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 Nephropathy Kidney Diseases Glomerulonephritis, Membranous Filgotinib GS-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) accepting new patients
    La Jolla California 92037 United States
  • Medical University of South Carolina, University Hospital accepting new patients
    Charleston South Carolina 92037 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT03285711
Phase
Phase 2
Study Type
Interventional
Last Updated
July 11, 2018