NCT02714959

Brief Summary

The purpose of this study is to determine whether low-dose IL-2 is effective in refractory autoimmune encephalitis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2016

Typical duration for phase_1

Status
completed

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

Study Start

First participant enrolled

March 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

3.3 years

First QC Date

March 14, 2016

Last Update Submit

September 23, 2021

Conditions

Encephalitis

Outcome Measures

Primary Outcomes (1)

  • Change of modified Rankin scale

    Week 0,12

Secondary Outcomes (5)

  • The change of percentage of regulatory T (Treg) cells

    Week 1, 3, 5, 9, 12, 21

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Week 1, 3, 5, 9, 12, 21

  • Quality of Life in Epilepsy Inventory (QOLIE)-31

    Week 21

  • Beck Depression Inventory (BDI)

    Week 21

  • Cognitive function

    Week 21

Study Arms (1)

Proleukin

EXPERIMENTAL

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

Drug: Proleukin

Interventions

ProleukinDRUG
Proleukin

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Klatzmann D, Abbas AK. The promise of low-dose interleukin-2 therapy for autoimmune and inflammatory diseases. Nat Rev Immunol. 2015 May;15(5):283-94. doi: 10.1038/nri3823. Epub 2015 Apr 17.

    PMID: 25882245BACKGROUND

  • Saadoun D, Rosenzwajg M, Joly F, Six A, Carrat F, Thibault V, Sene D, Cacoub P, Klatzmann D. Regulatory T-cell responses to low-dose interleukin-2 in HCV-induced vasculitis. N Engl J Med. 2011 Dec 1;365(22):2067-77. doi: 10.1056/NEJMoa1105143.

    PMID: 22129253BACKGROUND

  • Hartemann A, Bensimon G, Payan CA, Jacqueminet S, Bourron O, Nicolas N, Fonfrede M, Rosenzwajg M, Bernard C, Klatzmann D. Low-dose interleukin 2 in patients with type 1 diabetes: a phase 1/2 randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2013 Dec;1(4):295-305. doi: 10.1016/S2213-8587(13)70113-X. Epub 2013 Oct 8.

    PMID: 24622415BACKGROUND

  • Rosenzwajg M, Churlaud G, Mallone R, Six A, Derian N, Chaara W, Lorenzon R, Long SA, Buckner JH, Afonso G, Pham HP, Hartemann A, Yu A, Pugliese A, Malek TR, Klatzmann D. Low-dose interleukin-2 fosters a dose-dependent regulatory T cell tuned milieu in T1D patients. J Autoimmun. 2015 Apr;58:48-58. doi: 10.1016/j.jaut.2015.01.001. Epub 2015 Jan 26.

    PMID: 25634360BACKGROUND

  • Castela E, Le Duff F, Butori C, Ticchioni M, Hofman P, Bahadoran P, Lacour JP, Passeron T. Effects of low-dose recombinant interleukin 2 to promote T-regulatory cells in alopecia areata. JAMA Dermatol. 2014 Jul;150(7):748-51. doi: 10.1001/jamadermatol.2014.504.

    PMID: 24872229BACKGROUND

  • Humrich JY, von Spee-Mayer C, Siegert E, Alexander T, Hiepe F, Radbruch A, Burmester GR, Riemekasten G. Rapid induction of clinical remission by low-dose interleukin-2 in a patient with refractory SLE. Ann Rheum Dis. 2015 Apr;74(4):791-2. doi: 10.1136/annrheumdis-2014-206506. Epub 2015 Jan 21. No abstract available.

    PMID: 25609413BACKGROUND

MeSH Terms

Conditions

Encephalitis

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 22, 2016

Study Start

March 1, 2016

Primary Completion

June 12, 2019

Study Completion

June 12, 2019

Last Updated

September 29, 2021

Record last verified: 2021-09