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

NCT03134222 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2020-06-09

Study results available
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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

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

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2019-03-13
Completion
2019-12-18
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03134222 on ClinicalTrials.gov