Status:
COMPLETED
Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial
Lead Sponsor:
Peking University People's Hospital
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 cort...
Detailed Description
Active SLE patients 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...
Eligibility Criteria
Inclusion
- 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 , mycophenolate mofetil or other immunosuppressants.
- Negative urine pregnancy test
- Written informed consent form
Exclusion
- 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;
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04077684
Start Date
September 10 2019
End Date
August 30 2024
Last Update
December 3 2024
Active Locations (1)
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1
Peking University People's Hospital
Beijing, China, 100044