Immune Cell Subsets in SLE Patients Treated with Telitacicept

NCT06677801 | Active Not Recruiting Phase 4

• 1 other identifier: 2024-1010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a single-center cohort study. Patients with SLE who met the inclusion criteria were treated with tetanercept 160 mg once a week for a total of 24 weeks, and the clinical and laboratory indicators were collected before treatment, at the 4th week, at the 12th week, and at the 24th week, and blood samples were collected for the detection of immune cell subsets.

Conditions

Systemic Lupus Erythematosus (SLE)

Outcome Measures

Primary Outcomes (1)

• Changes of immune cell subsets after treatment

  24 weeks

Secondary Outcomes (1)

• SLE responder index (SRI) -4

  24 weeks

Study Arms (1)

Participant Group

ACTIVE COMPARATOR

SLE patients treated with Telitacicept

Biological: Telitacicept 160mg

Interventions

Telitacicept 160mg BIOLOGICAL

Telitacicept 160mg weekly for 24 weeks, and peripheral subtypes of immune cells will be measured at week 0, 4, 12, and 24.

Participant Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with confirmed active SLE, who meet at least 4 of the 11 criteria for SLE revised by the United States College of Rheumatology in 1997 at the time of diagnosis;
• Age 18\~65 years old, male or female, gender ratio is not limited;
• SLEDAI -2k score ≥ 8 points during the screening period;
• ANA positivity as defined by a clear reference range within half a year;
• Maintain a stable standard treatment regimen for at least 28 days prior to the date of the first dose of trial drug. Standard regimen refers to stable use of any of the following (alone or in combination): corticosteroids, antimalarials, nonsteroidal anti-inflammatory drugs (NSAIDs), other immunosuppressants or immunomodulators including azathioprine, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil), cyclophosphamide, methotrexate, leflunomide, tacrolimus, and cyclosporine.
• Understand the purpose and trial steps of this trial, and voluntarily sign a written informed consent form.

You may not qualify if:

• Renal disease: severe lupus nephritis (defined as urine protein \>6g/24 hours or serum creatinine \>2.5mg/dL or 221μmol/L) within 8 weeks prior to randomization, or requiring active nephritis with protocol-prohibited medications, or requiring hemodialysis or receiving prednisone ≥100mg/d or equivalent corticosteroid therapy for ≥ 14 days;
• Neurological diseases: those with central nervous system diseases caused by SLE or non-SLE within 8 weeks prior to randomization, including but not limited to epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.;
• Those with obvious abnormalities in laboratory examinations: a. ALT or AST≥2×ULN (upper limit of normal); b. Endogenous creatinine clearance \< 30 mL/min; c. White blood cell count \< 2.5×10 9/L; d. Hemoglobin \<85g/L; Platelet count \< 50×10 9/L;
• Current active hepatitis or previous severe liver lesions or medical history. Hepatitis B: excludes patients who are HBsAg positive. Patients who are HBsAg negative but HBcAb positive will need to be accounted for by HBV-DNA testing: if HBV-DNA is positive, the patient is excluded from participating in the study; If HBV-DNA is negative, the patient can participate in the study. Hepatitis C: excludes patients who are positive for hepatitis C antibodies;
• Immunodeficiency or active infection (such as herpes zoster, HIV virus infection, active tuberculosis, etc.) during the screening period;
• Patients with other connective tissue diseases, history of malignancy, or active/recurrent peptic ulcer;
• Pregnant women, lactating women, and males or females with birth plans during the trial;
• Those who have received a live vaccine within 28 days prior to randomization;
• Participation in any clinical trial within 28 days prior to randomization or within 5 times the half-life of the investigational drug enrolled in the clinical trial (whichever is longer);
• Use of B-cell-targeted therapy agents such as rituximab, epacizumab or belimumab, etc., within 12 months prior to randomization;
• Use of tumor necrosis factor inhibitors, interleukin receptor blockers within 12 months prior to randomization;
• Those who have been treated with intravenous immunoglobulin (IVIG), prednisone ≥ 100mg/d, or equivalent corticosteroids for ≥ 14 days within 28 days prior to randomization, and those who have undergone plasmapheresis;
• Use of interleukin-2, thalidomide, tripterygium wilfordii and tripterygium wilfordii-containing traditional Chinese medicine preparations within 28 days prior to randomization;
• Allergic reactions: history of allergy to human-derived biological products;
• Mentally ill persons with depression or suicidal thoughts;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the second affiliated hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310005, China

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: November 7, 2024
• Study Start: October 11, 2024
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

CN (1)