Immunoclassification of Psoriasis: a Strategy for Precision Medicine

Study Overview
=================
Brief Summary
-----------------
Through the combination of clinical manifestations and omics, the investigators aim to explore the skin cell atlas in different stages of psoriasis lesions, establish a clinical classification standard for psoriasis, and guide the precise treatment of psoriasis.

Detailed Description
-----------------
Psoriasis is a heterogeneous condition that can affect skin and other structures. Over the past decade, considerable advances have been made both in our understanding of the pathogenesis of psoriasis and in the revolutionized immunotherapy of its diverse manifestations. Psoriasis heterogeneity and its cutaneous microenvironment is the leading cause of resistance in patients. Novel approaches, including single-cell RNA sequencing technology and CyTOF, are proposed as methodological solutions. By their combination with immunotherapy, we can specifically evaluate the mechanism of psoriasis in the face of immunotherapy agents at the single-cell resolution by detecting the transcriptional activity of cytokines, immune checkpoints, screening neoantigens with high transcription levels, identifying rare cells, and assisting the dissection of the critical immune-metabolic pathways in this complex disease. We aim to improve short-term and long-term precision treatment strategies for patients with psoriasis.

Official Title
-----------------
Immunoclassification of Psoriasis: a Strategy for Precision Medicine

Conditions
-----------------
Immunoclassification, Psoriasis

Intervention / Treatment
-----------------
* Biological: adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.18 to 75 years of age 2.Moderate to severe chronic psoriasis, BSA≥3% 3.Duration of psoriasis≥6 months 4.Patients must be candidate for systemic therapy 5.Informed consent must be obtained 6.For female, ß-hCG test is negative and contraception is accepted Exclusion Criteria: Having severe infections, including hepatitis, HIV and tuberculosis Having significant allergies to biological agents Having a history of malignancy Refusal of contraception Having serious or unstable/uncontrolled illnesses

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>Patients will be treated with adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors or methotrexate. | Biological: adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexate<br>* Psoriasis patients will be treated with adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors or methotrexate.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in the number of immune cells (dendritic cells, macrophages) in the lesional skin, non-lesional skin of psoriasis patients and healthy skin. | The intensity of specific cell subsets will be assessed by flow cytometry in psoriasis patients and healthy controls. | 16 months | 
| Molecular analysis of psoriasis lesional skin by single-cell RNA sequencing. | To analyze the intensity of cytokines or chemokines, such as IL-17, IL-23, TNF in the dermis and epidermis of psoriasis patients | 16 months |