ankylosing spondylitis
Conditions
Interventions
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. Able to independently sign the informed consent and voluntarily participate in this QX002N Phase II extended trial; 2. Aged 18-70 years (including 18 and 70), regardless of gender; 3. Participate in the phase II clinical study of QX002N in the treatment of AS (main trial, study number: QX002NA-03) and meet the following criteria (1) or (2) : (1) Subjects completed the prescribed treatment and EOS (V9) visit according to the protocol; (2) The subject had early withdrawal due to objective reasons other than AE related to QX002N, and completed the early withdrawal visit according to the protocol, and the influencing factors that led to the early termination of the main trial treatment have disappeared/no longer affect the subject's participation in this extended study as assessed by the investigator and the sponsor; 4. Subjects and their partners agree to have no reproductive plans and to voluntarily use effective contraception during the entire study period (from screening to 6 months after the last dose).
Exclusion criteria
Exclusion criteria: 1. QX002N related SAE occurred in the main trial, or QX002N related AE resulted in the termination of QX002N treatment, which was deemed inappropriate to continue QX002N treatment after discussion between the investigator and the sponsor; 2. Subjects with poor compliance in the main trial who, in the judgment of the Investigator, are unable to complete the extended study, or who, in the judgment of the Investigator, are unable to benefit from the extended study because their symptoms do not improve or worsen; 3. Women who were pregnant or planned to become pregnant or breastfeed during the study; 4. Acute infections (other than upper respiratory tract infections) with clinically significant symptoms or signs, or infections requiring systemic antibiotic treatment, occurring within 2 weeks prior to screening; 5. Active or latent TB infection at the time of screening; 6. Any infectious disease screening indicator before screening meets the following criteria: Among the five items of hepatitis B, HBsAg positive (HBsAg negative but HBcAb positive, HBV-DNA quantitative test is required, HBV-DNA test results >= the upper limit of the reference value of each center or subjects requiring antiviral therapy are not eligible to participate in the study), hepatitis C antibody positive (HCV-RNA needs to be added, if negative, Eligible to be included), positive for syphilis antibody (if the syphilis serological test was positive, further non-syphilis serological test was performed, and the latter was negative and was judged by the investigator to have been cured of syphilis in the past), and HIV antibody test positive; 7. Diagnosis of active suicidal ideation on the Columbia-Suicide Severity Rating Scale (CSSRS) in the 3 months prior to screening was a positive (" yes ") response to question 4 or question 5 or additional question 6 of the CSSRS in the screening version.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Proportion of subjects achieving 20% improvement (ASAS 20) of the International Association for the Evaluation of Spinal Arthritis; | — |
Countries
China
Contacts
Public ContactXiaofeng Zeng
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed