Predicting Inflammatory Skin Disease Response to IL-23 Blockade

Phase 4

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Biological: Tildrakizumab

• Registration Number: NCT04541329
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-09
• Study Start: 2020-09-16
• Primary Completion: 2023-01-15
• Study Completion: 2023-01-15
• Results First Submitted: 2023-08-25
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-08
• Last Update Submitted: 2024-04-08
• Results First Posted: 2024-04-30
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tildrakizumab treatment	Tildrakizumab	-

Primary Outcome Measures

Name	Time	Method
Psoriasis Area and Severity Index (PASI) Score	baseline and 3 months	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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States