Summary

for people ages 18-75 (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

The primary objective of this study is to evaluate the efficacy of filgotinib and GS-9876 in adults with Lupus Membranous Nephropathy (LMN).

Official Title

A Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects With Lupus Membranous Nephropathy (LMN)

Keywords

Lupus Membranous NephropathyKidney DiseasesGlomerulonephritis, MembranousFilgotinibGS-9876

Eligibility

For people ages 18-75

Key Inclusion Criteria:

  • Male or female between 18 and 75 years of age, inclusive, at the time of initial informed consent
  • Kidney biopsy within the 36 months prior to screening with a histologic diagnosis of LMN (International Society of Nephrology [ISN] and the Renal Pathology Society [RPS] 2003 classification of lupus nephritis), either Class V alone, or Class V in combination with Class II.
  • Urine protein excretion ≥ 1.5 grams per day
  • Estimated glomerular filtration rate (eGFRMDRD) ≥ 40 mg/min/1.73m2 based on the MDRD formulation at screening

  • No evidence of active or latent TB as assessed during screening

Key Exclusion Criteria:

  • Prior treatments as follows:
  • Previous treatment with a JAK inhibitor within 3 months of Day 1
  • Use of rituximab or other selective B lymphocyte depleting agents (including experimental agents) within 6 months of Day 1. Enrollment is permitted if the last dose was given > 6 months and CD19-positive B cells are detectable at Screening.
  • Use of any concomitant prohibited medications as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • University of California San Diego (UCSD)
    La JollaCalifornia92037United States
  • Medical University of South Carolina, University Hospital
    CharlestonSouth Carolina92037United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT03285711
Phase
Phase 2
Study Type
Interventional
Last Updated