Efficacy and Safety Study of SUNPG1623

• Status: Completed
• Trial end date: 2019-09-24
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharma Global FZE; Sun Pharmaceutical Industries Limited

Criteria

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