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

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

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

Study Overview

• Status: Completed
• Conditions: Autoimmune Encephalitis
• Intervention / Treatment: Drug: Immunoglobulin G

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, aged more than 12 years.(adolescent or adult)

2. 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
3. Subjects or parent/legal representative willing to provide written informed consent

Exclusion Criteria:

1. Subject who has received Immunoglobulin therapy within 10 weeks prior to screening
2. Subject who has a history of hypersensitivity or shock to ingredient of immunoglobulin
3. Subject who has been diagnosed with IgA deficiency
4. Subject who has renal disorder (creatinine clearance < 10 ml/min) or requires dialysis
5. Subject who has been diagnosed with hemolytic anemia or anemia from blood loss
6. Subject who has been diagnosed with immuonological competence or immunodeficiency
7. Subject who has high risk of thrombus or embolism (History of thrombus/embolism or cerebro/cardiovascular disorder within 3 months prior to screening)
8. 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)
9. Subject who cannot prohibit the previously administrated steroids by investigator's discretion (ex. Suspicion of steroid dependence, hypoadrenocorticism, when treatment effects are expected, etc.)
10. Females who are pregnant or breast feeding
11. Subject who is considered by investigator to ineligible for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Investigational product(IP)	Drug: Immunoglobulin G; IGIV 10%(400mg/kg) QD for 5 consecutive days administrated intravenously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	28 days
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)	28 days
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)	28 days
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)	28 days
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)	28 days
The relationship	The relationship between neurological scale	28 days

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Investigators: Principal Investigator: Soon Tae Lee, MD, Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): June 11, 2020
• Study Completion (Actual): June 11, 2020

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 28, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Thyroid Diseases; Thyroiditis, Autoimmune; Thyroiditis; Encephalitis; Hashimoto Disease; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous; Immunoglobulin G
• Other Study ID Numbers: GC5107AE01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No