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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04541329
Other study ID # 19-29813
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 16, 2020
Est. completion date January 15, 2023

Study information

Verified date April 2024
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study examines the effect of IL-23 blockade with Tildrakizumab on the immune cells of psoriatic skin lesions.


Description:

This is a one-arm, open-label study to examine the effect of Tildrakizumab. Tildrakizumab is a FDA-approved medication for the treatment of cutaneous psoriasis. This study will examine how Tildrakizumab affects immune cells within psoriatic skin lesions. Fifteen subjects with moderate to severe psoriasis will be enrolled. Biopsy samples will be collected and undergo molecular profiling to correlate profiles with and to predict Tildrakizumab treatment response.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date January 15, 2023
Est. primary completion date January 15, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male or female =18 years of age at clinic visit. - Documentation of moderate-severe psoriasis or atypical psoriasis. - Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. Exclusion Criteria: - 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 - Tuberculosis, active serious infection, active systemic malignancy, - Received a systemic medication for psoriasis within 3 months of study screening

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Tildrakizumab
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 Psoriasis Area and Severity Index (PASI) Score Psoriasis Area and Severity Index (PASI) is a measure of psoriasis severity. The maximum score is 72, minimum score is 0. The higher the number, the more severe the psoriasis is. baseline and 3 months
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