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
|Condition or disease||Intervention/treatment||Phase|
|Encephalitis||Drug: Proleukin||Phase 1 Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of IL-2 in Refractory Autoimmune Encephalitis Patients: A Pilot Study|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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
- Change of modified Rankin scale [ Time Frame: Week 0,12 ]
- 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)
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): NCT02714959
|Contact: Chu Kon, MD, PhDfirstname.lastname@example.org|