Phase 3 trials of filgotinib in safely treating AS, like disease advancing

People ankylosing spondylitis, other axial spondyloarthritis form being enrolled

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by Patricia Inacio PhD |

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The first patient has been randomized in a pivotal Phase 3 program testing oral filgotinib in adults with active axial spondyloarthritis (AxS), including ankylosing spondylitis (AS).

The OLINGUITO program (NCT05785611) consists of two placebo-controlled, parallel clinical trials into the safety and efficacy of filgotinib in adults with active radiographic AxSpA (r-AxSpA, study A) and non-radiographic axial spondyloarthritis (nr-axSpA, study B).

Recruitment is underway at clinical sites in South Korea and Taiwan. Top-line data are expected in 2025.

“Axial spondyloarthritis is a chronic, painful, highly invalidating inflammatory condition that can profoundly impact patients’ quality of life,” Xenofon Baraliakos, MD, PhD, a professor of internal medicine and rheumatology at Ruhr-University Bochum in Germany, and the trial’s coordinating investigator, said in a press release.

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r-AxSpA, also known as ankylosing spondylitis, and nr-axSpA are two forms of axial spondyloarthritis, a type of arthritis that mainly affects the joints of the spine. AS is when the joint damage is visible through X-rays, and nr-axSpA is diagnosed when no such changes can be seen.

Filgotinib, developed and commercialized by Galapagos and Gilead Sciences, is an oral inhibitor of Janus kinase 1 (JAK1), a protein that plays a key role in inflammation. By blocking JAK1, filgotinib is expected to ease inflammation in multiple inflammatory diseases, including AS.

“There is a high unmet need for effective oral treatment options for this condition. I am pleased that the first trial sites have been initiated and look forward to continuing to work with Galapagos and with the other study sites to rapidly enroll patients in this pivotal trial,” Baraliakos said.

Each study will enroll around 238 patients who have had an inadequate response to conventional or biological treatments. Patients will be randomly assigned to a placebo or filgotinib, taken once daily at a dose of 200 mg for 16 weeks (about four months).

Their main endpoint, or goal, is to determine the proportion of patients who achieve a 40% improvement on the Assessment of Spondylarthritis International Society scale (ASAS40), in compliance with the European Medicines Agency’s guidelines. The ASAS40 scale includes four domains: pain, function, inflammation, and a patient global assessment.

The placebo-controlled trials will be followed by an open-label study, in which all patients will be treated with 200 mg of filgotinib, administered once daily for up to 52 weeks (one year).

According to Galapagos, patients who show sustained low disease activity in the open-label study will be randomly assigned to one of two doses of filgotinib, 100 mg or 200 mg, for another year.

“Patients … face a significant disease burden and given the limited available therapies, there remains a high unmet medical need for effective oral treatment options,” said Daniele D’Ambrosio, MD, PhD, therapeutic area head of immunology at Galapagos.

“Filgotinib has demonstrated a consistent efficacy and safety profile across a range of patient populations, and inflammatory conditions and has the potential to address the needs of patients living with [axial spondyloarthritis]. We look forward to advancing the OLINGUITO program,” D’Ambrosio added.

In the Phase 2 TORTUGA study (NCT03117270), AS patients treated with 200 mg filgotinib experienced a greater reduction in disease activity relative to placebo group patients after 12 weeks. Filgotinib’s use also was associated with a higher proportion of patients achieving a clinically significant reduction in disease activity, more frequent achievement of ASAS40, and quality of life improvements.

Filgotinib is approved in Europe and Japan — under the brand name Jyseleca — to treat adults with moderate to severe rheumatoid arthritis and ulcerative colitis, a form of  inflammatory bowel disease, who failed to respond to or cannot tolerate standard therapies.