Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
The management of active systemic lupus erythematosus (SLE) is challenging due to the
heterogeneous nature of the disease and lack of specific treatment. Current treatment
regimens mainly rely on corticosteroids and immunosuppressive agents which are associated
with substantial adverse effects including various infections. Therefore, there is an unmet
need for new therapies with better efficacy and less adverse effects.
Defective IL-2 production contributes to the unbalanced immune system in SLE. Previous short
term open-labelled trials showed that low-dose IL-2 was efficient and tolerated in active
SLE. It was suggested that low-dose IL-2 treatment promoted regulatory T cells (Treg) and
inhibited T helper 17 cells (Th17) and follicular helper T cells (Tfh). The immunological
rebalancing was associated with the induction of remission in SLE patients.
To establish that which low doses of IL-2 would be more efficacious and safe in active SLE,
we carried out a multi-center, randomized, double-blind, placebo-controlled trial of three
doses of IL2 (0.2 MIU, 0.5 MIU or 1 MIU) versus placebo.