Phase 3 Trial Evaluating Xeljanz’s Efficacy in Patients with Active Ankylosing Spondylitis Now Enrolling

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by Alice Melao |

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Tofacitinib Phase 3 trial enrollment

Pfizer is recruiting adult patients with active ankylosing spondylitis for a new Phase 3 clinical trial to evaluate the safety and therapeutic activity of Xeljanz (tofacitinib).

The study (NCT03502616) is expected to enroll about 240 participants who have not responded or been intolerant to standard treatment with a nonsteroidal anti-inflammatory drug (NSAID).

The trial will be conducted at 75 clinical sites in North America, Europe, Australia, South Korea, and Taiwan.

Xeljanz is a small-molecule inhibitor of the Janus kinase (JAK), an important mediator of inflammatory processes. The compound inhibits this inflammation cascade, leading to the relief of symptoms.

Xeljanz is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with moderately to severely active rheumatoid arthritis, ulcerative colitis, and active psoriatic arthritis.

Patients will randomly receive either 5 mgs of Xeljanz orally twice daily or a placebo for up to 48 weeks.

During this period, researchers will evaluate the efficacy of the treatment, as determined by the number of patients achieving a 20 percent improvement in the Assessment of SpondyloArthritis International Society (ASAS20) response score.

Changes in C-reactive protein blood levels (a marker of inflammation), Ankylosing Spondylitis Disease Activity Score (ASDAS), and Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) will also be determined as secondary efficacy measures. The treatment’s impact on patients’ quality of life and self-reported pain symptoms also will be evaluated.

The trial is expected to be concluded by August 2020. More information about the study is available here.

“Ankylosing spondylitis is often progressive and can lead to loss of mobility for some patients,” Michael Corbo, chief development officer, inflammation and immunology at Pfizer Global Product Development, said in a press release. “We are proud to initiate our Phase 3 study to evaluate tofacitinib in ankylosing spondylitis, given the significant need for additional treatment options for people living with this debilitating condition.”

Results from a previous Phase 2 trial (NCT01786668) showed that 80.8% of patients receiving 5 mg of Xeljanz twice daily reached an ASAS20 response, compared to 41.2% of patients in the placebo group. The treatment was also able to significantly reduce symptoms and spinal inflammation in adults with active disease.