Abbvie (ABT-981)

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

Abbvie (ABT-981) [NCT02087904]

Description:  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.

Biological: ABT-981
Other: Placebo

Primary Investigator: Swank

Drug/Device Information
To evaluate the safety, tolerability, efficacy and pharmacodynamic effects of ABT-981 in subjects diagnosed with osteoarthritis of the knee
ABT-981 is a dual-variable domain antibody that neutralizes both IL-1alpha and IL-1ß without interfering with IL-1 receptor antagonist mediated regulatory functions in the IL-1 pathway
Randomized to 25 mg ABT-981, 100 mg ABT-981, 200 mg ABT-981 or placebo SC every 2 weeks
AbbVie Inc.
Major Inclusion and Exclusion
Male or female between the ages of 35 and 74, inclusive
Must have radiographic evidence of knee OA in the medial compartment of the index knee with Kellgren-Lawrence Grade 2 or 3
Must have one or more clinical signs and symptoms of active inflammation in the index knee as defined by (but not limited to) localized pain, joint stiffness, swelling, and effusion
Must have presence of synovitis in the index knee confirmed by either ultrasound or MRI
Body mass index (BMI) is 18 to 34, inclusive, and maximum weight is 300 pounds