Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-03-29 @ 11:48 PM
Study NCT ID:
NCT07378527
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 344}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-01-23', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 2: Absolute change from baseline in UAS7 at Week 4.', 'timeFrame': '4 weeks'}, {'measure': 'Phase 3: Absolute change from baseline in UAS7 at Week 12', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Spontaneous Urticaria (CSU)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and safety of ICP-332 in moderate to severe chronic spontaneous urticaria subjects inadequately controlled by second generation H1-antihistamines'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Men and women aged 18 to 75 years.\n* 2\\. Diagnosis of CSU inadequately controlled by second generation H1-antihistamines.\n* 3\\. CSU duration for ≥ 6 months prior to randomization.\n* 4\\. Before initiating any screening or study-specific procedures, the subject must voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Having the other medical conditions related to CSU or other skin diseases/conditions.\n* 2\\. Potential medical conditions or issues.\n* 3\\. Pregnant female subjects or lactating female subjects.\n* 4\\. The investigator determines that the subject is unsuitable for participating in this study for any reason.'}, 'identificationModule': {'nctId': 'NCT07378527', 'briefTitle': 'Study of the Efficacy and Safety of ICP-332 in Participants With Chronic Spontaneous Urticaria', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing InnoCare Pharma Tech Co., Ltd.'}, 'officialTitle': 'A Phase II/III Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate the Efficacy and Safety of ICP-332 in Moderate to Severe Chronic Spontaneous Urticaria Subjects Inadequately Controlled by Second Generation H1-antihistamines', 'orgStudyIdInfo': {'id': 'ICP-CL-00613'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICP-332 dose A（Phase2）', 'description': 'ICP-332 will be administered as tablet', 'interventionNames': ['Drug: ICP-332 Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'ICP-332 dose B（Phase2）', 'description': 'ICP-332 will be administered as tablet', 'interventionNames': ['Drug: ICP-332 Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'ICP-332 dose C（Phase2）', 'description': 'ICP-332 will be administered as tablet', 'interventionNames': ['Drug: ICP-332 Tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo（Phase2）', 'description': 'ICP-332 Placebo will be administered as tablet', 'interventionNames': ['Drug: ICP-332 placebo Tablets']}, {'type': 'EXPERIMENTAL', 'label': 'ICP-332 dose A or dose B or dose C（Phase3）', 'description': 'ICP-332 will be administered as tablet', 'interventionNames': ['Drug: ICP-332 Tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo（Phase3）', 'description': 'ICP-332 Placebo will be administered as tablet', 'interventionNames': ['Drug: ICP-332 placebo Tablets']}], 'interventions': [{'name': 'ICP-332 Tablets', 'type': 'DRUG', 'description': 'ICP-332 will be administered as tablet for 12 weeks', 'armGroupLabels': ['ICP-332 dose A（Phase2）', 'ICP-332 dose B（Phase2）', 'ICP-332 dose C（Phase2）']}, {'name': 'ICP-332 placebo Tablets', 'type': 'DRUG', 'description': 'ICP-332 placebo will be administered as tablet for 12 weeks', 'armGroupLabels': ['Placebo（Phase2）', 'Placebo（Phase3）']}, {'name': 'ICP-332 Tablets', 'type': 'DRUG', 'description': 'ICP-332 will be administered as tablet for 24 weeks', 'armGroupLabels': ['ICP-332 dose A or dose B or dose C（Phase3）']}]}, 'contactsLocationsModule': {'locations': [{'zip': '233004', 'city': 'Bengbu', 'state': 'Anhui', 'country': 'China', 'contacts': [{'name': 'Congjun Jiang', 'role': 'CONTACT'}], 'facility': 'Bengbu Medical University First Affiliated Hospital', 'geoPoint': {'lat': 32.94083, 'lon': 117.36083}}, {'zip': '241000', 'city': 'Wuhu', 'state': 'Anhui', 'country': 'China', 'contacts': [{'name': 'Ruzhi Zhang', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Wannan Medical College', 'geoPoint': {'lat': 31.35259, 'lon': 118.42947}}, {'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Jianzhong Zhang', 'role': 'CONTACT'}, {'name': 'Cheng Zhou', 'role': 'CONTACT'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Aihua Wei', 'role': 'CONTACT'}], 'facility': 'Beijing Tongren Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'contacts': [{'name': 'Tao Cai', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '400021', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'contacts': [{'name': 'Qingchun Diao', 'role': 'CONTACT'}], 'facility': 'Chongqing Traditional Chinese Medicine Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'zip': '350005', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'contacts': [{'name': 'Niu Xiang', 'role': 'CONTACT'}], 'facility': 'First Affiliated Hospital of Fujian Medical University', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'zip': '510091', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Bin Yang', 'role': 'CONTACT'}], 'facility': 'Dermatology Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'country': 'China', 'contacts': [{'name': 'Xiaoguang Zhang', 'role': 'CONTACT'}], 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'city': 'Luoyang', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Bin Zhang', 'role': 'CONTACT'}], 'facility': 'The Second Affiliated Hospital of Henan University of Science and Technology', 'geoPoint': {'lat': 34.67345, 'lon': 112.43684}}, {'zip': '450003', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'contacts': [{'name': 'Hongwei Liu', 'role': 'CONTACT'}], 'facility': "Henan Provincial People's Hospital", 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '434020', 'city': 'Jingzhou', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Yi Sun', 'role': 'CONTACT'}], 'facility': 'Jingzhou Central Hospital', 'geoPoint': {'lat': 30.35028, 'lon': 112.19028}}, {'zip': '442000', 'city': 'Shiyan', 'state': 'Hubei', 'country': 'China', 'contacts': [{'name': 'Haixia Jing', 'role': 'CONTACT'}], 'facility': 'Shiyan Taihe Hospital', 'geoPoint': {'lat': 32.6475, 'lon': 110.77806}}, {'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'contacts': [{'name': 'Juan Su', 'role': 'CONTACT'}], 'facility': 'Xiangya hospital central south university', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '215002', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Jun Gu', 'role': 'CONTACT'}], 'facility': 'Suzhou Municipal Hospital', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '214001', 'city': 'Wuxi', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Xiaohong Zhu', 'role': 'CONTACT'}], 'facility': "Wuxi No. 2 People's Hospital", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}, {'zip': '210031', 'city': 'Zhenjiang', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Hui Xu', 'role': 'CONTACT'}], 'facility': 'Affiliated Hospital of Jiangsu University', 'geoPoint': {'lat': 32.21086, 'lon': 119.45508}}, {'zip': '130021', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'contacts': [{'name': 'Shan shan Li', 'role': 'CONTACT'}], 'facility': 'The First Hospital of Jilin University', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'contacts': [{'name': 'Zhen Wang', 'role': 'CONTACT'}], 'facility': "Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital）", 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '710061', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'contacts': [{'name': 'Yan Zheng', 'role': 'CONTACT'}], 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '250013', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Lihua Wang', 'role': 'CONTACT', 'email': 's18953116532@163.com'}], 'facility': 'Jinan Central Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '250022', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'contacts': [{'name': 'Furen Zhang', 'role': 'CONTACT'}], 'facility': 'Shandong Provincial Hospital for Skin Disease, Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'zip': '200443', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Yangfeng Ding', 'role': 'CONTACT'}], 'facility': 'Shanghai Skin Disease Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '030001', 'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'contacts': [{'name': 'Shuping Guo', 'role': 'CONTACT'}], 'facility': 'First Hospital of Shanxi Medical University', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '610017', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'bin Yin', 'role': 'CONTACT'}], 'facility': "Chengdu Second People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '610072', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'contacts': [{'name': 'Min Zhou', 'role': 'CONTACT'}], 'facility': "Sichuan Academy of Medical Sciences&Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '300131', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'contacts': [{'name': 'Litao Zhang', 'role': 'CONTACT'}, {'name': 'Yan Xu', 'role': 'CONTACT'}], 'facility': 'Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '650032', 'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'contacts': [{'name': 'Xiang Nong', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Kunming Medical University', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Xingang Wu', 'role': 'CONTACT'}], 'facility': "Hangzhou Third People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Liming Wu', 'role': 'CONTACT'}], 'facility': "Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Jianzhong Zhang', 'role': 'CONTACT', 'email': 'rmzjz@126.com', 'phone': '+86-010-88325474'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing InnoCare Pharma Tech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}