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Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH)

Primary Purpose

Autoimmune Hepatitis

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

JKB-122

Placebo

About this trial

This is an interventional treatment trial for Autoimmune Hepatitis focused on measuring Autoimmune Hepatitis, Orphan Disease, Aminotransferase, Steroid sparing, ALT

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female, 18 to 65 years old.
If female of childbearing potential, must not be pregnant or breastfeeding and either postmenopausal (no menses for previous 12 months) or using an effective method of birth control.
Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria.
New diagnosis of AIH that requires treatment according to the current EASL guidelines.
Has elevated liver test results (ALT) at least 5x ULN at screening.
Is capable of understanding and signing the informed consent document.

Exclusion Criteria:

Overlap syndrome with Primary Sclerosing Cholangitis (PSC) or Primary Biliary Cholangitis (PBC)
Has cirrhosis on liver biopsy, or Child-Pugh score greater than 6 at screening.
Has human immunodeficiency virus (HIV) or is hepatitis B virus or HCV positive.
Has history of alcohol intake > 25 g/day within the past six months.
Severe anemia, leukopenia , or thrombocytopenia.
Known intolerances to prednisolone or azathioprine.
Current treatment with prednisone/prednisolone and/or immunosuppressive medication for an indication other than autoimmune hepatitis
Has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold
Has unstable and uncontrollable hypertension (>180/110 mmHg)
Has current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully.
Has any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

JKB-122 Low dose

JKB-122 Medium dose

JKB-122 High dose

Placebo

Arm Description

JKB-122 5 mg daily for 104 weeks

JKB-122, 15 mg daily for 104 weeks

JKB-122 35 mg daily for 104 weeks

Matched placebo, daily for 104 weeks

Outcomes

Primary Outcome Measures

Reduction of inflammation in Autoimmune Hepatitis

The % of patients in each treatment group who achieve biochemical remission

Secondary Outcome Measures

Steroid sparing effect

Steroid accumulation dose in overall or in those who achieve resolution of histology without worsening of the fibrosis

Changes in liver histology as measured by Hepatic Activity Index (HAI)

The reduction of inflammation in histology refers to improve Autoimmune Hepatitis disease status

Full Information

NCT ID

NCT04371718

First Posted

April 29, 2020

Last Updated

August 28, 2020

Sponsor

TaiwanJ Pharmaceuticals Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04371718

Brief Title

Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH)

Official Title

A Phase II, Randomized, Double-Blind, Placebo Controlled, Trial of JKB-122 as an Adjunct Therapy to Prednisolone and Azathioprine in the Induction of Remission in Autoimmune Hepatitis (AIH)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 2020 (Anticipated)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

TaiwanJ Pharmaceuticals Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a Phase 2 study. All patients will receive prednisolone and AZA as standard of care (SOC) during the study. At the end of the study, all data collected will be analyzed the efficacy and safety of JKB-122 on SOC reduction and inflammation improvement in Autoimmune Hepatitis

Detailed Description

JKB-122 has been demonstrated effective reducing aminotransferase in refractory AIH patients with SOC.This is a new Phase 2 study to find an optimal dose for relevant phase 3 study in newly diagnostic AIH patients. All patients will receive prednisolone and AZA as standard of care (SOC) during the study. Subjects will be randomized to receive 5 mg JKB-122, 15 mg JKB-122, 35 mg JKB-122 or placebo in 1:1:1:1 ratio, adjunct to SOC. This protocol with the primary endpoint being biochemical remission and evaluation of 3 different treatment doses. The histology will be explored as secondary to test long term benefit and to show similar trend with the biomarkers.

6. Conditions and Keywords

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

Autoimmune Hepatitis

Keywords

Autoimmune Hepatitis, Orphan Disease, Aminotransferase, Steroid sparing, ALT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

JKB-122 Low dose

Arm Type

Experimental

Arm Description

JKB-122 5 mg daily for 104 weeks

Arm Title

JKB-122 Medium dose

Arm Type

Experimental

Arm Description

JKB-122, 15 mg daily for 104 weeks

Arm Title

JKB-122 High dose

Arm Type

Experimental

Arm Description

JKB-122 35 mg daily for 104 weeks

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matched placebo, daily for 104 weeks

Intervention Type

Drug

Intervention Name(s)

JKB-122

Intervention Description

JKB-122 is a TLR antagonist to immune modulate for autoimmune hepatitis

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

A capsule has same component but active drug

Primary Outcome Measure Information:

Title

Reduction of inflammation in Autoimmune Hepatitis

Description

The % of patients in each treatment group who achieve biochemical remission

Time Frame

6, 12, and 24 months

Secondary Outcome Measure Information:

Title

Steroid sparing effect

Description

Steroid accumulation dose in overall or in those who achieve resolution of histology without worsening of the fibrosis

Time Frame

week 104

Title

Changes in liver histology as measured by Hepatic Activity Index (HAI)

Description

The reduction of inflammation in histology refers to improve Autoimmune Hepatitis disease status

Time Frame

Week 104

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, 18 to 65 years old. If female of childbearing potential, must not be pregnant or breastfeeding and either postmenopausal (no menses for previous 12 months) or using an effective method of birth control. Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria. New diagnosis of AIH that requires treatment according to the current EASL guidelines. Has elevated liver test results (ALT) at least 5x ULN at screening. Is capable of understanding and signing the informed consent document. Exclusion Criteria: Overlap syndrome with Primary Sclerosing Cholangitis (PSC) or Primary Biliary Cholangitis (PBC) Has cirrhosis on liver biopsy, or Child-Pugh score greater than 6 at screening. Has human immunodeficiency virus (HIV) or is hepatitis B virus or HCV positive. Has history of alcohol intake > 25 g/day within the past six months. Severe anemia, leukopenia , or thrombocytopenia. Known intolerances to prednisolone or azathioprine. Current treatment with prednisone/prednisolone and/or immunosuppressive medication for an indication other than autoimmune hepatitis Has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold Has unstable and uncontrollable hypertension (>180/110 mmHg) Has current malignancy or a history of malignancy (within the past 5 years), except basal or non-metastatic squamous cell carcinoma of the skin that has been treated successfully. Has any form of current substance abuse, psychiatric disorder or a condition that, in the opinion of the Investigator, may invalidate communication with the Investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ying-Chu Shih, PhD

Phone

+88636587721

info@TaiwanJ.com

12. IPD Sharing Statement

Learn more about this trial

Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH)

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