Safety/Efficacy of Balicatib (AAE581) in Adults With Osteoarthritis of the Knee

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study will test efficacy and safety of AAE581 compared to placebo in limiting cartilage loss in patients with painful knee osteoarthritis which is confirmed by X-ray

• Phase: Phase 2

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• At least one knee with osteoarthritis with Kellgren-Lawrence grade 3

• Significant osteoarthritis pain in the knee

• Presence of at least one of the risk factors: obesity (BMI > 28), osteoarthritis at other sites, knee effusion, family history of total joint replacement

Exclusion Criteria:

• Women with childbearing potential

• Secondary osteoarthritis

• Treatment with intra-articular or systemic steroids

• Inability to undergo MRI acquisition

Other protocol defined inclusion/exclusion criteria may apply.