Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-02-28 @ 3:29 AM
Study NCT ID:
NCT06509334
Status:
RECRUITING
Last Update Posted:
2024-11-29
First Post:
2024-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of JYB1904 in Chronic Spontaneous Urticaria.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}], 'ancestors': [{'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2024-07-13', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urticaria activity score used for 7 consecutive days(UAS7)', 'timeFrame': 'Baseline through 16 weeks', 'description': 'Change from baseline in urticaria activity score used for 7 consecutive days (UAS7) at weeks 8, 12, and 16.Score 0-42, UAS7=0 for complete remission'}], 'secondaryOutcomes': [{'measure': 'Urticaria activity score used for 7 consecutive days(UAS7)', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Change from baseline in UAS7 at weeks 4, 24 and 32.Score 0-42, UAS7=0 for complete remission'}, {'measure': 'Itch severity score used for 7 consecutive days(ISS7)', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Change from baseline in itch severity score used for 7 consecutive days(ISS7) at weeks 4, 8, 12, 16, 24 and 32.Score 0-21, ISS7=0 for complete remission of itch'}, {'measure': 'Hive severity score used for 7 consecutive days (HSS7)', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Change from baseline in hive severity score used for 7 consecutive days(HSS7) at weeks 4, 8, 12, 16, 24, 32.Score 0-21, HSS7=0 for complete remission of hives'}, {'measure': 'Angioedema activity score used for 7 consecutive days(AAS7)', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Change from baseline in angioedema activity score used for 7 consecutive days(AAS7) at weeks 4, 8, 12, 16, 24, 32.Score 0-105, higher scores mean a worse outcome'}, {'measure': 'Urticaria activity score used for 7 consecutive days(UAS7)', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Proportion of subjects with UAS7=0 at weeks 4, 8, 12, 16, 24, 32.Score 0-42, UAS7=0 for complete remission'}, {'measure': 'Dermatology Life Quality Index(DLQI)', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Change from baseline in Dermatological Life Quality Index (DLQI) at weeks 4, 8, 12, 16, 24 and 32.Score 0-30, higher scores mean a worse outcome'}, {'measure': 'Safety and tolerability', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Adverse events (AEs) and serious adverse events (SAEs)'}, {'measure': 'Trends in serum total immunoglobulin E(IgE)', 'timeFrame': 'Baseline through 32 weeks', 'description': 'Serum total IgE levels at weeks 4, 8, 12, 16, 24 and 32'}, {'measure': 'Positive detection rate of anti-drug antibody (ADA)', 'timeFrame': 'Baseline through 32 weeks', 'description': 'ADA positive detection rate at 32 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Spontaneous Urticaria']}, 'descriptionModule': {'briefSummary': 'This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female adult subjects (≥18 years of age).\n* Diagnosis of Chronic Spontaneous Urticaria(CSU) ≥ 3 months prior to Screening Visit 1 and previously inadequately controlled with a second-generation H1 antihistamine.\n* Itching and hives lasting ≥ 6 weeks prior to Screening Visit 1.\n* Have a UAS7 (range 0 - 42) ≥ 16, an ISS7 (range 0 - 21) ≥ 6, and an HSS7 (range 0 - 21) ≥ 6 within 7 days prior to randomization.\n\nExclusion Criteria:\n\n* Induced urticaria with a defined trigger, including artificial urticaria (cutaneous scratches), cold-contact, heat-contact, solar, pressure, delayed-pressure, water-source, cholinergic, or contact urticaria\n* Any other dermatological condition with chronic itching, such as atopic dermatitis, herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in the opinion of the investigator may affect the study assessment and study results\n* Other conditions with symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria.\n* Previous allergic reaction or poor efficacy with omalizumab.\n* Contraindication or hypersensitivity to antihistamines (e.g., fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine) or any of the ingredients.'}, 'identificationModule': {'nctId': 'NCT06509334', 'briefTitle': 'Trial of JYB1904 in Chronic Spontaneous Urticaria.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jemincare'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Adult Patients with Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines', 'orgStudyIdInfo': {'id': 'JYB1904-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JYB1904: Dose-1', 'interventionNames': ['Drug: JYB1904']}, {'type': 'EXPERIMENTAL', 'label': 'JYB1904: Dose-2', 'interventionNames': ['Drug: JYB1904']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omalizumab', 'interventionNames': ['Drug: Omalizumab']}], 'interventions': [{'name': 'JYB1904', 'type': 'DRUG', 'description': 'Participants will receive JYB1904 at week0 and receive placebo at week4,8,12', 'armGroupLabels': ['JYB1904: Dose-1']}, {'name': 'JYB1904', 'type': 'DRUG', 'description': 'Participants will receive JYB1904 at week0,8 and receive placebo at week4,12', 'armGroupLabels': ['JYB1904: Dose-2']}, {'name': 'Omalizumab', 'type': 'DRUG', 'description': 'Participants will receive Omalizumab every 4 weeks for 12 weeks', 'armGroupLabels': ['Omalizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jianzhong Zhang', 'role': 'CONTACT', 'email': 'rmzjz@126.com', 'phone': '010-88325471'}, {'name': 'Cheng Zhou', 'role': 'CONTACT', 'email': 'rmpkzc@163.com', 'phone': '010-88325470'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yila Sha', 'role': 'CONTACT', 'email': 'shayila@jemincare.com', 'phone': '86-021-52887926'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jemincare', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}