NCT03134222

Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib and GS-9876 in Female Subjects With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (formerly GS-9876) in females with moderately-to-severely active cutaneous lupus erythematosus (CLE).

Conditions

• Cutaneous Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Lanraplenib	30 mg tablets administered orally once daily with or without food
DRUG	Filgotinib	200 mg tablets administered orally once daily with or without food
DRUG	Lanraplenib placebo	Tablets administered orally once daily with or without food
DRUG	Filgotinib placebo	Tablets administered orally once daily with or without food

Timeline

• Start date: 2017-05-24
• Primary completion: 2019-03-13
• Completion: 2019-12-18
• First posted: 2017-04-28
• Last updated: 2020-06-09
• Results posted: 2020-04-08

Locations

16 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study