NCT03100942

Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome

A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects With Active Sjogren's Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the efficacy of filgotinib, lanraplenib, and tirabrutinib in adults with active Sjogren's Syndrome (SjS).

Conditions

• Sjogren's Syndrome

Interventions

Type	Name	Description
DRUG	Lanraplenib	1 x 30 mg tablet administered orally once daily
DRUG	Filgotinib	1 x 200 mg tablet administered orally once daily
DRUG	Tirabrutinib	1 x 40 mg tablet administered orally once daily
DRUG	Lanraplenib placebo	1 x tablet administered orally once daily
DRUG	Filgotinib placebo	1 x tablet administered orally once daily
DRUG	Tirabrutinib placebo	1 x tablet administered orally once daily

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-01-10
• Completion: 2019-10-02
• First posted: 2017-04-04
• Last updated: 2020-10-23
• Results posted: 2020-01-22

Locations

53 sites across 4 countries: United States, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study