Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-01-06 @ 10:34 AM
Study NCT ID:
NCT06672393
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-04
First Post:
2024-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 375}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-06-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-31', 'studyFirstSubmitDate': '2024-10-31', 'studyFirstSubmitQcDate': '2024-10-31', 'lastUpdatePostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients achieving PASI 75 response at Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline.'}, {'measure': 'Proportion of patients achieving sPGA 0/1 with at least 2 points improvement from baseline at Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'Static physician\'s global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It\'s a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.'}], 'secondaryOutcomes': [{'measure': 'Incidence, severity and association with the study drug of adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation', 'timeFrame': 'Baseline to Week 56'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Baseline to Week 56', 'description': 'Clinical laboratory tests include hematology, coagulation testing, blood chemistry, urinalysis, stool analysis, high-sensitivity C-reactive protein, etc.'}, {'measure': 'Incidence of clinically significant changes in electrocardiogram (ECG)', 'timeFrame': 'Baseline to Week 56', 'description': 'ECG parameters include heart rate, PR interval, RR interval, QRS duration, QTcF interval.'}, {'measure': 'Number of participants with abnormalities of physical examination', 'timeFrame': 'Baseline to Week 56', 'description': 'Physical examination includes assessments of general appearance, skin, lymph nodes, head, neck, lung, heart, abdomen, spine, extremities, nervous system, etc.'}, {'measure': 'Number of participants with abnormalities of vital signs', 'timeFrame': 'Baseline to Week 56', 'description': 'Vital signs measured include blood pressure, pulse rate, and temperature.'}, {'measure': 'PASI 75 response rates at specified time points', 'timeFrame': 'Baseline to Week 56', 'description': 'Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 response is defined as 75% or greater improvement in PASI score from baseline.'}, {'measure': 'PASI 90 response rates at specified time points', 'timeFrame': 'Baseline to Week 56', 'description': 'Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 response is defined as 90% or greater improvement in PASI score from baseline.'}, {'measure': 'PASI 100 response rates at specified time points', 'timeFrame': 'Baseline to Week 56', 'description': 'Psoriasis Area and Severity Index (PASI) is a scoring system quantifying the severity of psoriasis based on both lesion severity and area of involvement. PASI assessment is performed by investigators, and the numeric score ranges from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 response is defined as 100% improvement in PASI score from baseline.'}, {'measure': 'Proportion of patients with sPGA 0/1 at specified time points', 'timeFrame': 'Baseline to Week 56', 'description': 'Static physician\'s global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It\'s a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "clear" or "almost clear" respectively.'}, {'measure': 'Proportion of patients with sPGA 0 at specified time points', 'timeFrame': 'Baseline to Week 56', 'description': 'Static physician\'s global assessment (sPGA) of psoriasis is an average assessment of all psoriatic lesions based on erythema, induration, and scale. It\'s a 5-point scale performed by investigators. A sPGA score of 0 means "clear".'}, {'measure': 'Proportion of patients achieving PSSD symptom score of 0 at specified time points among patients with a baseline symptom score ≥1', 'timeFrame': 'Baseline to Week 56', 'description': 'Psoriasis symptoms and signs diary (PSSD) is an 11-item patient-reported instrument. It assesses severity of 5 symptoms (itch, pain, stinging, burning, skin tightness) and 6 subject-observed signs (skin dryness, cracking, scaling, shedding or flaking, redness, bleeding). The severity of each item is rated from 0 (absent) to 10 (worst imaginable). Two subscores will be derived each ranging from 0 to 100: the psoriasis symptom score and the psoriasis sign score. A higher score indicates more severe disease.'}, {'measure': 'Proportion of patients achieving DLQI 0/1 at specified time points among patients with a baseline DLQI score ≥2', 'timeFrame': 'Baseline to Week 56', 'description': "The dermatology life quality index (DLQI) is a patient reported outcome measurement. It's a questionnaire consisting of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week. Each question is scored on a scale of 0 to 3, and the sum of each scores range from 0 (no impairment of life quality) to 30 (maximum impairment)."}, {'measure': 'Proportion of patients achieving ss-PGA 0/1 at Week 16 among patients with a baseline ss-PGA score ≥3', 'timeFrame': 'Baseline to Week 16', 'description': 'Scalp specific physician\'s global assessment (sPGA) of psoriasis is an assessment of the disease severity of scalp psoriasis based on erythema, thickness, and scale. It\'s a 5-point scale performed by investigators. A sPGA score of 0 or 1 means "absence of disease" or "very mild disease" respectively.'}, {'measure': 'Proportion of patients achieving PGA-F 0/1 at Week 16 among patients with a baseline PGA-F score ≥3', 'timeFrame': 'Baseline to Week 16', 'description': 'Physician\'s global assessment of fingernails (PGA-F) is a scale used to assess a patient\'s fingernail psoriasis. Ten fingernails on the hand will be globally evaluated separately for nail bed and nail matrix disease on a scale of 0 to 4. The overall global assessment of nails is the worse of the nail bed and nail matrix assessment. A PGA-F score of 0 or 1 means "clear" or "minimal" respectively.'}, {'measure': 'Proportion of patients achieving pp-PGA 0/1 at Week 16 among patients with a baseline pp-PGA score ≥3', 'timeFrame': 'Baseline to Week 16', 'description': 'Palmoplantar PGA (pp-PGA) is a scale performed by investigators to assess a patient\'s palmoplantar psoriasis lesions on a scale of 0 to 4. A pp-PGA score of 0 or 1 means "clear" or "almost clear" respectively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'descriptionModule': {'briefSummary': 'This study has been designed to confirm the clinical efficacy and safety of HS-10374 in the treatment of moderate to severe plaque psoriasis.', 'detailedDescription': 'This is a 52-week, multi-center, randomized, double-blind, placebo-controlled, Phase 3 study. The study duration includes a 4-week screening period, a 16-week placebo-controlled treatment period, a 36-week study drug treatment period, and a 4-week follow-up period. All eligible subjects will be randomly assigned in a 2:1 ratio to receive HS-10374 or placebo QD. At Week 16, subjects receiving placebo will be switched to HS-10374 QD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects aged 18 years and older\n* Diagnosis of plaque psoriasis for at least 6 months\n* Eligible for phototherapy or systemic therapy\n* Plaque covering ≥ 10% of BSA\n* PASI ≥ 12, sPGA ≥3\n\nExclusion Criteria:\n\n* Diagnosis of non-plaque psoriasis or drug-induced psoriasis\n* Recent history of infection, history or risk of serious infection\n* Any major illness or evidence of unstable condition of major organ systems including psychiatric disease\n* Any condition possibly affecting the PK process of the study drug\n* Evidence of other skin conditions that would interfere with the evaluation of psoriasis\n* History of hypersensitivity to the ingredients of study drugs, history of anaphylaxis\n* Prior exposure to TYK2 inhibitors\n* Have received the prohibited treatment during the protocol required washout period\n* Any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period'}, 'identificationModule': {'nctId': 'NCT06672393', 'briefTitle': 'A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hansoh BioMedical R&D Company'}, 'officialTitle': 'A Multi-Center, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HS-10374 in Adult Subjects With Moderate To Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'HS-10374-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HS-10374', 'description': 'Subjects will receive HS-10374 from Week 0 through Week 52.', 'interventionNames': ['Drug: HS-10374 6mg tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will receive HS-10374 matching placebo from Week 0 through Week 16, and HS-10374 from Week 16 through Week 52.', 'interventionNames': ['Drug: HS-10374 6mg tablets', 'Drug: HS-10374-matched placebo tablets']}], 'interventions': [{'name': 'HS-10374 6mg tablets', 'type': 'DRUG', 'description': 'Specified dose of HS-10374 tablets administered orally QD on specified days', 'armGroupLabels': ['HS-10374', 'Placebo']}, {'name': 'HS-10374-matched placebo tablets', 'type': 'DRUG', 'description': 'Specified dose of HS-10374-matched placebo tablets administered orally QD on specified days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital affiliated to Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Jinhua Xu, MD', 'role': 'CONTACT', 'email': 'xjhhsyy@163.com', 'phone': '(+86)13818978539'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hansoh BioMedical R&D Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}