The trial is currently recruiting at sites across the U.K., and first results are expected by early 2019.
Ankylosing spondylitis is a debilitating type of arthritis that mainly affects the joints of the spine, causing chronic pain and lifelong physical disability. Treatment options, including medications to reduce inflammation, physical therapy and surgery, usually focus on minimizing pain and delaying or preventing disease progression.
Namilumab is a monoclonal antibody designed to target the granulocyte macrophage-colony stimulating factor (GM-CSF) — a small protein (a cytokine) secreted by certain cells of the immune system that induces the production of inflammatory molecules.
The investigational therapy has been well-tolerated and effective in previous clinical trials enrolling more than 100 rheumatoid arthritis patients. More recently, it was considered a promising therapeutic target for ankylosing spondylitis in a study carried out by researchers at the University of Oxford.
The randomized, double-blind, placebo-controlled NAMASTE study (NCT03622658) is expected to enroll about 42 patients at 10 specialist centers in the UK to assess the efficacy of namilumab in patients’ clinical response compared to a placebo.
Half of the participants will be randomly assigned to four treatments over 10 weeks of either 150 mg of namilumab, administered through an injection under the skin, or a placebo. The trial’s primary goal is the number of patients reaching at least a 20 percent improvement according to the Assessment in Ankylosing Spondylitis Assessment (ASAS20) at week 12.
“I am delighted to be part of the team developing this innovative new therapy targeting ankylosing spondylitis. The condition can be devastating, and for many patients with more advanced disease current treatments are often ineffective,” Peter Taylor, PhD, the Norman Collinson Professor of Musculoskeletal Sciences at Oxford, and the study’s principal investigator, said in a press release.
“With new research indicating namilumab targets a key pathway in ankylosing spondylitis, I am excited at the prospect of exploring its potential to become an effective new therapy for this greatly underserved condition,” Taylor added.