Ankylosing Spondylitis
Conditions
Interventions
80mg
administered subcutaneously
Experimental group 2:QX002 injection
Experimental group 1:QX002 injection
40mg
q2wks
Experimental group 3:QX002 injection
160mg
controlled group:QX002 buffer prescription (placebo)
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for this study: 1. Between 18 and 60 years old (including 18 years old and 60 years old), regardless of gender; 2. Patients who can sign the informed consent and comply with the requirements of the informed consent; 3. Patients with BMI of 18-35 (including both ends), and male weight >= 50kg, female weight >= 45kg; 4. Patients who meet the diagnostic criteria (Appendix 5) of as revised in New York in 1984 and meet all of the following criteria: (1) The age of onset was less than 45 years old; (2) Bath Ankylosing Spondylitis activity index (BASDAI) >= 4, and chronic low back pain >= 4 (patient back pain intensity assessment question 1) (NRS score); (3) High sensitive C-reactive protein (hsCRP) and / or ESR > upper limit of normal value (ULN); (4) At least one non steroidal anti-inflammatory drug (NSAIDs) was used before randomization, but the symptoms were not relieved or drug intolerance, that is, one NSAID was used for more than 4 weeks before randomization or two NSAIDs were used for more than 2 weeks before randomization, each NSAIDs was treated for more than 2 weeks, and the symptoms were not relieved or drug intolerance; 5. Subjects taking NSAIDs or oral glucocorticoids should maintain a stable dose in the first two weeks and the whole study period before randomization, and take prednisone or other equivalent dose of glucocorticoids <= 10mg daily; 6. Those who agree to take effective contraceptive measures voluntarily without family planning during the trial and within 6 months after the end of the trial, see Appendix 4 for specific contraceptive measures.
Exclusion criteria
Exclusion criteria: Patients are not eligible for this study if they meet any of the following exclusion criteria: 1. Pregnant or nursing women; 2. The patients who are allergic to the drug components or auxiliary materials in this study, the patients who are allergic to the biological agents or the patients who are allergic to their own constitution; 3. The subjects who participated in blood donation within 2 months before screening and the amount of blood donation >= 400mL, or received blood transfusion; 4. Subjects who have participated in clinical trials of any drug or medical device within 3 months before screening; 5. Those who received live vaccine, live attenuated vaccine or planned live vaccine or live attenuated vaccine in the two months before screening; 6. Patients with a history of tuberculosis or those with clinical symptoms, physical signs, laboratory tests and imaging tests indicating active tuberculosis; 7. The subjects who smoked more than 5 cigarettes per day or habitually used nicotine containing products in the first 3 months of screening, and drank more than 14 units of alcohol per week in the first 6 months of screening (1 unit of alcohol = 360 ml of beer or 45 ml of spirits or 150 ml of wine with 40% alcohol content); 8. Subjects with positive urine drug abuse screening; 9. The subjects that the researchers think ECG abnormality has clinical significance; 10. Patients with the following diseases or disease history: (1) Patients with complete spinal rigidity; (2) There are other active inflammatory diseases with poor control besides as, including active inflammatory bowel disease, psoriasis, uveitis, systemic lupus erythematosus, rheumatoid arthritis, autoimmune hepatitis, etc; (3) History of malignant tumor or lymphoproliferative disease; (4) For unstable heart, lung, kidney, liver, nerve, endocrine, gastrointestinal, metabolic or blood system diseases, or abnormal laboratory test values, the researcher judges that participation in the study will put the subjects at unacceptable risk; (5) Cardiovascular and cerebrovascular diseases: moderate to severe congestive heart failure (New York Heart Association class III or IV), myocardial infarction, angina pectoris, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, transient ischemic attack or percutaneous transluminal angioplasty and coronary artery bypass grafting in the first three months of randomization; (6) The patients with recurrent herpes zoster or herpes simplex within the first 2 months or in the past were screened; (7) Mental illness; (8) Evidence of active infection within 1 month before screening, including acute and chronic infection and local infection, such as septicemia, abscess, cellulitis and opportunistic fungal infection; (9) Patients who had undergone spine or joint surgery within 6 months before screening. 11. Subjects who are taking or have the following medication history: (1) The dose of methotrexate, sulfasalazine or hydroxychloroquine was not stable in the first 4 weeks (dose stability means that the dose did not change during the period of administration); (2) Traditional anti rheumatic drugs, other than methotrexate, sulfasalazine or hydroxychloroquine, were used during the first two weeks of the study; (3) Those taking strong opioid analgesics (such as methadone, hydromorphone or morphine) within the first two weeks of randomization; (4) Those who received secukinumab or other biological drugs directly targeting IL-1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: vital signs (pulse rate, blood pressure, pulse and body temperature, Physical examinations, injection site reactions, 12-lead dECGs, routine blood test, serum biochemistry, coagulation and urinalysis, any adverse events;Pharmacokinetic parameters: Cmax, AUC0-inf, %AUCex, AUC0-t, AUCtau, Tmax, T1/2, ?z, Rac, Vz, CLss, MRT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving assessment of responders for the SpondyloArthritis International Society (ASAS20), ASAS40 response criteria at Week 4,8,12,16.;Change from baseline in PGA, PhGA, BASFI, BASDAI, hsCRP, ESR at Week 4,8,12,16.;Detection of anti-drug antibody (ADA) titer, number and percentage of subjects with positive ADA; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed