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Predicting Inflammatory Skin Disease Response to IL-23 Blockade

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT04541329
Collaborator
Sun Pharmaceutical Industries Limited (Industry)
40
Enrollment
1
Location
1
Arm
47.8
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Tildrakizumab
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Predicting Inflammatory Skin Disease Response to IL-23 Blockade
Actual Study Start Date :
Sep 16, 2020
Anticipated Primary Completion Date :
Sep 9, 2024
Anticipated Study Completion Date :
Sep 9, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tildrakizumab treatment

Biological: Tildrakizumab
IL-23 inhibitor

Outcome Measures

Primary Outcome Measures

  1. Change in Psoriasis Area and Severity Index (PASI) Score from Baseline to 3 months [baseline and 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94158

Sponsors and Collaborators

  • University of California, San Francisco
  • Sun Pharmaceutical Industries Limited

Investigators

  • Principal Investigator: Raymond Cho, MD, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT04541329
Other Study ID Numbers:
  • 19-29813
First Posted:
Sep 9, 2020
Last Update Posted:
Jun 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Psoriasis
Skin Diseases

Study Results

No Results Posted as of Jun 6, 2022