Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 5:29 AM
Study NCT ID:
NCT06775860
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2024-12-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 552}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-12-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-12-25', 'studyFirstSubmitQcDate': '2025-01-09', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline', 'timeFrame': '16 weeks'}, {'measure': 'Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from Baseline', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of oral ICP-332 in subjects with moderate to severe atopic dermatitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female subjects between 18 and 75 years of age.\n2. Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year\n3. Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.\n4. Subjects must meet the following criteria for disease activity:\n\n * Eczema Area and Severity Index (EASI) score ≥ 16 ;\n * (Body Surface Area )BSA affected by AD ≥ 10% ;\n * (validated Investigator's Global Assessment-AD)vIGA-AD score ≥3 ;\n * Baseline weekly average of daily Worst Pruritus NRS ≥ 4.\n5. Women of childbearing potential (WOCBP) and Men must agree\n\n5\\. Women of childbearing potential (WOCBP) and Men must agree to contraception. 6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.\n2. Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.\n3. Pregnant or breastfeeding females.\n4. History of any clinically major diseases, with the exception of atopic dermatitis.\n5. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study."}, 'identificationModule': {'nctId': 'NCT06775860', 'briefTitle': 'ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beijing InnoCare Pharma Tech Co., Ltd.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of Oral ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'ICP-CL-00604'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICP-332', 'interventionNames': ['Drug: ICP-332 Tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: ICP-332 Placebo Tablets']}], 'interventions': [{'name': 'ICP-332 Tablets', 'type': 'DRUG', 'description': 'ICP-332 will be administered as tablet', 'armGroupLabels': ['ICP-332']}, {'name': 'ICP-332 Placebo Tablets', 'type': 'DRUG', 'description': 'ICP-332 Placebo will be administered as tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230022', 'city': 'Hefei', 'state': 'Anhui', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zaixing Wang', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '241000', 'city': 'Wuhu', 'state': 'Anhui', 'status': 'RECRUITING', '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': '100020', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fang Liu', 'role': 'CONTACT'}], 'facility': 'Capital Medical University Affiliated Beijing Chaoyang Hospital', 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'China', 'contacts': [{'name': 'Lunfei Liu', 'role': 'CONTACT'}], 'facility': 'The Fourth Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 29.31506, 'lon': 120.07676}}], 'centralContacts': [{'name': 'Pengcheng Lei', 'role': 'CONTACT', 'email': 'pengcheng.lei@innocarepharma.com', 'phone': '+86 18501252185'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing InnoCare Pharma Tech Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}