Ignite Creation Date:
2025-12-26 @ 10:43 PM
Ignite Modification Date:
2025-12-26 @ 10:43 PM
Study NCT ID:
NCT06996912
Status:
RECRUITING
Last Update Posted:
2025-05-30
First Post:
2025-05-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study for HSK44459 in Participants With 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-03-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2025-05-21', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from baseline to week 12 in EASI', 'timeFrame': 'From Day 1 (first dose) to Day 85 (week 12)', 'description': 'Evaluate the clinical efficacy of 2 dose levels of HSK44459, compared to placebo, in adult participants with atopic dermatitis (AD) using EASI.\n\nA total EASI score range from 0 to 72 points will be recorded for each assessment, with higher scores reflecting worse severity of AD'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with EASI-75 at week 12', 'timeFrame': 'From Day 1 (first dose) to Day 85 (week 12)', 'description': 'Proportion of patients with EASI-75 (≥75% improvement from baseline) at week 12'}, {'measure': 'Proportion of patients with both IGA 0 to 1and a reduction from baseline of ≥2 points at week 12', 'timeFrame': 'From Day 1 (first dose) to Day 85 (week 12)', 'description': 'The IGA determines severity of AD and clinical response to treatment on a 5-point scale\n\n0 = Clear\n\n1. = Almost clear\n2. = Mild\n3. = Moderate\n4. = Severe'}, {'measure': 'Proportion of patients with reduction of pruritus WI-NRS ≥3 or WI-NRS ≥4 from baseline to week 12', 'timeFrame': 'From Day 1 (first dose) to Day 85 (week 12)', 'description': 'The WI-NRS ranges from 0 = "no itch" to 10 ="worst imaginable itch" for the worst intensity itch in the preceding 24-hour period.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic dermatitis'], 'conditions': ['Atopic Dermatitis (AD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy and safety of HSK44459 in adults with Atopic Dermatitis', 'detailedDescription': 'This is a multicenter, randomized, double-blind, parallel group, placebo controlled phase 2 study to assess the efficacy and safety of HSK44459 in adult participants with Atopic Dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent must be obtained\n* Male or female, ≥18 years old and ≤75 years old\n* Willing and able to comply with study-specific procedures and the requirements of this study protocol.\n* Atopic dermatitis has been present for at least 1 year and subject meets Hanifin and Rajka criteria\n* EASI score≥16 at the screening and baseline visits\n* IGA score≥3 at the screening and baseline visits\n* ≥10% body surface area (BSA) of AD involvement at the screening and baseline visits\n* Baseline WI-NRS≥4\n* History of inadequate response to TCS of medium to higher potency (with or without topical calcineurin inhibitors \\[TCI\\]) or systemic treatment for AD within 6 months prior to screening\n* Have applied a stable dose of topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit\n\nExclusion Criteria:\n\n* Subjects have used AD treatments within the time frame specified in protocol prior to the baseline visit\n* Prior exposure to any PDE4 inhibitor systemic treatment\n* Systemic use of known strong CYP3A inhibitors or strong CYP3A inducers within 4 weeks or 5 half-lives prior to randomization or during the course of the study\n* Participation in other clinical studies within 4 weeks or 5 half-lives prior to randomization\n* Subjects have laboratory values meeting the criteria in protocol\n* Presence of skin comorbidities that may interfere with study assessments\n* Concurrent conditions and history of other diseases as described in protocol'}, 'identificationModule': {'nctId': 'NCT06996912', 'briefTitle': 'A Study for HSK44459 in Participants With Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Haisco Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Phase 2 Study Investigating the Efficacy and Safety of HSK44459 Tablet Administered to Participants With Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'HSK44459-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HSK44459-Dose level 1', 'description': 'Participants will receive HSK44459 for 12 weeks', 'interventionNames': ['Drug: HSK44459']}, {'type': 'EXPERIMENTAL', 'label': 'HSK44459-Dose level 2', 'description': 'Participants will receive HSK44459 for 12 weeks', 'interventionNames': ['Drug: HSK44459']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive Placebo for 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'HSK44459', 'type': 'DRUG', 'description': 'HSK44459 will be administered orally twice daily', 'armGroupLabels': ['HSK44459-Dose level 1', 'HSK44459-Dose level 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered orally twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250022', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Furen Zhang', 'role': 'CONTACT', 'email': 'zhangfuren@hotmail.com', 'phone': '0531-87298847'}], 'facility': 'Affiliated Dermatology Hospital of Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yong Cao', 'role': 'CONTACT', 'email': 'caoyong@haisco.com', 'phone': '028-67258840'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xizang Haisco Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}