Predicting Inflammatory Skin Disease Response to IL-23 Blockade

Psoriasis Vulgaris Clinical Trial

Official title:

Predicting Inflammatory Skin Disease Response to IL-23 Blockade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04541329
• Other study ID #: 19-29813
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris
• Skin Diseases

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