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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05390515
Other study ID # 22-36503
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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