Efficacy and Safety of Low-dose IL-2 in Patients With SLE: a Multicenter, Randomised, Placebo-controlled Trial
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ClinicalTrials.gov Identifier: NCT04077684 |
Recruitment Status :
Recruiting
First Posted : September 4, 2019
Last Update Posted : March 27, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Systemic Lupus Erythematosus | Drug: Interleukin-2 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Low-dose Interleukin-2 in Patients With Systemic Lupus Erythematosus: a Multicenter, Randomised, Placebo-controlled Trial |
Actual Study Start Date : | September 10, 2019 |
Estimated Primary Completion Date : | August 31, 2024 |
Estimated Study Completion Date : | December 31, 2024 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
placebo s.c. injection every other day for the first 12 weeks and then once a week for the second 12 weeks
|
Drug: Interleukin-2
IL2 (0.2 MIU, 0.5 MIU or 1 MIU) : placebo = 1:1:1:1
Other Name: Human recombinant IL-2 |
Active Comparator: IL-2 at 0.2MIU
0.2 MIU doses of IL-2 s.c. injection every other day for the first 12 weeks and then once a week for the second 12 weeks
|
Drug: Interleukin-2
IL2 (0.2 MIU, 0.5 MIU or 1 MIU) : placebo = 1:1:1:1
Other Name: Human recombinant IL-2 |
Active Comparator: IL-2 at 0.5MIU
0.5 MIU doses of IL-2 s.c. injection every other day for the first 12 weeks and then once a week for the second 12 weeks
|
Drug: Interleukin-2
IL2 (0.2 MIU, 0.5 MIU or 1 MIU) : placebo = 1:1:1:1
Other Name: Human recombinant IL-2 |
Active Comparator: IL-2 at 1.0MIU
1.0 MIU doses of IL-2 s.c. injection every other day for the first 12 weeks and then once a week for the second 12 weeks
|
Drug: Interleukin-2
IL2 (0.2 MIU, 0.5 MIU or 1 MIU) : placebo = 1:1:1:1
Other Name: Human recombinant IL-2 |
- the response measured by the SLE Responder Index-4 (SRI-4) [ Time Frame: week 12 ]SRI response was defined as (1) a ≥ 4-point reduction in SELENA-SLEDAI score, (2) no new BILAG A score or ≤ 1 new BILAG B score, and (3) no deterioration from baseline in the physician's global assessment by ≥ 0.3 points.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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;

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04077684
Contact: Xia Zhang | 8615201303563 | haoxiamei@163.com | |
Contact: Jing He | 8618611707347 | hejing1105@126.com |
China | |
Peking University People's Hospital | Recruiting |
Beijing, China, 100044 | |
Contact: Xia Zhang, MD haoxiamei@163.com | |
Contact: Jing He, MD hejing1105@126.com | |
Principal Investigator: Zhan-Guo Li, MD |
Principal Investigator: | Zhanguo Li | Peking University Institute of Rheumatology and Immunology |
Responsible Party: | Zhanguo Li, Dept. Rheumatology and Immunology, Peking University People's Hospital |
ClinicalTrials.gov Identifier: | NCT04077684 |
Other Study ID Numbers: |
2018PHB041-01 |
First Posted: | September 4, 2019 Key Record Dates |
Last Update Posted: | March 27, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Interleukin-2 Antineoplastic Agents |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |