ConditionAxial Spondyloarthritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
About this trial
This study will evaluate the effect and safety of 608 in patients with nr-axSpA.
Eligibility criteria
Qualifiers
Female and male patients at least 18 years of age at the time of screening.
Diagnosis of axial spondyloarthritis according to Ankylosing Spondylo Arthritis International Society (ASAS) axial spondyloarthritis criteria
Objective signs of inflammation (magnetic resonance imaging (MRI) or abnormal C-reactive protein)
Total back pain as measured by NRS ≥ 4 at baseline
Disqualifiers
Patients with other uncontrolled active inflammatory diseases.
Clinical laboratory tests and other tests that reveal abnormalities with clinical significance
Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
History of cancer.
Trial design
Treatments tested in this trial
- 608
- 608
- Placebo
Treatment groups
180 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov