Efficacy and Safety Study of SUNPG1622

• Status: Terminated
• Trial end date: 2019-09-03
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, double-Blind, placebo-controlled Phase 2a study to evaluate the efficacy and safety of SUNPG1622.

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

Details

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

Criteria

Inclusion Criteria:

• Subject has provided informed written consent

• Subject is ≥ 18 years of age at time of Screening

• Subject must be on a stable dose of NSAID for ≥ 2 weeks prior to initiation of investigational product

• Subject has a negative test for TB within 4 weeks before initiating IMP

Exclusion Criteria:

• Subjects with known diagnosis of fibromyalgia or complex regional pain syndromes

• Active uveitis or symptomatic inflammatory bowel disease requiring therapy at screening

• Radiographic evidence of total ankylosis of the spine

• Subject has a planned surgical intervention between Baseline and the Week 24 evaluation for a pre-treatment condition