Psoriatic Immune Response to Tildrakizumab
- Registration Number
- NCT05390515
- Lead Sponsor
- University of California, San Francisco
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 18 years of age or older
- Patients with moderate-severe psoriasis or > 5% body surface area affected.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tildrakizumab treatment Tildrakizumab Prefilled Syringe Biological/vaccine: tildrakizumab
- Primary Outcome Measures
Name Time Method Change in Psoriasis Area and Severity Index (PASI) Score at baseline and 3 months of treatment Baseline, 3 months Change in severity and extent of psoriasis (calculated by Psoriasis Area and Severity Index (PASI) score); scale range of 0 to 72, 72 being maximal disease.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States