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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2050230093

Enrollment

Registered

2023-09-04

Start date

2023-09-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis not meeting radiographic

Interventions

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).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

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

Contacts

Public ContactHironori Nakagami

Osaka University Graduate school of Medicine

nakagami.hironori.med@osaka-u.ac.jp+81-6-6210-8359

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026