Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)
Trial ID or NCT#
NCT03285711
Status
NOT RECRUITING
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)
Eligibility Criteria
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Investigator(s)
Matthew C. Baker, MD MS
Immunologist,
Rheumatologist
Assistant Professor of Medicine (Immunology and Rheumatology)
Contact us to find out if this trial is right for you.
Contact
Matthew Baker
650-498-5630
View on ClinicalTrials.gov
