Evaluating Telitacicept and Low Dose IL-2 for Treating Systemic Lupus Erythematosus

Efficacy and Immunological Evaluation of Telitacicept and Low Dose IL2 in the Treatment of Systemic Lupus Erythematosus: a Randomise Prospective Study

This study is testing whether a combination of Telitacicept and low dose IL-2 can help people with systemic lupus erythematosus feel better and improve their immune system.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: tofacitinib, prednisone
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05339217 on ClinicalTrials.gov

What this trial studies

This study investigates the clinical and immunological effects of combining Telitacicept and low dose IL-2 in patients with systemic lupus erythematosus (SLE). It is a randomized, single-center, prospective trial where participants receive 160mg of Telitacicept and 1 million IU of IL-2, with adjustments based on individual circumstances. The study aims to assess improvements in clinical and laboratory measures, as well as monitor changes in immune cell subsets and cytokines over the treatment period.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old who meet the classification criteria for systemic lupus erythematosus.

Not a fit: Patients with severe laboratory abnormalities or serious complications such as heart failure or renal insufficiency may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing systemic lupus erythematosus.

How similar studies have performed: Previous studies have shown promise in using Telitacicept and IL-2 for SLE, indicating potential for success in this combined approach.

Eligibility criteria

Inclusion Criteria:

1. Male or female \>18 years of age at screening visits
2. Patients meet the American-European Consensus Group 2002 classification criteria of SLE.
3. The patient must be informed in writing of the consent to participate in the trial and the patient is expected to be able to comply with the requirements of the study follow-up plan and other protocols.
4. Dosing of antimalarials, prednisone or equivalent, cholinergic stimulants, and topical cyclosporine required to be stable for at least 4 weeks before screening and during study; maximum doses allowed:

   * Hydroxychloroquine, 400 mg/day;
   * Prednisone, 10 mg/day

Exclusion Criteria:

Any subject meeting any of the following criteria should be excluded:

1. Laboratory abnormality: • Hb≤9 g/dl • Neutrophil 10 mg/d) within 1 month.
2. Serious complications: including heart failure (≥ New York Heart Association (NYHA) class III), renal insufficiency (creatinine clearance ≤ 30 ml/min), liver dysfunction (serum Alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than three times the upper limit of normal, or total bilirubin greater than Normal upper limit.
3. Known allergies, hyperreactivity or intolerance of tofacitinib or its excipients.
4. Have a serious infection needing hospitalization (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or use intravenous antibiotics to treat infection in 2 months before the enrollment.
5. Infection with HIV (HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If seropositive, it is recommended to consult a doctor who has expertise in treating HIV or hepatitis C virus infection.
6. Any known history of malignancy in the past 5 years (except for nonmelanoma skin cancer, non-melanoma skin cancer or cervical tumor without recurrence within 3 months after surgical cure prior to the first study preparation).
7. Uncontrolled mental or emotional disorders, including a history of drug and alcohol abuse over the past 3 years, may hinder the successful completion of the study.
8. Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.

Where this trial is running

Beijing, Beijing

• Department of Rheumatology and Immunology, Peking University People's Hospital — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Zhanguo Li — Peking University Institute of Rheuamotology and Immunology
• Study coordinator: Tian Liu, Dr

Conditions Systemic Lupus Erythematosus; SLE; Telitacicept; IL-2