Clinical Trial: IL-2 in Refractory Autoimmune Encephalitis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: 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 Summary:

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


Sponsor: Seoul National University Hospital

Current Primary Outcome: Change of modified Rankin scale [ Time Frame: Week 0,12 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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:

  • 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)


Information By: Seoul National University Hospital

Dates:
Date Received: March 14, 2016
Date Started: March 2016
Date Completion: December 2017
Last Updated: March 23, 2016
Last Verified: March 2016