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Predicting Inflammatory Skin Disease Response to IL-23 Blockade

Primary Purpose

Psoriasis Vulgaris

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tildrakizumab
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tildrakizumab treatment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2020
Last Updated
June 2, 2022
Sponsor
University of California, San Francisco
Collaborators
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04541329
Brief Title
Predicting Inflammatory Skin Disease Response to IL-23 Blockade
Official Title
Predicting Inflammatory Skin Disease Response to IL-23 Blockade
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 16, 2020 (Actual)
Primary Completion Date
September 9, 2024 (Anticipated)
Study Completion Date
September 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Sun Pharmaceutical Industries Limited

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tildrakizumab treatment
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Tildrakizumab
Intervention Description
IL-23 inhibitor
Primary Outcome Measure Information:
Title
Change in Psoriasis Area and Severity Index (PASI) Score from Baseline to 3 months
Description
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.
Time Frame
baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Cheng, MD, PhD
Phone
415-575-0524
Email
rashes@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Cho, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Cheng, MD, PhD
Email
rashes@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Predicting Inflammatory Skin Disease Response to IL-23 Blockade

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