To Assess Safety, Tolerability and Efficacy of LJN452 in Patients With Primary Bile Acid Diarrhea.

Summary

The purpose of this study is to determine whether LJN452 improves the symptoms of bile acid diarrhea and to assess its safety and tolerability profile in patients with primary bile acid diarrhea (pBAD) to guide decision-making regarding further clinical development in this indication.

Timeline

Start

2016-01-16

Primary completion

2018-01-25

Completion

2018-01-25

Outcome

Mixed primary results

registry analysis (superiority test); LJN452 ALL Patients vs Placebo ALL Patients; p = 0.01; Mean Difference (Net) 4.04 (95% CI 0.98 to 7.11); Mixed Models Analysis NCT02713243 ↗

registry analysis (superiority test); LJN452 ALL Patients vs Placebo ALL Patients; p = 0.533; Mean Difference (Net) 0.12 (95% CI -0.27 to 0.52); Mixed Models Analysis NCT02713243 ↗

Publications

• Camilleri M, Nord SL, Burton D, Oduyebo I, Zhang Y, Chen J, Im K, Bhad P, Badman MK, Sanders DS, Walters JRF. Randomised clinical trial: significant biochemical and colonic transit effects of the farnesoid X receptor agonist tropifexor in patients with primary bile acid diarrhoea. Aliment Pharmacol Ther. 2020 Sep;52(5):808-820. doi: 10.1111/apt.15967. Epub 2020 Jul 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tropifexor	Small molecule	60 ug	Oral

Indications