This week, Genentech announced its phase 3 trial of Actemra for patients with systemic sclerosis has completed enrollment. The study will compare the drug’s safety and efficacy with placebo in patients with systemic sclerosis, according to a press release.
Patients were enrolled (n = 211) into the multicenter, randomized, double-blind, placebo-controlled, parallel-group study at 106 sites around the globe. For 48 weeks patients will be randomly assigned 162-mg subcutaneous Actemra (tocilizumab, Genentech) or placebo. The primary outcome is efficacy on skin sclerosis at 48 weeks, as measured by the modified Rodnan skin score, and the secondary outcome is pulmonary function at 48 weeks per forced vital capacity.
At trial’s end, patients assigned tocilizumab will continue to receive their subcutaneous dose as part of a 48-week open-label treatment period, according to the press release.
“Having reached our first milestone of completing enrollment, we continue to push forward with the determination that we can potentially deliver a therapeutic option to a patient population that has serious unmet need,” Jeffrey Siegel, MD, global head of rheumatology and rare diseases at Genentech, said in a press release. “We hope the phase 3 trial results will show that treatment with Actemra not only shows improvement in skin thickening over time, which is crucial for these patients, but also the preservation of lung function.”
The FDA granted tocilizumab Breakthrough Therapy Designation for systemic sclerosis in June 2015.