A Phase I, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Telitacicept in Chinese Subjects With Systemic Lupus Erythematosus (SLE)

18C020

This is a multi-center, open-label, phase I study.

2022-05-11

2023-10-25

2023-11-13

Completed

Early phase I

92

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..

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 92, 'type': 'ACTUAL'}}

2023-12-06