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

Summary

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.

Timeline

Start

2014-06-04

Primary completion

2016-06-07

Completion

2016-12-13

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs ABT-981 100 mg; p = 0.05; LS Mean Difference -2.9 (95% CI -5.73 to 0.01) NCT02087904 ↗

registry analysis (superiority test); Placebo vs ABT-981 25 mg; p = 0.145; LS Mean Difference 0.06 (95% CI -0.021 to 0.141) NCT02087904 ↗

registry analysis (superiority test); Placebo vs ABT-981 100 mg; p = 0.52; LS Mean Difference -0.03 (95% CI -0.11 to 0.056) NCT02087904 ↗

Publications

• Fleischmann RM, Bliddal H, Blanco FJ, Schnitzer TJ, Peterfy C, Chen S, Wang L, Feng S, Conaghan PG, Berenbaum F, Pelletier JP, Martel-Pelletier J, Vaeterlein O, Kaeley GS, Liu W, Kosloski MP, Levy G, Zhang L, Medema JK, Levesque MC. A Phase II Trial of Lutikizumab, an Anti-Interleukin-1alpha/beta Dual Variable Domain Immunoglobulin, in Knee Osteoarthritis Patients With Synovitis. Arthritis Rheumatol. 2019 Jul;71(7):1056-1069. doi: 10.1002/art.40840. Epub 2019 Jun 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lutikizumab	Monoclonal antibody	25 mg	Subcutaneous
Subject	Lutikizumab	Monoclonal antibody	100 mg	Subcutaneous
Subject	Lutikizumab	Monoclonal antibody	200 mg	Subcutaneous

Indications