Safety and Biologic Activity Study of Gevokizumab to Treat Erosive Osteoarthritis of the Hand

A Phase 2 Proof-of-Concept Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand

The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of active inflammatory, erosive osteoarthritis of the hand.

Inclusion Criteria:

• Diagnosis of hand osteoarthritis
• Joint tenderness and/or redness
• At least one erosion by X-ray (as determined by the central reader)
• Contraceptive measures adequate to prevent pregnancy during the study

Exclusion Criteria:

• History of inflammatory disease other than hand EOA including: secondary post-traumatic OA; rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia
• History of gout, pseudogout, or hemochromatosis
• History of allergic or anaphylactic reactions to monoclonal antibodies
• History of recurrent or chronic systemic infections
• Known allergy to acetaminophen
• Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding

Other protocol-defined inclusion/exclusion criteria may apply