A Multi-center RCT Clinical Trial on Personalized Precision Medicine for Patients With Psoriasis and Psoriatic Arthritis and Investigation on Cardiovascular Biomarkers

NCT07149792 | Recruiting Phase 4 DMC FDA Drug FDA Device

• 2 other identifiers: Taichung VGH Derm YenTCVGH-1445602C
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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. A 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. Participants were randomly assigned to one of two groups: Prescreen Strategy-Based Biologics Selection Group Standard-Based Biologics Selection Group Patients 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. Clinical assessments will include: Primary endpoints: PASI (Psoriasis Area and Severity Index), painful joint count, swollen joint count, and DAPSA (Disease Activity in Psoriatic Arthritis) score. Secondary 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.

Conditions

Psoriasis; Psoriasis Arthritis; Biologics

Keywords

Prescreen, Biologics, Psoriasis, Strategic selection, Psoriatic arthritis

Outcome Measures

Primary Outcomes (2)

• PASI (Psoriasis Area and Severity Index)

  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

  From enrollment to the end of treatment at 48 weeks

• DAPSA Score - Disease Activity in Psoriatic Arthritis

  DAPSA Formula (Total Score): DAPSA = TJC (68) \+ SJC (66) \+ Patient Global Assessment (0-10) \+ Patient Pain Assessment (0-10) \+ CRP (mg/dL) DAPSA=TJC (68)+SJC (66)+Patient Global Assessment (0-10)+Patient Pain Assessment (0-10)+CRP (mg/dL) Where: TJC = Tender Joint Count (out of 68 joints) SJC = Swollen Joint Count (out of 66 joints) Patient Global Assessment (PtGA) = Patient's rating of overall disease activity (0-10 scale) Pain VAS = Patient's self-reported pain (0-10 scale) CRP = C-reactive protein level (mg/dL) Interpreting DAPSA Scores: DAPSA Score and Disease Activity Level ≤4 Remission, \>4-14 Low disease activity, \>14-28 Moderate disease activity, \>28 High disease activity

  From enrollment to the end of treatment at 48 weeks

Secondary Outcomes (5)

• BSA (body surface area)

  From enrollment to the end of treatment at 48 weeks

• Pruritus score

  From enrollment to the end of treatment at 48 weeks

• Swelling joint counts

  From enrollment to the end of treatment at 48 weeks

• Tender joint counts

  From enrollment to the end of treatment at 48 weeks

• Dermatology Life Quality Index (DLQI)

  From enrollment to the end of treatment at 48 weeks

Study Arms (2)

Prescreen Based bDMARD Stategic Treatment Group

EXPERIMENTAL

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

Diagnostic Test: Prescreen platform; Biological: biologics treatment

Standard bDMARD Treatment Group

ACTIVE COMPARATOR

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.

Biological: biologics treatment

Interventions

Prescreen platform DIAGNOSTIC_TEST

Different biomarkers on PsO, PsA and paradoxical PsA

Prescreen Based bDMARD Stategic Treatment Group

biologics treatment BIOLOGICAL

All psoriasis patients are receiving biologics treatment

Prescreen Based bDMARD Stategic Treatment Group; Standard bDMARD Treatment Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects
• Psoriasis patients
• Psoriatic arthritis patients
• Agree to provide a blood sample

You may not qualify if:

• A current history of cancer,
• Recent hospitalization for infection or current antibiotic treatment
• HIV infection.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• Chang Gung Memorial Hospital: collaborator
• Chung Shan Medical University: collaborator
• Far Eastern Memorial Hospital: collaborator
• China Medical University Hospital: collaborator

Study Sites (2)

Taichung Veterans Hospital

Taichung, Taiwan, 407219, Taiwan

NOT YET RECRUITING

Taichung Vertenans General Hospital

Taichung, Taiwan, 886, Taiwan

RECRUITING

MeSH Terms

Conditions

Psoriasis; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases

Central Study Contacts

James Yen, MD PhD

CONTACT

886-4-23592525; vernayen@yahoo.com.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The psoriasis patients are arranged randomly by two groups: 1. 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. 2. Standard groups: This group patients receive biologics treatment according to present guideline without individual immune cells screen. The 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.

Study Record Dates

• First Submitted: August 17, 2025
• First Posted: September 2, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

TW (2)