Clinical trial NCT05262686: Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus
Official title: Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus: a Randomised Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to explore the clinical and immunological efficacy of belimumab plus low dose IL-2 in systemic lupus erythematosus.

Detailed description: Given that belimumab and low dose interleukin-2 (IL-2) have been widespreadly applied in the treatment of systemic lupus erythematosus (SLE), this study designed a randomised, single center, prospective study to investigate the effects and safety of combined utilization of belimumab and low dose IL-2. SLE patients were allocated in each group randomly (n=10) and regularly administered belimumab (10mg/kg) with or without IL-2 (1 million IU). Then, we evaluated the improvement of clinical and laboratory indexes and monitored the changes of immune cell subsets and cytokines.

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 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:

* 1. 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, Epstein-Barr virus (EBV), 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.

Primary outcomes:
measure: Immunological responses of B cell subsets
timeFrame: Week 24
Secondary outcomes:
measure: Proportion of SLE Responder Index (SRI)4 response
timeFrame: Week 12 and 24
measure: Prednisone dose
timeFrame: Week 12 and 24
measure: Immunoglobulin change from baseline
timeFrame: Week 12 and 24
measure: Autoantibody change from baseline
timeFrame: Week 12 and 24
measure: Change of complement C3 and C4 Levels from baseline
timeFrame: Week 12 and 24
measure: Safety and tolerability of the treatment
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Rheumatology and Immunology, Peking University People's Hospital
Study officials:
affiliation: Peking University Institute of Rheuamotology and Immunology
name: Zhanguo Li
role: PRINCIPAL_INVESTIGATOR
References: