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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03285711
Recruitment Status : Completed
First Posted : September 18, 2017
Results First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE September 14, 2017
First Posted Date  ICMJE September 18, 2017
Results First Submitted Date  ICMJE May 1, 2020
Results First Posted Date  ICMJE May 18, 2020
Last Update Posted Date May 18, 2020
Actual Study Start Date  ICMJE October 6, 2017
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2020)
Percent Change in Urine Protein From Baseline (Day 1) to Week 16 [ Time Frame: Baseline; Week 16 ]
Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2020)
  • Change From Baseline (Day 1) in Urine Protein at Week 16 [ Time Frame: Baseline; Week 16 ]
    Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
  • Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16 [ Time Frame: Baseline; Week 16 ]
  • Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16 [ Time Frame: Baseline; Week 16 ]
    UPCR was assessed by urine protein excretion during a 24-hour urine collection.
  • Percentage of Participants With Partial Remission at Week 16 [ Time Frame: Week 16 ]
    Partial Remission was defined as urine protein excretion below < 3 g/day and urine protein excretion decrease by ≥ 50% among participants with baseline (Day 1) nephrotic range proteinuria [urine protein excretion ≥ 3 g/day]; or urine protein excretion decrease by ≥ 50% among participants with subnephrotic range proteinuria [urine protein excretion < 3 g/day]).
  • Percentage of Participants With Complete Remission at Week 16 [ Time Frame: Week 16 ]
    Complete Remission was defined as urine protein excretion below 0.5 g/day, with no hematuria.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • 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.
  • Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16 [ Time Frame: Baseline to Week 16 ]
  • 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.
  • 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])
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety and Efficacy of Filgotinib and Lanraplenib in Adults With Lupus Membranous Nephropathy (LMN)
Official Title  ICMJE 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)
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lupus Membranous Nephropathy
Intervention  ICMJE
  • Drug: Filgotinib
    200 mg tablet administered orally once daily
    Other Names:
    • GS-6034
    • GLPG0634
  • Drug: Lanraplenib
    30 mg tablet administered orally once daily
    Other Name: GS-9876
  • Drug: Filgotinib placebo
    Tablet administered orally once daily
  • Drug: Lanraplenib placebo
    Tablet administered orally once daily
Study Arms  ICMJE
  • Experimental: Lanraplenib 30 mg

    Participants receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieve ≥ 35% reduction in urinary protein excretion from baseline continue to receive same blinded study treatment for additional 16 weeks. Participants who did not achieve a ≥ 35% reduction in urinary protein excretion will switch treatment.

    After 32 weeks of blinded treatment, participants who have ≥ 35% reduction in urinary protein excretion from baseline continue their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.

    Interventions:
    • Drug: Lanraplenib
    • Drug: Filgotinib placebo
  • Experimental: Filgotinib 200 mg

    Participants receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieve ≥ 35% reduction in urinary protein excretion from baseline continue to receive same blinded study treatment for additional 16 weeks. Participants who did not achieve a ≥ 35% reduction in urinary protein excretion will switch treatment.

    After 32 weeks of blinded treatment, participants who have ≥ 35% reduction in urinary protein excretion from baseline continue their assigned blinded treatment for additional 20 weeks in Extended Blinded Treatment Phase.

    Interventions:
    • Drug: Filgotinib
    • Drug: Lanraplenib placebo
  • Experimental: Lanraplenib 30 mg to Filgotinib 200 mg

    At Week 16, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switch treatment and receive filgotinib 200 mg + lanraplenib placebo for additional 16 weeks.

    At Week 32, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 can continue whichever treatment that lead to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.

    Interventions:
    • Drug: Filgotinib
    • Drug: Lanraplenib placebo
  • Experimental: Filgotinib 200 mg to Lanraplenib 30 mg

    At Week 16, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from baseline to Week 16 switch treatment and receive lanraplenib 30 mg + filgotinib placebo for additional 16 weeks.

    At Week 32, participants who do not achieve a ≥ 35% reduction in urinary protein excretion from Week 16 to Week 32 can continue whichever treatment that lead to the greatest reduction in urinary protein excretion, or either treatment per investigator's discretion for additional 20 weeks in Extended Blinded Treatment Phase.

    Interventions:
    • Drug: Lanraplenib
    • Drug: Filgotinib placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 6, 2019)
9
Original Estimated Enrollment  ICMJE
 (submitted: September 14, 2017)
32
Actual Study Completion Date  ICMJE February 3, 2020
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03285711
Other Study ID Numbers  ICMJE GS-US-437-4093
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Monitor Gilead Sciences
PRS Account Gilead Sciences
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP