A Phase 1, Open-label, Multi-center, Multiple-dose Study to Evaluate the Pharmacokinetics of Telitacicept in Subjects With Childhood-onset Systemic Lupus Erythematosus

18C018

This is a multi-center, open-label, phase 1 study.

2023-05-25

2024-10-01

2024-12-01

Recruiting

Early phase I

12

Main Inclusion Criteria: 1. Fulfills SLICC 2012 or 2019 EULAR/ACR classification criteria for SLE. 2. 12-17 years of age when signing the informed consent. 3. Parent or legal guardian provided written informed consent. 4. SELENA SLEDAI score ≥ 8 at screening. 5. Serum autoantibodies (ANA and/or anti ds-DNA) tested positive at screening. 6. Have been on a stable standard of care for SLE for at least 30 days prior to randomization. Main Exclusion Criteria: 1. Have received Telitacicept at any time. 2. Have received any of the following therapies within 6 months of baseline: B-cell targeted treatment, e.g., belimumab, rituximab, abatacept, other investigational biologicals. 3. Have received any of the following therapies within 90 days of baseline: anti-TNF or anti-IL-6 therapy, interleukin-1 receptor antagonist, intravenous immunoglobulin (IVIG), plasmapheresis. 4. Have received any of the following therapies within 30 days of baseline: Intravenous cyclophosphamide, non-biological investigational agents (within 30 days of baseline or 5 half-lives, whichever is longer), newly added immunosuppressive/immunomodulatory agent, anti-malarial, NSAID, high-dose prednisone or equivalent (\> 1.5 mg/kg/day) or any intramuscular or intravenous steroid. 5. Have received live vaccine within 30 days of baseline. 6. Participated in an interventional clinical trial within 6 months of screening. 7. Active CNS lupus requiring treatment within 60 days of baseline, including seizure, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis or CNS vasculitis. 8. Currently on kidney replacement therapy (hemodialysis, peritoneal dialysis) or in need of such therapy within 90 days of baseline. 9. eGFR\<30 mL/min/1.73m2. 10. Acute severe nephritis. 11. History of vital organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. 12. Significant unstable or uncontrolled acute or chronic diseases (cardiovascular, lung, hematology, gastrointestinal, liver, renal, neurologic, malignancy or infectious disease) that could be explained by causes other than SLE. 13. History of malignant neoplasm in the past 5 years. 14. Primary immune deficiency. 15. Acute or chronic infections requiring treatment. 16. HIV/HCV/HBsAg/HBcAb positive. 17. Tuberculosis. 18. Have planned surgery, laboratory abnormalities, other diseases or conditions that, in the opinion of the investigator, makes the subject unsuitable for the study.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ESTIMATED'}}

2023-09-06