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.

Stanford Investigator(s):

Intervention(s):

  • drug: Filgotinib
  • drug: Filgotinib placebo
  • drug: Lanraplenib
  • drug: Lanraplenib placebo

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.

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Matthew Baker
650-498-5630
Not Recruiting

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.