An open-label, uncontrolled study to evaluate the safety and immunogenicity of FPP003 in subjects with axial spondyloarthritis (phase IIa study) - An open-label, uncontrolled study to evaluate the safety and immunogenicity of FPP003 in subjects with axial spondyloarthritis (phase IIa study)

Tsuji Shigeyoshi0 个研究点目标入组 6 人开始时间: 2023年9月4日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Patients with a diagnosis of axial spondylarthritis who met the International Society for the Assessment of Spondylarthritis (ASAS) classification criteria for axial spondylarthritis according to any of the following criteria at the time of diagnosis
•2) Patients who meet all of the following criteria during the 24 weeks prior to informed consent
•3) Patients who meet all of the following criteria within 8 weeks prior to enrollment
•4) Patients with a latest ASDAS < 2.1 within 7 days prior to enrollment in this study
•5) Patients < 45 years of age at onset of axial spondylarthritis

•1) Patients with full ankylosis (fusion) of the spine.
•2) Patients with inflammatory diseases other than axial spondyloarthritis that may affect the evaluation of this drug (Reactive arthritis, spondyloarthritis associated with inflammatory bowel disease, fibromyalgia, ankylosing spondyloplasia, iliac osteitis sclerosus, spondylosis osteoarthritis, sacroiliac osteoarthritis, etc.)
•3) Patients with or with a history of inflammatory bowel disease.
•4) Patients with or with a history of uveitis.
•5) Patients with or suspected of having a systemic infection requiring treatment with antibiotics, antifungals, or antivirals intended for systemic action.
•6) Patients with or suspected of having active tuberculosis or latent tuberculosis infection, or patients with a history of such diseases.

发起方

Tsuji Shigeyoshi