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

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ClinicalTrials.gov Identifier: NCT03285711
Recruitment Status : Recruiting
First Posted : September 18, 2017
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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

Condition or disease Intervention/treatment Phase
Lupus Membranous Nephropathy Drug: Filgotinib Drug: GS-9876 Drug: Filgotinib placebo Drug: GS-9876 placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Filgotinib
Filgotinib + GS-9876 placebo
Drug: Filgotinib
200 mg tablet administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: GS-9876 placebo
Tablet administered orally once daily

Experimental: GS-9876
GS-9876 + filgotinib placebo
Drug: GS-9876
30 mg tablet administered orally once daily

Drug: Filgotinib placebo
Tablet administered orally once daily

Experimental: Extended Blinded Treatment Phase
Based on reduction in urinary protein excretion, participants will continue to receive their assigned blinded study treatment for an additional 20 weeks or continue to either study treatment per the Investigator's discretion.
Drug: Filgotinib
200 mg tablet administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: GS-9876
30 mg tablet administered orally once daily

Drug: Filgotinib placebo
Tablet administered orally once daily

Drug: GS-9876 placebo
Tablet administered orally once daily




Primary Outcome Measures :
  1. Percent Change in Urine Protein From Baseline (Day 1) to Week 16 [ Time Frame: Baseline to Week 16 ]
    Urine protein will be assessed by urinary protein excretion during a 24-hour urine collection.


Secondary Outcome Measures :
  1. Change From Baseline (Day 1) in Urine Protein at Week 16 [ Time Frame: Baseline to Week 16 ]
    Urine protein will be assessed by urinary protein excretion during a 24-hour urine collection.

  2. Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16 [ Time Frame: Baseline to Week 16 ]
  3. Change from Baseline (Day 1) in urine protein creatinine ratio (UPCR) at Week 16 [ Time Frame: Baseline to Week 16 ]
    UPCR will be assessed by urine protein excretion during a 24-hour urine collection.

  4. Proportion of Participants With Partial Remission at Week 16 [ Time Frame: Week 16 ]
    Partial Remission is defined as urine protein excretion below < 3 g/d and urine protein excretion decrease by ≥ 50% among participants with Baseline (Day 1) nephrotic range proteinuria [urine protein excretion ≥ 3 g/d]; or urine protein excretion decrease by ≥ 50% among participants with subnephrotic range proteinuria [urine protein excretion < 3 g/d])

  5. Proportion of Participants with Complete Remission [ Time Frame: Week 16 ]
    Complete Remission is defined as urine protein excretion below 0.5 g/day, with no hematuria.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03285711


Contacts
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
United States, Alabama
University of Alabama at Birmingham (UAB) Recruiting
Birmingham, Alabama, United States, 35294
United States, California
University of California San Diego (UCSD) Recruiting
La Jolla, California, United States, 92037
Stanford University Recruiting
Palo Alto, California, United States, 94304
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
University Of Florida, Jacksonville Recruiting
Jacksonville, Florida, United States, 32207
United States, Georgia
Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30303
Georgia Nephrology Research Institute Recruiting
Lawrenceville, Georgia, United States, 30046
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
University of North Carolina at Chapel Hill / UNC School of Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599-7155
PMG Research Inc. Recruiting
Wilmington, North Carolina, United States, 28401
United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Medical University of South Carolina, University Hospital Recruiting
Charleston, South Carolina, United States, 92037
United States, Texas
Metroplex Clinical Research Recruiting
Dallas, Texas, United States, 75231
Arthritis & Osteoporosis Center of South Texas Withdrawn
San Antonio, Texas, United States, 78332
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Gilead Study Monitor Gilead Sciences

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03285711     History of Changes
Other Study ID Numbers: GS-US-437-4093
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases