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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
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