A Phase 2a Study Evaluating the Safety and Efficacy of ABT-981 in Patients With Erosive Hand Osteoarthritis

Summary

This is a multicenter, randomized, double-blind, placebo-controlled study to compare the safety and efficacy of ABT-981 to placebo in subjects with erosive hand osteoarthritis.

Timeline

Start

2015-03

Primary completion

2016-07

Completion

2016-07

Outcome

Missed primary endpoint

registry analysis (other test); Placebo vs ABT-981; p = 0.386; LS Mean Difference 1.52 (95% CI -1.944 to 4.990); ANCOVA; NCT02384538 ↗

paper AUSCAN pain was not different among subjects treated with lutikizumab versus placebo at week 16 PMID 30552176 ↗

Publications

• Kloppenburg M, Peterfy C, Haugen IK, Kroon F, Chen S, Wang L, Liu W, Levy G, Fleischmann RM, Berenbaum F, van der Heijde D, Bansal P, Wittoek R, Feng S, Fang Y, Saltarelli M, Medema JK, Levesque MC. Phase IIa, placebo-controlled, randomised study of lutikizumab, an anti-interleukin-1alpha and anti-interleukin-1beta dual variable domain immunoglobulin, in patients with erosive hand osteoarthritis. Ann Rheum Dis. 2019 Mar;78(3):413-420. doi: 10.1136/annrheumdis-2018-213336. Epub 2018 Dec 14.

Drugs

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

Indications