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Flexion Enrolls First Patient in Phase 3 Trial of ZILRETTA for Hip OA

Results from the trial are expected in 2020

A PPM Brief

Flexion Therapeutics (Burlington, MA) announced1 that the first patient has been successfully enrolled in its Phase 3 clinical trial to evaluate the safety and efficacy of ZILRETTA (triamcinolone acetonide extended-release injectable suspension) in patients with hip osteoarthritis (OA).

The trial is supported by findings from a Phase 2, randomized, open-label, pharmacokinetic study in the shoulder and hip joints (known as the SHIP study). The results from that study demonstrated that ZILRETTA was generally safe and well tolerated; the medication’s pharmacokinetic profile observed in both joints was consistent with previous studies in the knee. Results also showed that an injection of ZILRETTA into the hip resulted in a 6-fold lower peak plasma levels and reduced systemic exposure compared to immediate-release triamcinolone acetonide in crystalline suspension (TAcs).

Results from the trial are expected in 2020. (Source: 123RF)

The double blind, placebo-controlled Phase 3 trial will evaluate the efficacy and safety of ZILRETTA in 440 patients, randomized to one of two treatment groups (1:1) and treated with a single intra-articular (IA) injection of either ZILRETTA or placebo. The primary endpoint will be the magnitude of pain relief versus placebo as measured on the Western Ontario and McMaster Universities Arthritis Index (WOMAC) A (pain) subscale at Week 12. Participants will be evaluated at Weeks 12, 16, 20 and 24 to determine whether a second IA injection for hip OA pain is indicated. If eligible, patients will receive open label ZILRETTA at the time of recurrent symptoms and will be followed up 12 weeks after the second injection (Patients who do not receive a second injection will be followed up to 24 weeks after their first injection).

“Like OA of the knee, OA of the hip is a serious disease that can profoundly affect one’s quality of life. These impacts are compounded by the fact that there are so few non-surgical treatment options available to manage OA hip pain, and we believe ZILRETTA may be able to play an important role in helping these patients find meaningful pain relief,” said Michael Clayman, MD, president and CEO of Flexion, in a company release.

Dr. Clayman noted that Phase 3 results are expected to roll out in 2020. The company also plans to initiate Phase 2 studies of ZILRETTA in the shoulder in late 2019.

Last updated on: January 16, 2019
Continue Reading:
Intra-Articular Injection for Knee OA Shows Positive Phase 3 Trial Results
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