Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)

Not Recruiting

Trial ID: NCT03285711


The primary objective of this study is to evaluate the efficacy of filgotinib and lanraplenib (previously 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)

Stanford Investigator(s)

Matthew C. Baker, MD MS
Matthew C. Baker, MD MS

Assistant Professor of Medicine (Immunology and Rheumatology)


Key Inclusion Criteria:

   - 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 (eGFR) ≥ 40 mg/min/1.73m^2 based on the
   modification of diet in renal disease (MDRD) formulation at screening

   - No evidence of active or latent tuberculosis (TB) as assessed during screening

Key Exclusion Criteria:

   - Prior treatments as follows:

      - Previous treatment with a janus kinase (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

   - Use of any concomitant prohibited medications as described in the protocol

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


drug: Filgotinib

drug: Filgotinib placebo

drug: Lanraplenib

drug: Lanraplenib placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Matthew Baker