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Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis:

Primary Purpose

Autoimmune Encephalitis

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Immunoglobulin G

About this trial

This is an interventional treatment trial for Autoimmune Encephalitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, aged more than 12 years.(adolescent or adult)
Subject who all three of the following diagnosis criteria for possible autoimmune encephalitis have been met.
- Subacute onset (rapid progression of less than 3 months) of working memory deficits(short-term memory loss), altered mental status, or psychiatric symptoms.
- At least one of the following:
  - New focal CNS findings
  - Seizure not explained by a previously known seizure disorder
  - CSF pleocytosis (WBC count ≥ 5/mm2)
  - MRI features suggestive of encephalitis
- Reasonable exclusion of alternative causes
Subjects or parent/legal representative willing to provide written informed consent

Exclusion Criteria:

Subject who has received Immunoglobulin therapy within 10 weeks prior to screening
Subject who has a history of hypersensitivity or shock to ingredient of immunoglobulin
Subject who has been diagnosed with IgA deficiency
Subject who has renal disorder (creatinine clearance < 10 ml/min) or requires dialysis
Subject who has been diagnosed with hemolytic anemia or anemia from blood loss
Subject who has been diagnosed with immuonological competence or immunodeficiency
Subject who has high risk of thrombus or embolism (History of thrombus/embolism or cerebro/cardiovascular disorder within 3 months prior to screening)
Subject who has low heart condition (Congestive heart failure >NYHA functional class Ⅱ: unstable coronary artery disease or myocardiac infarction within 3 months prior to screening)
Subject who cannot prohibit the previously administrated steroids by investigator's discretion (ex. Suspicion of steroid dependence, hypoadrenocorticism, when treatment effects are expected, etc.)
Females who are pregnant or breast feeding
Subject who is considered by investigator to ineligible for the study.

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

Investigational product(IP)

Outcomes

Primary Outcome Measures

Chage of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)

Change of mRS score 7 days and 28 days after IP administration compared with baseline(before IP administration)

Secondary Outcome Measures

Chage and improvement of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)

Change and improvment of mRS score 14 days and 28 days after IP administration compared with baseline(before IP administration)

Chage and improvement of Glasgow coma scale(GCS); 3(worse) to 15(better)

Change and improvment of Glasgow coma scale(GCS) 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)

Chage and improvement of Clinical Global Impression Scale-Severity; 1(better) to 7(worse)

Change and improvment of Clinical Global Impression Scale-Severity 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)

Chage and improvement of Clinical Global Impression Scale-Impovement; 1(better) to 7(worse)

Change and improvment of Clinical Global Impression Scale-Improvement 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)

Chage and improvement of CASE(Clinical Assessment scale of Encephalitis) score; 0(better) to 27(worse)

Change and improvment of CASE score 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)

The relationship

The relationship between neurological scale

Full Information

NCT ID

NCT04175522

First Posted

November 21, 2019

Last Updated

June 28, 2020

Sponsor

Green Cross Corporation

1. Study Identification

Unique Protocol Identification Number

NCT04175522

Brief Title

Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis:

Official Title

A Phase 2a, Prospective, Open-label, Single-arm, Single Center, Proof of Concept Study to Evaluate the Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

November 20, 2019 (Actual)

Primary Completion Date

June 11, 2020 (Actual)

Study Completion Date

June 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Green Cross Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of IGIV 10% in patients with autoimmune encephalitis

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autoimmune Encephalitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Experimental

Arm Description

Investigational product(IP)

Intervention Type

Drug

Intervention Name(s)

Immunoglobulin G

Intervention Description

IGIV 10%(400mg/kg) QD for 5 consecutive days administrated intravenously.

Primary Outcome Measure Information:

Title

Chage of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)

Description

Change of mRS score 7 days and 28 days after IP administration compared with baseline(before IP administration)

Time Frame

28 days

Secondary Outcome Measure Information:

Title

Chage and improvement of mRS(The Modified Rankin Scale) score; 0(better) to 6(worse)

Description

Change and improvment of mRS score 14 days and 28 days after IP administration compared with baseline(before IP administration)

Time Frame

28 days

Title

Chage and improvement of Glasgow coma scale(GCS); 3(worse) to 15(better)

Description

Change and improvment of Glasgow coma scale(GCS) 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)

Time Frame

28 days

Title

Chage and improvement of Clinical Global Impression Scale-Severity; 1(better) to 7(worse)

Description

Change and improvment of Clinical Global Impression Scale-Severity 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)

Time Frame

28 days

Title

Chage and improvement of Clinical Global Impression Scale-Impovement; 1(better) to 7(worse)

Description

Change and improvment of Clinical Global Impression Scale-Improvement 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)

Time Frame

28 days

Title

Chage and improvement of CASE(Clinical Assessment scale of Encephalitis) score; 0(better) to 27(worse)

Description

Change and improvment of CASE score 7 days, 14 days and 28 days after IP administration compared with baseline(before IP administration)

Time Frame

28 days

Title

The relationship

Description

The relationship between neurological scale

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, aged more than 12 years.(adolescent or adult) Subject who all three of the following diagnosis criteria for possible autoimmune encephalitis have been met. Subacute onset (rapid progression of less than 3 months) of working memory deficits(short-term memory loss), altered mental status, or psychiatric symptoms. At least one of the following: New focal CNS findings Seizure not explained by a previously known seizure disorder CSF pleocytosis (WBC count ≥ 5/mm2) MRI features suggestive of encephalitis Reasonable exclusion of alternative causes Subjects or parent/legal representative willing to provide written informed consent Exclusion Criteria: Subject who has received Immunoglobulin therapy within 10 weeks prior to screening Subject who has a history of hypersensitivity or shock to ingredient of immunoglobulin Subject who has been diagnosed with IgA deficiency Subject who has renal disorder (creatinine clearance < 10 ml/min) or requires dialysis Subject who has been diagnosed with hemolytic anemia or anemia from blood loss Subject who has been diagnosed with immuonological competence or immunodeficiency Subject who has high risk of thrombus or embolism (History of thrombus/embolism or cerebro/cardiovascular disorder within 3 months prior to screening) Subject who has low heart condition (Congestive heart failure >NYHA functional class Ⅱ: unstable coronary artery disease or myocardiac infarction within 3 months prior to screening) Subject who cannot prohibit the previously administrated steroids by investigator's discretion (ex. Suspicion of steroid dependence, hypoadrenocorticism, when treatment effects are expected, etc.) Females who are pregnant or breast feeding Subject who is considered by investigator to ineligible for the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Soon Tae Lee, MD, Ph.D.

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of IGIV 10% in Patients With Autoimmune Encephalitis:

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