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OpenTrials
Completed

NCT Number: NCT04541329

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, San Francisco

San Francisco, California, 94158, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tildrakizumab

Biological

IL-23 inhibitor

Primary outcomes

  1. Psoriasis Area and Severity Index (PASI) Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Sun Pharmaceutical Industries Limited

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 9, 2020
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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