Trial Search Results
Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)
The primary objective of this study is to evaluate the efficacy of filgotinib and lanreplenib (previously GS-9876) in adults with Lupus Membranous Nephropathy (LMN).
Stanford is currently accepting patients for this trial.
- Drug: Filgotinib
- Drug: Lanraplenib
- Drug: Filgotinib placebo
- Drug: Lanreplenib placebo
Key Inclusion Criteria:
- Male or female between 18 and 75 years of age, inclusive, at the time of initial
- 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/1.73m^2 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
- Use of any concomitant prohibited medications as described in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study