telitacicept study in chinese subjects with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: this is a multi-center, open-label, phase i study.

the purpose of this study is to evaluate the pharmacokinetics, safety and efficacy of telitacicept in chinese patients with systemic lupus erythematosus.

Eligibility criteria:
inclusion criteria: 1. subjects who give consent to this study participation and sign informed consent form; 2. males and females, between the ages of 18 and 65 years old, inclusive, at the screening visit; 3. diagnosis of sle as defined by the american college of rheumatology (acr) 1997 criteria, with 4 or more of the 11 acr criteria present; 4. selena-sledai score ≥8 points with a clinical selena-sledai score ≥6 points if low complement levels and/or anti-ds-dna antibodies are present at the screening visit; 5. subjects with unequivocally positive test for anti-nuclear antibody (ana) and/or anti-ds-dna serum antibody; 6. be on a sle standard treatment regimen (and remain stable) for a period of at least 30 days prior to day 0. the standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (nsaids), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine. exclusion criteria: 1. subjects with severe lupus kidney disease (defined by proteinuria \>6g/24h or serum creatinine \>2.5mg/dl or serum creatinine \>221μmol/l) or active nephritis requiring prohibited medications, or subjects requiring hemodialysis or prednisone (or its equivalent)≥100mg/d for a period of ≥14 days within 8 weeks of day 0; 2. central nervous system (cns) disease associated with lupus or not \[including seizures, psychosis, organic brain syndrome, cerebrovascular accident (cva), encephalitis, cns angiitis\] within 8 weeks prior to the screening visit; 3. laboratory abnormalities including, but not limited to the following: 1. alt/ast≥2×upper limit of normal (uln); 2. endogenous creatinine clearance rate\<30 ml/min; 3. white blood cell count\<2.5×10\^9/l; 4. hemoglobin\<85 g/l; 5. platelet count\<50×10\^9/l; 4. active hepatitis or a history of severe liver disease at the screening visit. positive test for hepatitis b surface antigen (hbsag) or anti-hepatitis c virus antibodies (hcvab). if anti-hbcab result is positive while hbsag result is negative, hepatitis b virus (hbv)-(dna) test will be performed. if hbv-dna result is negative, the patient is eligible; 5. subjects with immunodeficiency, uncontrolled severe infection or active/recurrent gastrointestinal ulcers; 6. pregnant or lactating female subjects or sexually active subjects who refuse to practice the protocol-specified contraception throughout the study; 7. history of allergy to humanized biological products; 8. subjects who received live vaccine within 28 days of day 0; 9. participation in any other investigational study drug trial in the past 28 days or 5 half-lives, whichever was longer, prior to day 0. subjects who participated in a clinical trial on b-cell-targeted drug, or tumor necrosis factor inhibitor, or interleukin receptor blocker within 12 months prior to day 0 would be excluded; 10. subjects who received other b-cell targeted drugs, such as belimumab, rituximab or epratuzumab within 12 months prior to day 0; 11. subjects who received tumor necrosis factor inhibitors, interleukin receptor blockers within 12 months prior to day 0; 12. subjects who received intravenous immune globulin (ivig), or high dose prednisone or its equivalents (≥100mg/d) for a period of ≥ 14 days, or plasma exchange within 28 days prior to day 0; 13. subjects who received il-2, thalidomide, tripterygium wilfordii or chinese medicinal preparations containing tripterygium wilfordii within 28 days prior to day 0; 14. subjects with active infections (herpes zoster, hiv infection, active tuberculosis, etc.) at the screening visit; 15. subjects with depression or suicidal thoughts; 16. any condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol..

Keywords: systemic lupus erythematosus telitacicept pharmacokinetics lupus erythematosus, systemic connective tissue diseases autoimmune diseases