Predicting Inflammatory Skin Disease Response to IL-23 Blockade

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-16

Study Completion Date

2023-01-15

Brief Summary

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

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Detailed Description

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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.

Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tildrakizumab treatment

Group Type EXPERIMENTAL

Tildrakizumab

Intervention Type BIOLOGICAL

IL-23 inhibitor

Interventions

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Tildrakizumab

IL-23 inhibitor

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No