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Status:

COMPLETED

Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)

Lead Sponsor:

Gilead Sciences

Conditions:

Lupus Membranous Nephropathy

Eligibility:

All Genders

18-75 years

Phase:

PHASE2

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

Inclusion

  • Key
  • 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

  • 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.

Key Trial Info

Start Date :

October 6 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 3 2020

Estimated Enrollment :

9 Patients enrolled

Trial Details

Trial ID

NCT03285711

Start Date

October 6 2017

End Date

February 3 2020

Last Update

May 18 2020

Active Locations (7)

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Page 1 of 2 (7 locations)

1

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States, 35294

2

Stanford University

Palo Alto, California, United States, 94304

3

University of Florida

Gainesville, Florida, United States, 32610-0272

4

Emory University School of Medicine

Atlanta, Georgia, United States, 30303