Ankylosing Spondylitis
Conditions
Interventions
Standard treatment group:Vunakizumab subcutaneous injection 240 mg, Q4W.
Extended dosing interval group:Vunakizumab subcutaneous injection 240 mg, Q8W.
Reduced-dose group:Vunakizumab subcutaneous injection 120 mg, Q4W.
Sponsors
First Affiliated Hospital of Kunming Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age: 18 years or above, gender not restricted; 2. It meets the criteria for the diagnosis of active ankylosing spondylitis, and has radiological evidence recorded by central review that conforms to the revised New York criteria for ankylosing spondylitis in 1984; 3. BASDAI >= 4 points, and the total back pain VAS score >= 4; 4. The patient has insufficient response to non-steroidal anti-inflammatory drugs (NSAIDs), or is intolerant to NSAIDs, or has contraindications to NSAIDs. Insufficient response to NSAID treatment is defined as continuous use of one approved dose of NSAIDs for >= 4 weeks, or using at least 2 approved doses of NSAIDs, with each treatment duration >= 2 weeks, and the symptoms remain unrelieved; 5. Before starting the study treatment, except for sulfasalazine and methotrexate, the disease-modifying antirheumatic drugs (DMARDs) also require a washout period; 6. Patients who have received no more than one targeted TNF inhibitor treatment in the past, and if they have insufficient response to the approved dose or are intolerant to the treatment, they can be included in this study after a washout period of 5 half-lives; 7. Fertile subjects (men and women) agree to use reliable contraceptive methods during the trial and for at least 6 months after the end of the study treatment; For female patients with fertility, the result of the blood human chorionic gonadotropin (hCG) pregnancy test before administration must be negative; 8. Patients voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with complete spinal rigidity; 2. Patients who have previously received anti-IL-17 or anti-IL-17 receptor drugs and have insufficient response to the approved dosage; 3. Patients with severe hypersensitivity reaction to the active ingredient of farnesoid Zn monoclonal antibody or any excipients; 4. Patients who have undergone spinal surgery or joint surgery within 6 months before screening; 5. Patients with a history of inflammatory bowel disease or other persistent active autoimmune diseases; 6. Patients with active tuberculosis TB at the time of screening; if only IGRA is positive for tuberculosis, without any active tuberculosis-related clinical symptoms, and the chest CT examination result is normal, it is recommended to complete at least 4 weeks of preventive anti-tuberculosis treatment before re-screening; 7. Positive for hepatitis B surface antigen (HBsAg) (if HBsAg is negative but HBcAb is positive and/or HBeAb is positive, then HBV-DNA quantitative test needs to be done; if HBV-DNA quantitative test is negative, the patient can be included); positive for hepatitis C antibody (anti-HCV Ab) (need to do HCV-RNA test; if negative, the patient can be included); positive for HIV antibody; 8. Patients with a history of lymphoma or other lymphoproliferative diseases; 9. Patients with a history of or current presence of malignant tumors within 5 years before screening; 10. Moderate to severe congestive heart failure (NYHA class III or IV); 11. Pregnant or lactating women or those with a positive hCG test during screening; 12. Patients currently taking potent opioid analgesics; 13. Other situations judged by the investigator as not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who achieved an ASAS 40 response within 12 weeks;The proportion of subjects who maintained clinical remission for 52 consecutive weeks; | — |
Countries
China
Contacts
Public ContactXu Jian
First Affiliated Hospital of Kunming Medical University
Outcome results
None listed