Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-01-13 @ 11:16 PM
Study NCT ID:
NCT07158151
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Trial of the Safety and Efficacy of RSS0309 Ointment in Adults With Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': 168}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with vIGA-AD success', 'timeFrame': 'Baseline, week 4', 'description': "The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear). IGA sucess is defined as a vIGA-AD score of 'clear' or 'almost clear' plus at least 2-grade improvement from baseline"}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75)', 'timeFrame': 'Up to 8 weeks', 'description': 'EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease).'}, {'measure': 'Percentage of subjects with vIGA-AD of "clear" or "almost clear"', 'timeFrame': 'Up to 8 weeks', 'description': 'The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).'}, {'measure': 'The change of WI-NRS', 'timeFrame': 'Up to 8 weeks', 'description': "The Worst Itch Numerical Rating Scale (WI-NRS) will be determined by the subject's recording of daily assessment of worst itch over the past 24 hours."}, {'measure': 'Safety: treatment emergence adverse events', 'timeFrame': 'Up to 8 weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis of Adults']}, 'descriptionModule': {'briefSummary': 'This study is ongoing to explore the efficacy and safety of different strengths of RSS0393 ointment in adults with atopic dermatitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years old and ≤75 years old at screening.\n2. History of atopic dermatitis ≥ 6 months.\n3. BSA is between 3% and 20% (inclusive) and EASI score is ≥ 5 and vIGA-AD is 2 or 3.\n4. The subjects signed informed consent before any study-related procedures began.\n\nExclusion Criteria:\n\n1. Diagnosis of other dermatologic diseases at screening.\n2. Subjects have other skin diseases or conditions that may affect the evaluation of the relevant endpoints of this study.\n3. Subjects with any other persistent active autoimmune disease.\n4. Subjects who have received topical medication for psoriasis within 14 days before baseline, or systemic medication or phototherapy for psoriasis within 28 days before baseline, or biological agents for psoriasis within a specified time before baseline.'}, 'identificationModule': {'nctId': 'NCT07158151', 'briefTitle': 'A Phase II Trial of the Safety and Efficacy of RSS0309 Ointment in Adults With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Reistone Biopharma Company Limited'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of RSS0393 Ointment in Adults With Mild to Moderate Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'RSS0393Oint-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group 1: RSS0393 ointment 0.05%', 'interventionNames': ['Drug: RSS0393 ointment']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group 2: RSS0393 ointment 0.01%', 'interventionNames': ['Drug: RSS0393 ointment']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group 3: RSS0393 ointment 0.03%', 'interventionNames': ['Drug: RSS0393 ointment']}, {'type': 'SHAM_COMPARATOR', 'label': 'Treatment group 4: RSS0393 ointment placebo', 'interventionNames': ['Drug: RSS0393 ointment']}], 'interventions': [{'name': 'RSS0393 ointment', 'type': 'DRUG', 'description': 'RSS0393 ointment 0.05%', 'armGroupLabels': ['Treatment group 1: RSS0393 ointment 0.05%']}, {'name': 'RSS0393 ointment', 'type': 'DRUG', 'description': 'RSS0393 ointment 0.01%', 'armGroupLabels': ['Treatment group 2: RSS0393 ointment 0.01%']}, {'name': 'RSS0393 ointment', 'type': 'DRUG', 'description': 'RSS0393 ointment 0.03%', 'armGroupLabels': ['Treatment group 3: RSS0393 ointment 0.03%']}, {'name': 'RSS0393 ointment', 'type': 'DRUG', 'description': 'RSS0393 ointment placebo', 'armGroupLabels': ['Treatment group 4: RSS0393 ointment placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510091', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bin Yang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fang Wang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dermatology Hospital of Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zeting Pan', 'role': 'CONTACT', 'email': 'zeting.pan@hengrui.com', 'phone': '18814090443'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reistone Biopharma Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}