A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis
A Phase 2, Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Study of JKB-122 in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis
1 other identifier
interventional
300
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2020
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2020
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedStudy Start
First participant enrolled
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 13, 2020
February 1, 2020
3 years
January 24, 2020
February 11, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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
52 weeks
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.
52 weeks
Secondary Outcomes (2)
Evaluate the changes of hepatic fat content
52 weeks
Evaluate the changes of fibrosis score
52 weeks
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo, oral, daily
Dose 1
EXPERIMENTALJKB-122, Dose 1, oral, daily
Dose 2
EXPERIMENTALJKB-122, Dose 2, oral, daily
Interventions
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
January 24, 2020
First Posted
February 5, 2020
Study Start
June 30, 2020
Primary Completion
June 30, 2023
Study Completion
December 31, 2023
Last Updated
February 13, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share