Psoriatic Immune Response to Tildrakizumab
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tildrakizumab Prefilled Syringe.
- Who it may be relevant to
- Registry conditions: Psoriasis Vulgaris. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the IL23 blocker, tildrakizumab.
Detailed description
This is a one-arm, open-label study to examine the effect of Tildrakizumab on cutaneous and blood immune cells of psoriatic patients. Ten subjects with moderate to severe psoriasis will be enrolled. Biopsy and blood samples will be collected before and during treatment and undergo molecular profiling to assess for tildrakizumab-corrected signatures.
Interventions
- Drug Tildrakizumab Prefilled Syringe
IL-23 inhibitor
Primary outcome measures
- Change in Psoriasis Area and Severity Index (PASI) Score at baseline and 3 months of treatment [Time frame: Baseline, 3 months]
Eligibility criteria
Inclusion criteria
- 18 years of age or older
- Patients with moderate-severe psoriasis or > 5% body surface area affected.
Exclusion criteria
- taking systemic immunosuppressives in the last 4 weeks
- pregnancy
- severe immunodeficiency (either from genetic or infectious causes).
- tuberculosis or other active serious infection
- active systemic malignancy.
- breast-feeding
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT05390515 · 22-36503