Predicting Inflammatory Skin Disease Response to IL-23 Blockade

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

Study Overview

• Status: Recruiting
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Biological: Tildrakizumab

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jeffrey Cheng, MD, PhD; Phone Number: 415-575-0524; Email: rashes@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • University of California, San Francisco
      • Contact: Jeffrey Cheng, MD, PhD; Email: rashes@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tildrakizumab treatment	Biological: Tildrakizumab; IL-23 inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Psoriasis Area and Severity Index (PASI) Score from Baseline to 3 months	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 and 3 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 16, 2020
• Primary Completion (ANTICIPATED): September 9, 2024
• Study Completion (ANTICIPATED): September 9, 2024

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (ACTUAL): September 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Psoriasis; Skin Diseases
• Other Study ID Numbers: 19-29813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No