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Trial record 2 of 2 for:    Filgotinib | lupus

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

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).

Condition or disease Intervention/treatment Phase
Lupus Membranous Nephropathy Drug: Filgotinib Drug: Lanraplenib Drug: Filgotinib placebo Drug: Lanraplenib placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 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
Actual Primary Completion Date : May 3, 2019
Actual Study Completion Date : February 3, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
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.

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

Drug: Filgotinib placebo
Tablet administered orally once daily

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.

Drug: Filgotinib
200 mg tablet administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Lanraplenib placebo
Tablet administered orally once daily

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.

Drug: Filgotinib
200 mg tablet administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Lanraplenib placebo
Tablet administered orally once daily

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.

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

Drug: Filgotinib 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; Week 16 ]
    Urine protein was 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; Week 16 ]
    Urine protein was 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; Week 16 ]
  3. 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.

  4. 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]).

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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.


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


Locations
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United States, Alabama
University of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States, 35294
United States, California
Stanford University
Palo Alto, California, United States, 94304
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610-0272
United States, Georgia
Emory University School of Medicine
Atlanta, Georgia, United States, 30303
Georgia Nephrology Research Institute
Lawrenceville, Georgia, United States, 30046
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, North Carolina
University of North Carolina at Chapel Hill / UNC School of Medicine
Chapel Hill, North Carolina, United States, 27599-7155
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Monitor Gilead Sciences
  Study Documents (Full-Text)

Documents provided by Gilead Sciences:
Study Protocol  [PDF] March 21, 2018
Statistical Analysis Plan  [PDF] January 28, 2020


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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03285711    
Other Study ID Numbers: GS-US-437-4093
First Posted: September 18, 2017    Key Record Dates
Results First Posted: May 18, 2020
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, Membranous
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases