NCT04255069

A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis

A Phase 2, Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled Study of JKB-122 in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: TaiwanJ Pharmaceuticals Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Nonalcoholic Steatohepatitis (NASH) With Fibrosis

Interventions

Type	Name	Description
DRUG	Placebo	A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
DRUG	Dose 1 JKB-122	A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
DRUG	Dose 2 JKB-122	A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily

Timeline

• Start date: 2020-06-30
• Primary completion: 2023-06-30
• Completion: 2023-12-31
• First posted: 2020-02-05
• Last updated: 2020-02-13

Regulatory

• FDA-regulated drug study