Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Apr 2022
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMarch 25, 2022
March 1, 2022
1.2 years
February 22, 2022
March 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Immunological responses of B cell subsets
A significant reduction of active B cell subsets including naive B cells and transitional B cells after different interventions. P values below 0.05 are considered statistically significant in this study.
Week 24
Secondary Outcomes (6)
Proportion of SLE Responder Index (SRI)4 response
Week 12 and 24
Prednisone dose
Week 12 and 24
Immunoglobulin change from baseline
Week 12 and 24
Autoantibody change from baseline
Week 12 and 24
Change of complement C3 and C4 Levels from baseline
Week 12 and 24
- +1 more secondary outcomes
Study Arms (3)
belimumab plus low dose IL-2
EXPERIMENTAL10mg/kg belimumab was intravenously injected to patients with systemic lupus erythematosus every month for 24 weeks. Interleukine-2 was first added to the original treatment for systemic lupus erythematosus with 1 million IU qod for 12 weeks, injected subcutaneously at the outer side of upper arm, abdomen and thigh, then the same dose of IL-2 was injected once a week for 12 weeks subcutaneously.
belimumab
ACTIVE COMPARATOR10mg/kg belimumab was administrated to patients with systemic lupus erythematosus for at least 24 weeks, intravenously injected every month.
low dose IL-2
ACTIVE COMPARATORThe first stage: interleukine-2 was added to the original treatment for systemic lupus erythematosus with 1 million IU qod for 12 weeks, injected subcutaneously at the outer side of upper arm, abdomen and thigh; The second stage: 1 million IU IL-2 was injected once a week for 12 weeks subcutaneously.
Interventions
Belimumab was intravenously administrated at a dose of 10mg/kg once a month for at least 24 weeks.
Low lose interleukine-2 at a dose of 1 million IU was injected once every other day for 12 weeks, then the same dose of IL2 was injected once a week at the second stage for 12 weeks.
Eligibility Criteria
You may qualify if:
- \- 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.
- \. 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
You may not qualify if:
- \. 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.
- \. 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.
- \. 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.
- \. 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.
- \. 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).
- \. 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.
- \. Pregnant, lactating women (WCBP) are reluctant to use medically approved contraceptives during treatment and 12 months after treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Rheumatology and Immunology, Peking University People's Hospital
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhanguo Li
Peking University Institute of Rheuamotology and Immunology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2022
First Posted
March 2, 2022
Study Start
April 1, 2022
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
March 25, 2022
Record last verified: 2022-03