A Prospective, Interventional, Exploratory Study Evaluating the Efficacy of Small-Molecule Compound XJH05 Ointment in the Treatment of Plaque Psoriasis

I. Background Psoriasis Characteristics: Psoriasis is a chronic, recurrent, inflammatory,and systemic disease mediated by immunity, induced by a combination of genetic andenvironmental factors. It is clinically characterized by scaly erythema or plaques,non‐contagious, difficult to treat, and often lifelong.Pathogenesis & Cellular Mechanisms: Driven by T lymphocyte‐mediated and multi‐immunecell‐involved responses, causing hyperproliferation of keratinocytes andjoint/synovial/chondrocyte inflammation.Current Unmet Medical Needs: Plaque psoriasis accounts for 90% of cases, and 80% aremild (≤2% BSA) primarily managed with topical agents (e.g., vitamin "D" _3 derivatives,glucocorticoids, retinoids). Although many therapies exist, psoriasis remains incurable.Mechanism of XJH05: Recent studies show the LCN2/SLC22A17 axis activates the SREBP2pathway to induce keratinocyte cholesterol metabolism dysfunction, acting synergisticallywith the NLRC4 inflammasome to release IL‐1$\beta$ and IL‐18 and recruit neutrophils.Direct SLC22A17 inhibitors are lacking in current clinical development.Investigational Drug: XJH05 is a novel small‐molecule compound that specifically binds tothe SLC22A17 active site, blocking LCN2 binding and inhibiting the LCN2‐SREBP2‐NLRC4signaling axis. Preclinical animal studies and in vitro human lesion assays demonstratedexcellent safety and efficacy, but clinical evaluation of XJH05 ointment in patients isneeded.II. Study Objectives 1. Primary Objective: To evaluate the therapeutic efficacy of XJH05 ointment inpatients with plaque psoriasis in a prospective clinical setting. 2. Secondary Objectives:To assess the safety, local tolerability, and incidence of adverse events (AEs)associated with topical XJH05 ointment application.To observe improvements in lesion severity, affected body surface area (BSA), and patientquality of life.III. Study Design & Procedures 1. Study Type: A prospective, interventional, exploratory clinical trial. 2. Dosing Protocol: Topical application of XJH05 ointment on target lesions for adefined treatment duration (e.g., 4‐12 weeks, as specified by trial protocol). 3. Key Study Phases: ‐ Screening/Run‐in Phase: Patient eligibility assessment and baseline scoring. ‐ Treatment Phase: Standardized topical application of XJH05 ointment with periodic follow‐up evaluations. ‐ Follow‐up Phase: Post‐treatment safety and relapse observation. IV. Patient Selection1. Inclusion Criteria: ‐ Diagnosis of plaque psoriasis. ‐ Mild‐to‐moderate disease presentation suitable for topical intervention (e.g., ≤2%to 10% BSA). ‐ Provision of written informed consent prior to study procedures. 2. ExclusionCriteria: ‐ Non‐plaque subtypes (e.g., erythrodermic, pustular, or generalized guttatepsoriasis). ‐ Recent use of systemic antipsoriatic therapies, biologics, or topicalsteroids/retinoids within the protocol‐defined washout period. ‐ Active localized skin infection at target sites or known hypersensitivity to XJH05or ointment ingredients.V. Methods & Technical Route 1. Preclinical to Clinical Translation:‐Target Verification: Blockade of the SLC22A17 receptor active site → inhibition ofLCN2 interaction → downregulation of the LCN2‐SREBP2‐NLRC4 signaling pathway →reduction of pro‐inflammatory cytokines (IL‐1B, IL‐18) → prevention of keratinocytehyperproliferation and neutrophil infiltration. 2. Trial Execution Route: ‐ Screening & Informed Consent → Baseline Clinical & Biomarker Evaluation →Intervention (XJH05 Ointment Application) → Serial Follow‐ups & Outcome Measurement → Statistical Analysis & Translation Assessment.VI. Outcome Measures & Follow‐Up Timing 1. Primary Outcome Measures: ‐ Proportion of patients achieving PASI‐75 / PASI‐50 (Psoriasis Area and Severity Index) improvement from baseline. ‐ Investigator's Global Assessment (IGA) score change/clearance rate. 2. Secondary Outcome Measures: ‐ Change in Body Surface Area (BSA) affected. ‐ Patient‐reported outcomes (e.g., Dermatology Life Quality Index / DLQI). ‐ Reduction in local inflammatory biomarkers (if lesion biopsies/swabs are performed). 3. Follow‐Up Timing: ‐ Periodic clinic visits scheduled at Baseline (Week 0), Week 2, Week 4, Week 8, and Week 12 (or end‐of‐treatment / follow‐up evaluation).VII. Adverse Event Monitoring 1. Safety Assessments: Continuous evaluation of local application site reactions (e.g.,erythema, burning, pruritus, scaling, irritation) and systemic toxicity throughoutthe trial. 2. AE/SAE Reporting: Documentation of all Treatment‐Emergent Adverse Events (TEAEs),severity grading (CTCAE standard), causality assessment, and immediate reporting forAny Serious Adverse Events (SAEs).VIII. Statistical Analysis SPSS 26.0 software for data analysis; compare efficacy/safetybetween groups using appropriate statistical methods.