Immunoclassification of Psoriasis: a Strategy for Precision Medicine

NCT05503875 | Recruiting

• 1 other identifier: 2022-0205
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Immunoclassification; Psoriasis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

treatment

EXPERIMENTAL

Patients will be treated with adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors or methotrexate.

Biological: adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexate

Interventions

adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors, methotrexate BIOLOGICAL

Psoriasis patients will be treated with adalimumab, secukinumab, ixekizumab, guselkumab, Jak inhibitors or methotrexate.

treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Psoriasis

Interventions

Adalimumab; secukinumab; ixekizumab; guselkumab; Janus Kinase Inhibitors; Methotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Xiao-yong Man

CONTACT

13600516219; manxy@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: August 17, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 12, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)