A Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis

A Phase 2a Study Evaluating the Safety, Efficacy, and Pharmacodynamic Effects of ABT-981 in Patients With Knee Osteoarthritis

A Phase 2a, multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic effect of ABT-981 in patients with symptomatic, radiographic, and inflammatory knee osteoarthritis.

Inclusion Criteria:

1. Radiographic knee osteoarthritis with Kellgren-Lawrence Grade 2 or 3
2. Body Mass Index (BMI) 18-34 kg/m2
3. One or more clinical signs and symptoms of active inflammation in the index knee

Exclusion Criteria:

1. History of allergic reaction to any constituents of the study drug, or to any Immunoglobulin G (IgG)-containing product
2. History of anaphylactic reaction to any agent
3. Significant trauma or surgery to the index knee
4. Severe knee malalignment
5. Any uncontrolled medical illness or an unstable treatment or therapy