Low-dose IL-2( Interleukin-2) Treatment in SLE

NCT02084238 | Completed Results DMC

• 1 other identifier: 2014-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study will test the efficacy and safety of low dose IL-2 treatment in Systemic lupus erythematosus.

Conditions

Systemic Lupus Erythematosus

Keywords

SLE, IL-2

Outcome Measures

Primary Outcomes (1)

• 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 2，week 4，week 6，week 8，week 10

Secondary Outcomes (5)

• Immunological Responses

  week 0 and week 10

• The Immunologic Impact of Low Dose IL-2 Treatment in SLE Patients

  week 0 and week 10

• SELENA SLEDAI Score

  week 0, week 10

• Number of Relapses

  24 weeks

• Safety Assessment

  up to Day 180

Study Arms (1)

Interleukin-2

EXPERIMENTAL

Interleukin-2 to treat activated SLE.

Drug: Interleukin-2

Interventions

Interleukin-2 DRUG

Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease.

Also known as: Recombinant Human Interleukin-2,125Ala, SL Pharm

Interleukin-2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the American College of Rheumatology criteria for the diagnosis of SLE.
• 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.
• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Monash University: collaborator

Study Sites (1)

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

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (1)

• Liang K, He J, Wei Y, Zeng Q, Gong D, Qin J, Ding H, Chen Z, Zhou P, Niu P, Chen Q, Ding C, Lu L, Chen XX, Li Z, Shen N, Yu D, Deng J. Sustained low-dose interleukin-2 therapy alleviates pathogenic humoral immunity via elevating the Tfr/Tfh ratio in lupus. Clin Transl Immunology. 2021 Jun 1;10(6):e1293. doi: 10.1002/cti2.1293. eCollection 2021.

  PMID: 34094549 DERIVED

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Interleukin-2

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Results Point of Contact

• Title: Dr. Jing He
• Organization: Peking University People's Hospital

hejing1105@126.com

86

Study Officials

• Zhanguo Li, MD and PhD

  Peking University Institute of Rheumatology and Immunology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2014
• First Posted: March 11, 2014
• Study Start: August 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: October 1, 2015
• Last Updated: April 3, 2020
• Results First Posted: April 13, 2015

Record last verified: 2020-03

Locations

CN (1)