the pharmacokinetics, pharmacodynamics and safety of JYB1904 in patients with allergic asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide written informed consent voluntarily;\n* Aged 18-75 years, weight ≥ 40 kg, male or female;\n* Diagnosed Allergic asthma.\n\nExclusion Criteria:\n\n* Prior exposure to anti-IgE therapy within 1 year;\n* Allergic to anti-IgE biologics;\n* Current smokers, or quit smoking within 1 year;\n* Combined with other non-allergic diseases that cause IgE elevation；\n* History of malignancy, autoimmune diseases, Immune complex mediated diseases, Hypereosinophilic syndrome;\n* Other conditions unsuitable for the trial judged by the investigator.'}, 'identificationModule': {'nctId': 'NCT06438757', 'briefTitle': 'Trial of JYB1904 in Patients With Allergic Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jemincare'}, 'officialTitle': 'Phase IIa Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety of JYB1904 in Patients With Allergic Asthma', 'orgStudyIdInfo': {'id': 'JYB1904-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JYB1904: Dose-1', 'interventionNames': ['Drug: JYB1904']}, {'type': 'EXPERIMENTAL', 'label': 'JYB1904: Dose-2', 'interventionNames': ['Drug: JYB1904']}, {'type': 'EXPERIMENTAL', 'label': 'JYB1904: Dose-3', 'interventionNames': ['Drug: JYB1904']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omalizumab', 'interventionNames': ['Drug: Omalizumab']}], 'interventions': [{'name': 'JYB1904', 'type': 'DRUG', 'description': 'Participants will receive JYB1904 every 8 weeks for 24 weeks.', 'armGroupLabels': ['JYB1904: Dose-1', 'JYB1904: Dose-2', 'JYB1904: Dose-3']}, {'name': 'Omalizumab', 'type': 'DRUG', 'description': 'Participants will receive Omalizumab every 2/4 weeks for 24 weeks.', 'armGroupLabels': ['Omalizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201203', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Min Zhang', 'role': 'STUDY_CHAIR', 'affiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jemincare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}