Autoimmune HepatitisPhase 2NCT04371718
Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH)
A Phase 2 study testing JKB-122 in people with Autoimmune Hepatitis, run by TaiwanJ Pharmaceuticals Co., Ltd.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- JKB-122
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Feb 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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)
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
Read the 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.
- Conditions
- Autoimmune Hepatitis
- Being tested
- JKB-122, Placebo
- Keywords
- Autoimmune Hepatitis, Orphan Disease, Aminotransferase, Steroid sparing, ALT
- Medical subject headings
- Hepatitis, Autoimmune, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JKB-122Drug
JKB-122 is a TLR antagonist to immune modulate for autoimmune hepatitis
PlaceboOther
A capsule has same component but active drug
| Study group | Role | What they receive |
|---|---|---|
| JKB-122 Low dose | Experimental | JKB-122 5 mg daily for 104 weeks Receives: Drug: JKB-122 |
| JKB-122 Medium dose | Experimental | JKB-122, 15 mg daily for 104 weeks Receives: Drug: JKB-122 |
| JKB-122 High dose | Experimental | JKB-122 35 mg daily for 104 weeks Receives: Drug: JKB-122 |
| Placebo | Placebo comparator | Matched placebo, daily for 104 weeks Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of inflammation in Autoimmune Hepatitis
The % of patients in each treatment group who achieve biochemical remission
Measured: 6, 12, and 24 months
Secondary outcomes (2)
Steroid sparing effect
Steroid accumulation dose in overall or in those who achieve resolution of histology without worsening of the fibrosis
Measured: week 104
Changes in liver histology as measured by Hepatic Activity Index (HAI)
The reduction of inflammation in histology refers to improve Autoimmune Hepatitis disease status
Measured: Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study startNov 2020 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies 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
- 120 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
- NCT04371718
- Sponsor's protocol ID
- JKB-122 AIH01
- Status last verified
- Aug 2020
- First submitted
- 29 Apr 2020
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04371718
- Acronym / sponsor ID
- JKB-122 AIH01
- Conditions
- Autoimmune Hepatitis
- Keywords
- Autoimmune Hepatitis, Orphan Disease, Aminotransferase, Steroid sparing, ALT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- TaiwanJ Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 1 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JKB-122 Low dose | Experimental | Drug: JKB-122JKB-122 5 mg daily for 104 weeks |
| JKB-122 Medium dose | Experimental | Drug: JKB-122JKB-122, 15 mg daily for 104 weeks |
| JKB-122 High dose | Experimental | Drug: JKB-122JKB-122 35 mg daily for 104 weeks |
| Placebo | Placebo comparator | Other: PlaceboMatched placebo, daily for 104 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| JKB-122JKB-122 is a TLR antagonist to immune modulate for autoimmune hepatitis | Drug | JKB-122 High dose, JKB-122 Low dose, JKB-122 Medium dose |
| PlaceboA capsule has same component but active drug | Other | Placebo |
Primary outcome
Reduction of inflammation in Autoimmune Hepatitis
Time frame: 6, 12, and 24 months
The % of patients in each treatment group who achieve biochemical remission
2 secondary outcomes
Steroid sparing effect
Time frame: week 104
Changes in liver histology as measured by Hepatic Activity Index (HAI)
Time frame: Week 104
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2020.
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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 JKB-122 in people with Autoimmune Hepatitis, 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 6 inclusion and 11 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 1 Sep 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 (+88636587721, info@TaiwanJ.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of inflammation in Autoimmune Hepatitis (time frame: 6, 12, and 24 months). 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 1 Sep 2020.