Clinical trial

Psoriatic Immune Response to Tildrakizumab

Name
22-36503
Description
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.
Trial arms
Trial start
2022-09-01
Estimated PCD
2025-09-01
Trial end
2025-09-01
Status
Recruiting
Phase
Early phase I
Treatment
Tildrakizumab Prefilled Syringe
IL-23 inhibitor
Arms:
Tildrakizumab treatment
Size
10
Primary endpoint
Change in Psoriasis Area and Severity Index (PASI) Score at baseline and 3 months of treatment
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 10, 'type': 'ESTIMATED'}}
Updated at
2023-08-29

1 organization

1 product

1 indication