Kyowa Hakko Kirin Announces Initiation of Global Phase 3 Study of KHK4827 (Brodalumab) in Patients with Axial Spondyloarthritis (axSpA)
April 24, 2017
Tokyo, Japan, April 24, 2017--- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announces the initiation of a global Phase 3 clinical study evaluating KHK4827 (brodalumab) for Axial Spondyloarthritis (axSpA).
The Phase 3 study is a multi-regional, randomized, double-blind, placebo-controlled study in Japan, South Korea and Taiwan, to evaluate the efficacy and safety of brodalumab (subcutaneous injection) in patients with axSpA (ankylosing spondylitis and non-radiographic axial spondyloarthritis).
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.
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| Target Disease | Axial Spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) |
|---|---|
| Phase | Phase 3 |
| Design | Multi-regional, Randomized, Double-blind, Placebo-controlled Study with an Open Label Extension Study |
| Administration Group | KHK4827(brodalumab), placebo |
| Location | Japan, South Korea, Taiwan |
- About Axial spondyloarthritis
Axial spondyloarthritis, which characterized by predominant involvement of the chronic enthesitis of the spine and/or sacroiliac joints, include ankylosing spondylitis with sacroiliitis detected by X-ray radiography and non-radiographic axial spondyloarthritis without radiographic sacroiliitis.
- About KHK4827 (brodalumab)
Brodalumab is a fully human anti-interleukin-17 (IL-17) receptor A antibody that inhibits biological activity of IL-17A, IL-17F and other IL-17s. Brodalumab has been approved in Japan in July 2016 for psoriasis (psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and psoriatic erythroderma) that respond inadequately to existing therapies.
