Immunoclassification of Psoriasis: a Strategy for Precision Medicine

Psoriasis Clinical Trial

Official title:

Immunoclassification of Psoriasis: a Strategy for Precision Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05503875
• Other study ID #: 2022-0205
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiao-yong Man
• Phone: 13600516219
• Email: manxy[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

1. Having severe infections, including hepatitis, HIV and tuberculosis

2. Having significant allergies to biological agents

3. Having a history of malignancy

4. Refusal of contraception

5. Having serious or unstable/uncontrolled illnesses

Related Conditions & MeSH terms

• Psoriasis

Intervention

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

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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