Ankylosing Spondylitis
Conditions
Interventions
Experimental group:BCD-085 injection
Control group:Placebo
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients fully understand the purpose, process and possible adverse reactions of this study, voluntarily participate in the study and sign an informed consent form approved by the Ethics Committee (IEC); 2. Men or women aged 18-65 (both ends inclusive) on the day of signing the ICF; 3. Meet the diagnostic criteria for ankylosing spondylitis (the modified New York criteria in 1984), the patient has a history of back pain for >= 3 months, and the age of onset is = 4, spinal pain score [using 0-10 points Numerical Rating Scale (NRS)] >= 4; 5. Non-steroidal anti-inflammatory drugs (NSAIDs) are not effective or ineffective: received at least 2 NSAIDs before randomization (the total medication cycle is not less than 4 weeks), and each NSAIDs medication cycle is not less than 2 weeks (dose The clinical therapeutic dose); if the treatment is stopped due to intolerable toxicity or contraindications, the treatment cycle may be less than 4 weeks; 6. For patients who regularly take NSAIDs as ankylosing spondylitis treatment, it is required to maintain a stable dose for at least 2 weeks before randomization; 7. During the screening period, if the patient has used or is currently using TNF-a inhibitors (no more than 1 type), the drug cycle must be no less than 3 months (the dosage is the approved dose) and the curative effect is not good or the TNF-a inhibitor is not effective. Alpha inhibitor intolerance; 8. During the screening period, if the patient is using methotrexate (MTX) (= 3 months, and in Maintain a stable dose for at least 4 weeks before randomization; patients need to stop taking disease-modifying antirheumatic drugs (DMARDs) except MTX and sulfasalazine 4 weeks before randomization; patients need to stop taking leflunomide 8 weeks before randomization ( except for cholestyramine cleaning); 9. During the screening period, if the patient is using corticosteroids, the average dose of <= 10 mg/day prednisone (or other hormones equivalent to this dose of prednisone) must be met, and the stable dose should be maintained for at least 2 weeks before randomization; 10. Female patients have a negative blood pregnancy test (this requirement does not apply to patients who have undergone surgical sterilization and women who have been postmenopausal for at least 2 years). Fertile patients and their partners must take reliable contraceptive methods specified in the protocol from the signing of the informed consent (ICF) to 20 weeks after the last dose of the study treatment.
Exclusion criteria
Exclusion criteria: 1. Complete ankylosis of the spine, with ligamentous osteophytes on the sides of the cervical, thoracic, and lumbar vertebrae in all intervertebral spaces; 2. Known hypersensitivity to any component of the test drug or other excipients; 3. Drug treatment: (1) Previous use of any monoclonal antibody targeting interleukin 17 (IL-17) or interleukin 17 receptor (IL-17R), IL-12/23 or any other treatment of ankylosing spondylitis (targeting TNF-a except for antibodies); (2) More than one targeted TNF-a inhibitor has been used in the past, or the targeted TNF-a inhibitor and its biosimilars have been used within 4 weeks or 5 half-lives (whichever is longer) before randomization (e.g. etanercept within 4 weeks, infliximab within 8 weeks, adalimumab, golimumab, certolizumab within 10 weeks); (3) JAK inhibitors have been used within 4 weeks before randomization (or within 5 half-lives, whichever is shorter); (4) Use of alkylating agents within 12 months before randomization; (5) Intra-articular glucocorticoids were used within 4 weeks before randomization; (6) Received live vaccine within 8 weeks before randomization; (7) Have used traditional Chinese medicine for ankylosing spondylitis (such as tripterygium glycosides, total glycosides of paeony, sinomenine, etc.) within 4 weeks before randomization; 4. Tuberculosis (TB) infection or latent TB (QuantiFERON®-TBGold or T-SPOT.TB test positive and no imaging signs of tuberculosis) present or in the past; 5. Have a history of lymphoproliferative diseases such as lymphoma or current signs and symptoms suggesting lymphoproliferative diseases; 6. Within 5 years before screening, have any active malignant tumor or malignant disease history (except cured squamous cell carcinoma in situ or basal cell carcinoma of the skin or cervical cancer in situ); 7. Have undergone major surgery (including joint surgery) within 3 months before screening, or plan to have surgery during the study; 8. The patient has the following active infection or infection history: (1) Serious infection requiring hospitalization or systemic anti-infective drug (intravenous or oral) treatment within 2 months before randomization; (2) Opportunistic, recurrent, or chronic infections that the investigator believes may be detrimental to the patient [an opportunistic infection is an infection caused by an uncommon pathogen (eg, Pneumocystis, Cryptococcus) or caused by a common pathogen ( eg, unusually severe infection due to cytomegalovirus, herpes zoster]; 9. Hepatitis B [hepatitis B surface antigen positive (HBsAg+), or anti-hepatitis B core antibody positive (HBcAb+) and HBV DNA positive], hepatitis C [hepatitis C antibody (anti-HCVAb) positive and HCV-RNA positive], human immunodeficiency virus (HIV) or syphilis infection; 10. History of epileptic seizures or convulsions; 11. Chronic intestinal inflammatory diseases (except Crohn's disease and non-specific ulcerative colitis); 12. Alcohol [drink more than 14 units per week, (1 unit = 360 mL beer or 45 mL 40% spirits or 150mL red wine) or drug abuse history before screening; 13. Other medical conditions that may increase the risk of adverse events during the study or affect the evaluation of main disease symptoms (may mask, enhance or change the symptoms of ankylosing spondylitis), or cause clinical or laboratory symptoms similar to ankylosing spondylitis: (1) Spinal arthritis and other forms of osteoarthritis associated with loss of function or disability; (2) Nervous system diseases ac
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients reaching ASAS20; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients reaching ASAS40;The proportion of patients reaching ASAS5/6;Proportion of patients achieving partial ASAS remission;Change from baseline in BASDAI;Change from baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI);Change from baseline in chest expansion;Change from baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES);9) Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI);Change from baseline in Ankylosing Spondylitis Disease Activity Score-C-reactive Protein (ASDAS-CRP);Change from baseline in C-reactive protein (CRP) concentration;Change from baseline in Short Form Health Survey (SF-36);Change from baseline in Ankylosing Spondylitis Quality of Life Score (ASQoL);Change from baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire;Change from baseline in spinal pain;Change from baseline in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS);Change from baseline in Ankylosing Spondylitis Spinal MRI Activity Score (ASspiMRI);Change from baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) index;Proportion of patients without MRI progression;Proportion of patients without radiological progression; | — |
Countries
China
Contacts
Public ContactZeng Xiaofeng
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed