A Study of LY2951742 in Participants With Mild to Moderate Osteoarthritis Knee Pain

Summary

The main purpose of this study is to test if LY2951742 relieves mild to moderate knee pain. The study drugs will be given as an injection under the skin and as an oral capsule. The study will last about 28 weeks for each participant.

Timeline

Start

2014-07

Primary completion

2015-04

Completion

2015-06

Outcome

Missed primary endpoint

Stopped: “Interim assessment: Lack of efficacy”

paper None of the galcanezumab arms demonstrated clinically meaningful improvement (range: 1.5 to -5.0 mm) or met the prespecified success criteria. PMID 30240937 ↗

paper The study was terminated after interim analysis suggested inadequate efficacy. PMID 30240937 ↗

Publications

• Jin Y, Smith C, Monteith D, Brown R, Camporeale A, McNearney TA, Deeg MA, Raddad E, Xiao N, de la Pena A, Kivitz AJ, Schnitzer TJ. CGRP blockade by galcanezumab was not associated with reductions in signs and symptoms of knee osteoarthritis in a randomized clinical trial. Osteoarthritis Cartilage. 2018 Dec;26(12):1609-1618. doi: 10.1016/j.joca.2018.08.019. Epub 2018 Sep 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Celecoxib	Other / unclassified	200 mg	Oral
Subject	Galcanezumab	Monoclonal antibody	5 mg	Subcutaneous
Subject	Galcanezumab	Monoclonal antibody	50 mg	Subcutaneous
Subject	Galcanezumab	Monoclonal antibody	120 mg	Subcutaneous
Subject	Galcanezumab	Monoclonal antibody	300 mg	Subcutaneous

Indications