NCT02465580

A Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus

A Phase II Pilot-Study With Low-dose hrIL-2 for the Treatment of Systemic Lupus Erythematosus

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by the investigator's group, the investigators found that the Low-dose IL-2 was effective and well tolerated in active SLE, and the effect was associated with selective modulation of CD4+ T cell subsets. This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).

Detailed description

Each SLE patients (n=60) with Scores\>=8 on SLEDAI received low-dose IL-2 or placebo (active group: placebo group =1:1, 1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3 cycles. The end points were safety and clinical and immunologic response.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	hrIL-2 active	active group: placebo group =1:1
DRUG	hrIL-2 placebo	active group: placebo group =1:1

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2015-06-08
• Last updated: 2015-06-08

Locations

1 site across 1 country: China