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.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: Filgotinib
  • Drug: Lanraplenib
  • Drug: Filgotinib placebo
  • Drug: Lanreplenib placebo

Phase:

Phase 2

Eligibility


Key Inclusion Criteria:

   - Male or female between 18 and 75 years of age, inclusive, at the time of initial
   informed consent

   - 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
      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

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting