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

JRCT ID: jRCT2050230093

Registered date:04/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis not meeting radiographic
• Date of first enrollment: 08/09/2023
• Target sample size: 6
• Study type: Interventional
• Intervention(s): 15 mg of FPP003 will be administered subcutaneously four times at the start, at week 4 of the treatment period, at week 8 of the treatment period, and at the end of the treatment period (week 20).

Outcome(s)

Primary Outcome

Safety endpoint: frequency of adverse events
Immunogenicity endpoint: geometric mean fold increase (GMFR) in anti-IL-17A antibody titer

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 65age old
• Gender: Both

Include criteria

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

Exclude criteria

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.

Related Information

• Primary Sponsor: Tsuji Shigeyoshi