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NCT Number: NCT05503875

Immunoclassification of Psoriasis: a Strategy for Precision Medicine

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

XiaoYong Man

CONTACT

[email protected]

13600516219

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

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

Primary outcomes

  1. Differences in the number of immune cells (dendritic cells, macrophages) in the lesional skin, non-lesional skin of psoriasis patients and healthy skin.

    Time frame: 16 months

    The intensity of specific cell subsets will be assessed by flow cytometry in psoriasis patients and healthy controls.

  2. Molecular analysis of psoriasis lesional skin by single-cell RNA sequencing.

    Time frame: 16 months

    To analyze the intensity of cytokines or chemokines, such as IL-17, IL-23, TNF in the dermis and epidermis of psoriasis patients

Study contacts

Contact information is provided by the study sponsor or research team.

Xiao-yong Man

CONTACT

[email protected]

13600516219

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 17, 2022
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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