Status:
COMPLETED
Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus
Lead Sponsor:
RemeGen Co., Ltd.
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a multi-center, open-label, phase I study.
Detailed Description
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
- Subjects who give consent to this study participation and sign informed consent form;
- Males and females, between the ages of 18 and 65 years old, inclusive, at the screening visit;
- Diagnosis of SLE as defined by the American College of Rheumatology (ACR) 1997 criteria, with 4 or more of the 11 ACR criteria present;
- 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;
- Subjects with unequivocally positive test for anti-nuclear antibody (ANA) and/or anti-ds-DNA serum antibody;
- 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
- 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;
- 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;
- Laboratory abnormalities including, but not limited to the following:
- ALT/AST≥2×upper limit of normal (ULN);
- endogenous creatinine clearance rate\<30 mL/min;
- white blood cell count\<2.5×10\^9/L;
- hemoglobin\<85 g/L;
- platelet count\<50×10\^9/L;
- 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;
- Subjects with immunodeficiency, uncontrolled severe infection or active/recurrent gastrointestinal ulcers;
- Pregnant or lactating female subjects or sexually active subjects who refuse to practice the protocol-specified contraception throughout the study;
- History of allergy to humanized biological products;
- Subjects who received live vaccine within 28 days of Day 0;
- 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;
- Subjects who received other B-cell targeted drugs, such as Belimumab, rituximab or Epratuzumab within 12 months prior to Day 0;
- Subjects who received tumor necrosis factor inhibitors, interleukin receptor blockers within 12 months prior to Day 0;
- 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;
- Subjects who received IL-2, Thalidomide, Tripterygium wilfordii or Chinese medicinal preparations containing Tripterygium wilfordii within 28 days prior to Day 0;
- Subjects with active infections (herpes zoster, HIV infection, active tuberculosis, etc.) at the screening visit;
- Subjects with depression or suicidal thoughts;
- Any condition or circumstance that, in the opinion of the investigator, may compromise the patient's ability to comply with the study protocol..
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2023
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05247203
Start Date
May 11 2022
End Date
November 13 2023
Last Update
December 6 2023
Active Locations (19)
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1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233004
2
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, China, 230001
3
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
4
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510260