Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 December 2023
• Main ID: NCT05247203
• Date of registration: 26/01/2022
• Prospective Registration: Yes
• Primary sponsor: RemeGen Co., Ltd.
• Public title: Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus
• Scientific title: A Phase I, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Telitacicept in Chinese Subjects With Systemic Lupus Erythematosus (SLE)
• Date of first enrolment: May 11, 2022
• Target sample size: 92
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT05247203
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

China

Key inclusion & exclusion 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..



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Drug: standard therapy

Biological: Telitacicept

Primary Outcome(s)

Observed plasma concentration of Telitacicept just prior to the beginning of a dosing interval (Ctrough) [Time Frame: up to 42 days following the last dose of Telitacicept]

Average concentration (Cav) of Telitacicept [Time Frame: up to 42 days following the last dose of Telitacicept]

Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of Telitacicept [Time Frame: up to 42 days following the last dose of Telitacicept]

Area under the curve from time zero to last quantifiable concentration (AUC 0-t) of Telitacicept [Time Frame: up to 42 days following the last dose of Telitacicept]

Peak plasma concentration (Cmax) of Telitacicept [Time Frame: up to 42 days following the last dose of Telitacicept]

Time to reach Cmax (tmax) of Telitacicept [Time Frame: up to 42 days following the last dose of Telitacicept]

Terminal elimination rate constant (?z) of Telitacicept [Time Frame: up to 42 days following the last dose of Telitacicept]

Area under the curve from time zero to tau (AUC 0-tau) of Telitacicept [Time Frame: up to 42 days following the last dose of Telitacicept]

Terminal elimination half-life (t1/2z) of Telitacicept [Time Frame: up to 42 days following the last dose of Telitacicept]

Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F) of Telitacicept [Time Frame: up to 42 days following the last dose of Telitacicept]

Secondary Outcome(s)

Change From Baseline to W24 in IgG [Time Frame: Week 4, 8, 12, 16, 20, and 24]

Change From Baseline to W24 in IgM [Time Frame: Week 4, 8, 12, 16, 20, and 24]

Number of Participants Experiencing Adverse Events (AEs) [Time Frame: up to 28 days following the last dose of Telitacicept]

Change From Baseline to W24 in C3 [Time Frame: Week 4, 8, 12, 16, 20, and 24]

Change From Baseline to W24 in C4 [Time Frame: Week 4, 8, 12, 16, 20, and 24]

Change From Baseline to W24 in IgA [Time Frame: Week 4, 8, 12, 16, 20, and 24]

Change From Baseline to W24 in patient global assessment (PGA) [Time Frame: Week 4, 8, 12, 16, 20, and 24]

Percentage of participants achieving a SLE Responder Index (SRI) [Time Frame: Week 4, 8, 12, 16, 20, and 24]

Percentage of participants achieving a SELENA-SLEDAI improvement of =4 points [Time Frame: Week 4, 8, 12, 16, 20, and 24]

Secondary ID(s)

18C020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors