Trial Search Results
Study to Evaluate the 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 lanraplenib (previously GS-9876) in adults with lupus membranous nephropathy (LMN).
Stanford is currently not accepting patients for this trial.
- Drug: Filgotinib
- Drug: Lanraplenib
- Drug: Filgotinib placebo
- Drug: Lanraplenib placebo
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.
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study