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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lupus Membranous Nephropathy
Interventions Drug: Filgotinib
Drug: Lanraplenib
Drug: Filgotinib placebo
Drug: Lanraplenib placebo
Enrollment 9
Recruitment Details Participants were enrolled at study sites in United States. The first participant was screened on 06 October 2017. The last study visit occurred on 03 February 2020.
Pre-assignment Details 22 participants were screened.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg Lanraplenib 30 mg to Filgotinib 200 mg Filgotinib 200 mg to Lanraplenib 30 mg
Hide Arm/Group Description

Participants received lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment for additional 16 weeks.

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

Participants received filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment for additional 16 weeks.

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

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

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

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

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

Period Title: Blinded Phase (Up to Week 16)
Started 4 5 0 0
Completed 1 4 0 0
Not Completed 3 1 0 0
Reason Not Completed
Adverse Event             2             1             0             0
Protocol Violation             1             0             0             0
Period Title: Blinded Phase (Week 16 to 32)
Started 0 [1] 3 [2] 1 [3] 1 [4]
Completed 0 3 0 1
Not Completed 0 0 1 0
Reason Not Completed
Lack of Efficacy             0             0             1             0
[1]
1 participant switched treatment to filgotinib.
[2]
1 participant switched treatment to lanraplenib.
[3]
1 participant switched treatment from lanraplenib.
[4]
1 participant switched treatment from filgotinib.
Period Title: Extended Blinded Phase (Week 32 to 52)
Started 0 3 0 1
Completed 0 2 0 1
Not Completed 0 1 0 0
Reason Not Completed
Lack of Efficacy             0             1             0             0
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg Total
Hide Arm/Group Description Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 9 participants
36  (15.8) 35  (16.9) 35  (15.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female 3 4 7
Male 1 1 2
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Hispanic or Latino 0 0 0
Not Hispanic or Latino 4 5 9
Unknown or Not Reported 0 0 0
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
American Indian or Alaska Native 0 0 0
Asian 0 1 1
Native Hawaiian or Other Pacific Islander 0 0 0
Black or African American 4 3 7
White 0 1 1
More than one race 0 0 0
Unknown or Not Reported 0 0 0
24-Hour Urine Protein  
Mean (Standard Deviation)
Unit of measure:  G/day
Number Analyzed 4 participants 5 participants 9 participants
6.0  (4.65) 3.3  (2.47) 4.5  (3.62)
Estimated Glomerular Filtration Rate (eGFR)  
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73m^2
Number Analyzed 4 participants 5 participants 9 participants
116.1  (55.41) 102.6  (30.61) 108.6  (40.87)
Urine Protein Creatinine Ratio (UPCR)  
Mean (Standard Deviation)
Unit of measure:  Mg/mg
Number Analyzed 4 participants 5 participants 9 participants
5.1  (4.38) 1.9  (1.04) 3.3  (3.23)
1.Primary Outcome
Title Percent Change in Urine Protein From Baseline (Day 1) to Week 16
Hide Description Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
Time Frame Baseline; Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set (included all randomized participants who took at least 1 dose of study drug) with available data were analyzed.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg
Hide Arm/Group Description:
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
Overall Number of Participants Analyzed 1 4
Mean (Standard Deviation)
Unit of Measure: percent change
-2.8 -51.2  (25.67)
2.Secondary Outcome
Title Change From Baseline (Day 1) in Urine Protein at Week 16
Hide Description Urine protein was assessed by urinary protein excretion during a 24-hour urine collection.
Time Frame Baseline; Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg
Hide Arm/Group Description:
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
Overall Number of Participants Analyzed 1 4
Mean (Standard Deviation)
Unit of Measure: g/day
-0.177 -2.151  (2.2591)
3.Secondary Outcome
Title Change From Baseline (Day 1) in Estimated Glomerular Filtration Rate (eGFR) at Week 16
Hide Description [Not Specified]
Time Frame Baseline; Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg
Hide Arm/Group Description:
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
Overall Number of Participants Analyzed 1 4
Mean (Standard Deviation)
Unit of Measure: mL/min/1.73 m^2
-59.4 -2.0  (11.35)
4.Secondary Outcome
Title Change From Baseline (Day 1) in Urine Protein Creatinine Ratio (UPCR) at Week 16
Hide Description UPCR was assessed by urine protein excretion during a 24-hour urine collection.
Time Frame Baseline; Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg
Hide Arm/Group Description:
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
Overall Number of Participants Analyzed 1 4
Mean (Standard Deviation)
Unit of Measure: mg/mg
-4.407 -0.808  (0.7539)
5.Secondary Outcome
Title Percentage of Participants With Partial Remission at Week 16
Hide Description 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]).
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg
Hide Arm/Group Description:
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
Overall Number of Participants Analyzed 1 4
Measure Type: Number
Unit of Measure: percentage of participants
0 50
6.Secondary Outcome
Title Percentage of Participants With Complete Remission at Week 16
Hide Description Complete Remission was defined as urine protein excretion below 0.5 g/day, with no hematuria.
Time Frame Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Lanraplenib 30 mg Filgotinib 200 mg
Hide Arm/Group Description:
Participants were randomized to receive lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
Participants were randomized to receive filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.
Overall Number of Participants Analyzed 1 4
Measure Type: Number
Unit of Measure: percentage of participants
0 0
Time Frame First dose date up to the last dose date plus 30 days (maximum: 56 weeks)
Adverse Event Reporting Description The Safety Analysis Set included all participants who took at least 1 dose of study drug.
 
Arm/Group Title Up to Week 16: Lanraplenib 30 mg Up to Week 16: Filgotinib 200 mg After Week 16: Lanraplenib 30 mg After Week 16: Filgotinib 200 mg After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg
Hide Arm/Group Description Participants received lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase. Participants received filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily for 16 weeks in Blinded Treatment Phase.

At Week 16, participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment (lanraplenib 30 mg tablet + filgotinib placebo tablet orally once daily) for additional 16 weeks.

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

At Week 16, participants who achieved ≥ 35% reduction in urinary protein excretion from baseline continued to receive same blinded study treatment (filgotinib 200 mg tablet + lanraplenib placebo tablet orally once daily) for additional 16 weeks.

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

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

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

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

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

All-Cause Mortality
Up to Week 16: Lanraplenib 30 mg Up to Week 16: Filgotinib 200 mg After Week 16: Lanraplenib 30 mg After Week 16: Filgotinib 200 mg After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/5 (0.00%)   0/0   0/3 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
Up to Week 16: Lanraplenib 30 mg Up to Week 16: Filgotinib 200 mg After Week 16: Lanraplenib 30 mg After Week 16: Filgotinib 200 mg After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)   0/5 (0.00%)   0/0   0/3 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Musculoskeletal and connective tissue disorders             
Systemic lupus erythematosus  1  1/4 (25.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders             
Acute kidney injury  1  1/4 (25.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Up to Week 16: Lanraplenib 30 mg Up to Week 16: Filgotinib 200 mg After Week 16: Lanraplenib 30 mg After Week 16: Filgotinib 200 mg After Week 16: Lanraplenib 30 mg to Filgotinib 200 mg After Week 16: Filgotinib 200 mg to Lanraplenib 30 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   3/5 (60.00%)   0/0   1/3 (33.33%)   1/1 (100.00%)   1/1 (100.00%) 
Blood and lymphatic system disorders             
Anaemia  1  0/4 (0.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  1/1 (100.00%) 
Leukopenia  1  0/4 (0.00%)  1/5 (20.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Neutropenia  1  0/4 (0.00%)  2/5 (40.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  1/1 (100.00%) 
Eye disorders             
Amaurosis fugax  1  1/4 (25.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Vitreous floaters  1  1/4 (25.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders             
Dyspepsia  1  0/4 (0.00%)  1/5 (20.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Food poisoning  1  0/4 (0.00%)  0/5 (0.00%)  0/0  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%) 
Nausea  1  0/4 (0.00%)  1/5 (20.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
General disorders             
Fatigue  1  0/4 (0.00%)  1/5 (20.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Oedema peripheral  1  1/4 (25.00%)  0/5 (0.00%)  0/0  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%) 
Pain  1  0/4 (0.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  1/1 (100.00%) 
Infections and infestations             
Bronchitis  1  2/4 (50.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Furuncle  1  0/4 (0.00%)  1/5 (20.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  1/1 (100.00%) 
Nasopharyngitis  1  0/4 (0.00%)  0/5 (0.00%)  0/0  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%) 
Sinusitis  1  1/4 (25.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Upper respiratory tract infection  1  1/4 (25.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Injury, poisoning and procedural complications             
Contusion  1  0/4 (0.00%)  0/5 (0.00%)  0/0  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%) 
Fall  1  0/4 (0.00%)  0/5 (0.00%)  0/0  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%) 
Investigations             
Lymphocyte count decreased  1  1/4 (25.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders             
Hypercholesterolaemia  1  0/4 (0.00%)  1/5 (20.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Hypoalbuminaemia  1  1/4 (25.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia  1  0/4 (0.00%)  0/5 (0.00%)  0/0  1/3 (33.33%)  0/1 (0.00%)  1/1 (100.00%) 
Muscle spasms  1  0/4 (0.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  1/1 (100.00%)  0/1 (0.00%) 
Musculoskeletal pain  1  0/4 (0.00%)  0/5 (0.00%)  0/0  1/3 (33.33%)  0/1 (0.00%)  0/1 (0.00%) 
Systemic lupus erythematosus  1  1/4 (25.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Nervous system disorders             
Headache  1  0/4 (0.00%)  1/5 (20.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Psychiatric disorders             
Anxiety  1  1/4 (25.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders             
Pollakiuria  1  0/4 (0.00%)  1/5 (20.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders             
Rash  1  0/4 (0.00%)  0/5 (0.00%)  0/0  0/3 (0.00%)  0/1 (0.00%)  1/1 (100.00%) 
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Gilead made a decision to discontinue enrollment after very low enrollment over 16 months. This decision was not due to any safety concerns. Only 9 participants were enrolled and 3 participants completed study, no inferential analyses were performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT03285711    
Other Study ID Numbers: GS-US-437-4093
First Submitted: September 14, 2017
First Posted: September 18, 2017
Results First Submitted: May 1, 2020
Results First Posted: May 18, 2020
Last Update Posted: May 18, 2020