Brief Summary

Dysfunction of regulatory T (Treg) cells has been detected in diverse autoimmune diseases, which can be promoted by interleukin-2 (IL-2). In a previous small sample trail performed by the investigator's group, the investigators found that the Low-dose IL-2 was effective and well tolerated in active SLE, and the effect was associated with selective modulation of CD4+ T cell subsets. This clinical study will confirm the efficacy and safety of low dose IL-2 treatment in SLE. The investigators perform a single-centre, double-blind pilot trial with hrIL-2 in SLE.The investigators evaluate the effectiveness and safeness of low-dose hrIL-2 for Systemic lupus erythematosus by randomized controlled study (hrIL-2 (N = 30) versus placebo group (N = 30)).

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Jun 2015

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

June 1, 2015

Completed

2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2015

Completed

5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2015

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

Last Updated

June 8, 2015

Status Verified

June 1, 2015

Enrollment Period

2 years

First QC Date

June 3, 2015

Last Update Submit

June 4, 2015

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

Number of Participants Who Were SLE Responders (SRI)
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.
week 24
Evaluation of the safety (type and number of adverse events and serious adverse events) of low-doseIL-2 in patients with SLE
Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event，drug-induced liver and kidney damage.
24 weeks

Study Arms (2)

hrIL-2 active

ACTIVE COMPARATOR

Intervention：Add hrIL-2 according to the protocol to original treatment. HrIL-2 active: 1 million U doses of human recombinant interleukin-2 s.c. injection

Drug: hrIL-2 active

hrIL-2 placebo

PLACEBO COMPARATOR

1 million U doses of placebo s.c. injection

Drug: hrIL-2 placebo

Interventions

hrIL-2 activeDRUG

active group: placebo group =1:1

Also known as: Human recombinant IL-2

hrIL-2 active

hrIL-2 placeboDRUG

active group: placebo group =1:1

hrIL-2 placebo

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Meet the American College of Rheumatology criteria for the diagnosis of SLE，1997.
Background treatment failed to control flares or to permit prednisone tapering
With at least one of the following manifestations: thrombocytopenia, disease-associated rash, mouth ulcer, non-infectious type of fever, active vasculitis, renal disorder(proteinuria\>0.5g/day), neuropsychiatric SLE.
Positive for at least one of the following laboratory tests: ANA\>1:160, anti-dsDNA, immunoglobulin\>20g/L, decreased C3 or C4, leukopenia\<3×10\^9/L, thrombocytopenia\<100×10\^9/L;
SLE disease activity index(SLEDAI) ≥ 8.
Negative HIV test.
Negative for hepatitis B and C virus.
Negative urine pregnancy test.
Written informed consent form.

You may not qualify if:

Sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases\> 3N) )
Serious infection such as bacteremia, sepsis;
Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
High-dose steroid pulse therapy (\>1.5mg/kg) or IV bolus of corticosteroids in the last 2 months.
History of administration of rituximab or other biologics;
Purified protein derivative (tuberculin) \>10mm
Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
Inability to comply with IL-2 treatment regimen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking University People's Hospitallead
Monash Universitycollaborator
Beijing ShuangLu Pharmaceutical Co., Ltd.collaborator

Study Sites (1)

Department of Rheumatology and Immunology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (3)

Miao M, Xiao X, Tian J, Zhufeng Y, Feng R, Zhang R, Chen J, Zhang X, Huang B, Jin Y, Sun X, He J, Li Z. Therapeutic potential of targeting Tfr/Tfh cell balance by low-dose-IL-2 in active SLE: a post hoc analysis from a double-blind RCT study. Arthritis Res Ther. 2021 Jun 11;23(1):167. doi: 10.1186/s13075-021-02535-6.
PMID: 34116715DERIVED
Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.
PMID: 33687069DERIVED
He J, Zhang R, Shao M, Zhao X, Miao M, Chen J, Liu J, Zhang X, Zhang X, Jin Y, Wang Y, Zhang S, Zhu L, Jacob A, Jia R, You X, Li X, Li C, Zhou Y, Yang Y, Ye H, Liu Y, Su Y, Shen N, Alexander J, Guo J, Ambrus J, Lin X, Yu D, Sun X, Li Z. Efficacy and safety of low-dose IL-2 in the treatment of systemic lupus erythematosus: a randomised, double-blind, placebo-controlled trial. Ann Rheum Dis. 2020 Jan;79(1):141-149. doi: 10.1136/annrheumdis-2019-215396. Epub 2019 Sep 19.
PMID: 31537547DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

Zhanguo Li, MD
Peking University Institute of Rheumatology and Immunology
PRINCIPAL INVESTIGATOR

Central Study Contacts

Tian Liu, MD

CONTACT

8613661345637 mikle317@163.com

Jing He, MD

CONTACT

8618611707347 hejing1105@126.com

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Dept. Rheumatology and Immunology

Study Record Dates

First Submitted

June 3, 2015

First Posted

June 8, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

June 8, 2015

Record last verified: 2015-06

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

hrIL-2 active

hrIL-2 placebo

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations