Moderate to severe active ankylosing spondylitis (AS)
Conditions
Interventions
Placebo group:Placebo subcutaneous injection Q4W
Test group:Recombinant Anti-human IL-17A/F Humanized Monoclonal Antibody Injection.
Sponsors
The Second Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female age >= 18; 2. Ability to understand and communicate with the Investigator, ability to comply with study requirements, and ability to sign the ICF prior to any study assessments; 3. Patients with active AS, who are eligible for the revised New York Criteria (1984) based on radiological evidence (i.e., x-ray) of readings by the study site and have a persistent symptom of chronic back pain for >=3 months at the age of = 4; (2) Spinal pain >= 4 as measured by Question 2 of BASDAI; (3) Total back pain >= 4 as measured by Question 1 of Back Pain Intensity Assessment (NRS score); 5. Must have at least one of the following: Inadequate response, or intolerance, or contraindications to NSAIDs. Incomplete response to NSAIDs treatment, defined as no response after >= 4 weeks of continuous use of one NSAIDs of approved doses, or no response after use of more than 2 NSAIDs of approved doses for a cumulative duration of >= 4 weeks (>= 2 weeks of use of either NSAIDs); 6. Patients who take NSAIDs or analgesics (including opioids with mild potency) or glucocorticoids orally shall maintain a stable dose for at least 2 weeks before randomization (oral dose of glucocorticoids shall be <= 10 mg/d of prednisone or equivalent); 7. Patients who have started taking methotrexate [<= 25 mg/week] or sulfasalazine [<= 3 g/day] or hydroxychloroquine [<= 400 mg/day] at least 12 weeks before randomization, and whose dose and route of administration have been stable for at least 4 weeks before randomization can continue this drug (folic acid supplementation is recommended for patients taking MTX); if it is not in stable use, a washout period of at least 4 weeks is required; 8. TNFi-experienced patients must have had incomplete response to at least 12 weeks of treatment with the approved dose, or be intolerant to treatment; 9. Patients who agree to take effective contraception during the study and within 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or women who plan to become pregnant during the study or within 6 months after the last dose; 2. Have participated in a clinical study of XKH004 and received at least 1 dose (including placebo); 3. Allergy to the ingredients or excipients of XKH004,allergy to biologics or allergic constitution; 4. Have participated in another drug clinical study within 3 months or at least 5 half-lives (whichever is longer) before screening, or participated in any medical device clinical study within 1 month before screening; 5. Complete rigidity of the spine or complete fusion of the bilateral sacroiliac joints; 6. Symptoms of fibromyalgia or osteoarthritis that may interfere with the efficacy evaluation as considered by the Investigator; 7. Acute uveitis anterior within 6 weeks before randomization; 8. Patients who have received more than 1 TNFi, or more than 2 non-TNF-a targeted biological immunomodulators, or any biological immunomodulators targeting IL-17 or IL-17R; 9. Patients who are taking or have taken prohibited drugs listed in Table 2, with the mandatory washout period not reached relative to randomization (baseline visit) (5 half-lives of washout for unlisted biologics/drugs); 10. Have received live vaccines (including attenuated vaccines) 2 months before randomization or are planned to receive live vaccines (including attenuated vaccines) during the study. Subjects who had received COVID-19 vaccine within 1 week prior to randomization; 11. Subjects with tuberculosis (TB) infection, or at high risk for acquired TB infection, or with present nontuberculous mycobacteria (NTMB) infection or previous NTMB infection; * Patients with latent tuberculosis (LTB) [IGRA positive and diagnosed as LTB by a TB specialist] who did not develop hepatotoxicity (alanine aminotransferase [ALT]/aspartate aminotransferase [AST] maintained ULN. **A positive hepatitis C (HCV) test is defined as a positive hepatitis C antibody (HCV-Ab) and a positive HCV-RNA by quantitative determination. 14. Subjects with a history of lymphoproliferative diseases such as lymphoma or current signs and symptoms su
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ASAS40; | — |
Secondary
| Measure | Time frame |
|---|---|
| ASAS20;Bath Ankylosing Spondylitis Functional Index;Bath Ankylosing Spondylitis Metrology Index;Maastricht Ankylosing Spondylitis Enthesitis Score; | — |
Countries
China
Contacts
Public ContactHuji Xu
The Second Affiliated Hospital of Naval Medical University
Outcome results
None listed