A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome

Summary

This is a randomized, double-blind, placebo-controlled, two-treatment arm, parallel-group study designed to evaluate the effects of RO5459072 treatment on disease activity and symptoms of Sjogren's syndrome in adult participants with moderate to severe primary Sjogren's syndrome. The total duration of the study for each participant will be approximately 18 weeks (including screening).

Timeline

Start

2016-07-05

Primary completion

2017-07-10

Completion

2017-07-10

Outcome

Missed primary endpoint

paper There was no clinically relevant improvement in ESSDAI score (primary endpoint) PMID 36864622 ↗

registry analysis (other test); Placebo vs RO5459072; p = 0.7955; Difference in Response Rates 4.27 (95% CI -20.55 to 29.08); Chi-square with Schouten Correction NCT02701985 ↗

Publications

• Bentley D, Fisher BA, Barone F, Kolb FA, Attley G. A randomized, double-blind, placebo-controlled, parallel group study on the effects of a cathepsin S inhibitor in primary Sjogren's syndrome. Rheumatology (Oxford). 2023 Nov 2;62(11):3644-3653. doi: 10.1093/rheumatology/kead092.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PETESICATIB	Small molecule	100 mg	Oral

Indications