Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-01 @ 9:39 PM
Study NCT ID:
NCT07149792
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2025-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The psoriasis patients are arranged randomly by two groups:\n\n1. Strategic groups: This group patients prescreen to various biologics on their immune cells and choose the most proper biologics according to a set of biomarkers for individual psoriasis patient before starting the treatment.\n2. Standard groups: This group patients receive biologics treatment according to present guideline without individual immune cells screen.\n\nThe patients are enrolled need washout bioloigics1 month but dMARD is exceptional. We will collect the clinical data including PASI, BSA, Pruritus score, Swelling joint counts, Tender joint counts, DAPSA score, DLQI score in the follwing timetable to 3 years.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-24', 'studyFirstSubmitDate': '2025-08-17', 'studyFirstSubmitQcDate': '2025-08-24', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PASI (Psoriasis Area and Severity Index)', 'timeFrame': 'From enrollment to the end of treatment at 48 weeks', 'description': 'The skin condition of psoriasis patients is assessed using the PASI (Psoriasis Area and Severity Index), which ranges from 0 to 72, with higher scores indicating more severe disease'}, {'measure': 'DAPSA Score - Disease Activity in Psoriatic Arthritis', 'timeFrame': 'From enrollment to the end of treatment at 48 weeks', 'description': "DAPSA Formula (Total Score):\n\nDAPSA = TJC (68)\n\n\\+ SJC (66)\n\n\\+ Patient Global Assessment (0-10)\n\n\\+ Patient Pain Assessment (0-10)\n\n\\+ CRP (mg/dL) DAPSA=TJC (68)+SJC (66)+Patient Global Assessment (0-10)+Patient Pain Assessment (0-10)+CRP (mg/dL)\n\nWhere:\n\nTJC = Tender Joint Count (out of 68 joints)\n\nSJC = Swollen Joint Count (out of 66 joints)\n\nPatient Global Assessment (PtGA) = Patient's rating of overall disease activity (0-10 scale)\n\nPain VAS = Patient's self-reported pain (0-10 scale)\n\nCRP = C-reactive protein level (mg/dL)\n\nInterpreting DAPSA Scores:\n\nDAPSA Score and Disease Activity Level\n\n≤4 Remission, \\>4-14 Low disease activity, \\>14-28 Moderate disease activity, \\>28 High disease activity"}], 'secondaryOutcomes': [{'measure': 'BSA (body surface area)', 'timeFrame': 'From enrollment to the end of treatment at 48 weeks', 'description': 'The severity of psoriatic disease can be assessed using the Body Surface Area (BSA) score, which ranges from 0 to 100%. A higher BSA score indicates more extensive and severe skin involvement'}, {'measure': 'Pruritus score', 'timeFrame': 'From enrollment to the end of treatment at 48 weeks', 'description': 'The severity of psoriatic disease can be assessed using the pruritus score, which ranges from 0 to 10. A higher pruritus score indicates more severe skin involvement'}, {'measure': 'Swelling joint counts', 'timeFrame': 'From enrollment to the end of treatment at 48 weeks', 'description': '0 swollen joints = No active synovitis (remission or well-controlled disease)\n\nHigher counts = More active joint inflammation and more severe disease'}, {'measure': 'Tender joint counts', 'timeFrame': 'From enrollment to the end of treatment at 48 weeks', 'description': '0 tender joints = No current joint pain (remission or well-controlled disease) Higher TJC = Greater disease burden or active joint inflammation'}, {'measure': 'Dermatology Life Quality Index (DLQI)', 'timeFrame': 'From enrollment to the end of treatment at 48 weeks', 'description': "The DLQI (Dermatology Life Quality Index) score ranges from 0 to 30, with higher scores indicating a greater impact of the disease on the patient's quality of life"}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Prescreen, Biologics, Psoriasis, Strategic selection, Psoriatic arthritis'], 'conditions': ['Psoriasis', 'Psoriasis Arthritis', 'Biologics']}, 'descriptionModule': {'briefSummary': 'The inclusion criteria for this study were patients aged 18 to 75 years with a confirmed diagnosis of psoriasis by a dermatologist or psoriatic arthritis by a rheumatologist. Patients with active infections or suspected malignancies were excluded.\n\nA total of 40 patients with psoriasis, with or without psoriatic arthritis, were enrolled from multiple centers in Taiwan. All participants were recruited from the outpatient clinics of either the Department of Allergy, Immunology, and Rheumatology or the Department of Dermatology in tertiary hospitals across Taiwan.\n\nParticipants were randomly assigned to one of two groups:\n\nPrescreen Strategy-Based Biologics Selection Group\n\nStandard-Based Biologics Selection Group\n\nPatients will be followed up at weeks 4, 8, 12, 24, 32, 40, 48, 56, 64, and 72. Follow-up may be extended up to 3 years if necessary.\n\nClinical assessments will include:\n\nPrimary endpoints: PASI (Psoriasis Area and Severity Index), painful joint count, swollen joint count, and DAPSA (Disease Activity in Psoriatic Arthritis) score.\n\nSecondary endpoints: DLQI (Dermatology Life Quality Index), BSA (Body Surface Area), pruritus score, and internal carotid artery thickness measured at 6 months, 1 year, and 2 years.', 'detailedDescription': 'To prepare the PBMC (peripheral blood mononuclear cell) culture, 16 mL of peripheral blood is collected from each patient using sodium citrate tubes (Vacutainer CPT, BD Biosciences, Franklin Lakes, NJ, USA). PBMCs are isolated by centrifugation at 1800 × g for 20 minutes at room temperature with the brake turned off, resulting in the separation of plasma, PBMCs, gel plugs, and red blood cell (RBC) layers.\n\nThe isolated PBMCs are washed with phosphate-buffered saline (PBS) and then cultured in RPMI-1640 medium supplemented with 10% fetal bovine serum (FBS) and 1% penicillin/streptomycin at 37 °C in a 5% CO₂ incubator.\n\nA total of 6 × 10⁵ cells/mL are seeded into 12-well plates and treated for 24 hours under the following conditions:\n\nControl\n\nStreptococcus pyogenes only\n\nS. pyogenes + adalimumab (4 μg/mL)\n\nS. pyogenes + golimumab (0.5 μg/mL)\n\nS. pyogenes + certolizumab (20 μg/mL)\n\nS. pyogenes + ustekinumab (0.25 μg/mL)\n\nS. pyogenes + ixekizumab (3.5 μg/mL)\n\nS. pyogenes + secukinumab (16.7 μg/mL or 34 μg/mL)\n\nS. pyogenes + guselkumab (1.2 μg/mL)\n\nS. pyogenes + risankizumab (2 μg/mL)\n\nCulture supernatants are collected for subsequent cytokine measurement. The concentrations of biological agents used correspond to the trough serum concentrations at steady state as indicated in the pharmacokinetic sections of reference data. The two concentrations of secukinumab (16.7 μg/mL and 34 μg/mL) reflect the two common clinical doses of 150 mg and 300 mg per month, respectively.\n\nCytokine Analysis\n\nCytokine levels are measured in the collected supernatants using a protein multiplex immunoassay system (Bio-Plex Cytokine Array System, Bio-Rad Laboratories, Hercules, CA, USA). The following cytokines and chemokines are analyzed:\n\nIL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12, IL-13, IL-17A, IFN-γ, TNF-α, monocyte chemoattractant protein-1 (MCP-1), macrophage inflammatory proteins (MIP-1α and MIP-1β), platelet-derived growth factor-BB (PDGF-BB), and chemokine (CC motif) ligand 5 (RANTES).\n\nScreening Method for Biologic Agents\n\nRANTES Exclusion First, biologics that induce a RANTES level ≥1.5 times higher than that of S. pyogenes-only treatment are excluded.\n\nScoring System for Biologic Selection in Psoriasis\n\nRemaining biologics are categorized into three grades based on biomarker levels:\n\nIFN-γ\n\nIL-17A\n\nIFN-γ/IL-4\n\nIFN-γ/IL-13\n\nIL-17A/IL-4\n\nIL-17A/IL-13\n\nGrade 1 (Most appropriate): Lowest biomarker values\n\nGrade 2 (Possibly appropriate): Intermediate values\n\nGrade 3 (Not recommended): Highest values\n\nEach grade is subdivided into a, b, and c groups:\n\nLower values within a grade are ranked as a, followed by b, then c\n\nScoring is as follows:\n\n1. a = +3, 1b = +2, 1c = +1.5\n2. a = +1, 2b = +0.5, 2c = 0\n3. a = -0.5, 3b = -1, 3c = -1.5\n\nThe total score for each biologic is the sum of individual biomarker scores. Based on total scores:\n\nHigh score = Most appropriate\n\nMedium score = Possibly appropriate\n\nLow score = Not recommended\n\nScoring for Psoriatic Arthritis (PsA)\n\nFor PsA, biologics are selected based on the lowest RANTES, MCP-1 and IFN-γ levels:\n\nGrade 1 (Most appropriate): Lowest biomarker values Grade 2 (Possibly appropriate): Intermediate values Grade 3 (Not recommended): Highest values RANTES: 2+, 1+, 0 MCP-1: 1+, 0.5+, 0 IFN-γ: 1+, 0.5+, 0 The final score is the sum of RANTES MCP-1 and IFN-γ scores. Biologics with the lowest total scores are preferred.\n\nPatient Assignment in Strategic Group\n\nBiologics from the "most appropriate" group are selected for each patient in the strategic group. The following clinical indicators are monitored over time:\n\nAbsolute PASI\n\nTender joint count\n\nSwollen joint count\n\nDAPSA score\n\nDLQI\n\nInternal carotid artery intima thickness\n\nFollow-up Timeline\n\nClinical assessments: Weeks 0, 2, 4, 12, 24, and 48\n\nIntima thickness: Weeks 0 and 48\n\nOutcome Comparison Outcomes between the strategic selection group and standard care group are compared at Weeks 24 and 48, with extended follow-up up to 5 years. Primary outcomes include PASI and DLQI scores.\n\nStatistical Analysis\n\nAll statistical analyses are conducted using SPSS version 22 (IBM, Armonk, NY, USA). Demographic and clinical characteristics, as well as outcome measures (PASI, joint counts, DAPSA, DLQI, and carotid intima thickness), are analyzed using the Mann-Whitney U test and Spearman\'s rho correlation.\n\nData are presented as mean ± standard deviation. Two-sided p values \\< 0.05 are considered statistically significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects\n* Psoriasis patients\n* Psoriatic arthritis patients\n* Agree to provide a blood sample\n\nExclusion Criteria:\n\n* A current history of cancer,\n* Recent hospitalization for infection or current antibiotic treatment\n* HIV infection.'}, 'identificationModule': {'nctId': 'NCT07149792', 'acronym': 'SMILE', 'briefTitle': 'A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers', 'orgStudyIdInfo': {'id': 'Taichung VGH Derm Yen'}, 'secondaryIdInfos': [{'id': 'TCVGH-1445602C', 'type': 'OTHER_GRANT', 'domain': 'TAICHUNG VETERANS GENERAL HOSPITAL'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prescreen Based bDMARD Stategic Treatment Group', 'description': 'Strategic groups: This group patients prescreen to various biologics (such as Adalimumab (Humira), Etanercept (Enbrel), Certolizumab pegol (Cimzia) Golimumab (Simponi), Ustekinumab (Stelara),Secukinumab (Cosentyx) Ixekizumab (Taltz),Bimekizumab (Bimzelx), Brodalumab (Lumicef)) on their immune cells and choose the most proper biologics according to a set of biomarkers for individual psoriasis patient before starting the treatment', 'interventionNames': ['Diagnostic Test: Prescreen platform', 'Biological: biologics treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard bDMARD Treatment Group', 'description': 'This group patients receive biologics treatment (such as Adalimumab (Humira), Etanercept (Enbrel), Certolizumab pegol (Cimzia) Golimumab (Simponi), Ustekinumab (Stelara),Secukinumab (Cosentyx) Ixekizumab (Taltz),Bimekizumab (Bimzelx), Brodalumab (Lumicef)) according to present guideline without individuals immune cells screen.', 'interventionNames': ['Biological: biologics treatment']}], 'interventions': [{'name': 'Prescreen platform', 'type': 'DIAGNOSTIC_TEST', 'description': 'Different biomarkers on PsO, PsA and paradoxical PsA', 'armGroupLabels': ['Prescreen Based bDMARD Stategic Treatment Group']}, {'name': 'biologics treatment', 'type': 'BIOLOGICAL', 'description': 'All psoriasis patients are receiving biologics treatment', 'armGroupLabels': ['Prescreen Based bDMARD Stategic Treatment Group', 'Standard bDMARD Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '407219', 'city': 'Taichung', 'state': 'Taiwan', 'status': 'NOT_YET_RECRUITING', 'country': 'Taiwan', 'facility': 'Taichung Veterans Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '886', 'city': 'Taichung', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'James Yen, PhD', 'role': 'CONTACT', 'email': 'vernayen@yahoo.com.tw', 'phone': '886-4-23592525', 'phoneExt': '5301'}], 'facility': 'Taichung Vertenans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'centralContacts': [{'name': 'James Yen, MD PhD', 'role': 'CONTACT', 'email': 'vernayen@yahoo.com.tw', 'phone': '886-4-23592525', 'phoneExt': '5303 or 5301'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'only IPD used in the results publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, {'name': 'Chung Shan Medical University', 'class': 'OTHER'}, {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, {'name': 'China Medical University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}