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

Not Recruiting

Trial ID: NCT03285711

Purpose

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)

Eligibility


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
      Screening.

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

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

Intervention(s):

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
650-498-5630