Autoimmune HepatitisPhase 2NCT02556372
Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies
A Phase 2 study testing JKB-122 in people with Autoimmune Hepatitis, run by TaiwanJ Pharmaceuticals Co., Ltd at 16 sites in United States.
Trial summary
This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 1.25 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take… Read more about this study
- Who is it for?
- Ages 18 years and older
- 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?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 16 sitesUnited States
- Study dates
- 30 Apr 2016to 21 Jan 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has definite or probable AIH diagnosis.
- Has had a liver biopsy or Fibroscan™ within 3 years and the severity of hepatic dysfunction is limited to the following:
- Metavir Stage 0 to stage 3 fibrosis (according to liver biopsy) or Fibroscan™ results
- ALT and AST values not exceeding 10x ULN
- Normal bilirubin and prothrombin time (PT/INR)
- Has elevated liver test results (ALT) at least 1.25 x ULN and not exceeding 10 x ULN at baseline.
- Has had a failed response, incomplete response, intolerant, ineligible or unwilling to take current immunosuppressive therapies. Current immunosuppressive therapy is defined as prednisone or other steroids with or without azathioprine.
Who cannot join
- Has history of allergy to JKB-122 or related compounds
- Has human immunodeficiency virus (HIV) or is hepatitis B virus or hepatitis C virus (HCV) positive
- Has positive urine drug screen at Screening
- Has been diagnosed with other overlapping liver diseases such as primary biliary cirrhosis (PBC) or primary sclerosing cholangitis (PSC)
- Is currently consuming alcoholic drinks greater than 25g/day and within 3 months prior to the first screening visit.
- Is being treated with any prescription narcotic drug (including transdermal delivery systems)
Show all 19Show fewer
- Concurrent medications within 30 days prior to screening:
- Opioids
- Thioridazine
- Silymarin and related medications
- Potentially hepatotoxic drugs
- 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) or a blood pressure reading at baseline of 150/90 mmHg on 2 occasions separated by a 30 minute interval
- Is currently receiving dietary supplements other than a multivitamin to treat AIH
- Has received other investigational agents within 90 days prior to the first screening visit
- Has impaired renal function
- Has malignancy.
- If female, pregnant or lactating
- Has history of gastroesophageal varices, ascites, hepatic encephalopathy, hepatocellular carcinoma, and s/p liver transplantation
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Massachusetts General Hospital
Boston, Massachusetts
Northwestern University
Chicago, Illinois, 60611
Methodist Dallas Medical Center
Dallas, Texas, 75203
Duke University Medical Center
Durham, North Carolina, 27710
University of Florida Hepatology Research at CTRB
Gainesville, Florida, 32610-0272
Advanced Liver Therapies, Baylor College of Medicine
Houston, Texas, 77030
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Ruane Clinical Research Group, Inc.
Los Angeles, California, 90036
Tulane University
New Orleans, Louisiana
Mount Sinai Hospital
New York, New York, 10029
University of California Davis Medical Center - Ticon 1
Sacramento, California, 95817
The Texas Liver Institute
San Antonio, Texas, 78215
Taxes Liver Institute
San Antonio, Texas
California Pacific Medical Center
San Francisco, California
Swedish Medical Center - Organ Transplant and Liver Center
Seattle, Washington, 98104
University of Washington
Seattle, Washington, 98104
About this study
Official title: A Phase 2, Pilot Study of JKB-122 to Assess Liver Tests (ALT) in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies
This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 1.25 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The dose of JKB-122 will be escalated monthly.
Read the detailed description
This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks to subjects with AIH who have liver enzymes that are 1.25 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to or unwilling to take current immunosuppressant therapies. Current immunosuppressant therapy is defined as prednisone or other steroids with or without azathioprine. Failed response is defined as being non-responsive to or worsening in symptoms (elevated Alanine Aminotransferase (ALT)/aspartate aminotransferase (AST) and/or total bilirubin) despite compliance with the standard of care (SOC) over a 6 months period. Incomplete response is defined as lack of a sustained normalization of elevated ALT/AST to current standard of care (SOC) for at least 6 months. "Refractory" to the current therapy includes patients who had a failed response to, or incomplete response to the current therapy.
Subjects will be at least 18 years of age, either male or female and will have been on therapy for AIH and have not had a normalization of ALT with the current therapy.
- Conditions
- Autoimmune Hepatitis
- Being tested
- JKB-122
- Keywords
- AIH, JKB-122, autoimmune, hepatitis
- Medical subject headings
- Hepatitis, Autoimmune, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JKB-122Drug
Orally administered capsules of JKB-122 which will be taken once daily with dose escalation from 5mg up to 40mg depending on the monthly response.
| Study group | Role | What they receive |
|---|---|---|
| JKB-122 | Experimental | AIH-positive subjects (n=20) who are intolerant, refractory, ineligible or unwilling to take current therapies, and have liver enzymes that are 2 to 10 times the upper limit of normal Receives: Drug: JKB-122 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in ALT in AIH subjects given daily doses of JKB-122
To assess changes in ALT in AIH subjects given daily doses of JKB-122
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start30 Apr 2016
- Primary completion21 Jan 2019
- Study completion21 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Intervention model
- Sequential
- Model description
- The patient takes 5mg up to 40mg depending on the monthly response.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- TaiwanJ Pharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ying-Chu Shih, PhD, Study director, TaiwanJ Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556372
- Sponsor's protocol ID
- JKB-122AIH
- Status last verified
- Jul 2020
- First submitted
- 20 Sep 2015
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Chung YY, Rahim MN, Heneghan MA. Autoimmune hepatitis and pregnancy: considerations for the clinician. Expert Rev Clin Immunol. 2022 Apr;18(4):325-333. doi: 10.1080/1744666X.2022.2044307. Epub 2022 Mar 2.
PubMed 35179437
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Pilot Study of JKB-122 to Assess Liver Tests (ALT) in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies
- ClinicalTrials.gov ID
- NCT02556372
- Acronym / sponsor ID
- JKB-122AIH
- Conditions
- Autoimmune Hepatitis
- Keywords
- AIH, JKB-122, autoimmune, hepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- TaiwanJ Pharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2016 (actual)
- Primary completion
- 21 Jan 2019 (actual)
- Study completion
- 21 Jan 2019 (actual)
- First posted
- 22 Sep 2015 (estimated)
- 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, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 1.25 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The dose of JKB-122 will be escalated monthly.
Detailed description
This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks to subjects with AIH who have liver enzymes that are 1.25 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to or unwilling to take current immunosuppressant therapies. Current immunosuppressant therapy is defined as prednisone or other steroids with or without azathioprine. Failed response is defined as being non-responsive to or worsening in symptoms (elevated Alanine Aminotransferase (ALT)/aspartate aminotransferase (AST) and/or total bilirubin) despite compliance with the standard of care (SOC) over a 6 months period. Incomplete response is defined as lack of a sustained normalization of elevated ALT/AST to current standard of care (SOC) for at least 6 months. "Refractory" to the current therapy includes patients who had a failed response to, or incomplete response to the current therapy.
Subjects will be at least 18 years of age, either male or female and will have been on therapy for AIH and have not had a normalization of ALT with the current therapy.
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The patient takes 5mg up to 40mg depending on the monthly response.
| Arm | Type | Receives |
|---|---|---|
| JKB-122 | Experimental | Drug: JKB-122AIH-positive subjects (n=20) who are intolerant, refractory, ineligible or unwilling to take current therapies, and have liver enzymes that are 2 to 10 times the upper limit of normal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has definite or probable AIH diagnosis.
- Has had a liver biopsy or Fibroscan™ within 3 years and the severity of hepatic dysfunction is limited to the following:
- Has elevated liver test results (ALT) at least 1.25 x ULN and not exceeding 10 x ULN at baseline.
- Has had a failed response, incomplete response, intolerant, ineligible or unwilling to take current immunosuppressive therapies. Current immunosuppressive therapy is defined as prednisone or other steroids with or without azathioprine.
Key exclusion criteria (19 listed)
- Has history of allergy to JKB-122 or related compounds
- Has human immunodeficiency virus (HIV) or is hepatitis B virus or hepatitis C virus (HCV) positive
- Has positive urine drug screen at Screening
- Has been diagnosed with other overlapping liver diseases such as primary biliary cirrhosis (PBC) or primary sclerosing cholangitis (PSC)
- Is currently consuming alcoholic drinks greater than 25g/day and within 3 months prior to the first screening visit.
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-122Orally administered capsules of JKB-122 which will be taken once daily with dose escalation from 5mg up to 40mg depending on the monthly response. | Drug | JKB-122 |
Primary outcome
Changes in ALT in AIH subjects given daily doses of JKB-122
Time frame: baseline and 24 weeks
To assess changes in ALT in AIH subjects given daily doses of JKB-122
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Derived from this study: PubMed 35179437Chung YY, Rahim MN, Heneghan MA. Autoimmune hepatitis and pregnancy: considerations for the clinician. Expert Rev Clin Immunol. 2022 Apr;18(4):325-333. doi: 10.1080/1744666X.2022.2044307. Epub 2022 Mar 2.
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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.
Ying-Chu Shih, PhD study director
TaiwanJ Pharmaceuticals
16 sites in 1 country: see every site and its status.
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 at 16 sites in United States.
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 7 inclusion and 19 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: finished, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in ALT in AIH subjects given daily doses of JKB-122 (time frame: baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02556372, which also lists 1 linked publication.
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 21 Jul 2020.