Back to resultsA Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis
Primary Purpose
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Placebo
Dose 1 JKB-122
Dose 2 JKB-122
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis (NASH) With Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Is male or female, 18 years to 70 years of age.
- 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 (e.g., oral contraceptives, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy plus a barrier method).
- Is diagnosed with non-alcoholic steatohepatitis (NASH) NAS >4.0
- Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
- Subjects taking lipid lowering agents should keep their dose stable during the study.
- Stable use of insulin sensitizing agents (PPARs, SGLT2 inhibitors, or GLP-1 agonists for 6 months prior to screening liver biopsy).
- Is capable of understanding and signing the informed consent document. If subject is unable to sign the informed consent form, then the subject's legal representative or guardian may provide written consent per local regulations.
- Agrees to comply with protocol requirements.
Exclusion Criteria:
- Has human immunodeficiency virus (HIV) or is hepatitis B or C positive.
- Has history of liver cirrhosis.
- Has glycated hemoglobin (HbA1c ) greater than 9%.
- Binge drinking as drinking 5 or more alcoholic drinks
- Significant alcohol consumption
- Is being treated with any prescription narcotic drug (including transdermal delivery systems).
- 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 received other therapies for NAFLD in the last 4 weeks prior to the screening visit (Day -7).
- Requires concomitant use of or treatment with opioids or other excluded drugs such as hepatotoxic medications.
- Has received other investigational agents within 30 days prior to the screening visit (Day -7).
- Has either autoimmune or genetic liver disease.
- Alpha- fetoprotein greater than 20 mcg/L. Has impaired renal function (i.e. serum creatinine CLcr < 60 mL/min).
- Subjects who gained or lost weight greater than 5 kg in the past 3 months.
- Any form of chronic liver disease other than NASH
- Suspected or confirmed cirrhosis. -
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Dose 1
Dose 2
Arm Description
Placebo, oral, daily
JKB-122, Dose 1, oral, daily
JKB-122, Dose 2, oral, daily
Outcomes
Primary Outcome Measures
To evaluate the effect of JKB-122 compared to placebo to achieve NASH resolution on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis
Assessment will be based on the proportion of JKB-122 15 mg or 35 mg treated patients relative to placebo achieving NASH resolution with at least a 2 point reduction in NAS and no worsening of fibrosis
To evaluate the effect of JKB-122 compared to placebo to achieve a ≥ 1 stage fibrosis improvement on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis
Assessment will be based on the proportion of JKB-122 15 mg or 35 mg treated patients relative to placebo achieving at least a 1 stage improvement in fibrosis (NASH Clinical Research Network system) by liver biopsy with no worsening of NAS.
Secondary Outcome Measures
Evaluate the changes of hepatic fat content
The changes of fatty liver content (%) will be measured by MRI-PDFF.
Evaluate the changes of fibrosis score
The changes of fibrosis score (kPa) will be measured by FibroScan.
Full Information
NCT ID
NCT04255069
First Posted
January 24, 2020
Last Updated
February 11, 2020
Sponsor
TaiwanJ Pharmaceuticals Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04255069
Brief Title
A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis
Official Title
A Phase 2, Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Study of JKB-122 in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 30, 2020 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (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
No
5. Study Description
Brief Summary
A double-blind placebo controlled randomized Phase 2 study to determine if JKB-122 compared with placebo resolves NASH on liver biopsy and improves fibrosis
Detailed Description
This is a Phase 2 study in which JKB-122 is given once daily for 52 weeks to subjects with Nonalcoholic steatohepatitis (NASH) with Fibrosis who have biopsy reading more than NAS 4 with a fibrosis reading more than 1 and no cirrhosis. Subjects will be at least 18 years of age, either male or female.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, oral, daily
Arm Title
Dose 1
Arm Type
Experimental
Arm Description
JKB-122, Dose 1, oral, daily
Arm Title
Dose 2
Arm Type
Experimental
Arm Description
JKB-122, Dose 2, oral, daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
Intervention Type
Drug
Intervention Name(s)
Dose 1 JKB-122
Other Intervention Name(s)
JKB-122
Intervention Description
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
Intervention Type
Drug
Intervention Name(s)
Dose 2 JKB-122
Other Intervention Name(s)
JKB-122
Intervention Description
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
Primary Outcome Measure Information:
Title
To evaluate the effect of JKB-122 compared to placebo to achieve NASH resolution on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis
Description
Assessment will be based on the proportion of JKB-122 15 mg or 35 mg treated patients relative to placebo achieving NASH resolution with at least a 2 point reduction in NAS and no worsening of fibrosis
Time Frame
52 weeks
Title
To evaluate the effect of JKB-122 compared to placebo to achieve a ≥ 1 stage fibrosis improvement on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis
Description
Assessment will be based on the proportion of JKB-122 15 mg or 35 mg treated patients relative to placebo achieving at least a 1 stage improvement in fibrosis (NASH Clinical Research Network system) by liver biopsy with no worsening of NAS.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Evaluate the changes of hepatic fat content
Description
The changes of fatty liver content (%) will be measured by MRI-PDFF.
Time Frame
52 weeks
Title
Evaluate the changes of fibrosis score
Description
The changes of fibrosis score (kPa) will be measured by FibroScan.
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is male or female, 18 years to 70 years of age.
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 (e.g., oral contraceptives, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy plus a barrier method).
Is diagnosed with non-alcoholic steatohepatitis (NASH) NAS >4.0
Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
Subjects taking lipid lowering agents should keep their dose stable during the study.
Stable use of insulin sensitizing agents (PPARs, SGLT2 inhibitors, or GLP-1 agonists for 6 months prior to screening liver biopsy).
Is capable of understanding and signing the informed consent document. If subject is unable to sign the informed consent form, then the subject's legal representative or guardian may provide written consent per local regulations.
Agrees to comply with protocol requirements.
Exclusion Criteria:
Has human immunodeficiency virus (HIV) or is hepatitis B or C positive.
Has history of liver cirrhosis.
Has glycated hemoglobin (HbA1c ) greater than 9%.
Binge drinking as drinking 5 or more alcoholic drinks
Significant alcohol consumption
Is being treated with any prescription narcotic drug (including transdermal delivery systems).
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 received other therapies for NAFLD in the last 4 weeks prior to the screening visit (Day -7).
Requires concomitant use of or treatment with opioids or other excluded drugs such as hepatotoxic medications.
Has received other investigational agents within 30 days prior to the screening visit (Day -7).
Has either autoimmune or genetic liver disease.
Alpha- fetoprotein greater than 20 mcg/L. Has impaired renal function (i.e. serum creatinine CLcr < 60 mL/min).
Subjects who gained or lost weight greater than 5 kg in the past 3 months.
Any form of chronic liver disease other than NASH
Suspected or confirmed cirrhosis. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying-Chu Shih, PhD
Phone
+886-36587721
Email
info@taiwanj.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis
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