Active ankylosing spondylitis
Conditions
Interventions
Placebo group:Placebo
Sponsors
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years(including 18 and 70), regardless of gender; 2. Be able to sign informed conset form and comply with it; 3. The subjects met the diagnostic criteria for AS revised by New York, 1984, and met the age of onset = 4 and spinal pain score >= 4; 5. At least one non-steroidal anti-inflammatory drug (NSAIDs.was used before the screening without symptom remission or drug intolerance, that is, one NSAIDs was used for >= 4 weeks before the screening or at least two NSAIDs were used before the screening, each NSAIDs was used for >= 2 weeks without remission or drug intolerance; 6. If patients were still receiving NSAIDs at screening, the dose should be steady for at least two weeks; prednisone dose <= 10 mg (or an equivalent dose of another glucocorticoid); 7. Agree not to have a family planning during the trial period and six months after the trial, and voluntarily use effective contraception.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Subjects have participated in another drug study or are participating in another investigational drug study within twelve weeks before the screening or at least five half-lives (whichever is longer); 3. Subjects who participated in blood donation with blood volume >= 400 mL or received blood transfusion within two months before the screening; 4. Participant in any medical device clinical trial within three months before the screening; 5. Subjects who had received live vaccine or attenuated live vaccine within two months before the screening; 6. Clinically relevant or significant ECG abnormalities, including ECG QT interval (QTcF) > 500 ms corrected for heart rate using the Fridericia correction formula; 7. Presence or a history of the following diseases: (1) Those who are allergic to the drug ingredients or excipients in the study, those who are allergic to biological agents or those who are allergic themselves; (2) Complete ankylosing of the spine; (3) Those who have received spinal surgery or joint surgery within six months; (4) Have other poorly controlled active inflammatory diseases other than axial spondylitis, including active Crohn's disease (CD), active ulcerative colitis (UC), psoriasis, uveitis, systemic lupus erythematosus, rheumatoid arthritis, autoimmune hepatitis, etc.; (5) History of malignant tumor or lymphoid hyperplasia; (6) Cardiovascular and cerebrovascular disease: moderate to severe congestive heart failure (New York Heart Association Class III or IV), screening for myocardial infarction, angina pectoris, percutaneous coronary angioplasty, coronary artery bypass graft, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemic attack within three months; (7) Patients with a history of herpes zoster or herpes simplex within two months before the screening; (8) Have a history of active tuberculosis, or active or latent tuberculosis infection at screening time, or suspected tuberculosis infection at screening time; (9) The presence of any medical or mental illness that the investigator considers would prevent the subject following the protocol or completing the study according to the protocol; (10) Evidence of active infection, including acute and chronic infection and local infection; 8. Taking or has the following medication history: (1) Prior use of tumor necrosis factor a (TNF-a) inhibitors within five half-lives (adamuzumab: 3 months, galimuzumab: 3 months, cestuzumab: 3 months, infliximab: 60 days, enacipl: 28 days, recombinant human tumor necrosis factor receptor antibody fusion protein for injection: 20 days) or at least one TNF-a inhibitor (the generic name of the drug is counted as one); (2) Prior to screening, subjects were treated with Secukinumab, Ixekizumab, or other biologic drugs that directly target IL-17 antibodies or IL-17 receptors; (3) Those who received JAK inhibitors (Tofacitinib, Baricitinib, etc.) within five half-lives before the screening; (4) Patients who received corticosteroid intramuscular or intravenous therapy within two weeks before screnning;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving 20% improvement (ASAS 20) of the International Association for the Evaluation of Spinal Arthritis ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving 40% improvement (ASAS 40) of the International Association for the Evaluation of Spinal Arthritis;Adverse event; | — |
Countries
China
Contacts
Public ContactZeng Xiaofeng
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed