Safety and Efficacy of Filgotinib and GS-9876 in Adults With Lupus Membranous Nephropathy (LMN)



Status:Active, not recruiting
Conditions:Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Nephrology / Urology
Healthy:No
Age Range:18 - 75
Updated:2/10/2019
Start Date:October 6, 2017
End Date:April 2021

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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)

The primary objective of this study is to evaluate the efficacy of filgotinib and GS-9876 in
adults with Lupus Membranous Nephropathy (LMN).


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.
We found this trial at
14
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1801 N Broad St
Philadelphia, Pennsylvania 19122
(215) 204-7000
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1648 Pierce Dr NE
Atlanta, Georgia 30322
(404) 727-5640
Emory University School of Medicine Emory University School of Medicine has 2,359 full- and part-time...
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Gainesville, Florida 32610
(352) 392-3261
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Seattle, Washington 98104
(206) 543-2100
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
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Birmingham, Alabama 35294
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Dallas, Texas 75231
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Jacksonville, Florida 32209
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La Jolla, California 92093
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Lawrenceville, Georgia 30046
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Palo Alto, California 94304
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Wilmington, North Carolina 28401
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