Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    500
  • sponsor
    Peking University People's Hospital
Updated on 2 March 2022
corticosteroids
cyclophosphamide
immunosuppressive agents
interleukin-2
hydroxychloroquine
lupus
mycophenolate

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.

Description

Five hundred patients with active SLE at 18 to 75 years of age were enrolled. Patients were randomly assigned (in a 1:1:1:1 ratio) to one of the four arms (placebo or IL-2 at 0.2 MIU, 0.5 MIU or 1 MIU) in the study. IL-2 (0.2 MIU, 0.5 MIU or 1 MIU) or placebo was administered subcutaneously every other day for the first 12 weeks , and then was adjusted to once a week for the second 12 weeks. Follow-up visits occurred on weeks 4, 8,12,16,20 and 24. The end points were safety and clinical and immunologic response.

Details
Condition Systemic Lupus Erythematosus
Treatment Interleukin-2
Clinical Study IdentifierNCT04077684
SponsorPeking University People's Hospital
Last Modified on2 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Meet the 1997 revised classification criteria of the American College of Rheumatology
SLE disease activity index(SLEDAI) 8
age:18 to 75 years, weight 45-80Kg
Patients had an inadequate response to standard treatment for 3 months. The background treatment included corticosteroids (1.0 mg/kg), hydroxychloroquine, cyclophosphamide or mycophenolate mofetil
Negative urine pregnancy test
Written informed consent form

Exclusion Criteria

allergic to IL-2, corticosteroids, hydroxychloroquine, cyclophosphamide or mycophenolate mofetil
active severe neuropsychiatric manifestations of SLE
hepatic insufficiency (alanine aminotransferase or aspartate aminotransferase 2 times of the upper limit of the normal range)
pregnancy or lactation in females
Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma)
Serious infection such as bacteremia, sepsis;history of chronic infection
active infection (hepatitis B or C virus, Epstein-Barr virus, human immunodeficiency virus or Mycobacterium tuberculosis)
history vision and visual field disorders, cataract
severe comorbidities including heart failure ( grade III NYHA)
active peptic ulcers
complicated with other autoimmune diseases
History of administration of rituximab or other biologics within 6 months
therapy with other immunosuppressors
participate in other clinical trial within 4 weeks
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