A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VTX958 in Patients With Active Psoriatic Arthritis

VTX958-203

The objective of this study is to evaluate if VTX958 is safe and effective in adult participants with active Psoriatic Arthritis. Approximately 195 eligible participants will take VTX958 Dose A, VTX958 Dose B, or matching placebo (no active drug) for 16 weeks and then move on to a 36 week Long Term Extension (LTE). The study will include 16 weeks of treatment, 36 weeks of LTE, and a 30-day follow-up period.

2023-01-31

2024-01-02

2024-01-02

Terminated

Early phase I

205

Inclusion Criteria: * Diagnosed with Psoriatic Arthritis for 6 months or more prior to Screening * Documented history or active signs of at least 1 confirmed lesion of plaque psoriasis and/or nail changes attributed to psoriasis * Active PsA as defined by 3 or more swollen joints and 3 or more tender joints at Screening and Day 1 * Women must not be of childbearing potential or must agree to use a highly effective contraception during the study and for 30 days after the last dose of the study product * Men with a partner who is of childbearing potential must agree to use condoms during the study and for 90 days after the last dose of study product Exclusion Criteria: * Has non-plaque psoriasis at Screening or Day 1 * Has inflammatory bowel disease or active uveitis * Has a history of chronic or recurrent infectious disease * Has a known immune deficiency or is immunocompromised * Has hepatitis B or hepatitis C infection, human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or active tuberculosis (TB) at screening

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are randomly assigned at the beginning of the study to either Dose A, Dose B, or placebo group, where they stay for the remainder of the study.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'The study has a double-blind design, meaning that the participant, care provider, and investigator will not know what treatment group each participant has been assigned to. This blinding will last from randomization until the end of the study.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 205, 'type': 'ACTUAL'}}

2024-01-08