norUrsodeoxycholic Acid vs Placebo in PSC

Phase 3 Active not recruiting 303 enrolled Dr. Falk Pharma GmbH

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of Primary Sclerosing Cholangitis.

Timeline

Start: 2018-02-08
Primary completion: 2025-01
Completion: 2026-06

Outcome

Met primary endpoint

release “Study results demonstrate superiority of norucholic acid (NCA) over placebo in the combined primary endpoint.” drfalkpharma.com ↗

Publications

Li T, Chiang JYL. Bile Acid Signaling in Metabolic and Inflammatory Diseases and Drug Development. Pharmacol Rev. 2024 Oct 16;76(6):1221-1253. doi: 10.1124/pharmrev.124.000978.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	norUrsodeoxycholic Acid	Unknown	1500 mg	Oral