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Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04371718
Recruitment Status : Not yet recruiting
First Posted : May 1, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
TaiwanJ Pharmaceuticals Co., Ltd

Brief 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

Condition or disease Intervention/treatment Phase
Autoimmune Hepatitis Drug: JKB-122 Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: JKB-122 Low dose
JKB-122 5 mg daily for 104 weeks
Drug: JKB-122
JKB-122 is a TLR antagonist to immune modulate for autoimmune hepatitis

Experimental: JKB-122 Medium dose
JKB-122, 15 mg daily for 104 weeks
Drug: JKB-122
JKB-122 is a TLR antagonist to immune modulate for autoimmune hepatitis

Experimental: JKB-122 High dose
JKB-122 35 mg daily for 104 weeks
Drug: JKB-122
JKB-122 is a TLR antagonist to immune modulate for autoimmune hepatitis

Placebo Comparator: Placebo
Matched placebo, daily for 104 weeks
Other: Placebo
A capsule has same component but active drug




Primary Outcome Measures :
  1. Reduction of inflammation in Autoimmune Hepatitis [ Time Frame: 6, 12, and 24 months ]
    The % of patients in each treatment group who achieve biochemical remission


Secondary Outcome Measures :
  1. Steroid sparing effect [ Time Frame: week 104 ]
    Steroid accumulation dose in overall or in those who achieve resolution of histology without worsening of the fibrosis

  2. Changes in liver histology as measured by Hepatic Activity Index (HAI) [ Time Frame: Week 104 ]
    The reduction of inflammation in histology refers to improve Autoimmune Hepatitis disease status



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 to 65 years old.
  2. 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.
  3. Probable or definite diagnosis of autoimmune hepatitis according to the International Autoimmune Hepatitis Study Group criteria.
  4. New diagnosis of AIH that requires treatment according to the current EASL guidelines.
  5. Has elevated liver test results (ALT) at least 5x ULN at screening.
  6. Is capable of understanding and signing the informed consent document.

Exclusion Criteria:

  1. Overlap syndrome with Primary Sclerosing Cholangitis (PSC) or Primary Biliary Cholangitis (PBC)
  2. Has cirrhosis on liver biopsy, or Child-Pugh score greater than 6 at screening.
  3. Has human immunodeficiency virus (HIV) or is hepatitis B virus or HCV positive.
  4. Has history of alcohol intake > 25 g/day within the past six months.
  5. Severe anemia, leukopenia , or thrombocytopenia.
  6. Known intolerances to prednisolone or azathioprine.
  7. Current treatment with prednisone/prednisolone and/or immunosuppressive medication for an indication other than autoimmune hepatitis
  8. Has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold
  9. Has unstable and uncontrollable hypertension (>180/110 mmHg)
  10. 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.
  11. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04371718


Contacts
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Contact: Ying-Chu Shih, PhD +88636587721 info@TaiwanJ.com

Sponsors and Collaborators
TaiwanJ Pharmaceuticals Co., Ltd
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Responsible Party: TaiwanJ Pharmaceuticals Co., Ltd
ClinicalTrials.gov Identifier: NCT04371718    
Other Study ID Numbers: JKB-122 AIH01
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by TaiwanJ Pharmaceuticals Co., Ltd:
Autoimmune Hepatitis
Orphan Disease
Aminotransferase
Steroid sparing
ALT
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases