Predicting Inflammatory Skin Disease Response to IL-23 Blockade
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Psoriasis Area and Severity Index (PASI) Score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported