A Study to Investigate the Pharmacokinetics, Pharmacodynamic Effects, Safety and Tolerability of Repeated Dosing of RO5459072 in Volunteers With Celiac Disease

Summary

A randomized, double-blind, placebo-controlled, two treatment, parallel group study to investigate the effects of RO5459072, a cathepsin S inhibitor, on the immune response to a gluten challenge in volunteers with celiac disease. Volunteers with previously diagnosed celiac disease will be randomized to receive either 100 milligrams (mg) RO5459072 or placebo twice daily with food for 28 days (Days 1 to 28).

Timeline

Start

2016-03-06

Primary completion

2016-08-28

Completion

2016-08-28

Outcome

Missed primary endpoint

paper Therefore, the primary end point was not met, although the study was underpowered to detect a treatment effect under these circumstances. PMID 39739628 ↗

Publications

• Bentley D, Mannino M, Manchester M, Teixeira PC, Reis B, Boyce M, Nagel S. A randomized, double-blind, placebo-controlled, multiple dose, parallel study to investigate the effects of a cathepsin S inhibitor in celiac disease. Clin Transl Sci. 2025 Jan;18(1):e13901. doi: 10.1111/cts.13901.

Drugs

Indications