GSK starts phase III clinical development programme with otilimab
5 July 2019 -

United Kingdom-based GSK has commenced a phase III clinical development programme with otilimab, an investigational anti-granulocyte macrophage colony-stimulating factor monoclonal antibody, it was reported yesterday.

The product is intended for patients with moderate to severe rheumatoid arthritis who have had an inadequate response to disease modifying anti-rheumatic drugs or targeted therapies.

The product's progression into phase III follows the results of the phase II BAROQUE study, which were announced in October 2018. The phase III clinical programme (named 'ContRAst') is the first in RA to include head-to-head comparisons of otilimab with current treatments across all pivotal studies. It compares otilimab against two treatments with different modes of actions: tofacitinib (a Janus Kinase (JAK) inhibitor) and sarilumab (an anti-IL6). The programme also enrols a broad range of difficult-to-treat patients who have had an inadequate response to or have been unable to tolerate currently available treatments. It includes three pivotal studies and a long-term extension study. The primary endpoint for the pivotal studies is the proportion of patients achieving the American College of Rheumatology criteria (ACR20) at week 12 (against placebo).