NCT02701985

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

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Sjogren's Syndrome

Interventions

Type	Name	Description
DRUG	Placebo	Matching-placebo capsules will be administered orally, 2 times a day with food.
DRUG	RO5459072	RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day with food.

Timeline

• Start date: 2016-07-05
• Primary completion: 2017-07-10
• Completion: 2017-07-10
• First posted: 2016-03-08
• Last updated: 2018-08-01
• Results posted: 2018-08-01

Locations

31 sites across 6 countries: United States, France, Germany, Poland, Portugal, United Kingdom