A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2b Study to Demonstrate the Safety and Efficacy of Tildrakizumab in Subjects With Active Psoriatic Arthritis

CLR_16_23

This is a randomized, double-blind, placebo-controlled, multiple-dose, phase 2b study to demonstrate the safety and efficacy of SUNPG1623

2017-04-19

2019-03-01

2019-09-24

Completed

Early phase I

391

Inclusion Criteria: * Subject has provided written informed consent * Subject is ≥ 18 years of age at time of Screening * Subject must be on stable dose of NSAID for ≥ 4 weeks prior to initiation of IMP * Subject has a negative evaluation for TB within 4 weeks before initiating IMP * Subject has a diagnosis of PsA (by the Classification of Psoriatic Arthritis \[CASPAR\] criteria) with symptoms present for at least 6 months. * Subject has ≥ 3 tender and ≥ 3 swollen joints at Screening and Baseline. Exclusion Criteria: * Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pretreatment condition * Subject has an active infection or history of infections * Subject has any concurrent medical condition or uncontrolled, clinically significant systemic disease * Subject has a known history of infection with hepatitis B, hepatitis C, or human immunodeficiency virus

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 391, 'type': 'ACTUAL'}}

2023-01-27