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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 : Not yet recruiting
First Posted : September 4, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Zhanguo Li, Peking University People's Hospital

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 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

Detailed 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.

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Study Type : Interventional
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
Estimated Study Start Date : September 10, 2019
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

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




Primary Outcome Measures :
  1. 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
Criteria

Inclusion Criteria:

  1. Meet the 1997 revised classification criteria of the American College of Rheumatology
  2. SLE disease activity index(SLEDAI) ≥ 8
  3. age:18 to 75 years, weight 45-80Kg
  4. 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
  5. Negative urine pregnancy test
  6. Written informed consent form

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
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Contact: Xia Zhang 8615201303563 haoxiamei@163.com
Contact: Jing He 8618611707347 hejing1105@126.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Zhanguo Li Peking University Institute of Rheumatology and Immunology

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Responsible Party: Zhanguo Li, Dept. Rheumatology and Immunology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04077684     History of Changes
Other Study ID Numbers: 2018PHB041-01
First Posted: September 4, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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