Clinical trial NCT03285711: Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lupus Membranous Nephropathy
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2017-09-18
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Urine Protein From Baseline (Day 1) to Week 16
timeFrame: Baseline; Week 16
Secondary outcomes:
measure: Change From Baseline (Day 1) in Urine Protein at Week 16
timeFrame: Baseline; Week 16
measure: Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16
timeFrame: Baseline; Week 16
measure: Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16
timeFrame: Baseline; Week 16
measure: Percentage of Participants With Partial Remission at Week 16
timeFrame: Week 16
measure: Percentage of Participants With Complete Remission at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB)
state: Alabama
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Lawrenceville
country: United States
facility: Georgia Nephrology Research Institute
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill / UNC School of Medicine
state: North Carolina
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Monitor
role: STUDY_DIRECTOR
References:
citation: Baker M, Chaichian Y, Genovese M, Derebail V, Rao P, Chatham W, Bubb M, Lim S, Hajian H, Gurtovaya O, Patel U, Tumlin J. Phase II, randomised, double-blind, multicentre study evaluating the safety and efficacy of filgotinib and lanraplenib in patients with lupus membranous nephropathy. RMD Open. 2020 Dec;6(3):e001490. doi: 10.1136/rmdopen-2020-001490.