NCT02556372

Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies

Completed Phase 2 Last updated 21 July 2020

What this trial tests

Phase 2 trial testing JKB-122 in Autoimmune Hepatitis in 20 participants. Completed in 21 January 2019.

Timeline

30 April 2016

Primary endpoint
21 January 2019

21 January 2019

Quick facts

Lead sponsor	TaiwanJ Pharmaceuticals Co., Ltd
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	30 April 2016
Primary completion	21 January 2019
Estimated completion	21 January 2019
Sites	16 locations across United States

Drugs / interventions tested

• JKB-122

Conditions studied

• Autoimmune Hepatitis — all drugs for Autoimmune Hepatitis →

Sponsor

TaiwanJ Pharmaceuticals Co., Ltd — full company profile →

Who can join

18 and older, any sex, with Autoimmune Hepatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent clinical trends in Toll-like receptor targeting therapeutics.
   Anwar MA, Shah M, Kim J, Choi S. · · 2019 · cited 209× · PMID 30450666 · DOI 10.1002/med.21553
2. Small Molecule NF-κB Pathway Inhibitors in Clinic.
   Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164
3. Autoimmmune hepatitis.
   Terziroli Beretta-Piccoli B, Mieli-Vergani G, Vergani D. · · 2022 · cited 118× · PMID 34580437 · DOI 10.1038/s41423-021-00768-8
4. Autoimmune hepatitis: Standard treatment and systematic review of alternative treatments.
   Terziroli Beretta-Piccoli B, Mieli-Vergani G, Vergani D. · · 2017 · cited 88× · PMID 28970719 · DOI 10.3748/wjg.v23.i33.6030
5. Toll-Like Receptors as a Therapeutic Target in the Era of Immunotherapies.
   Farooq M, Batool M, Kim MS, Choi S. · · 2021 · cited 70× · PMID 34671606 · DOI 10.3389/fcell.2021.756315
6. Clinical management of autoimmune hepatitis.
   Pape S, Schramm C, Gevers TJ. · · 2019 · cited 58× · PMID 31700628 · DOI 10.1177/2050640619872408
7. Autoimmune hepatitis: Current and future therapies.
   Reau NS, Lammert CS, Weinberg EM. · · 2024 · cited 19× · PMID 38836863 · DOI 10.1097/hc9.0000000000000458
8. Damage-associated molecular patterns (DAMPs) in diseases: implications for therapy.
   Lin H, Xiong W, Fu L, Yi J, et al · · 2025 · cited 17× · PMID 40877572 · DOI 10.1186/s43556-025-00305-3