Psoriatic Immune Response to Tildrakizumab

Psoriasis Vulgaris Clinical Trial

Official title:

Psoriatic Immune Response to Tildrakizumab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05390515
• Other study ID #: 22-36503
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Raymond Cho, MD, PhD
• Phone: 415-575-0524
• Email: rashes[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the IL23 blocker, tildrakizumab.

Description:

This is a one-arm, open-label study to examine the effect of Tildrakizumab on cutaneous and blood immune cells of psoriatic patients. Ten subjects with moderate to severe psoriasis will be enrolled. Biopsy and blood samples will be collected before and during treatment and undergo molecular profiling to assess for tildrakizumab-corrected signatures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Patients with moderate-severe psoriasis or > 5% body surface area affected.

Exclusion Criteria:

• taking systemic immunosuppressives in the last 4 weeks

• pregnancy

• severe immunodeficiency (either from genetic or infectious causes).

• tuberculosis or other active serious infection

• active systemic malignancy.

• breast-feeding

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Tildrakizumab Prefilled Syringe
IL-23 inhibitor

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Sun Pharmaceutical Industries Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Psoriasis Area and Severity Index (PASI) Score at baseline and 3 months of treatment	Change in severity and extent of psoriasis (calculated by Psoriasis Area and Severity Index (PASI) score); scale range of 0 to 72, 72 being maximal disease.	Baseline, 3 months