Nonalcoholic Steatohepatitis (NASH) With FibrosisPhase 2NCT04255069
A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis
A Phase 2 study testing Dose 1 JKB-122 and Dose 2 JKB-122 in people with Nonalcoholic Steatohepatitis (NASH) With Fibrosis, run by TaiwanJ Pharmaceuticals Co., Ltd.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis (NASH) With Fibrosis
- What is being tested?
- Dose 1 JKB-122 and Dose 2 JKB-122
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2020to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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. -
Trial locations and contacts
No sites are listed yet.
About this study
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
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
Read the 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.
- Being tested
- Placebo, Dose 1 JKB-122, Dose 2 JKB-122
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
Dose 1 JKB-122Drug
Also called JKB-122
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
Dose 2 JKB-122Drug
Also called JKB-122
A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo, oral, daily Receives: Drug: Placebo |
| Dose 1 | Experimental | JKB-122, Dose 1, oral, daily Receives: Drug: Dose 1 JKB-122 |
| Dose 2 | Experimental | JKB-122, Dose 2, oral, daily Receives: Drug: Dose 2 JKB-122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 52 weeks
Secondary outcomes (2)
Evaluate the changes of hepatic fat content
The changes of fatty liver content (%) will be measured by MRI-PDFF.
Measured: 52 weeks
Evaluate the changes of fibrosis score
The changes of fibrosis score (kPa) will be measured by FibroScan.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 Jun 2020 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonalcoholic Steatohepatitis (NASH) With FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TaiwanJ Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255069
- Sponsor's protocol ID
- TWJ-NAF
- Status last verified
- Feb 2020
- First submitted
- 24 Jan 2020
- Last updated
- 13 Feb 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04255069
- Acronym / sponsor ID
- TWJ-NAF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- TaiwanJ Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, oral, daily |
| Dose 1 | Experimental | Drug: Dose 1 JKB-122JKB-122, Dose 1, oral, daily |
| Dose 2 | Experimental | Drug: Dose 2 JKB-122JKB-122, Dose 2, oral, daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboA treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily | Drug | Placebo |
| Dose 1 JKB-122Also: JKB-122A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily | Drug | Dose 1 |
| Dose 2 JKB-122Also: JKB-122A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily | Drug | Dose 2 |
Primary outcome
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
Time frame: 52 weeks
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
Time frame: 52 weeks
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.
2 secondary outcomes
Evaluate the changes of hepatic fat content
Time frame: 52 weeks
Evaluate the changes of fibrosis score
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dose 1 JKB-122 and Dose 2 JKB-122 in people with Nonalcoholic Steatohepatitis (NASH) With Fibrosis, run by TaiwanJ Pharmaceuticals Co., Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ying-Chu Shih, PhD (+886-36587721, info@taiwanj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.