Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic Lupus Erythematosus
NCT05262686 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2022-03-25
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.
Conditions
Interventions
- DRUG
-
Belimumab
Belimumab was intravenously administrated at a dose of 10mg/kg once a month for at least 24 weeks.
- DRUG
-
Interleukin-2
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.
Sponsors & Collaborators
-
Peking University People's Hospital
lead OTHER
Principal Investigators
-
Zhanguo Li · Peking University Institute of Rheuamotology and Immunology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-01
- Primary Completion
- 2023-06-01
- Completion
- 2023-06-01
Countries
- China
Study Locations
More Related Trials
-
Efficacy and Safety of Belimumab in SLE Patients
NCT04515719 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial
NCT04077684 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
NCT00410384 ·Status: COMPLETED ·Phase: PHASE3
-
GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia
NCT01345253 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Belimumab in Patients With Active Lupus Nephritis
NCT01639339 ·Status: COMPLETED ·Phase: PHASE3
-
Phase 1 Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
NCT00657007 ·Status: COMPLETED ·Phase: PHASE1
-
Anti-infection of Low-does IL-2 in SLE
NCT02932137 ·Status: COMPLETED ·Phase: NA
-
Single Dose Study to Investigate the Pharmacokinetics (PK) and Safety of Belimumab 200 Milligrams (mg) Intravenous and 200 mg Subcutaneous Via Auto-injector in Chinese Healthy Subjects
NCT04136145 ·Status: COMPLETED ·Phase: PHASE1
-
Trial of Belimumab Combined With Multi-target Induction Therapy in Lupus Nephritis
NCT05863936 ·Status: UNKNOWN ·Phase: PHASE3
-
Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy
NCT02270970 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
NCT06411249 ·Status: RECRUITING ·Phase: PHASE4
-
A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus
NCT04961567 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE)
NCT01632241 ·Status: COMPLETED ·Phase: PHASE4
-
Belimumab Assessment of Safety in SLE
NCT01705977 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus (SLE)
NCT00424476 ·Status: COMPLETED ·Phase: PHASE3
-
A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus.
NCT07069972 ·Status: NOT_YET_RECRUITING
-
Belimumab Phase I Study in Chinese Subjects With Systemic Lupus Erythematosus
NCT02880852 ·Status: COMPLETED ·Phase: PHASE1
-
The Incidence of Infection in Treatment of Low-dose IL-2 of SLE Patients
NCT04136106 ·Status: UNKNOWN
-
Transcriptional and Immune Parameters of Response to Belimumab
NCT04570306 ·Status: COMPLETED
-
A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057
NCT00712933 ·Status: COMPLETED ·Phase: PHASE3
-
A Comparative Study of the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus Involving Multiple Units, Based on Previous Data.
NCT07053137 ·Status: ACTIVE_NOT_RECRUITING
-
A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE
NCT03312907 ·Status: COMPLETED ·Phase: PHASE3
-
A Continuation Trial for Subjects With Systemic Lupus Erythematosus That Have Completed Protocol LBSL02
NCT00583362 ·Status: COMPLETED ·Phase: PHASE2
-
A Continuation Trial for Subjects With Lupus Who Completed Protocol HGS1006-C1056 in the United States
NCT00724867 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of a Biologic to Treat Systemic Lupus Erythematosus
NCT02265744 ·Status: COMPLETED ·Phase: PHASE2