GSK today announced the start of a phase III clinical development programme with otilimab, an investigational anti-granulocyte macrophage colony-stimulating factor (anti GM-CSF) monoclonal antibody, for patients with moderate to severe rheumatoid arthritis (RA) who have had an inadequate response to disease modifying antirheumatic drugs (DMARD) or targeted therapies.
The progression of otilimab (previously GSK3196165) into phase III follows the results of the phase II BAROQUE study which were announced in October 2018.
Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said: “Our phase II data showed encouraging clinical benefits in patients treated with otilimab. The unique phase III studies, designed in consultation with regulators, will help us understand how this potential new medicine could benefit appropriate patients living with rheumatoid arthritis.”
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 comprises 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).
- contRAst-1 (201790): Compares the efficacy and safety of otilimab with placebo and with tofacitinib, all in combination with methotrexate (MTX), over 52-weeks in approximately 1500 -1700 patients with moderately to severely active RA who have an inadequate response to MTX.
- contRAst-2 (201791): Compares the efficacy and safety of otilimab with placebo and with tofacitinib, all in combination with conventional synthetic DMARDs, over 52-weeks in approximately 1500-1800 patients with moderately to severely active RA who have an inadequate response to conventional synthetic DMARDs or biologic DMARDs.
- contRAst-3 (202018): Compares the efficacy and safety of otilimab with placebo and with sarilumab, all in combination with conventional synthetic DMARDs, over 24-weeks in approximately 500-600 patients with moderately to severely active RA who have an inadequate response to biological DMARDs and/or JAK inhibitors.
- contRAst-X (209564): Patients who complete the pivotal studies may be eligible to participate in a long-term extension study to further evaluate the efficacy and safety of otilimab for up to 4 years.
Otilimab is not approved for use anywhere in the world.
Source: Company Press Release