Clinical trial NCT04371718: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Autoimmune Hepatitis
Keywords: Autoimmune Hepatitis
Orphan Disease
Aminotransferase
Steroid sparing
ALT
Lead sponsor: TaiwanJ Pharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-05-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female, 18 to 65 years old.
2. 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.
3. Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria.
4. New diagnosis of AIH that requires treatment according to the current EASL guidelines.
5. Has elevated liver test results (ALT) at least 5x ULN at screening.
6. Is capable of understanding and signing the informed consent document.

Exclusion Criteria:

1. Overlap syndrome with Primary Sclerosing Cholangitis (PSC) or Primary Biliary Cholangitis (PBC)
2. Has cirrhosis on liver biopsy, or Child-Pugh score greater than 6 at screening.
3. Has human immunodeficiency virus (HIV) or is hepatitis B virus or HCV positive.
4. Has history of alcohol intake \> 25 g/day within the past six months.
5. Severe anemia, leukopenia , or thrombocytopenia.
6. Known intolerances to prednisolone or azathioprine.
7. Current treatment with prednisone/prednisolone and/or immunosuppressive medication for an indication other than autoimmune hepatitis
8. Has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold
9. Has unstable and uncontrollable hypertension (\>180/110 mmHg)
10. 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.
11. 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.

Primary outcomes:
measure: Reduction of inflammation in Autoimmune Hepatitis
timeFrame: 6, 12, and 24 months
Secondary outcomes:
measure: Steroid sparing effect
timeFrame: week 104
measure: Changes in liver histology as measured by Hepatic Activity Index (HAI)
timeFrame: Week 104
Other outcomes:
Locations:
Study officials:
References: