Predicting Inflammatory Skin Disease Response to IL-23 Blockade

NCT04541329 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 19-29813
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Tildrakizumab treatment

EXPERIMENTAL

Biological: Tildrakizumab

Interventions

Tildrakizumab BIOLOGICAL

IL-23 inhibitor

Tildrakizumab treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Sun Pharmaceutical Industries Limited: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Interventions

tildrakizumab

Results Point of Contact

• Title: Raymond Cho, MD, PhD
• Organization: University of California, San Francisco

rashes@ucsf.edu

415 353 7800

Study Officials

• Raymond Cho, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Study Start: September 16, 2020
• Primary Completion: January 15, 2023
• Study Completion: January 15, 2023
• Last Updated: April 30, 2024
• Results First Posted: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)