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IL-2 in Refractory Autoimmune Encephalitis

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ClinicalTrials.gov Identifier: NCT02714959
Recruitment Status : Unknown
Verified March 2016 by Kon Chu, Seoul National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 22, 2016
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Kon Chu, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE March 14, 2016
First Posted Date  ICMJE March 22, 2016
Last Update Posted Date March 24, 2016
Study Start Date  ICMJE March 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
Change of modified Rankin scale [ Time Frame: Week 0,12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • The change of percentage of regulatory T (Treg) cells [ Time Frame: Week 1, 3, 5, 9, 12, 21 ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Week 1, 3, 5, 9, 12, 21 ]
  • Quality of life [ Time Frame: Week 21 ]
    Quality of Life in Epilepsy Inventory (QOLIE)-31
  • Quality of life [ Time Frame: Week 21 ]
    Beck Depression Inventory (BDI)
  • Cognitive function [ Time Frame: Week 21 ]
    Mini-mental state examination (MMSE)
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2016)
  • The change of percentage of regulatory T (Treg) cells [ Time Frame: Week 1, 3, 5, 9, 12, 21 ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Week 1, 3, 5, 9, 12, 21 ]
  • Quality of life [ Time Frame: W21 ]
    Quality of Life in Epilepsy Inventory (QOLIE)-31
  • Quality of life [ Time Frame: Week 21 ]
    Beck Depression Inventory (BDI)
  • Cognitive function [ Time Frame: Week 21 ]
    Mini-mental state examination (MMSE)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IL-2 in Refractory Autoimmune Encephalitis
Official Title  ICMJE Effect of IL-2 in Refractory Autoimmune Encephalitis Patients: A Pilot Study
Brief Summary The purpose of this study is to determine whether low-dose IL-2 is effective in refractory autoimmune encephalitis.
Detailed Description

Autoimmune encephalitis is a recently recognized etiology of encephalitis which is mediated by various autoantibodies targeting neural cells or synapses. The responses to immunotherapy is generally good, considerable proportion of patients with autoimmune encephalitis have unfavorable clinical outcomes. Recently, depletion of regulatory T cell (Treg cell) is reported in variable autoimmune diseases and multiple studies have shown that low-dose interleukin-2(IL-2) specifically activates Treg cells to control autoimmunity and inflammation.

Protocol: This study is a single arm open-label study assessing clinical responses to the administration of low-dose IL-2 in autoimmune encephalitis patients who are refractory to first- and second-line immunotherapy.

Objective: To assess the efficacy of low-dose IL-2 in autoimmune encephalitis, resistant to first- and second- line immunotherapy.

Methods: This is a single arm open-label study. Each patients will receive four cycles of subcutaneous Proleukin (Interleukin-2, IL-2) (Week-1; 1.5 million IU (MIU)/d from Day-1 to Day-5, Week-3, -6, -9; 3MIU/d from Day-1 to Day-5) in the hospital. The patients will be followed up for 3 months (Week-21).

Primary outcome - clinical efficacy by modified Rankin Scale Secondary outcome - Immunologic follow-up of Treg cells before, during, and after IL-2 therapy, quality of life, cognitive function, side effect of low-dose IL-2

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Encephalitis
Intervention  ICMJE Drug: Proleukin
Study Arms  ICMJE Experimental: Proleukin
Proleukin (subcutaneous injection) 1.5 MIU/day from day 1 to 5 at W1 3 MIU/day from day 1 to day 5 at W3, W6, and W9
Intervention: Drug: Proleukin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 16, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18 years
  • Clinical diagnosis of autoimmune encephalitis
  • Positive for autoantibody (serum and or CSF) : NMDAR, anti-leucine-rich glioma inactivated-1(LGI-1), contactin-associated protein-like 2 (CASPR2), α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPA) 1, AMPA2, GABAB-R, anti-Hu, -Yo, -Ri, -Ma2, -CV2/collapsing response mediator protein 5 (CRMP5), -amphiphysin, or glutamic acid decarboxylase (GAD)
  • Refractory to first-line (high-dose steroid or intravenous immunoglobulin) and second line (rituximab or cyclophosphamide) immunotherapy
  • Written informed consent form.

Exclusion Criteria:

  • low hemoglobin <8.0 g/dL, absolute neutrophil count<1600/mm3, lymphocytes <600/mm3, platelets <140,000/mm3
  • heart failure (≥ grade III NYHA), hepatic insufficiency (aspartate amino transferase >200 IU/L, amino alanine transferase, >200 IU/L), or lung failure
  • Positive for HIV serology, active hepatitis B
  • Significant abnormality in chest X-ray other than these linked to the diseases under investigation
  • Infection
  • Other progressive neurological degenerative disease.
  • Poor venous access not allowing repeated blood tests
  • pregnant or lactating women
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02714959
Other Study ID Numbers  ICMJE 1510112713
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kon Chu, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seoul National University Hospital
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP