NCT04371718

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2020

Typical duration for phase_2

Status
unknown

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

First Submitted

Initial submission to the registry

April 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

September 1, 2020

Status Verified

August 1, 2020

Enrollment Period

3 years

First QC Date

April 29, 2020

Last Update Submit

August 28, 2020

Conditions

Autoimmune Hepatitis

Keywords

Autoimmune HepatitisOrphan DiseaseAminotransferaseSteroid sparingALT

Outcome Measures

Primary Outcomes (1)

  • Reduction of inflammation in Autoimmune Hepatitis

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

    6, 12, and 24 months

Secondary Outcomes (2)

  • Steroid sparing effect

    week 104

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

    Week 104

Study Arms (4)

JKB-122 Low dose

EXPERIMENTAL

JKB-122 5 mg daily for 104 weeks

Drug: JKB-122

JKB-122 Medium dose

EXPERIMENTAL

JKB-122, 15 mg daily for 104 weeks

Drug: JKB-122

JKB-122 High dose

EXPERIMENTAL

JKB-122 35 mg daily for 104 weeks

Drug: JKB-122

Placebo

PLACEBO COMPARATOR

Matched placebo, daily for 104 weeks

Other: Placebo

Interventions

JKB-122DRUG

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

JKB-122 High doseJKB-122 Low doseJKB-122 Medium dose
PlaceboOTHER

A capsule has same component but active drug

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hepatitis, AutoimmuneRare Diseases

Interventions

JKB-122

Condition Hierarchy (Ancestors)

Hepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ying-Chu Shih, PhD

CONTACT

+88636587721info@TaiwanJ.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2020

First Posted

May 1, 2020

Study Start

November 1, 2020

Primary Completion

November 1, 2023

Study Completion

February 1, 2024

Last Updated

September 1, 2020

Record last verified: 2020-08